Thursday , December 14 2017
Home / 2016 / December

Monthly Archives: December 2016

FDA Approves Biogen’s Spinraza, the First Treatment for Spinal Muscular Atrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) approved Biogen’s (NASDAQ: BIIB) SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants …

Read More »

Genentech’s Ocrevus Demonstrates Positive Results in Phase III Multiple Sclorosis Study

December 21, 2016 05:00 PM Eastern Standard Time SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple …

Read More »

Alexion’s Soliris Fails to Meet Primary Endpoint in Mid-Stage Study in Kidney Transplant Patients

December 21, 2016 04:04 PM Eastern Standard Time NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today reported results from the PROTECT Study, a Phase 2/3 registration trial of eculizumab (Soliris®) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney. …

Read More »

Incyte and Merus Partner to Discover and Develop Bispecific Antibodies

WILMINGTON, Del. & UTRECHT, Netherlands–(BUSINESS WIRE)–Dec. 21, 2016– Incyte Corporation (NASDAQ:INCY) and Merus N.V. (NASDAQ:MRUS) announced today that they have entered into a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The Collaboration and License Agreement grants Incyte …

Read More »

Genentech’s Emicizumab for Hemophilia A Meets Primary Endpoint in Phase III Study

December 22, 2016 01:00 AM Eastern Standard Time SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the primary endpoint has been met for the Phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or …

Read More »

FDA Accepts sNDA for Pfizer’s Ibrance in HR+, HER2- Metastatic Breast Cancer

Wednesday, December 21, 2016 – 8:00am EST Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE® (palbociclib). The sNDA supports the conversion of the accelerated approval of IBRANCE in combination …

Read More »

Merrimack Discontinues Phase 2 Trial of MM-302 in HER2-Positive Metastatic Breast Cancer

CAMBRIDGE, Mass., Dec. 21, 2016 /PRNewswire/ — Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that, following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer …

Read More »

Galapagos Reports Positive Results From Its Phase 2 Study of Its Cystic Fibrosis Drug

Mechelen, Belgium; 20 December 2016 – Galapagos NV (Euronext & NASDAQ: GLPG) reports topline results from its SAPHIRA 1 Phase 2 study in cystic fibrosis patients with potentiator GLPG1837. The SAPHIRA 1 trial included 26 patients with the G551D mutation in CFTR each receiving three sequential doses of GLPG1837. Of …

Read More »

Allergan to Acquire Acelity L.P. Inc.’s LifeCell Corporation for $2.9 Billion

DUBLIN, Dec. 20, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, and Acelity today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire the regenerative medicine company LifeCell for $2.9 billion in cash, subject to customary adjustments. The acquisition …

Read More »

FDA Grants Breakthrough Therapy Designation to Juno and Celgene’s JCAR017 in Lymphoma

SEATTLE & SUMMIT, N.J.–(BUSINESS WIRE)–Juno Therapeutics, Inc. (NASDAQ: JUNO) and Celgene Corporation (NASDAQ: CELG), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large …

Read More »