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Mylan may have overcharged U.S. for EpiPen by $1.27 billion: HHS

The U.S. government may have overpaid Mylan by as much as $1.27 billion between 2006-2016 for its EpiPen emergency allergy treatment, the Department of Health and Human Services said.

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Ohio sues five drug companies over opioid crisis

Ohio Attorney General Mike DeWine said his office sued five drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers, helping fuel a drug addiction epidemic.

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Teva’s migraine drug clears late-stage study

Teva Pharmaceutical’s experimental drug to prevent migraine cleared a late-stage study, paving the way for a U.S. regulatory submission during 2017.

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Nicox Receives FDA Approval Of Zerviate 0.24%

The U.S. FDA approved the New Drug Application for Nicox S.A.’s Zerviate, the first topical ocular formulation of the well-known antihistamine cetirizine.

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Meet the 31-Year Old Worth $3 Billion Helping Drug Companies Like Bristol-Myers Squibb and Pfizer Market in Doctors’ Offices

One of healthcare’s latest tech billionaires did not develop a new drug or device. Instead, Rishi Shah, founder of Outcome Health, installs tablet computers and large-format touch screens in physician’s waiting rooms and offices. The company announced a financing round that valued it at $5 billion pre-money. That means the 31-year-old Shah is now worth about $3.2 billion.

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Lilly Announces Phase 3 RANGE Urothelial Cancer Trial of Cyramza Met Primary Endpoint, Improving Progression-Free Survival

Eli Lilly and Company announced that its Phase 3 RANGE study of Cyramza (ramucirumab) met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement. The Phase 3 global, randomized, double-blinded, placebo-controlled trial is evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Bladder cancer accounts for the majority of all urothelial carcinoma.

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CRISPR, Editas Medicine and Intellia Fall as Scientific Paper Warns of Unintended Mutations Linked to Gene Editing

Are there unintended consequences of gene editing? A paper published in Nature Methods indicates there are and that news sent share prices of CRISPR, Editas Medicine and Intellia tumbling.

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Akari CEO Abruptly Steps Down Amid Investigation Into Phase II Trial Data

A little more than two weeks after being placed on administrative leave, Gur Roshwalb – chief executive officer of Akari Therapeutics – resigned his position.

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Spectacular Data Posted for Novartis’ Next Generation CAR-T Drug

Switzerland-based Novartis AG announced findings from a pilot study of CTL119 that had dazzling results. CTL119 is a CAR-T cell therapy, where T cells that express chimeric antigen receptors (CAR) are engineered to target any cancer antigen desired.

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Outcome Health Raises Financing at $5 Billion Valuation to Accelerate Growth and Transform Healthcare

Outcome Health announced a financing round valuing the company at $5 billion pre-money, to expand its impact from 20% to 70% of all U.S. physician practices by 2020.

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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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