|
Found 206 result(s) FROM 1963 pages containing the term 'Food and Drug Administration'.
Thursday Dec 03, 2009
In the News This Week
Read what MSKreport has been tweeting about this week...
Thursday Nov 19, 2009
French Government Buys Into Naproxinod
NicOx has submitted an NDA for naproxinod for osteoarthritis, and is raising $149 million for the launch...
Tuesday Nov 03, 2009
Naproxen/Nexium Combo Prevents Ulcers in OA Patients
Combining naproxen esomeprazole magnesium relieves OA pain while protecting the stomach...
Wednesday Oct 28, 2009
Third RA Patient Has PML After Rituximab
The FDA's MedWatch warning system reports that a third rheumatoid arthritis (RA) patient treated with Genentech's Rituxan (rituximab) has developed PML, this time without prior anti-TNF exposure...
Wednesday Sep 30, 2009
FDA Finally OKs Stelara for Psoriasis
The FDA has approved Centocor's Stelara (ustekinumab) for moderate to severe psoriasis...
Wednesday Aug 05, 2009
Black Box Added to TNF Inhibitors for Kids, Teens
The FDA has expanded TNF blocker “black box” warnings to include lymphoma and other cancers in children and teens, leukemia in all patients, and new-onset psoriasis...
Tuesday Aug 04, 2009
FDA Spikes Pegloticase Gout OK
Savient Pharmaceuticals' shares tanked on the FDA's refusal to approve Krystexxa™ for gout...
Friday Jun 05, 2009
FDA OKs 2-Year Reclast for Osteoporosis
Reclast (zoledronic acid) injection has been approved as the first therapy to prevent osteoporosis for 2 years with a single dose...
Friday May 15, 2009
FDA Going Back for Second Look At Menaflex
The US FDA, responding to criticism about the Menaflex approval process, is planning to take another look...
Thursday May 14, 2009
FDA OKs UCB's Cimzia for Moderate to Severe RA
Cimzia® (certolizumab pegol), the only pegylated anti-TNF, has been approved for use in the US...
Wednesday Apr 29, 2009
Simponi Approved in US for RA, PsA, AS
The US Food and Drug Administration this week joined Canada's drugs agency in approving Simponi (golimumab) for moderate to severe RA, active PsA, and active ankylosing spondylitis...
Thursday Apr 09, 2009
Genentech Pulls Psoriasis Drug Raptiva Due to PML
Roche's Genentech unit will pull the psoriasis drug Raptiva® (efalizumab) due to PML risk...
Wednesday Apr 08, 2009
FDA Warns Pharma on "Sponsored Links"
FDA has warned 14 pharmaceutical companies about the brief ads that accompany internet search results...
Wednesday Mar 25, 2009
Licorice Reduces Cyclosporine, Raises Methotrexate Levels
Licorice, often used in candies and food flavorings, significantly reduces absorption of cyclosporine, leading to lower than expected blood levels, but prolongs methotrexate clearance...
Thursday Feb 19, 2009
Raptiva® Pulled in EU After 3rd PML Case; FDA Warns US Docs
European regulators suspended sales of the psoriasis drug Raptiva® after a 3rd PML death, and the FDA warned US doctors of a 4th suspected case...
Monday Feb 16, 2009
FDA Gives Nod to Uloric® (febuxostat), First New Gout Treatment in 40 Years
The US FDA approved 40 mg and 80 mg doses of Takeda Pharmaceutical's febuxostat (Uloric) for the chronic management of hyperuricemia in patients with gout...
Friday Feb 13, 2009
La Jolla and Biomarin Dump Riquent, Cite “Futile” Phase 3 Lupus Data
La Jolla Pharmaceutical has ended work on Riquent® (abetimus sodium)after the first interim efficacy analysis for the ASPEN Phase 3 lupus nephritis trial...
Wednesday Jan 21, 2009
FDA Grounds Pfizer's Fablyn Osteoporosis Drug
Pfizer's Fablyn (lasofoxifene) is still on hold as FDA seeks more safety data...
Thursday Jan 08, 2009
BioMarin Bets $289 Million That Riquent Works in Lupus Nephritis
BioMarin has bet $289 million that the third time is the charm for La Jolla Pharmaceutical's experimental lupus drug Riquent® (abetimus sodium), which failed to reach primary endpoints in 2 previous clinical trials...
Thursday Dec 04, 2008
FDA Panel Okays Febuxostat for Gout
A US FDA panel voted 12-0 this week to recommend approval of Takeda Pharmaceutical's febuxostat (Uloric®), the first new gout drug in 40 years...
Thursday Nov 20, 2008
BioLineRx, Yissum Sign a Licensing Agreement for the Development of an Anti-Leptin Compound for the Treatment of IBD
BioLineRx signed an exclusive license agreement with Yissum Ltd to develop and commercialize BL-5040, an antagonist of leptin with anti-inflammatory properties for the treatment of inflammatory bowel disease (IBD)...
Thursday Nov 20, 2008
FDA Says Bisphosphonates Do Not Cause Atrial Fibrillation
The FDA has concluded that there is no causal link between the use of bisphosphonates and atrial fibrillation...
Tuesday Nov 18, 2008
Centocor's Golimumab Gives Durable Skin, Joint Relief in Psoriatic Arthritis, ACR Studies Say
More than half of active psoriatic arthritis patients receiving subcutaneous injections of 50 mg or 100 mg of golimumab (CNTO 148) every 4 weeks showed improvements that lasted through 1 year in the joint and skin symptoms...
Friday Sep 12, 2008
Breaking News: FDA Warns About Fatal PML in RA Patient Taking Rituxan®
FDA issued a MedWatch warning reporting the first fatal PML case in a patient taking Rituxan for RA...
Thursday Sep 11, 2008
Total Ankle Replacements are Coming Into their Own—Finally
Total ankle replacements are expected to soon rival hip and knee replacements in design, function, and durability. Airbags and seatbelts contribute to growing demand…
Monday Sep 08, 2008
FDA Warns of Histoplasmosis, Invasive Fungal Infections in Patients Taking TNF Inhibitors
The US Food and Drug Administration has issued a “MedWatch” warning about the risk of histoplasmosis and other invasive fungal infections in patients taking TNF blockers...
Thursday Sep 04, 2008
“Good Bugs” Offer New Way to Turn Down Inflammatory Response
“Probiotic” helpful bacteria might be able to turn down the body's inflammatory response...
Wednesday Jul 02, 2008
Bush Administration Freezes Medicare Fee Cuts
DHHS has temporarily frozen the 10.6% Medicare fee cut that had been set to take effect after July 1...
Monday Jun 30, 2008
Ghrelin, Leptin Changes Link Menstrual Dysfunction, Bone Health in Teen Athletes
Changes in two hormones that affect both appetite and estrogen secretion appear to be the link between athletic activity, loss of menstrual function, and bone health in some adolescent female athletes...
Wednesday Jun 11, 2008
Merck Announces Initiation of Second Phase II/III Pivotal Clinical Study of Atacicept in SLE
Merck and development partner ZymoGenetics have initiated a phase II/III trial of atacicept (formerly TACI-Ig) in patients with systemic lupus erythematosus (SLE). Atacicept inhibits the two growth factors BLyS and APRIL that are known to impact disease progression...
Monday Jun 09, 2008
FDA Launches Major Investigation of Cancer Risk in Children Taking TNF Blockers
The FDA is investigating a possible link between TNF blockers and cancer in children and young adults...
Monday Jun 09, 2008
Genta Announces Phase I Clinical Trial Results for G4544, an Oral Formulation of Gallium Nitrate, a Novel Potent Drug for Bone Disease
Results from the phase I clinical trial of G4544 showed that the drug was well-tolerated and that blood levels were achieved in a range known to be clinically bioactive...
Friday May 30, 2008
Texas, New Jersey Appeals Overturn Nearly $40 Million in Vioxx Awards
Merck won two major appeals court cases involving older Vioxx cases this week...
Monday May 19, 2008
AACE Experts Warn of Vitamin D Problems in Vegans, Urge Routine Monitoring in Osteoporosis Patients
Vitamin D deficiency research reported at the 2008 American Association for Clinical Endocrinology meetings included a warning about vegan diets, evidence that osteoporosis patients in treatment are still not getting enough vitamin D, and evidence that even a hip fracture does not lead to adequate vitamin D therapy...
Thursday May 08, 2008
Trubion Initiates Phase IIb Study of TRU-015, a CD20-directed Drug Candidate, Plus MTX for the Treatment of RA
Trubion's partner Wyeth Pharmaceuticals has commenced patient dosing in a multicenter, phase IIb clinical trial of TRU-015; previously reported data demonstrated TRU-015's ability to significantly improve RA signs and symptoms...
