Merck & Co. Inc. succeeded in overcoming regulatory friction to win FDA approval for Zinplava (bezlotoxumab), a monoclonal antitoxin antibody targeting Clostridium difficile infection (CDI) in adults at high risk for recurrence of the infection who are also on antibacterial therapy.
Theravance Biopharma Inc. and Mylan NV reported that revefenacin, a nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), met the primary endpoints in twin phase III studies, demonstrating statistically significant improvements from baseline over placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of dosing for each of two doses studied.
SAN FRANCISCO – Significant and justified excitement in the microbiome therapeutics space remains tempered by very real challenges in the field’s R&D and business pursuits, executives said Tuesday during the first day of the BIO Investor Forum.
The rise of a complex and lucrative specialty drug market in the U.S. has created not only new opportunities for drugmakers, but also new challenges. With a significant portion of care shifting from in-patient to out-patient settings and insurers tightening the reins on specialty drug coverage, drugmakers have turned to patient assistance programs (PAPs) to help them succeed.
The third quarter's biggest disclosed biopharma partnership has hit a snag. Just a month after Regeneron Pharmaceuticals Inc. convinced Teva Pharmaceutical Industries Ltd. to pay $250 million up front and significant milestones to co-develop lead pain asset fasinumab, the FDA has placed a clinical hold on a phase IIb study testing the drug against chronic lower back pain.
Contravir Pharmaceuticals Inc. reported that 10 hepatitis B patients treated with its once-daily tenofovir prodrug, CMX157 (tenofovir exalidex), saw viral load reductions comparable to those achieved with Viread, an earlier tenofovir prodrug from Gilead Sciences Inc.
Rxi Pharmaceuticals Corp. negotiated an exclusive option to acquire privately held cancer immunotherapy developer Mirimmune Inc. The all-stock deal will give Mirimmune shareholders nearly a 20 percent equity stake in Rxi should it close as expected and could provide it further equity-based payments upon hitting certain undisclosed milestones.
Full results of Tesaro Inc.'s phase III NOVA trial presented at the European Society for Medical Oncology meeting show that the company's once-daily PARP inhibitor, niraparib, significantly extended the time during which women with recurrent ovarian cancer were able to live with their disease before their tumors began to grow again.
Clovis Oncology Inc. (NASDAQ:CLVS) shares fell 17.8 percent on Friday as investors wrestled with the competitive implications of data submitted in rucaparib's new drug application (NDA) and presented at the European Society for Medical Oncology congress in Copenhagen. p>
Vtesse Inc. has notched new progress toward full enrollment of a pivotal trial of its experimental Niemann-Pick type C1 (NPC) therapy, VTS-270, dosing its first patient in Germany.
