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.
Amgen and Daiichi Sankyo announce agreement to commercialize biosimilars in Japan
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- Category: Daiichi Sankyo
Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE 4568) today announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.
Boehringer Ingelheim and Lilly announce clinical trial collaboration in metastatic breast cancer
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- Category: Boehringer Ingelheim
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC.
FDA approves first and only single monthly injection for a PCSK9 inhibitor
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- Category: Amgen
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) PushtronexTM system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.
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- Bristol-Myers Squibb acquires Cormorant Pharmaceuticals
- Novo Nordisk and Aarhus University team up on world-class talents
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- Bristol-Myers Squibb and PsiOxus Therapeutics announce immuno-oncology clinical collaboration