Tuesday May 06, 2008
Lexicon's RA Drug Candidate LX2931, Targeting S1P Lyase, Shows Positive Results in Phase 1a Clinical Trial; Dose-Dependent, Rapid-Onset Decrease in Circulating Lymphocytes Observed
Positive results were obtained from Lexicon's phase 1a clinical trial of LX2931, an orally-delivered, small molecule targeting sphingosine-1-phosphate (S1P) lyase for the treatment of RA and other autoimmune conditions...
Tuesday May 06, 2008
FDA Adds “Black Box” Warning About Infections to Enbrel Label
FDA has heightened warnings on the prescribing information for etanercept with regard to serious infections and has warned clinicians to screen patients for latent TB before beginning treatment...
Tuesday Apr 29, 2008
Alendronate Linked to Atrial Fibrillation
A case-control study reports that women who have used alendronate are nearly twice as likely to develop atrial fibrillation as those who have never used bisphosphonates...
Monday Apr 14, 2008
Orencia Gets FDA Okay for JIA
Pediatric rheumatologists gained a new tool for use in treating juvenile idiopathic arthritis (JIA) with the US Food and Drug Administration’s approval of Orencia® (abatacept)...
Friday Apr 11, 2008
FDA Warns of Progressive Multifocal Leukoencephalopathy With CellCept
FDA informed healthcare professionals that it is investigating a potential association between the use of mycophenolate mofetil and development of PML...
Thursday Feb 28, 2008
Adult Stem Cells Nearing Clinical Use for RA, SLE, Other Autoimmune Diseases
Adult stem cells offer a safer, less controversial approach than embryonic stem cells to treat various rheumatoid and autoimmune diseases, and are now entering randomized clinical trials...
Wednesday Feb 20, 2008
Studies of OA, Back Pain Drugs Reported at AAPM Meeting
Extended-release analgesics get top billing at AAPM meeting...
Monday Jan 14, 2008
Drug Approved. Is Disease Real?
As Pfizer markets Lyrica® (pregabalin), the first approved medicine to treat fibromyalgia, doctors debate the legitimacy of the pain syndrome...
Tuesday Jan 08, 2008
FDA Warns of Severe Bone, Joint, Muscle Pain Linked to Bisphosphonates
FDA warning highlights "severe and sometimes incapacitating" musculoskeletal pain in patients taking bisphosphonates...
Wednesday Dec 05, 2007
Drug Update: Infliximab
Researchers offer advice on reducing infliximab infusion times in RA, predicting who will respond, and what to expect in patients with ankylosing spondylitis...
Wednesday Oct 31, 2007
BREAKING NEWS: FDA Heightens Warning About Miscarriage, Birth Defects With Drug Used Off-Label for Lupus Nephritis
FDA has raised the warning level for mycophenolate mofetil (MMF) from Category C to Category D (positive evidence of fetal risk)...
Tuesday Oct 23, 2007
Experts Fret About How to Regulate "Generic" Biologics
Biopharmaceuticals are beginning to come off patent, promising cost savings for patients and headaches for regulators...
Thursday Aug 30, 2007
Vitamin K2 Supplements Protect Bone Architecture
Three years of dietary supplementation with vitamin K2 maintained bone strength and architecture despite having little effect on BMD...
Tuesday Aug 14, 2007
Novartis Withdraws Lumiracoxib (Prexige®) in Australia in Response to Decision From Therapeutic Goods Administration to Cancel Registration
Novartis Pharmaceuticals Australia Pty Ltd announced the immediate recall of all doses (100 mg, 200 mg, and 400 mg tablets) of lumiracoxib (Prexige®), a COX-2 inhibitor for the treatment of osteoarthritis (OA) and acute pain...
Thursday Jul 12, 2007
Coffee Consumption Slashes Gout Risk
Coffee may stave off gout before it starts, but patients who do develop gout are likely to receive suboptimal care...
Thursday Jun 07, 2007
High Plasma Homocysteine Predicts Hip Fracture
Elevated plasma total homocysteine (tHcy) may be a modifiable risk factor for osteoporotic hip fracture...
Tuesday May 29, 2007
Biomechanics, Damage Outside Cartilage May Doom Chondroprotection
Chondroprotection seemed like a reasonable approach to OA when the disease was thought to result from wear and tear on cartilage, but it has had little success in clinical trials. Biomechanics and damage outside the cartilage may be the reason...
Monday Apr 23, 2007
Current Viewpoints
CIAOMed Roundtable: Lupus Experts Predict More Use of RA Drugs, Seek Biomarkers to Speed Clinical Trials
Decades have passed since the last FDA approval of a new drug for lupus, but CIAOMed's "Virtual Roundtable" of lupus experts expect major gains from drugs adopted recently from RA treatment and they hope for promising advances from research consortia seeking lupus biomarkers...
Monday Apr 23, 2007
Rigel Provides Clinical Update of R788 Phase II Trials in ITP and RA
Rigel Pharmaceuticals, Inc, a clinical-stage drug development company, provided an update on R788, currently involved in ongoing phase II clinical trials in immune thrombocytopenic purpura (ITP) and rheumatoid arthritis (RA)...
Tuesday Apr 17, 2007
Is the "Golden Moment of Opportunity" to Improve FDA's Drug Safety Work About to Be Wasted?
The FDA's proposals for the reauthorization of the Prescription Drug User Fee Act are weighed and found wanting by experts in three New England Journal of Medicine commentaries...
Friday Apr 13, 2007
FDA Panel Rejects Merck's Arcoxia By 20-to-1 Vote
Citing increased cardiovascular risks, an FDA advisory panel voted 20-to-1 against recommending approval of the COX-2 inhibitor ArcoxiaR (etoricoxib) for the treatment of osteoarthritis...
Thursday Apr 05, 2007
More Evidence Points Toward Safety of Anti-TNF Drugs During Pregnancy
Three recent case reports add to an accumulating body of evidence that the TNF-blockers are safe during pregnancy, but one new report is far from the final word on the issue...
Monday Apr 02, 2007
News Analysis: New FDA Conflict-of-Interest Guidelines May Impact Advisory Committees
FDA is moving to tighten financial conflict-of-interest guidelines for members of FDA advisory committees, despite evidence that excluding participants with such interests would have had no impact on the vote outcomes of prior meetings…
Monday Mar 19, 2007
Medivir Begins Initial Clinical Trial of Osteoporosis Drug Cathepsin K Inhibitor
Medivir AB, a clinical-stage pharmaceutical company, announced the start of its first osteoporosis clinical trial of MIV-701, an orally bioavailable inhibitor of cathepsin K, a thiol (cysteine) protease that is expressed by osteoclasts and degrades key bone and cartilage matrix proteins, including type 1 collagen...
Thursday Mar 01, 2007
Larger Study Fails to Confirm Link Between Red Meat and RA
The largest study to date to examine dietary protein, iron, and meat consumption and risk of rheumatoid arthritis (RA) has not confirmed a link between red meat intake and RA suggested by earlier studies...
Monday Jan 22, 2007
Merrion Reports Positive Clinical Results for Osteoporosis Drug MER 103, An Innovative Dosage Form of Alendronate (Fosamax); Absorbed More Effectively and Improved Dosing Ritual vs Fosamax
Merrion Pharmaceuticals Ltd, a privately-held international specialty pharmaceutical company engaged in the development of improved oral dosage forms of drugs that have poor bioavailability, announced the successful completion of a phase II clinical pharmacology study of MER 103.
Tuesday Jan 16, 2007
FDA Sets New Rule on Calcium/Vitamin D Osteoporosis Claims for Food, Diet Supplement Labeling
The FDA will permit a new "calcium plus vitamin D" claim in food and dietary supplement labeling for reducing the risk of osteoporosis and will shorten the required label in the hope that more dairy, juice, and other products that qualify will put it on their packaging, thus increasing consumer awareness...
Monday Jan 08, 2007
MedImmune In-Licenses from Japan Tobacco anti-ICOS Monoclonal Antibody for Inflammatory Diseases
MedImmune, Inc announced an exclusive license agreement with Japan Tobacco, Inc (JT), for a human monoclonal antibody inhibiting inducible costimulator (ICOS), a protein associated with T-cell activation that plays a key role in controlling adaptive immune responses.
Thursday Dec 21, 2006
Peripheral Sensory Neuropathy in Lupus—Is Vitamin B6 Toxicity to Blame? —Updated
As growing numbers of Americans turn to vitamin and mineral supplements to boost their health, a new case report showing that vitamin B6 toxicity may have caused peripheral sensory neuropathy in a patient with systemic lupus erythematosus (SLE) is cause for concern...
