|Shire and FDA Agree on Proposal of Midodrine; Bristol-Myers Enters Clinical Collaboration Agreement With Tibotec|
|By Staff and Wire Reports|
|Friday, 02 December 2011 18:40|
Shire plc (NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct additional clinical trials to confirm the clinical benefit of ProAmatine® (midodrine HCl), a medicine approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH).
This joint clinical trials proposal from CDER and Shire is being reviewed by the FDA Commissioner and, if accepted, will negate the need for a public hearing requested by Shire on this topic. Under the agreement, Shire will conduct two additional clinical trials and expects to begin the trials as soon as possible with an anticipated completion by the end of 2014. Midodrine HCl in its generic formulations will remain available to patients who rely on this medicine while the trials are conducted.
"The timeframe outlined in the proposal for additional clinical trials is consistent with Shire's original request and we are appreciative that we have come to agreement with CDER on this path forward," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire. "We've been committed to completing these additional clinical trials to confirm the efficacy of midodrine as a treatment for SOH and keep this important medication available for patients."
Bristol-Myers Squibb Co. (NYSE:BMY) announced that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus or HCV.
Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone.
The study is planned to start in the first half of 2012.
Biodel Inc. (Nasdaq: BIOD) will issue its fourth quarter fiscal year 2011 financial results on December 6, 2011.
Cepheid (NASDAQ: CPHD) today announced that its executives will be speaking at the following investor conferences, and invited investors to participate via webcast.
Corning Incorporated (NYSE:GLW) announced today that it has completed the acquisition of Mediatech, Inc., a Virginia-based corporation, including Mediatech’s subsidiary, KD Medical, Inc., a Maryland-based corporation.
Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the 2011 Deutsche Bank BioFEST Conference will be webcast and may be accessed at www.hgsi.com.
Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company focused on developing products to treat and prevent serious infectious diseases, announced that Russell H. Plumb, President and Chief Executive Officer, is scheduled to present an overview of the company and its pipeline of differentiated antiviral compounds at the Deutsche Bank BioFEST Conference on Monday, December 5, 2011 at 2:15pm EST.
Micro Imaging Technology, Inc. (OTCBB: MMTC) (OTCQB: MMTC) announced today that the Company's Annual General Meeting of Shareholders was held at MIT's offices on Wednesday, November 30, 2011 at 10:00 AM (PST) in accordance with the U.S. Securities and Exchange Commission approval of its October 11, 2011 Schedule 14A Filing - Information Required in a Proxy Statement.
Northwest Biotherapeutics (OTC.BB: NWBO) (Northwest Bio) announced today that it has implemented a major clean-up of its balance sheet, removing $31.5 million of liabilities through settlement, retirement and conversion.
Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY) ("Oncolytics") today announced that interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN®in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.
Pfizer Inc. (NYSE: PFE) announced today that it has completed its acquisition of Excaliard Pharmaceuticals, Inc., a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring.