Despite their insistence that the bar for opioid painkillers must be raised, two FDA advisory committees voted 14-3 Tuesday to recommend approval of Teva Pharmaceutical Industries Ltd.'s Vantrela ER (hydrocodone) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative options are inadequate. Read More

SHANGHAI – Epimab Biotherapeutics Inc., of Shanghai, inked its first licensing deal for its bispecific antibody platform technology to one of China's rising biopharma stars, Innovent Biologics Inc., of Suzhou. Read More

Citing "unclean hands," a U.S. district judge barred Merck & Co. Inc., of Kenilworth, N.J., Monday from asserting two patents against Foster City, Calif.-based Gilead Sciences Inc., overturning a $200 million award a jury had granted Merck earlier this year. Although Gilead's sales of hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) infringed Merck's patents, Judge Beth Labson Freeman determined that "Merck's persistent misconduct involving repeated fabricated testimony and improper business conduct" outweighed its right to sue Gilead for infringement. Read More

Vascular Biogenics Ltd., of Tel Aviv, Israel, said it has agreed to sell and issue approximately 4.36 million ordinary shares to institutional investors in the U.S. at $5.50 per share in a registered direct offering with gross proceeds of approximately $24 million. Rodman & Renshaw, a unit of H.C. Wainwright & Co., acted as the exclusive placement agent for the registered direct offering. Read More

Relmada Therapeutics Inc., of New York, said the FDA designated d-Methadone (dextromethadone, REL-1017), a N-methyl-d-aspartate receptor antagonist, as an orphan drug to manage postherpetic neuralgia. Read More

Aeterna Zentaris Inc., of Charleston, S.C., reconfirmed its expectation that the pivotal, phase III trial for Zoptrex (zoptarelin doxorubicin) in women with advanced, recurrent endometrial cancer, is expected to be completed in the third quarter of 2016, with a planned new drug application for the candidate to follow in the first half of 2017. Read More

Bergenbio AS, of Bergen, Norway, said clinical data from its lead product candidate BGB324, a first-in-class selective Axl kinase inhibitor demonstrated the clinical activity, tolerability and mechanism-of-action of BGB324 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Read More

CHICAGO – Immunotherapy is increasingly becoming a pillar of cancer treatment, as checkpoint inhibitors continue to demonstrate tumor regression and survival benefits, and a growing body of biomarker research informs treatment decisions. Read More

HONG KONG – China's Frontier Biotechnologies Co. Ltd. achieved positive results in a phase III study for the world's first injectable long-acting HIV drug. The weekly dose drug is targeted at Chinese patients via local development and manufacturing. Read More

But for outcomes in "a patient or two," Alexion Pharmaceuticals Inc.'s top-line results from the trial called Regain with Soliris (eculizumab) in refractory generalized myasthenia gravis (gMG) "would have been very different," CEO David Hallal said, calling the data package available so far "compelling and certainly supportive of the potential efficacy." Read More

Bone Therapeutics SA's autologous osteoblastic cell therapy for osteonecrosis of the hip hit the primary endpoint of a phase IIb trial, with one single treatment sufficient to slash fracture rates in two and to induce clinical responses that lasted up to three years. Read More

Biogen Inc. shares (NASDAQ:BIIB) sank 12.8 percent to close at $252.86 on Tuesday after the company said that opicinumab missed both the primary and secondary efficacy endpoints in the phase II study Synergy, which evaluated the candidate as a therapy for people with relapsing forms of multiple sclerosis (MS). Despite the miss, the company said, "evidence of a clinical effect with a complex, unexpected dose-response was observed." Read More

SAN FRANCISCO – With "the age of authoritarian medicine" fast giving way to an era of consumer-driven health care, patients are more often "involved from the beginning" in defining what happens at the FDA, Commissioner Robert Califf told attendees at the BIO International Convention. The latitude drugmakers have to do so remains fuzzier. Read More

SAN FRANCISCO – With last week's European nod for Fabry disease drug Galafold (migalastat), Amicus Therapeutics Inc. has performed a feat few biopharmas get to experience: Completing the transition from start-up to commercialization. Read More

SAN FRANCISCO – America's journey into the tricky landscape of value-based health care, pioneered by hospitals and insurers, continues to beckon drugmakers to get onboard. But logistical difficulties and open questions around who benefits from the approach are slowing its march, panelists said during a session on the subject at the BIO International Convention. Read More

In a brief statement released following Monday's market close, Sarepta Therapeutics Inc. revealed that the FDA requested additional dystrophin data as part of its ongoing review of the new drug application (NDA) for Duchenne muscular dystrophy (DMD) candidate, eteplirsen. According to Sarepta, the agency said the dystrophin data, as measured by Western blot, could be acquired from biopsies already obtained from PROMOVI, the ongoing confirmatory study of eteplirsen. Read More