Tuesday Dec 19, 2006
FDA Warns of Fatal PML Risk With Rituximab Treatment
FDA reports deaths of two lupus patients treated with rituximab, warns of PML risk...
Tuesday Dec 19, 2006
FDA Approves Celebrex for JRA
The US Food and Drug Administration has approved celecoxib (Celebrex) for treatment of juvenile rheumatoid arthritis...
Thursday Nov 30, 2006
FDA Panel Gives Nod to Celebrex for JRA
Despite a desire for more long term safety data, an advisory committee of the US Food and Drug Administration voted 15-1 Wednesday to recommend approval of celecoxib (CelebrexR) for the treatment of juvenile rheumatoid arthritis (JRA)...
Monday Nov 20, 2006
Pregabalin Offers Durable Pain Relief in Fibromyalgia
The anticonvulsant pregabalin may offer extended pain relief to fibromyalgia patients... Crofford LJ, et al. Presented at: ACR 2006 Meeting.
Wednesday Nov 15, 2006
FDA's Woodcock Pushes for Biomarkers as Key to New Drug Development and Improving Drug Safety
Janet Woodcock, MD, the FDA's deputy chief for operations, speaking at the American College of Rheumatology meeting, said that the 1990s era of blockbuster drugs is over, and that a fast public/private collaboration to identify biomarkers that permit drug researchers to "move beyond demographics" is needed to get new drug development moving and to improve drug safety... ACR 2006 Meeting.
Tuesday Oct 10, 2006
Novogen's Isoflavonoid Investigational Drug for Inflammatory Bowel Disease Enters Phase Ib Clinical Trial
Novogen Limited announced that its investigational anti-inflammatory compound NV-52, an isoflavonoid-based drug candidate, is entering its second human clinical study following the successful completion of toxicology testing...
Wednesday Sep 27, 2006
UCB, Immunomedic Phase III of Epratuzumab in Patients With Systemic Lupus Erythematosus on Clinical Hold
UCB, SA, licensing partner of Immunomedics, Inc. (Morris Plains, NJ), announced that it has voluntarily, temporarily suspended dosing in the phase III clinical studies of epratuzumab (humanized anti-CD22 antibody) in patients with systemic lupus erythematosus (SLE) because of end-stage manufacturing observations by UCB during a recent routine quality assurance audit of the Immunomedics facilities.
Tuesday Sep 12, 2006
Safety Studies Clear Most Coxibs of Class Effect, Raise Questions About Diclofenac
Two new analyses published early online today by JAMA because of their public health implications show kidney and heart problems associated with rofecoxib (even after brief use) but not with other COX-2 inhibitors, and raise new questions about the safety of diclofenac...
Friday Sep 01, 2006
NMDA Receptor Antibodies Tied to Depression in Lupus, But Not to Cognitive Changes
Anti-NR2 antibodies, which target the NMDA receptor, are associated with depression in patients with lupus but not with cognitive dysfunction... Lapteva L, et al. Arthritis Rheum. 2006;54:2505-2514.
Friday Aug 11, 2006
Fish Oil Reduces CV Risk Factors, NSAID Requirements in RA Patients
Two tablespoons of fish oil per day significantly improved some cardiovascular risk factors and reduced NSAID requirements in patients with rheumatoid arthritis... Cleland LG, et al. J Rheumatol. 2006 Aug 01; [Epub ahead of print]
Thursday Aug 10, 2006
HGS to Initiate Phase III Trials of LymphoStat-B in Lupus; to Receive $24 Million from GSK
Human Genome Sciences, Inc. announced its phase III clinical development plans for LymphoStat-Bâ„¢ (belimumab, a human monoclonal antibody that specifically inhibits the biological activity of B-lymphocyte stimulator [BLyS], a protein required for the development of B-lymphocyte cells into mature plasma B cells) in patients with active systemic lupus erythematosus (SLE).
Thursday Aug 10, 2006
La Jolla Pharmaceutical Reactivates Enrollment in Phase III Study of Riquent in Lupus; Patients to Receive Higher Doses Than in Previous Studies
La Jolla Pharmaceutical Company announced that it has reactivated enrollment in its phase III 12-month treatment trial of RiquentR (abetimus sodium) for the treatment of lupus renal disease.
Tuesday Aug 01, 2006
Schering-Plough's REMICADE Receives EU Approval as Monotherapy for Treatment of Psoriatic Arthritis; Abbott's HUMIRA Receives FDA Approval for Treatment of Ankylosing Spondylitis
Schering-Plough Corporation announced that the European Commission approved the use of REMICADE® (infliximab) as monotherapy in the treatment of active and progressive psoriatic arthritis (PsA) in patients who show intolerance to methotrexate (MTX) or for whom MTX is contraindicated.
Monday Jul 31, 2006
Expert Scientific Group Proposes Recommendations to Improve Safety of First-In-Man Clinical Trials Following TeGenero's TGN 1412 Drug Trial
The Expert Scientific Group on phase I clinical trials, an independent committee established by the UK Secretary of State for Health to examine the safety and design of first-in-man clinical studies involving biologic molecules with novel mechanisms of action, new investigational agents with a highly species-specific action, and new drugs directed toward immune system targets, has published its interim report for public comment.
Friday Jul 28, 2006
Serono Initiates First Large-Scale European Pharmaco-Epidemiologic Study to Gather Additional Safety Data on RaptivaR in Psoriasis
Serono announced that it has initiated a prospective 7-year cohort, multi-national, multicenter study in more than 7000 adult patients with moderate-to-severe plaque psoriasis who have been treated with RaptivaR (efalizumab).
Friday Jul 28, 2006
Strontium Ranelate Reduces Fracture Risk in Postmenopausal Women With Osteoporosis
Strontium ranelate significantly reduces the risk of veretebral fractures, increases BMD at all sites and may prevent nonspine fracture in postmenopausal women with osteoporosis, a Cochrane Review concludes. ... O'Donnell S, et al. Cochrane Database for Systematic Reviews. 2006, Issue 3.
Thursday Jul 27, 2006
FDA Approves 13 Generic Versions of Mobic
FDA approves 13 meloxicam formulations for the treatment of osteoarthritis
Wednesday Jul 26, 2006
GAO, HHS Inspector General Push FDA to Tighten Up on Postmarketing Studies
A report from the Department of Health and Human Services Inspector General adds to growing pressure for the US Food and Drug Administration to hold pharma companies accountable for the burgeoning number of promised—but never completed—postmarketing studies.
Friday Jun 30, 2006
NEJM Vioxx Correction Casts Doubt on Short-Term Safety
A correction in the July 13 New England Journal of Medicine throws out the the original APPROVe study conclusion that Vioxx-related cardiovascular risk increases only after 18 months of use and casts doubt on the implied safety of briefer exposure. N Engl J Med. July 13, 2005 available at www.nejm.org.
Tuesday Jun 20, 2006
Abatacept Effective in MTX-Resistant RA
Abatacept (Orencia®) significantly reduces disease activity and retards radiographic progression in patients with active rheumatoid arthritis despite treatment with methotrexate... Kremer JM, et al. Ann Intern Med. 2006;144:865-876.
Monday Jun 05, 2006
New Treatment for Lupus Brought to (UVA-1) Light
Sunlight can trigger exacerbations of systemic lupus erythematosus, but the long-wave ultraviolet A-1 light can normalize some immune function in lupus patients, and should be considered for therapeutic use... Pavel S. Rheumatology. 2006;45:653-655.
Wednesday May 24, 2006
Bone-Sparing, Metal-on-Metal Hip Resurfacing System Benefits Young, Active Patients
A just-approved bone-sparing hip-resurfacing system will likely relieve pain and improve hip function among younger, active patients who have good bone quality, but caveats remain...
Tuesday May 09, 2006
Calcium Supplements Don't Reduce Fracture Risk Unless Patients Take Them
Supplementation with calcium carbonate tablets is ineffective at reducing fracture rates in the ambulatory elderly as a mass public health intervention due to poor long-term compliance, but the supplements are effective in patients who actually take them... Prince RL, et al. Arch Intern Med. 2006;166:869-875.
Monday May 08, 2006
Additional Neuropathies Linked to TNF Inhibitors
Guillain-Barré syndrome, demyelinating and axonal neuropathies, and a central nervous system syndrome have been reported recently in patients treated with TNF inhibitors... Shin I-SJ, et al. Arthritis Rheum. 2006;54:1429-1434; Jarand J, et al. J Rheumatol. 2006;33:1018-1020.
Thursday May 04, 2006
CV Risk With Vioxx Rises in First 60 Days
Rofecoxib (Vioxx) increases the risk of cardiovascular events, typically within the first 60 days of use, while naproxen reduces such risk, and other coxibs and nonselective NSAIDs have no effect... Solomon DH, et al. Arthritis Rheum. 2006;54:1378-1389.
