Archive for July, 2008

Genmab A/S and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study Summary: Phase III Pivotal Study of Ofatumumab in Refractory CLL Meets Primary Endpoint

Thursday, July 31st, 2008

COPENHAGEN, July 31 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) and GlaxoSmithKline announced today positive top-line results from an interim analysis of the Phase III pivotal study evaluating ofatumumab (HuMax-CD20(R)) to treat two groups of chronic lymphocytic leukemia (CLL) patients with high unmet medical need. At the interim analysis, the study met the primary endpoint in both populations...

Bayer AG Names New U.S. CEO to Head Bayer Corporation

Thursday, July 31st, 2008

PITTSBURGH, July 31 /PRNewswire/ -- The Management Board of Bayer AG announced today that Greg Babe will become President and CEO of Bayer Corporation and the Senior Bayer Representative in North America, succeeding Dr. Attila Molnar, who will retire from the company after 30 years of service, effective October 1, 2008. Bayer Corporation is the U.S. subsidiary of the Bayer Group of Germany...

Biogen Idec, Inc. (Massachusetts), Elan Corporation PLC Report Tysabri Brain Disease Cases; Shares Fall After Market

Thursday, July 31st, 2008
LOS ANGELES (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and Elan Corp Plc (ELN.I: Quote, Profile, Research) said on Thursday they have notified regulators of two confirmed cases of a potentially deadly brain disease in multiple sclerosis (MS) patients being treated with Tysabri.

Biogen Idec, Inc. (Massachusetts), Elan Corporation PLC Report Tysabri Brain Disease Cases; Shares Fall After Market Thursday

Thursday, July 31st, 2008
LOS ANGELES (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and Elan Corp Plc (ELN.I: Quote, Profile, Research) said on Thursday they have notified regulators of two confirmed cases of a potentially deadly brain disease in multiple sclerosis (MS) patients being treated with Tysabri.

Amgen Licenses Molecule for the Treatment of Chronic and Neuropathic Pain to Ortho-McNeil-Janssen Pharmaceuticals, Inc. in a Deal Worth Potentially $385 Million

Thursday, July 31st, 2008
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Amgen (NASDAQ: AMGN - News) today announced that it has licensed a clinical stage molecule for the treatment of chronic and neuropathic pain to Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company. The terms of the agreement include a $50 million upfront payment, the potential for $385 million in success-based milestones and additional...

MDRNA, Inc. Announces Phase 2 Trial of PYY(3-36) Does not Meet Weight Loss Endpoint

Thursday, July 31st, 2008
BOTHELL, Wash.--(BUSINESS WIRE)--MDRNA, Inc. (Nasdaq: MRNA - News) announced today results from a Phase 2 clinical trial evaluating PYY(3-36) Nasal Spray (PYY) for the treatment of obesity. The data indicate that PYY did not meet the primary efficacy endpoint of a dose response of weight loss vs. PYY dose, nor did PYY meet the secondary efficacy endpoint of greater weight loss than the active control...

Gilead Sciences Ltd. and Merck & Co., Inc. Enter Into an Agreement to Register and Distribute HIV Medication Atripla(R) in Twelve Countries

Thursday, July 31st, 2008
FOSTER CITY, Calif. & WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) and Merck & Co., Inc. (NYSE:MRK - News) today announced that the companies have entered into an agreement through which Gilead will assume the lead role for the distribution of Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in 12 countries located primarily...

Biogen Idec, Inc. (Massachusetts), Elan Corporation PLC Report Tysabri Brain Disease Cases; Shares Fall

Thursday, July 31st, 2008
LOS ANGELES (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and Elan Corp Plc (ELN.I: Quote, Profile, Research) said on Thursday they have notified regulators of two confirmed cases of a potentially deadly brain disease in multiple sclerosis (MS) patients being treated with Tysabri.

Vertex Pharmaceuticals Incorporated Hepatitis C Drug Meets Study Goal

Thursday, July 31st, 2008
CAMBRIDGE, Mass. - Vertex Pharmaceuticals Inc. said late Thursday its hepatitis C drug candidate telaprevir was both safe and prompted a response in patients during a midstage study.

EKR Therapeutics, Inc. Receives FDA Approval for Ready-to-Use Intravenous Bags of Cardene(R) I.V.

Thursday, July 31st, 2008
BEDMINSTER, N.J.--(BUSINESS WIRE)--EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and Drug Administration for Cardene I.V. (nicardipine hydrochloride) premixed injection, a patented, ready-to-use (RTU), single use intravenous bag for the administration of...