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FDA Approves Sublocade, the First Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder

Indivior PLC announced that the U.S. FDA approved Sublocade (buprenorphine extended-release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

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Exclusive: U.S. health regulator Verma eyes new methods for drug pricing

The U.S. government is considering setting new payment methods aimed at curbing costs for Medicare and Medicaid coverage of breakthrough medical treatments with very high prices, particularly novel gene-based therapies for cancer and other diseases, a top health official said.

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Aimovig Halves Length of Migraine Attacks in Study

Amgen unveiled results from a late-stage study that shows the company’s Phase III drug Aimovig reduced monthly migraine attacks in half.

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Nine Biotechs Facing FDA Decisions in December 2017

The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.

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FDA aims to approve more drugs based on early clinical data

The U.S. Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival, the head of the agency told lawmakers at a hearing.

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ArmaGen’s AGT-181 Granted Fast Track Designation for the Treatment of Hurler Syndrome

ArmaGen Inc. today reported that the U.S. FDA granted Fast Track designation to AGT-181. The novel, investigational enzyme replacement therapy is being developed for the treatment of somatic and cognitive symptoms in patients with Hurler syndrome (also known as mucopolysaccharidosis type I, or MPS I).

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GSK starts large African study of injectable drug to prevent HIV

ViiV Healthcare, GlaxoSmithKline Plc’s HIV unit, said it started an African study to evaluate long-acting injectable drug for the prevention of HIV infection in sexually active women.

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FDA Clears First Medical Device Accessory for Apple Watch

AliveCor today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime and anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.

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The Medicines Co. Deals Infectious Disease Biz

The Medicines Company is selling its infectious disease business unit to Melinta Therapeutics. The deal is expected to close in the first quarter of 2018.

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Sanofi expects $120 million hit as dengue vaccine hits major snag

Use of Sanofi’s dengue vaccine, the world’s first approved shot against the mosquito-borne virus, is to be strictly limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

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