Thursday May 04, 2006
Adding Alefacept Increases MTX Response in Psoriatic Arthritis
Alefacept plus methotrexate significantly increased response rates in patients with psoriatic arthritis... Mease PJ, et al. Arthritis Rheum. 2006;54:1638-1645.
Monday May 01, 2006
Abbott's HumiraR (Adalimumab) Receives Positive Opinion From EMEA for Ankylosing Spondylitis
Abbott Laboratories, of Abbott Park, Illinois, announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), issued a positive opinion recommending approval of Humira® (adalimumab)...
Friday Apr 28, 2006
Labopharm's Phase III Study for Once-Daily Tramadol Achieves Primary Endpoint in Patients With OA of the Knee
Labopharm Inc, of Laval, Quebec, Canada, announced that the phase III clinical trial for its once-daily formulation of the analgesic tramadol in patients with osteoarthritis (OA) of the knee achieved statistical significance for the primary endpoint...
Wednesday Apr 26, 2006
Neurochem's Eprodisate (Fibrillexâ„¢) Granted Priority Review by US FDA for the Treatment of Amyloid A Amyloidosis
Neurochem International Ltd, of Lausanne, Switzerland, announced that its new drug application for eprodisate (1,3-propanedisulfonate, Fibrillexâ„¢) for the treatment of Amyloid A amyloidosis has been granted priority review by the FDA...
Monday Apr 17, 2006
LEO Pharma and Warner Chilcott Launch Taclonex®, a Dual-Action, Once-Daily, Topical Therapy for Plaque Psoriasis in the US
Warner Chilcott, of Rockaway, NJ, and LEO Pharma A/S, of Copenhagen, Denmark, announced that Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) is now available for prescription in the US...
Friday Apr 14, 2006
Centocor's Remicade® Designated for Priority Review by FDA for Pediatric Crohn's Disease
Centocor, Inc, of Horsham, Pennsylvania, announced that the supplemental Biologics License Application (sBLA) for Remicade® (infliximab)...
Tuesday Apr 11, 2006
Biogen Idec to Sell Worldwide Rights to Its Psoriasis Drug Amevive to Astellas for $60 Million
Astellas Pharma US, Inc, of Deerfield, Illinois, and Biogen Idec Inc, of Cambridge, Massachusetts, announced an agreement for Astellas to purchase the worldwide rights, in all indications, to Amevive® (alefacept)...
Tuesday Apr 11, 2006
UK Regulatory Authority's Interim Report Concludes That the Serious AEs Caused by TeGenero's Investigational Superagonistic Anti-CD28 Antibody Were Triggered by an "Unpredicted Biological Action of the Drug in Humans"
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulatory authority responsible for clinical trial approval, found in its interim report that
the serious adverse events (AEs) (collectively labeled "cytokine release syndrome")...
Thursday Mar 30, 2006
Sodium Hyaluronate Effective in Chronic Shoulder Pain
Injections of sodium hyaluronate may be an effective and safe alternative to cyclooxygenase-2 inhibitors and other nonsteroidal anti-inflammatory drugs for the treatment of chronic shoulder pain... Blaine TA, et al. Presented at: 73rd Annual Meeting of the American Academy of Orthopaedic Surgeons; March 22–26, 2006; Chicago, Ill. Abstract 426.
Tuesday Mar 21, 2006
Local Bisphosphonate Administration May Improve Implant Fixation
Local treatment with the bisphosphonate alendronate combined with bone compaction may improve implant fixation... Jakobsen T, et al. Presented at: 52nd Annual Meeting of the Orthopaedic Research Society; March 18–22, 2006; Chicago, Ill. Abstract 89.
Monday Mar 13, 2006
NPS Receives Approvable Letter From US FDA for Recombinant Human Parathyroid Hormone for Osteoporosis; FDA Expresses Concern Regarding Hypercalcemia
NPS Pharmaceuticals, Inc, of Salt Lake City, Utah, announced that it has received an "approvable letter" from the US Food and Drug Administration (FDA) for their new drug application for PREOS®...
Monday Mar 06, 2006
Phase III Data for Centocor's Remicade® Show Rapid and Marked Improvement in Moderate to Severe Plaque Psoriasis
Centocor, Inc, of Horsham, Pennsylvania, announced the results from its phase III EXPRESS II study of Remicade® (infliximab)...
Friday Mar 03, 2006
Rituximab Approved for Rheumatoid Arthritis Patients Refractory to TNF-Antagonists
The US Food and Drug Administration has approved the anti-CD20+ B-cell-targeted monoclonal antibody rituximab (Rituxan®) in combination with methotrexate for adult patients with moderate to severe rheumatoid arthritis who experienced an adequate response to one or more tumor necrosis factor antagonists...
Friday Feb 17, 2006
Neurochem Seeks FDA Marketing Approval for Fibrillexâ„¢ for the Treatment of Amyloid A Amyloidosis
Neurochem International Limited announced the submission to the US Food and Drug Administration (FDA) of the final modules of its rolling NDA for eprodisate...
Monday Feb 13, 2006
BioMimetic Therapeutics Files for IPO
BioMimetic Therapeutics, Inc, of Franklin, Tennessee, announced that it has filed a registration statement with the US Securities and Exchange Commission...
Wednesday Feb 08, 2006
Etanercept in Combination with Sulfasalazine, Hydroxychloroquine, or Gold Is Safe and Effective Treatment for RA
Etanercept in combination with sulphasalazine, hydroxychloroquine, or intramuscular gold is an effective and well-tolerated treatment for rheumatoid arthritis. O'Dell JR, et al. J Rheumatol. 2006;33:213-218.
Monday Feb 06, 2006
Shire Submits European Regulatory Approval Application for Mesalazine for Ulcerative Colitis
Shire plc announced that it has submitted Marketing Authorization Applications to European regulatory agencies for SPD476 (mesalazine)...
Monday Jan 30, 2006
Can-Fite BioPharma Submits Clinical Protocol to FDA for Multinational Phase IIb Study of A3 Adenosine Receptor Agonist for RA
Can-Fite BioPharma, of Petach Tikva, Israel, announced that it has submitted a draft protocol to the US Food and Drug Administration...
Monday Jan 30, 2006
PharmaFrontiers Obtains Exclusive License to T-Cell Vaccine for RA
PharmaFrontiers Corp, of The Woodlands, Texas, announced that it has acquired an exclusive worldwide license...
Monday Jan 23, 2006
Ocera Completes $14.5M Series A Financing and Files IND for Crohn's Compound
Ocera Therapeutics, of San Diego, California, has announced the closing of a $14.5 million Series A round of financing...
Wednesday Jan 18, 2006
Human Genome Sciences to Advance LymphoStat-Bâ„¢ to Phase III in Lupus
Human Genome Sciences, Inc, announced plans to initiate in 2006 a phase III clinical trial of LymphoStat-Bâ„¢ (belimumab)...
Wednesday Jan 18, 2006
FDA to Require Additional Positive Pivotal Trial for Genelabs' Lupus Drug Prestaraâ„¢
Genelabs Technologies, Inc, of Redwood City, California, announced that the US Food and Drug Administration will require an additional pivotal trial...
Wednesday Jan 11, 2006
Manhattan's PTH 1-34, a Topical Treatment for Psoriasis, Enters Phase IIa Trials
Manhattan Pharmaceuticals, Inc, of New York City, announced the initiation of a phase IIa clinical study of PTH 1-34, a parathyroid hormone-related peptide analog, for the topical treatment...
Wednesday Jan 11, 2006
Repligen and University of Michigan File Infringement Complaint Against BMS Over Orencia®
Repligen Corporation of Waltham, Massachusetts, announced that Repligen and the University of Michigan (UM) have filed a joint complaint against Bristol-Myers Squibb Corporation (BMS) for infringement of a US patent...
Wednesday Jan 11, 2006
Boniva® Injection Approved for Postmenopausal Osteoporosis
Roche and GlaxoSmithKline announced that the US Food and Drug Administration has approved Boniva® (ibandronate sodium) Injection...
Tuesday Jan 10, 2006
Federal Court Rules Lilly Breached Agreement with Emisphere Regarding Oral Formulation of Forteo® for Osteoporosis; Lilly turns to Alkermes for Development of Inhaled Version
Emisphere Technologies, Inc, of Tarrytown, NY, announced that a Federal District Court judge ruled that Eli Lilly and Company had violated an agreement with Emisphere regarding the use of Emisphere's Eligen technology for the development of an oral formulation of Forteo® ...
