Phase III
Safety Concerns Force Loss of Breakthrough Therapy Designation for Synthetic Biologic’s C. Diff Drug
Shares of Synthetic Biologics are down more than 14 percent this morning after the company announced that SYN-004 (ribaxamase), the company’s treatment for the Clostridium difficile infection (CDI), lost the Breakthrough Therapy Designation awarded by U.S. Food and Drug Administration last year.
Prothena Corporation announced it had shuttered its NEOD001 program for AL amyloidosis after the failure of its Phase IIb PRONTO study and Phase III VITAL study. Shares dropped 60 percent in premarket trading at the news.
Novartis released new information that showed siponimod consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.
The U.S. Food and Drug Administration (FDA)’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously recommended the approval of London, UK-based GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Amgen announced final data from its Phase IIIb LIBERTY clinical trial of Aimovig (erenumab), with positive results likely to lead to a blockbuster drug for migraine sufferers.
Nearly two months after Eli Lilly secured an expanded approval indication for its cancer drug Verzenio, the company unveiled final data from the MONARCH 3 trial that won the latest nod from the U.S. Food and Drug Administration for the treatment of some breast cancer patients.
Johnson & Johnson reported a strong first quarter with $20 billion in sales that was fueled by significant growth in its pharmaceuticals business.
The U.S. Food and Drug Administration (FDA) granted Genentech, a Roche company, Breakthrough Therapy Designation for Hemlibra (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors.
Bristol-Myers Squibb announced initial positive Phase III data, yet company shares dropped more than six percent.
Industry watchers and investors have shown some concern that Merck is abandoning other potentially lucrative areas of research to focus on exploiting every last bit of Keytruda’s potential
PRESS RELEASES