Pfizer reported today that it had cut short a Phase III study of palbociclib, recently approved under an accelerated pathway as Ibrance, after clearly demonstrating that it had met its primary endpoint: progression-free survival with a combination of Ibrance plus fulvestrant in women with hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer.
Belgium's Galapagos says that its oral JAK1 inhibitor filgotinib met its primary and other endpoints in a crucial Phase IIb study for rheumatoid arthritis.
In the checkpoint receptors race, Bristol-Myers Squibb is out in front with the biggest and fastest effort, a comeback Merck is in hot pursuit and Roche/Genentech and AstraZeneca are following but still in the front of the pack.
Two Maryland-based companies are racing to get a vaccine for respiratory syncytial virus to market--and one just picked up a regulatory boost.
Two months ago Shire CEO Flemming Ornskov held up the rare liver disease drug SHP625 as a prime example of its most promising development programs. Today, though, Shire was forced to concede that the drug flopped against both the primary and secondary endpoints in the first of several Phase II studies.
Portola Pharmaceuticals has snapped in the last piece to a Phase III program puzzle for its "breakthrough" anti-anticoagulant, painting a clear path to an accelerated regulatory submission later in the year.
Ocular Therapeutix needed a clean sweep in its expansive Phase III program for a postoperative eye treatment in order to set itself up for a clear shot at an FDA approval. But it didn't get it.
While GlaxoSmithKline is still awaiting late-stage results for its shingles vaccine, HZ/su, Cowen & Co. analysts believe the vaccine may just be better than Merck's Zostavax.
Two Ebola vaccines, one developed by the NIH and GlaxoSmithKline and the other by Merck and NewLink, have sailed through Liberian trials and, based on the results, may now advance to Phase III trials.
PledPharma has posted Phase IIb data linking its oxidative stress protector to a 43% drop in incidence of chemotherapy-induced peripheral neuropathy. The data triggered a 20% jump in the stock price of the company as investors responded to the results and talk of a possible partnership.