Wednesday Jan 04, 2006
Bristol-Myers Squibb Receives US Approval for Orencia® (Abatacept) for RA
Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has approved Orencia® (abatacept) for the treatment of rheumatoid arthritis (RA)
Wednesday Jan 04, 2006
Osiris Raises $19 Million in Private Equity Funding for Adult Stem-Cell Trials
Osiris Therapeutics, Inc, of Baltimore, Maryland, announced that it has closed a $19 million private equity round of financing in support of ongoing clinical trial programs employing its adult mesenchymal stem-cell technology...
Tuesday Dec 20, 2005
Borean Achieves Preclinical Validation of TNF-Alpha Antagonist Derived from C-Type Lectin Domain Library
Borean Pharma A/S of Aarhus, Denmark, announced that its proprietary C-Type Lectin Domain (CTLD)–derived trimeric tumor necrosis factor-alpha (TNF-a) antagonist demonstrated a dose-dependent slowing of polyarthritis disease progression in transgenic mice expressing human TNF-a...
Friday Dec 16, 2005
Novel Gout Drug Febuxostat More Effective Than Allopurinol in Lowering Urate Levels
New data from a phase III trial show that febuxostat, a next-generation nonpurine selective xanthine oxidase inhibitor and the first new agent for gout in 40 years, is significantly more effective than standard doses of allopurinol in lowering serum uric acid levels to <6.0 mg/dL... Becker MA, et al. N Engl J Med. 2005;353:2450-2461.
Wednesday Dec 14, 2005
Critical Therapeutics' Fully Human Monoclonal Antibodies Against HMGB1 Demonstrate Efficacy in Preclinical Models of Inflammation; Triggers $1.25 Million Milestone Payment From MedImmune
Critical Therapeutics, Inc, of Lexington, Massachusetts, announced that its fully human monoclonal antibodies against high mobility group box 1 (HMGB1) provide significant protection...
Wednesday Dec 14, 2005
New England Journal of Medicine Editors Call for Correction of VIGOR Trial
In response to the revelation that three additional myocardial infarctions were withheld from the original Vioxx® GI Outcomes Research (VIGOR) trial submitted to the New England Journal of Medicine, the editors of the journal have called into question the integrity of the data and requested that the authors submit a correction to account for the "inaccuracies and deletions" in the original published article...Curfman GD, et al. N Engl J Med. 2005;353:2813-2814.
Tuesday Dec 13, 2005
Osiris to Initiate Phase II Trial of Prochymalâ„¢ for Crohn's Disease
Osiris Therapeutics, Inc, of Baltimore, Maryland, has announced the start of enrollment for its phase II clinical trial of Prochymalâ„¢...
Monday Dec 05, 2005
Roche Receives 510(k) Clearance to Market Osteocalcin Test for Osteoporosis
Roche Diagnostics of Indianapolis, Indiana, announced that it has received 510(k) clearance from the US Food and Drug Administration...
Friday Dec 02, 2005
New Gout Drug PEG-Uricase May Benefit Severe, Refractory Patients
A new study has found that multiple doses of PEG-uricase, a novel polyethylene glycol conjugate of porcine uricase (urate oxidase), has shown substantial and sustained reductions in plasma urate levels in patients with severe, refractory gout... Presented at: Annual Meeting of the American College of Rheumatology; November 12–17, 2005; San Diego, Calif. Abstract 1836.
Tuesday Nov 29, 2005
Galderma Laboratories Receives FDA Approval for Clobex® Spray for Psoriasis
Galderma Laboratories of Fort Worth, Texas, announced that the US Food and Drug Administration has granted marketing approval for Clobex® ...
Tuesday Nov 29, 2005
Bio-Rad Granted FDA Clearance to Market Interpretive Software for Autoimmune Testing
Bio-Rad Laboratories, Inc, of Hercules, California, a manufacturer and distributor of life science research products and clinical diagnostics, announced...
Monday Nov 21, 2005
Genentech, Biogen IDEC's Rituxan® Benefits RA Patients Unresponsive to Methotrexate and Anti-TNF Therapies
Genentech, Inc, and Biogen IDEC, who filed in October for US Food and Drug Administration approval to market rituximab (Rituxan®)...
Thursday Nov 17, 2005
Three Novel and Distinct Agents Show Promise in RA
Three promising new rheumatoid arthritis (RA) drugs—including an oral small-molecule inhibitor that targets a novel adenosine receptor (AR) and a new anti-tumor necrosis factor-alpha (TNF-α) agent—may soon augment the rheumatologist's ever-expanding armamentarium... Presented at: Annual Meeting of the American College of Rheumatology; November 12–17, 2005; San Diego, Calif.
Thursday Nov 10, 2005
Vitamin D Status More Important Than High Calcium Intake for Calcium Homeostatis
New research suggests that maintaining adequate serum vitamin D levels can ensure ideal parathyroid hormone (PTH) values without the need for calcium intake above 800 mg/day; findings that provide further evidence of the importance of vitamin D to optimal bone health…Steingrimsdottir L, et al. JAMA. 2005;294:2336-2341.
Monday Nov 07, 2005
Positive Phase III Results for Remicade® in Pediatric Crohn's Disease Drives Fast Track Designation for Indication
Centocor, Inc (Horsham, Pa.), announced at the 18th Annual Meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition...
Tuesday Nov 01, 2005
Lupus Foundation Program Heralds Robust Drug Development Pipeline
The number of new agents for the management of systemic lupus erythematosus (SLE), from mycophenolate mofetil and abatacept to rituximab and belimumab, suggests a robust therapeutic pipeline for SLE, a heterogeneous disease for which there have been few therapeutic advances in the last 40 years, according to experts speaking at an October 29 conference in New York titled "Lupus Now: State-of-the-Art Approaches from the Experts."
Tuesday Nov 01, 2005
US FDA Accepts sBLA and Grants Priority Review Status for Rituxan® for RA
Biogen Idec, Inc, of Cambridge, Massachusetts, and Genentech, Inc, of South San Francisco, California, announced that the US Food and Drug Administration (FDA) has granted priority status to the supplemental Biologics License Application (sBLA) for Rituxan®...
Monday Oct 24, 2005
La Jolla Pharmaceutical Secures Funding to Commence Re-enrollment of Phase III Trial of Riquent® for Lupus Renal Disease
La Jolla Pharmaceutical Corporation of San Diego, California, announced that it has entered into an agreement...
Tuesday Oct 18, 2005
MedImmune Completes Acquisition of Cellective and Its CD19-Directed Monoclonal Antibody; Files IND with Medarex for Lupus
MedImmune, Inc, of Gaithersburg, Maryland, announced that it has completed its acquisition of Cellective Therapeutics, Inc...
Thursday Oct 06, 2005
Abbott's HumiraR (Adalimumab) Approved in Europe for Psoriatic Arthritis and Severe Rheumatoid Arthritis
Abbott Laboratories announced that it has received US Food and Drug Administration (FDA) approval to market HumiraR (adalimumab)...
Thursday Oct 06, 2005
Human Genome Sciences' LymphoStat-Bâ„¢ for Lupus Fails to Meet Primary Endpoints in Phase II Trial
Human Genome Sciences, Inc (Rockville, Md), announced that its investigational drug for lupus, LymphoStat-Bâ„¢, (belimumab) failed to meet the overall primary efficacy endpoints...
Friday Sep 23, 2005
FDA Issues "Non-Approvable Letter" for Pfizer's Injectable COX-2 Drug
Just 1 week after receiving a nonapprovable letter for their new osteoporosis drug lasofoxifene (Oporia), Pfizer Inc announced Tuesday that the Food and Drug Administration (FDA) has issued a nonapprovable letter for parecoxib sodium, an injectable COX-2 inhibitor used to treat acute pain in the postsurgical setting... Pfizer receives FDA non-approvable letter on parecoxib [press release]. PR Newswire; September 20, 2005.
Thursday Sep 22, 2005
US FDA Issues Nonapprovable Letter for Pfizer's Injectable COX-2 Inhibitor
A nonapprovable letter from the US Food and Drug Administration was received by Pfizer Inc for parecoxib sodium, an injectable COX-2 inhibitor used to treat acute pain after surgery...
Wednesday Sep 21, 2005
Johnson & Johnson's Remicade (infliximab) First Biologic Approved by US FDA for Treatment of Ulcerative Colitis
Centocor, Inc, a biotech unit of Johnson & Johnson, has announced that Remicade® (infliximab) has been approved by the US Food and Drug Administration...
Monday Sep 19, 2005
A Leading Rheumatologist Reflects on How Cyclooxygenase Became a Household Word
Just as it appeared that the dust from the great COX-2 controversies had begun to settle, a jury in Texas awarded a plaintiff a judgment against Merck & Co for one quarter of a billion dollars - indeed, for a death that, arguably, was not Vioxx-related.
