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The Pulse of the Pharmaceutical Industry

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Trump pushes drugmakers for lower prices, more U.S. production

U.S. President Donald Trump called on the pharmaceutical industry to boost U.S. production and lower prices, while also vowing to speed up approval times for new medicines and appoint a new U.S. Food and Drug Administration leader soon.

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OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375

OptiNose today announced the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application (NDA) for the investigational new product OPN-375 for the treatment of nasal polyposis in adults.

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U.S. court ruling on MS drug deals blow to Teva

A bitter defeat in a U.S. patents case is the latest in a series of setbacks for Teva that has investors calling for major changes at the generic drugmaker.

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Pfizer Quietly Kills 3 Pipeline Programs

At its annual financial report, Pfizer quietly indicated that it had canceled three pipeline projects from its programs.

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Lilly Reports Fourth-Quarter and Full-Year 2016 Results

Fourth-quarter 2016 revenue increased 7 percent, driven by volume growth from Trulicity and other new pharmaceutical products. Full-year 2016 revenue increased 6 percent to $21.2 billion.

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Votubia receives EU approval for new indication

Novartis broadened the indications for its Votubia drug with EU approval of its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex.

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Mylan says being investigated over EpiPen practices

Mylan NV said U.S. antitrust authorities had launched an investigation into its EpiPen emergency allergy treatment.

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U.S. Court Of Appeals Affirms Cumberland Pharmaceuticals’ Victory In Patent Litigation Case

Cumberland Pharmaceuticals Inc. – a specialty pharmaceutical company focused on hospital acute care and gastroenterology – announced that the U.S. Court of Appeals for the Federal Circuit ruled in favor of Cumberland in a patent case associated with its Acetadote product.

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FDA Approves Two Teva Asthma Inhalers

Teva Pharmaceutical Industries Ltd. announced FDA approval of two products for adolescent and adult patients with asthma: AirDuo RespiClick and ArmonAir RespiClick.

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Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a First-in-class, Small Molecule Arginase Inhibitor

Incyte Corporation and Calithera Biosciences Inc. announced that the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology.

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Merck Reveals Recent U.S. Drug Price Increases

As drug pricing continues to be a concern for the public and the new presidential administration, Merck pulled back the curtain on its U.S. pricing practices.

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How Trump’s Immigration Ban is Already Hurting Science

Billed as a measure to bolster national security, President Donald Trump’s executive order blocking travel, immigrants and refugees from seven majority-Muslim countries is having ripple effects impacting the science and biotech communities and could be the start of a brain drain in the U.S.

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Danish drugmaker Novo Nordisk bets $145 million on post-Brexit UK science

Novo Nordisk – the world’s top maker of diabetes drugs – is investing 115 million pounds ($145 million) in a new research center in Britain, undeterred by Brexit.

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Europe faces steep price increases for some old cancer drugs

European prices for some off-patent cancer drugs have risen by more than 100 percent in the past five years, with two cases of hikes exceeding 1,000 percent, according to data presented at a medical conference.

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Facebook Chief, Chan Charity Buys Artificial Intelligence Startup to Battle Disease

The Chan Zuckerberg Initiative – founded by Priscilla Chan, a physician, and her husband, Facebook chief executive officer Mark Zuckerberg – acquired Torontobased artificial intelligence company Meta.

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Amgen Receives Positive CHMP Opinion For ABP 501 (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications.

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Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending XELJANZ (tofacitinib citrate) 5 mg twice daily for the treatment of patients with moderate to severe active rheumatoid arthritis.

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