Big Lots BIG Seasonal Play Print E-mail
By Staff and Wire Reports   
Monday, 02 November 2015 08:53
In Monday’s Goldman Guide we reviewed the recent successes of some mega cap stocks. Bigger is better right now. Additionally, we mentioned the fact that year end seasonality usually favors small cap stocks. Finally, there is the holiday retail effect.
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.
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.
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.
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.
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.
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.       
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.
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.
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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