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European Commission Approves Pfizer’s Trumenba to Help Prevent Meningococcal Group B Disease in Adolescents and Adults

Pfizer Inc. announced that the European Commission approved Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.

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Germany’s Evotec Plans to Hire Scientists and Execs at New U.S. HQ

Germany-based Evotec AG recently cut the ribbon on its U.S. headquarters in Princeton, NJ. The company indicates that it chose Princeton, over, for example, Cambridge, Mass., or the San Francisco Bay Area, because it liked the talent pool there.

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Bay Area Biotech, J&J Ink IBS Deal

J&J subsidiary Janssen inked a collaboration deal to develop Protagonist Therapeutics’ PTG-200 for various gastrointestinal diseases.

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Merck Receives FDA Approval of Isentress HD

Merck announced that the U.S. FDA approved Isentress HD, a new 1,200 mg once-daily dose of the company’s integrase inhibitor Isentress (raltegravir).

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Novartis has assets to sell, investors wary of what it might buy

As Novartis considers asset sales that could raise $50 billion, investors are worried any cash raised may give the Swiss drugmaker firepower for another unsuccessful megadeal.

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Gilead’s HIV drug meets goal in four late-stage studies

Gilead Sciences Inc. said a combination of its experimental HIV drug with existing therapies met the main goal in four late-stage studies.

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Array BioPharma and Bristol-Myers Squibb Announce Strategic Collaboration

Array BioPharma and Bristol-Myers Squibb announced the companies have entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Array’s investigational MEK inhibitor binimetinib in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors.

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Kite NHL Drug Receives FDA Priority Review

Kite Pharma announced that the U.S. FDA accepted for priority review the BLA for axicabtagene ciloleucel for refractory aggressive non-Hodgkin lymphoma (NHL).

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Journalist Sues FDA for Documents Related to Sarepta’s DMD Drug

Charles Seife, a journalist, author and professor at New York University, filed a federal lawsuit against the U.S. Food and Drug Administration related to documents over the approval of Sarepta Therapeutics’ Exondys 51 for Duchenne muscular dystrophy (DMD).

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Biocryst Stock Caught Fire After Reporting Positive Phase II HAE Data

Investors are cooling off on Biocryst Pharmaceuticals despite the company’s strong interim reports for its Phase II hereditary angioedema (HAE) treatment. After rising about 45 percent in premarket trading, shares of Biocryst were down more than 14 percent.

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February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!


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