Tuesday Sep 13, 2005
Two New Treatments Show Promise in Paget's Disease
Zoledronic acid and osteoprotegerin found to be promising new therapies for the management of Paget's disease... Reid IR, et al. N Engl J Med. 2005;353:898-908; Cundy MD, et al. N Engl J Med. 2005;353:918-923.
Friday Sep 09, 2005
FDA's Advisory Committee Recommends Approval of Bristol-Myers Squibb's Orencia® for RA
Bristol-Myers Squibb Company (Princeton, NJ) has announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA)...
Friday Sep 09, 2005
FDA Arthritis Advisory Committee Gives Preliminary Go-ahead to Abatacept
A Food and Drug Administration Arthritis Advisory Committee unanimously recommended approval of Orencia® (abatacept) Tuesday, stating that the benefits of the costimulation blocker for rheumatoid arthritis (RA) outweighed the risks of serious infections like pneumonia and some cancers.
Friday Sep 09, 2005
Preliminary Data on Genelabs' Prestaraâ„¢ Show Positive Effects on BMD in SLE Patients Taking Glucocorticoids
Genelabs Technologies, Inc, of Redwood City, California, has announced positive results from a preliminary analysis
Tuesday Aug 09, 2005
FDA Approves Celebrex for Ankylosing Spondylitis, and an Added Boxed Warning
Pfizer's selective cyclo-oxygenase 2 (COX-2) inhibitor Celebrex (celecoxib) has been approved by the US Food and Drug Administration (FDA) for the relief of the clinical signs and symptoms associated with ankylosing spondylitis
Monday Aug 08, 2005
Vitamin D Supplements May Not Help African American Women's Bones
Supplementation with vitamin D3 has no effect on bone loss or bone turnover markers in calcium-replete, postmenopausal African American women ... Aloia JF, et al. Arch Intern Med. 2005;165:1618-1623
Sunday Aug 07, 2005
Neurochem Initiates Submission of NDA With US FDA for Fibrillexâ„¢ in AA Amyloidosis
Neurochem has announced that it has initiated, under the Continuous Marketing Application Pilot 1 program...
Thursday Aug 04, 2005
Scientists Develop New Technique to Grow Bone In Vivo
In a development that one day may revolutionize spinal and knee-replacement surgery and the treatment of osteoporosis, researchers at Vanderbilt University in Nashville, Tennessee, have demonstrated for the first time that healthy new bone can be grown in one part of the body to repair bony defects at another location... Stevens MM, et al. In vivo engineering of organs: The bone bioreactor. Proc Natl Acad Sci. 2005; scheduled to appear online before print. Available at: http://www.pnas.org/.
Wednesday Aug 03, 2005
PREOSR parathyroid hormone NDA accepted for review by FDA
NPS Pharmaceuticals, Inc, of Salt Lake City, Utah, announced that the US Food and Drug Administration has accepted for review the company's new drug application (NDA) for PREOSR, a recombinant parathyroid hormone (PTH 1-84) for the treatment of osteoporosis in postmenopausal women.
Tuesday Jul 26, 2005
Osteologix's Strontium Formulation in Phase 1 Development for Osteoporosis
Osteologix, Inc., announced that patient enrollment has been completed in its Phase I clinical trial of NBS-101, an improved formulation of strontium for the treatment of osteoporosis.
Monday Jul 25, 2005
Government Crackdown on Palladone and Fentanyl Continues to Fuel Fear of Prescribing Pain Medication
Withdrawal of Palladone in the US, the advisory report issued on the fentanyl patch, and the continued DEA scrutiny of doctors who prescribe opioids and other narcotic analgesics may have a chilling effect on the optimal use of these agents for the relief of acute and persistent pain.
Friday Jul 08, 2005
Genelabs' PrestaraTM Gains Orphan Drug Exclusivity to Prevent SLE Bone Loss
Genelabs Technologies, Inc, reported that PrestaraTM, a synthetic form of the hormone dehydroepiandrosterone (DHEA), has been granted orphan drug exclusivity by the US Food and Drug Administration (FDA) for the
Wednesday Jun 29, 2005
EMEA Recommends HumiraR as First Line for Moderate-to-Severe RA
Abbott Laboratories announced that the European Medicines Agency (EMEA) has recommended approval of HumiraR (adalimumab) for first-line treatment of moderate-to-severe early rheumatoid arthritis (RA).
Tuesday Jun 28, 2005
Botox Injections Improve Symptoms in Patients With Raynaud's Phenomenon
Injections of botulinum toxin type A may accelerate the rewarming process by inhibiting vasoconstriction in patients with secondary Raynaud's phenomenon... Presented at: Annual European Congress of Rheumatology of EULAR; June 8-11, 2005; Vienna, Austria.
Friday Jun 17, 2005
Immunomedics' Anti-CD22 Antibody Shows Promise for Sjogren's Syndrome
Immunomedics, Inc, reported encouraging initial safety and clinical efficacy results from its open-label, non-randomized, Phase I/II trial of epratuzumab for the treatment of patients with Sjogren's syndrome (ss).
Thursday Jun 16, 2005
Chelsea Launches Phase I Trial of Its Lead Antifolate Compound
Chelsea Therapeutics, Inc. announced the initiation of a Phase I clinical trial in the UK of its lead orally available, metabolically inert antifolate (CH-1504), which, in a nonpivotal, independent, 6-month pilot clinical study involving 20 rheumatoid arthritis (RA) patients in Peru suggested a lower toxicity and improved tolerability, and increased effectiveness versus methotrexate (MTX), even among patients who had previously failed to demonstrate improvement with MTX.
Wednesday Jun 15, 2005
Etanercept Expands PsA Indication to Include Improvement of Physical Function
Amgen Inc and Wyeth Pharmaceuticals announced that the US Food and Drug Administration (FDA) expanded the marketing approval of Enbrel® (etanercept) to include the improvement of physical function in patients with psoriatic arthritis (PsA).
Thursday Jun 09, 2005
A Conversation at EULAR: Dr. Ricard Cervera on Biologics and Pregnancy
The preeminent immunologist comments on the increasing use of TNF-α inhibitors and other biologic drugs-particularly among women, who bear the brunt of autoimmune disease-and the concern about their potential effects on pregnancy... Cervera R. Annual European Congress of Rheumatology of EULAR; June 8-11, 2005; Vienna, Austria.
Wednesday Jun 08, 2005
OsteoBiologics' PolyGraftR Receives Canadian Clearance for Bone Void Repair
OsteoBiologics, Inc, a San Antonio, Texas-based developer and manufacturer of bioabsorbable, tissue-engineered scaffolds for the repair and replacement of musculoskeletal tissues, announced that it has received a Medical Device License authorizing the marketing in Canada of its PolyGraftR products for bone void repair.
Tuesday May 17, 2005
Infliximab Approved for Treatment of Psoriatic Arthritis
Infliximab joins etanercept as an anti-TNF-α treatment option for patients with active psoriatic arthritis...FDA approves Remicade® for ninth indication: psoriatic arthritis [press release]. Malvern, Pa: Centocor, Inc; May 17, 2005.
Thursday May 12, 2005
Arakis RA Drug Completes Phase IIa Trial
Arakis Ltd announced that in a multicenter Phase IIa, placebo-controlled study, its candidate rheumatoid arthritis compound AD 452, a novel small-molecule cytokine modulator, demonstrated acceptable pharmacokinetics, safety, and tolerability in RA patients already receiving methotrexate.
Thursday May 12, 2005
More Evidence for Cardiovascular Risk Among Selective and Nive Nonsteroidals
Several weeks after the US Food and Drug Administration called for sweeping changes to the labels of prescription and over-the-counter NSAIDs reflecting a potential cardiovascular risk, a Danish study confirms that they increase the chances of hospitalization for MI...Johnsen SP, et al. Arch Intern Med. 2005;165:978-984.
Monday May 09, 2005
Immunomedics Acquires Funding to Continue Development of a Humanized Anti-CD20 Monoclonal Antibody for Lupus
Immunomedics, Inc, has raised more than $37 million for Phase III trials of epratuzumab, the company's humanized anti-CD20 monoclonal antibody, for the treatment of patients with moderate-to-severe lupus. Details of the clinical protocols have been finalized with the US Food and Drug Administration and the European Medicines Agency, and two Phase III trials are to be initiated in the first half of this year. Immunomedics continues to evaluate potential strategic partnerships for the commercialization of epratuzumab in lupus. The funds were secured through a closed private placement of its 5% Senior Convertible Notes and common stock warrants.
