The U.S. Food and Drug Administration has granted breakthrough therapy designation for ocrelizumab (OCREVUS) for treating people with primary progressive multiple sclerosis (PPMS), Swiss drugmaker Roche said on Wednesday.   There are no approved treatments now for PPMS, a debilitating form of the disease marked by steadily worsening symptoms. “Roche plans to pursue marketing authorization […]

Flexion Therapeutics Inc’s pain drug was found to be effective in a late-stage study, taking the company one step closer to its first ever U.S. marketing approval. Flexion’s shares jumped about 38 percent in extended trading on Tuesday as the announcement revived hopes for the drug, which is touted to rake in peak U.S. sales […]

Join TrialScope’s Chief Strategy Officer, Thomas Wicks and Senior Product Specialist, Matt DeFranco, for a timely discussion of how life sciences teams can prepare for these changing requirements.

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

BioCryst Announces Results From OPuS-2 RESEARCH TRIANGLE PARK, N.C., Feb. 08, 2016 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc., (NASDAQ:BCRX) today announced results from OPuS-2 (Oral ProphylaxiS-2), a clinical trial of avoralstat administered three times daily as a liquid-filled soft gel formulation for the prophylactic treatment of hereditary angioedema (HAE) attacks. In the OPuS-2 study, HAE […]

– Study Stopped Early for Efficacy   THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ — Amgen (AMGN) today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO® (blinatumomab) […]

Privately owned vaccine developer Hawaii Biotech Inc has joined the race to produce a vaccine for the mosquito-borne Zika virus, a fast-spreading infection which has been linked to severe birth defects in babies. The company initiated a formal program to test a Zika vaccine last fall, as the virus began to gain traction in Brazil, […]

January 29, 2016By Mark Terry, BioSpace.com Breaking News Staff   Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. (REGN) recently filed with the town of East Greenbush, N.Y. to build a second campus in Rensselaer County. East Greenbush is a suburb of Tarrytown, where the company is headquartered. It employs approximately 1,200 people in East Greenbush, which is […]

January 28, 2016By Alex Keown, BioSpace.com Breaking News Staff   BOSTON – An issue of patient compliance in taking Vertex (VRTX)’s new blockbuster cystic fibrosis drug Orkambi is at the root of why the company has not issued sales guidance yet, the Boston Business Journal reported this morning. During the J.P. Morgan Healthcare Conference earlier […]

Incyte Corp said on Wednesday that it would stop a mid-stage study on its combination treatment after it failed to prove to be sufficiently effective to treat metastatic colorectal cancer. The results cast a shadow on the prospects of the drug, Jakafi, which is also being studied in a late-stage trial to treat advanced pancreatic […]