SOUTH SAN FRANCISCO, Calif.— Genentech announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe
MADISON, Wis. — Nimble Therapeutics announced a multi-year collaboration with Genentech, a member of the Roche Group, to accelerate discovery and development of novel peptide-based medicines for targets across a range of diseases. The collaboration will leverage Nimble’s proprietary peptide synthesis, screening and optimization platform, chemical diversity, and integrated suite of assays to enable
WASHINGTON – Pharmaceutical Research and Manufacturers of America (PhRMA) announced today that Genentech, a member of the Roche Group, South San Francisco, and Gilead Sciences, Inc., Foster City, Calif. joined the association as members. Genentech and Gilead Sciences are two of the world’s leading biopharmaceutical companies dedicated to discovering and developing medicines to fundamentally change how patients with life-threatening
SOUTH SAN FRANCISCO, Calif. — Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action
McKINNEY, Texas — Soleo Health, an innovative leader in specialty infusion services, announced the company has been selected by Genentech (member of the Roche Group), a world-leading biotechnology company with multiple products on the market and a strong development pipeline, to dispense two limited distribution drugs, Hemlibra and Ocrevus. Hemlibra (emicizumab-kxwh), for patients with hemophilia A with factor VIII inhibitors, received approval from
SOUTH SAN FRANCISCO, Calif. — Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The FDA is expected to make a decision on approval by
PITTSBURGH and BENGALURU, India — Mylan N.V. has received Food and Drug Administration approval for Ogivri (trastuzumab-dkst), a biosimilar oncology drug co-developed with Biocon Ltd. Mylan said Friday that Ogivri is a biosimilar of Herceptin (trastuzumab) from Genentech, indicated for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
ARLINGTON, Va. — The Healthcare Distribution Alliance (HDA) has made new appointments to its executive committee and HDA Research Foundation board of directors. HDA said Thursday that Paul Dickson, president of Morris & Dickson Co., has been elected as a member of the HDA Executive Committee. He currently serves as a member of the HDA
COLORADO SPRINGS, Colo. — Henry Dale Smith Jr., chairman and chief executive officer of H.D. Smith Holding Co., has received the 2016 Nexus Award for Lifetime Achievement from the HDA Research Foundation. Smith was presented the award, the pharmaceutical distribution industry’s highest individual honor, at the Healthcare Distribution Alliance (HDA) 2016 Business and Leadership Conference
