Q BioMed and Mannin Sign Definitive License Agreement Print E-mail
By Staff and Wire Reports   
Sunday, 01 November 2015 22:31
Q BioMed Inc. (OTC Pink: QBIO), a biotechnology acceleration company is pleased to announce it has signed a definitive license, with the option to acquire, the platform technology assets of Mannin Research Inc.
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Amgen's first-in-class Oncolytic Drug wins FDA Approval Print E-mail
By Damian Garde-FierceBiotech   
Wednesday, 28 October 2015 13:45
Amgen ($AMGN) won a landmark approval for a re-engineered virus designed to fight skin cancer, preparing to launch a first-of-its-kind therapy that could star in future combination treatments.
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AstraZeneca Announces FDA Recommendation for Lesinurad Print E-mail
By Silvia Fernandez - Pioneer News   
Sunday, 25 October 2015 17:35
Today, pharmaceutical giant AstraZeneca announced that the US Food and Drug Administration Arthritis Advisory Committee (FDA AAC) voted 10-4 in favor of recommending approval for lesinurad 200 mg tablets.
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Shire hit with another setback as FDA rejects top pipeline drug Print E-mail
By John Carroll - FierceBiotech   
Friday, 23 October 2015 09:59
Shire CEO Flemming Ornskov has yet another setback to grapple with as his company winds toward the end of a strange year. The FDA has rejected the company's application for the dry-eye drug lifitegrast, a key drug that the biotech has billed as a blockbuster earner, despite its mixed record in the clinic.
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FDA Reviewers Raise Doubts about AstraZeneca's $1.3B Gout Drug Print E-mail
By Damian Garde - FierceBiotech   
Wednesday, 21 October 2015 20:39
AstraZeneca's (NYSE: AZN) new gout therapy, acquired in a $1.3 billion buyout, might not be effective enough to outweigh its safety risks, according to FDA staff, casting doubts on the drug's future as it heads for a key panel vote.
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Bristol-Myers, Five Prime Expand Work on Cancer, Other Drugs Print E-mail
By Linda A. Johnson - AP   
Thursday, 15 October 2015 20:08
Drugmaker Bristol-Myers Squibb Co. is expanding its collaboration with Five Prime Therapeutics Inc., which could receive more than $1.75 billion if they succeed in turning Five Prime's antibody-based drug candidates into approved medicines for cancer and immune-system disorders.       
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Medtronic CoreValve® System Demonstrates Excellent Clinical Outcomes in First Report of 'Real-World' U.S. Experience Print E-mail
By Staff and Wire Reports   
Monday, 12 October 2015 18:43
Medtronic plc (NYSE: MDT) released the first CoreValve® Transcatheter Aortic Valve Replacement (TAVR) System outcomes data using CoreValve data from The Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry.
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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib Print E-mail
By Staff and Wire Reports   
Thursday, 08 October 2015 20:02
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.
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Novartis' (NVS) Sandoz Files for Enbrel Biosimilar in the U.S Print E-mail
By Zacks Equity Research   
Monday, 05 October 2015 19:02
Novartis NVS (NYSE: NVS) announced the FDA has accepted its generic arm, Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s AMGN blockbuster drug, Enbrel (etanercept).
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Researchers help S.A. diabetic woman with new procedure Print E-mail
By KENS5.com   
Monday, 05 October 2015 10:04
San Antonio has double the nationwide diabetic rate according to the American Diabetes Association but a local woman could be the first person cured with a new cell transplant procedure.
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