Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer
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- Category: Novartis
Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
Pfizer aims to become industry leader in gene therapy with acquisition of Bamboo Therapeutics, Inc.
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) has acquired Bamboo Therapeutics, Inc., a privately held biotechnology company based in Chapel Hill, N.C., focused on developing gene therapies for the potential treatment of patients with certain rare diseases related to neuromuscular conditions and those affecting the central nervous system.
Bristol-Myers Squibb reports second quarter financial results
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the second quarter of 2016, which were highlighted by strong sales, key regulatory and clinical milestones in Immuno-Oncology and business development transactions that strengthened the company's Immuno-Oncology pipeline.
Merck receives Breakthrough Therapy Designation from FDA and PRIME status from EMA for investigational Ebola Zaire vaccine (V920)
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- Category: Merck
Merck (NYSE:MRK), known as MSD outside the United States and Canada, has announced two regulatory milestones for the company's investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status.
Roche delivers continued growth in the first half of 2016
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- Category: Roche
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline,
The European Stroke Organisation and Boehringer Ingelheim launch the "Angels Initiative"
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- Category: Boehringer Ingelheim
Suffering a stroke is one of the most devastating medical emergencies that can happen to a person. It is also a great challenge for the medical personnel treating the patient, trying to save their patients' life and independence.
Pfizer receives World Health Organization prequalification for multi-dose vial presentation of Prevenar 13®
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced today that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 - valent, adsorbed]). WHO prequalification allows for the global use of Prevenar 13® MDV by United Nations agencies and countries worldwide that require WHO prequalification.
More Pharma News ...
- Amgen and Daiichi Sankyo announce agreement to commercialize biosimilars in Japan
- Boehringer Ingelheim and Lilly announce clinical trial collaboration in metastatic breast cancer
- FDA approves first and only single monthly injection for a PCSK9 inhibitor
- Merck and Pfizer initiate Phase III trial to evaluate Avelumab as first-line treatment for ovarian cancer
- Merck commits €1.5 million to the Grant for Fertility Innovation (GFI) for 2016/17
- Sanofi Pasteur signs research agreement for Zika vaccine
- Bristol-Myers Squibb acquires Cormorant Pharmaceuticals