AstraZeneca announced positive results from its Phase III OlympiAD trial comparing LYNPARZA (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.
Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.
Fremont, Calif.-based Ardelyx announced that its Phase III clinical trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis met its primary endpoint.
Another experimental amyloid-targeting Alzheimer’s treatment has failed. Merck & Co. pulled the plug on its Phase II/III study of verubecestat for use in patients with mild-to-moderate Alzheimer’s disease.
Gilead Sciences has thrown down a challenge to GlaxoSmithKline with good clinical trial results for an experimental HIV drug.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
The New Jersey Rare Disease Alliance will hold its annual Rare Disease Day commemoration on February 27 at the New Jersey Business and Industry Association (NJBIA).
Shares of Acorda Therapeutics were up more than 14 percent after the company announced its Phase III drug CVT-301 hit its endpoints in treating patients with Parkinson’s disease experiencing OFF periods.
AstraZeneca canceled its combination of PD-L1 durvalumab and CTLA-4 medication tremelimumab in pancreatic ductal carcinoma.
Amgen Inc. said its potent cholesterol fighter Repatha significantly reduced the risk of heart attacks, strokes and death in patients with heart disease.