Wednesday May 04, 2005
CoTherix's Treatment for Pulmonary Arterial Hypertension Reaches Market
CoTherix, Inc, has recently announced the commercial availability of VentavisR (iloprost) Inhalation Solution, for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class III or IV symptoms. Approved by the US Food and Drug Administration in December 2004, Ventavis, an inhaled formulation of iloprost that is structurally similar to prostacyclins, provides PAH patients with a noninvasive treatment option that avoids the complications associated with intravenous or subcutaneous prostacyclin delivery. A recognized complication of lupus, PAH can be life-threatening and require heart-lung transplantation. Ventavis, licensed from Schering AG, is currently marketed by Schering AG in several European countries and Australia. - Nicholas K. Zittell
Tuesday Apr 26, 2005
American College of Rheumatology Responds to the Recent FDA Action on NSAIDs
Citing a lack of evidence implicating OTC and prescription NSAIDs in CV risk, the American College of Rheumatology criticized aspects of the recent FDA decision... American College of Rheumatology letter to Lester M. Crawford, DVM, PhD, acting commissioner of the FDA. April 21, 2005.
Thursday Apr 14, 2005
Investigational New Drug Application Filed for Selective Androgen Receptor Modulator
TAP Pharmaceutical Products submitted an investigational new drug application to the US Food & Drug Administration to evaluate LGD2941, a selective androgen receptor modulator (SARM), as a potential new therapy for the treatment of osteoporosis and frailty, triggering a $1.5 million milestone payment to Ligand Pharmaceuticals, the drug's developer.
Wednesday Apr 13, 2005
Genelabs' Prasterone (Prestara®) Fails to Increase Bone Mineral Density in Women with Lupus
Genelabs Technologies, Inc. reported recently that in a 9-month, Phase III trial, treatment with Prestara (prasterone), a synthetic form of the human hormone dehydroepiandrosterone, failed to achieve the primary endpoint of improving bone mineral density (BMD) in the lumbar spine in women with systemic lupus erythematosus receiving concomitant glucocorticoids.
Monday Apr 11, 2005
FDA Approves Alendronate Sodium/Cholecalciferol (Fosamax Plus DR) for Osteoporosis; the Only Bisphosphonate With a Weekly Dose of Vitamin D
Merck & Co, Inc, received marketing approval from the US Food and Drug Administration for its once-weekly tablet containing alendronate sodium (FosamaxR) and vitamin D3 (cholecalciferol) for postmenopausal women with osteoporosis.
Friday Apr 08, 2005
Thalidomide May Play a Role in Treatment of Refractory Radiculopathic Pain
Banned from use in the 1960s due to its teratogenic effects, thalidomide is being reexamined as a treatment for inflammatory and other types of disorders... Presented at the 24th Annual Scientific Meeting of the American Pain Society; March 30-April 2, 2005; Boston, Massachusetts
Thursday Apr 07, 2005
FDA Orders Valdecoxib (Bextra) Withdrawn, Citing No Added Advantage
The agency also mandated black box warnings for celecoxib and stricter label warnings on traditional NSAIDs, including over-the-counter products... US Food and Drug Administration teleconference April 7, 2005.
Monday Apr 04, 2005
Analgesic Drug Pipeline, Though Relatively Dry, Poised for Revitalization
Despite a relative paucity in the current analgesic pipeline, a greater understanding of complex pain processes, pharmacogenetics, and new diagnostic tools and therapeutic targets, including assays and biomarkers, may open the doorway to more effective therapies, as well as better use of existing treatments...Presented at: 24th Annual Scientific Meeting of the American Pain Society; March 30-April 2, 2005; Boston, Mass.
Thursday Mar 31, 2005
Lidocaine Patch May Be as Effective as Oral Medications for Improving Osteoarthritis Pain
As physicians seek alternatives to coxibs, traditional nonsteroidal anti-inflammatory drugs and opioids, a new study suggests that lidocaine patches may play a role in treating localized knee pain due to OA...Galer B, et al. Presented at: 24th Annual Scientific Meeting of the American Pain Society; March 30-April 2, 2005; Boston, Massachusetts.
Wednesday Mar 30, 2005
FDA Approves Monthly Ibandronate for Treatment and Prevention of Osteoporosis
The new formulation simplifies osteoporosis drug therapy and addresses problems of adherence among patients using bisphosphonates
Monday Mar 28, 2005
Case Study Suggests Humanized Anti-CD20 Monoclonal Antibody Effective in Rituximab-Resistant Lupus
Researchers at the Centre for Rheumatology at University College, in London, England, report in the April 2005 issue of Rheumatology the first case of a patient with severe systemic lupus erythematosus (SLE), who, having become unresponsive to the chimeric anti-CD20 antibody rituximab, exhibited a good response to a fully-human anti-CD20 antibody (hCD20) provided on a compassionate use basis by Immunomedics, Inc.1
Friday Mar 25, 2005
Genetic Variation Helps Predict Response to Etanercept in Rheumatoid Arthritis
As the FDA takes action to speed the clinical application of pharmacogenetics, the possibility of personalized medicine for RA patients got a boost from a new study showing that a polymorphism in TNF-α affects the response to etanercept therapy...Kang CP, et al. Rheumatology. 2005;44:547-552.
Tuesday Mar 15, 2005
Trials of Gout Drug Febuxostat Demonstrate Promising Efficacy
Results of Phase II and Phase III studies of the novel xanthine oxidase inhibitor suggest that it may play an important role in treating hyperuricemic patients with renal insufficiency and allopurinol hypersensitivity...Becker MA, et al. Arthritis Rheum. 2005;52:916-923.
Monday Mar 14, 2005
Accelerated FDA Approval Unlikely for La Jolla Pharmaceutical's Riquent.
La Jolla Pharmaceutical Company (LJPC) of San Diego, California, announced earlier this month that RiquentR (abetimus sodium), the company's treatment for lupus renal disease, is unlikely to receive an accelerated approval.
Monday Feb 28, 2005
New Minimally Invasive Knee Arthroplasty Techniques Present Promise, Challenges
Direct-to-consumer marketing has spurred patient demand for minimally invasive joint replacements, but widespread application of these procedures is limited by a lack of experienced surgeons and of data supporting their use... The 72nd Annual Meeting of the American Academy of Orthopaedic Surgeons; February 23-27, 2005; Washington, DC.
Friday Feb 25, 2005
The Future of Spinal Surgery: Artificial Discs and Bone Growth Factors Show Promise
PCM cervical discs, Charité lumbar discs, and BMPs demonstrate improved outcomes and greater patient satisfaction as alternatives to traditional spinal fusion surgery...72nd Annual Meeting of the American Academy of Orthopedic Surgeons; February 23, 2005.
Saturday Feb 19, 2005
FDA Panel Splits 17 to 15 in Favor of Putting Rofecoxib Back on the Market
An FDA advisory panel recommends a strong black box warning for cardiovascular risk, dose restrictions, and strict guidelines to indications for use of Vioxx...US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 18, 2005.
Friday Feb 18, 2005
FDA Advisory Panel Votes to Keep Pfizer COX-2 Inhibitors Celecoxib and Valdecoxib on the Market
An FDA advisory panel concluded today that while safety concerns clearly exist with celecoxib and valdecoxib, their overall benefits outweigh potential CV risks... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 18, 2005.
Friday Feb 18, 2005
Public Outcry Over Embattled Pain Relievers at FDA Advisory Panel Hearing
Some called for the withdrawal of all coxibs, while others pleaded for a return of the withdrawn rofecoxib (Vioxx) during public testimony at the FDA advisory meeting... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 17, 2005.
Friday Feb 18, 2005
Despite Proven GI Benefits, Problems Predicted for Newest Coxibs Seeking FDA Approval
Two coxibs currently in the approval pipeline are likely to face substantial hurdles as an FDA advisory panel determines the fate of the COX-2 inhibitor class...US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 17, 2005.
Friday Feb 18, 2005
European Medicines Agency Calls Cardiovascular Risk a Class Effect of Coxibs
EMEA calls for stricter labeling and restricted use for COX-2 inhibitors... will the FDA follow suit? EMEA press release. London, UK; February 17, 2005.
Thursday Feb 17, 2005
Pfizer, Merck & Co Grapple Over Cardiovascular Risk Associated With Coxibs
With the fate of a drug class on the line, all eyes are on an FDA advisory panel as they assess the data on coxibs and make recommendations that could lead to a labeling change or their withdrawal from the market... FDA joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 16, 2005.
Thursday Feb 17, 2005
FDA Whistleblower Cites Unpublished Data on Dose-Dependent Cardiovascular Risk of Coxibs
The FDA advisory panel on COX-2 inhibitors heard testimony today from a leading voice in the movement to restrict their use... US FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 16, 2005.
