Trevena Inc on Tuesday said only some doses of its experimental opioid painkiller were found as effective as morphine in two late-stage studies, even though the drug outperformed a placebo – meeting its main study goals. Trevena’s intravenous formulation, which is designed to extract the pain-reducing potential of an opioid but with fewer side-effects, was…
Pfizer Blood Cancer Drug Tops Standard Therapy for Untreated Patients
Pfizer Inc said on Monday its cancer drug, Bosulif, was found superior to Novartis AG’s Gleevec in a late-stage study on untreated patients with a form of blood and bone marrow cancer characterized by abnormal white blood cells production. Most people with chronic myeloid leukemia (CML) have a genetic mutation, called the Philadelphia chromosome, which…
Pfizer’s Herceptin Biosimilar Succeeds in Key Breast Cancer Study
Pfizer Inc said on Wednesday its experimental biosimilar of Roche Holding AG’s blockbuster breast cancer treatment Herceptin was found comparable with the branded version in a key study. Biotech drugs such as Herceptin are made in living cells, and then extracted and purified. They are more complex than traditional drugs and cannot be copied with…
Anthem Says It Will Not Cover Sarepta’s Approved Duchenne Drug
Health insurer Anthem Inc said it will not cover Sarepta Therapeutics Inc’s drug to treat the rare condition of Duchenne muscular dystrophy (DMD), calling it “investigational and not medically necessary.” The U.S. Food & Drug Administration approved the drug last month under pressure from patient advocates, even though an outside panel of experts and the…
Regeneron’s Eylea Combination Therapy Fails Mid-Stage Study
Regeneron Pharmaceuticals Inc said a combination therapy containing its flagship eye drug, Eylea, was inferior to Eylea alone in a mid-stage trial involving patients with wet age-related macular degeneration (AMD), a leading cause of blindness in the elderly. Regeneron’s shares fell 3.6 percent, and were the biggest drag on the Nasdaq biotech index. Shares of…
FDA Approves J&J’s Autoimmune Drug Stelara for Crohn’s Disease
Johnson & Johnson said on Monday that the U.S. Food and Drug Administration approved the company’s blockbuster psoriasis drug, Stelara, for use in adults with Crohn’s disease. The drug is approved in the United States to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. Read more. Source: Reuters
FDA Panel Recommends Dropping Serious Warning on Pfizer’s Chantix
A serious warning on Pfizer Inc’s (PFE.N) quit smoking drug should be removed, 10 of 19 independent panelists to the U.S. Food and Drug Administration recommended on Wednesday, after reviewing additional trial data on the controversial treatment. Pfizer’s Chantix was approved about a decade ago, but thousands of reports of mental health problems in users…
Retrophin Kidney Drug Exceeds Expectations, Shares Jump
Retrophin Inc said its drug for a rare kidney disorder, which has no specific treatment, was found safe and effective in a mid-stage study, sending the company’s shares soaring as much as 44 percent on Wednesday. Analysts said the efficacy and safety profile of the drug, sparsentan, exceeded expectations, keeping them optimistic about the possibility…
Lilly Cancer Drug Hits Hurdle, Panel Recommends Study Continue
An independent panel’s interim analysis of Eli Lilly and Co’s breast cancer drug abemaciclib showed the treatment did not meet the effectiveness criteria in a late-stage trial. The panel recommended the trial continue through the first half of 2017, the company said on Wednesday. Read more. Source: Reuters