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11/21 Promacta Approved Glaxo wins U.S. approval for platelet drug ... Promacta, also known by the chemical name eltrombopag, is approved for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy ... [ Reuters ] 11/21 AZN Layoffs in Manufacturing in Europe; New Jobs in China; No Changes (for now) in US AstraZeneca to cut 1,400 jobs ... The company's site in Macclesfield, England will see 250 job losses by 2010, while facilities in Spain, Belgium and Sweden will close. ... [ Telegraph (UK) ] 11/21 Even 'Targeted Therapies' Have Significant Risks FDA 'black box' warning advised for cancer drug Avastin ... About 12% of people who take Avastin develop blood clots in the veins, a rate that's about 30% higher than among cancer patients not taking it ... [ USA Today ] 11/21 Changing of the Guard at House Energy and Commerce Committee Will Waxman, the New Boss, Be the Same as the Old Boss? ... Incoming House committe chair Henry Waxman has been a bulldog on drug issues, as much as outgoing Rep. John Dingell. Waxman is trying to derail efforts by the FDA and industry that would ease rules against off-label promotion of medicines ... [ WSJ Health Blog ] 11/21 Uloric, for Gout, Gets Positive Signal FDA sees no heart risk with Takeda gout drug ... The FDA finding was released ahead of an advisory panel meeting. Takeda's febuxostat is a treatment for hyperuricemia, a build up of uric acid that can lead to swollen joints and arthritis flare-ups ... [ Reuters ] 11/21 Oral Med Works as Well as Chemo for Grim Diagnosis Iressa Proves Just as Effective as Chemotherapy for Lung Cancer ... When comparing all treated lung cancer patients, median overall survival for those receiving Iressa was 7.6 months and one-year survival was 32 percent, compared to 8 months and a 34 percent one-year survival for those taking chemotherapy ... [ University of Texas M. D. Anderson Cancer Center ] 11/21 Little Blue Pill Won't Be OTC in Europe Viagra Stays Behind EU Counters ... Pfizer believes Viagra meets all the criteria for nonprescription status under the European Commission's guidelines, but decided to withdraw the application after concerns were raised by the European Medicines Agency ... [ Forbes ] 11/21 Motesanib Trial Halted Amgen Drug for Lung Cancer Suspended After Deaths ... The trial was halted after an independent monitoring committee's review of 600 patients found higher early mortality rates among those getting the experimental cancer drug motesanib compared with those on a placebo. Amgen and Takeda were testing motesanib as a first-line treatment in combination with chemotherapy ... [ Bloomberg ] 11/21 Sodium Oxybate Successful in Phase III Jazz, UCB Say Treatment Helps Fibromyalgia Patients ... Sodium oxybate helped patients achieve a 30 percent reduction in pain compared with a placebo in a study... Five percent or more patients suffered side effects such as dizziness, diarrhea and vomiting ... [ Bloomberg ] 11/21 Keeping the Faith in Biotech Personal medicine is goal of Eli Lilly & Co ... Lilly chair Sidney Taurel (who was CEO 1998-2008) maintains that the future of the pharmaceutical industry rests not with blockbuster drugs but with targeted therapies that work for smaller groups of people based on their biological makeup. He acknowledged progress has been much slower than expected ... [ Arizona Republic ] 11/21 Internet Drug News Miscellaneous Short Takes: AstraZeneca wins first round in Teva litigation Forbes Abbott settles lawsuit related to its cholesterol drugs Reuters U.S. panel votes against Arpida antibiotic iclaprim Reuters Roche ordered to pay $13M to users of acne drug AP Vanda Pharmaceuticals takes second shot at FDA approval for schizophrenia treatment iloperidone Washington Business Journal 11/20 Negotiations for Major Health Reform Get Rolling Health Insurers Want Mandatory Coverage for Americans ... The health insurance industry proposed guaranteeing coverage for every American, regardless of medical condition, in return for an enforceable requirement that everyone have a policy. ... [ Bloomberg ] 11/20 Elan "Will Run Out of Money in 2 Years" Elan seeks deals to raise cash ... In the nine months ended September 2008, Elan posted a net loss of $240.5 million. It is burning cash at a rate of more than $300 million a year, and it has $1.7 billion in debt that comes due over the next five years ... [ Reuters ] 11/20 MRSA Treatment Passes Panel Theravance Wins U.S. Panel's Backing for Antibiotic ... Outside advisers to the Food and Drug Administration voted 21-5 that the once-a-day infusion, telavancin, is safe and effective against methicillin-resistant Staphylococcus aureus (MRSA) ... [ Bloomberg ] 11/20 A Lot of Kids are on Atypicals US panel urges study of antipsychotics in children ... Atypical antipsychotics, are increasingly being prescribed to children for unapproved uses, such as attention deficit hyperactivity disorder, or ADHD.... Children and teens now make up nearly 25 percent of all patients who fill a prescription for Risperdal... ... [ Reuters ] 11/20 Novartis Scrambles to Make Its Numbers Novartis to Combine Heart Pills as Afinitor Cancer Drug Delayed ... Novartis said it will combine the newer heart pill Tekturna with Diovan as well as other treatments, and plans to bring them to market before Diovan's 2012 patent loss. The experimental cancer drug Afinitor may reach the market in the first quarter of 2009 ... [ Bloomberg ] 11/20 Can You Skip Phase II? Novartis could cut drug development by a year ... Novartis's new approach, which uses disease models to predict measurable markers and responses, could apply in areas like oncology and genetic diseases and allow mid-stage trials to be shortened or even, in some cases, omitted completely ... [ Reuters ] 11/20 What Happens When Governments Negotiate Drug Prices UK government secures 3.9 pct cut in drug prices ... prices paid by the UK's state health service will be cut by 1.9 percent more in January 2010.... A flexible element has been added which will allow drug companies to supply drugs to the NHS at lower initial prices, with the option of higher charges if they prove to be of additional benefit to patients ... [ Reuters ] 11/20 Rough Day for AZN AstraZeneca hit by double Pulmicort, Zactima blow ... Teva has received FDA approval and can launch a generic copy of Pulmicort Respules... Also, AstraZeneca released study results showing that cancer drug Zactima will be useful in about 40 percent of second line patients suffering from non small cell lung cancer. The drug will not be the home run the company needed ... [ Reuters ] 11/20 Hormone Wars Continue Nevada sues drug manufacturers for trade practices ... The suit contends that Wyeth and Pfizer intentionally minimized the risks and exaggerated the benefits of their hormone therapy drugs, resulting in over-prescribing and a dramatic increase in hormone-positive breast cancers in post-menopausal women ... [ CNN Money ] 11/20 Allegra Settlement Teva paying more than $30M to settle Sanofi-Aventis suit ... Agreement is to settle patent infringement litigation over Teva's and Barr's U.S. generic versions of Aventis Pharmaceuticals' Allegra allergy medicine. ... [ Philadelphia Business Journal ] 11/20 Internet Drug News Miscellaneous Short Takes: Study Suggests Attending Religious Services Sharply Cuts Risk of Death Albert Einstein College of Medicine of Yeshiva University Gleevec May Treat Type 1 Diabetes HealthDay US teen lives 118 days without heart Reuters ADHD Medications Do Not Cause Genetic Damage in Children NIH News Release Sanofi Reps' Morale Hits New Low as Layoff Rumors Circulate bnet |
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