Tuesday Feb 15, 2005
Meta-Analysis Shows Coxibs Raise Blood Pressure Relative to Traditional NSAIDs
Analysis of pooled data provides additional evidence of cardiovascular risk associated with coxibs and suggests differing effects among members of the class...Aw T-J, et al. Arch Intern Med. 2005;165:1-7.
Thursday Feb 10, 2005
Anti-TNF Therapy Does Not Increase Overall Cancer Risk in Patients With Rheumatoid Arthritis, but Is Linked to Higher Number of Lymphomas
Swedish researchers note that the types of lymphomas, including non-Hodgkin's lymphoma and Hodgkin's disease, were in line with those recently reported in RA patients...Geborek P, et al. Ann Rheum Dis. 2005
Tuesday Jan 25, 2005
Three New Studies Further Elucidate Risks and Benefits of Coxibs
Newly published study findings from CRESCENT show that rofecoxib significantly increases 24-hour blood pressure after 6 weeks of therapy, while celecoxib and naproxen do not; two other published studies address COX-2 risks and benefits... Sowers JR, et al. Arch Intern Med. 2005;165:161-168.
Monday Jan 24, 2005
Continuing Concerns of the Cardiovascular Risks of the COX-2s
As the European Medicines Agency is set to determine the fate of COX-2s in the European community and the US Food and Drug Administration readies for a rare advisory meeting in mid-February, the journal Circulation has presented a meta-analysis of two clinical trials that provide further evidence that valdecoxib increases cardiovascular risk in CABG patients, including a study that provides a better understanding of the mechanisms in these agents that may accelerate the atherogenic process& Egan KM, et al. Circulation. 2005; 111:334-342.
Friday Jan 21, 2005
The Promise and Peril of the Next Generation of COX-2 Inhibitors
CIAOMed continues its series on the impact of the withdrawal of rofecoxib (VioxxR) from the worldwide market. The first installment (CIAOMed.org; November 9, 2004) discussed possible mechanisms of the cardiovascular (CV) risk observed with rofecoxib, and whether they apply to other selective cyclooxygenase-2 (COX-2) inhibitors. The second (CIAOMed.org; December 10, 2004) examined the impact of recent disclosures about COX-2s and CV risk on patient management. This third and final installment focuses on the clues to CV risk profiles of the second-generation COX-2 inhibitors and the role these newer drugs will play if they are approved for marketing in the US& Brune K, Hinz B. Scand J Rheumatol. 2004;33:1-6.
Wednesday Dec 22, 2004
National Institutes of Health Halts Alzheimer's Prevention Trial Involving Aleve and Celebrex
Federal officials noted that patients taking the OTC formulation of naproxen had a 50% greater rate of cardiovascular (CV) events compared with placebo; those in the COX-2 inhibitor arm of the trial saw no increased CV risk...National Institutes of Health, December 20, 2004.
Tuesday Dec 21, 2004
Cancer-Prevention Trial Reveals Elevated Cardiovascular Risk Associated With Celebrex
National Cancer Institute study results, which showed a heightened cardiovascular risk versus placebo among patients taking the COX-2 inhibitor celecoxib at up to 4 times higher than recommended doses, runs counter to recent evidence that the agent may have cardioprotective properties in some arthritis patients... Kimmel SE, et al. Ann Intern Med. 2005;142(3).
Thursday Dec 16, 2004
Pfizer's COX-2 Agent to Include Updated Risk Warnings on Label
The FDA announces important new information on risks of CV adverse events in some postsurgical cardiac patients and potentially life-threatening skin reactions associated with use of valdecoxib...US Food and Drug Administration. December 9, 2004.
Monday Dec 13, 2004
New Studies Confirm Efficacy and Tolerability of Once Daily Lumiracoxib for the Treatment of Osteoarthritis
New clinical trials data on the efficacy and tolerability of lumiracoxib (PrexigeR) provide evidence that the selective cyclooxygenase-2 (COX-2) inhibitor taken 100 mg daily offers reduced pain intensity in the target knee compared to placebo while improving the functional status of patients' osteoarthritis of the knee...Lehmann R, et al. Presented at: The 9th World Congress of the Osteoarthritis Research Society International; December 2-5 2004; Chicago, Illinois.
Monday Dec 13, 2004
Clinical Decisions With COX-2s: Balancing GI Protection and Cardiovascular Risk
CIAOMed continues its series about the impact of the withdrawal of rofecoxib (VioxxR) from the worldwide market. The first installment (CIAOMed.org; November 9, 2004) discussed possible mechanisms of the cardiovascular (CV) risk observed with rofecoxib, and whether they apply to other cyclooxygenase-2 (COX-2) inhibitors. This second installment examines the impact of recent disclosures on changes in the selection of appropriate candidates for COX-2 inhibitors, on the reemergence of traditional antiinflammatory agents such as nonselective nonsteroidal antiinflammatory drugs (NSAIDs) for patients at risk for gastrointestinal complications, and on therapeutic decisions for those who require aspirin to maintain cardiovascular protection& Simon LS. Advanced Studies in Medicine. 2004;4:522-523.
Tuesday Nov 09, 2004
COX-2s, Pain Relief, and Cardiovascular Risk: Where Do We Go From Here?
In the first of a 3-part series, CIAOMed will examine possible underlying mechanisms that may be responsible for elevated cardiovascular risk in select COX-2 inhibitors and whether such explanations extend to all coxibs. Subsequent installments will examine how to manage patients in light of the new reports and the future of this frequently used drug class... Simon LS, Strand V. Cleve Clin J Med. 2004;71:849-856.
Thursday Nov 04, 2004
Next generation COX-2 Inhibitor Arcoxia Receives FDA Approvable Letter
Final approval of etoricoxib must await FDA review of additional safety and efficacy data... Baraf HSB, et al. Presented at: Annual Meeting of the American College of Rheumatology; San Antonio, Tex.
Wednesday Nov 03, 2004
Merck Withdraws NDA for COX-2 Inhibitor Arcoxia
Just days after receiving an FDA "approvable letter", the company has withdrawn the new drug application for etoricoxib until additional safety and efficacy data are available...
Wednesday Oct 20, 2004
Adalimumab Markedly Reduces Psoriatic Arthritis Symptoms
Striking benefits are shown for psoriatic arthritis patients' skin and joint symptoms with adalimumab vs placebo... Mease PJ, et al. Presented at Annual Meeting of the American College of Rheumatology; October 19, 2004; San Antonio, Texas
Tuesday Oct 19, 2004
Studies of TNF-Alpha Blockers in Rheumatoid Arthritis Focus on Understanding Safety Issues
A new postmarketing surveillance analysis shows that infliximab is safe at approved doses, and patients have no greater risk of infection than those taking methotrexate ... Yocum DE et al. Presented at: Annual Meeting of the American College of Rheumatology; October 19, 2004; San Antonio, Tex.
Tuesday Oct 19, 2004
APPROVe Study Shows Two-Fold Increased Risk of Coronary Events with VIOXX
Cardiovascular events in the placebo arm of the trial appeared to stop occurring after 18 months, while they continued among patients taking rofecoxib, according to the first detailed report of the drug's withdrawal ...
Sunday Oct 17, 2004
COX-2 Inhibitor Bextra Found to Increase Cardiac Risk in Patients Undergoing Bypass Surgery
Two weeks after Merck & Co. pulled its cyclooxygenase-2 (COX-2) inhibitor rofecoxib (Vioxx) from the market because its use was associated with heightened risk of cardiovascular disease, Pfizer Inc. told doctors that its COX-2 inhibitor valdecoxib (Bextra) increases the risk of heart attack or stroke in patients undergoing coronary artery bypass surgery.
Monday Oct 04, 2004
FDA Approves Etanercept as Pre-Filled Syringe, Infliximab as First-Line Therapy for Moderate to Severe RA
The FDA has approved etanercept (Enbrel) as a pre-filled syringe formulation for once weekly use, and granted approval for a supplemental labeling change stating that the medication can induce a major clinical response in patients with rheumatoid arthritis (RA). In another regulatory decision, the FDA has approved the use of infliximab (Remicade) in combination with methotrexate as a first-line treatment for patients with RA.
Monday Aug 30, 2004
SLE Researchers Encouraged to Use Biomarkers, Surrogate Markers as Study Endpoints; New Research Shows B-Cell Depletion to Have Role in SLE Therapy
(Schiffenbauer J, et al. Arthritis Rheum. 2004;50:2415-2422; Looney RJ, et al. Arthritis Rheum. 2004;50:2580-2589.)
Monday Aug 30, 2004
Incidence of Gout Increasing; New Therapies Have Promise to Make Disease More Manageable
(Bieber JD, Terkeltaub RA, et al. Arthritis Rheum. 2004;50:2400-2414.)
|
