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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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Troubled Otonomy Cuts Jobs

Otonomy, which develops innovative therapeutics for diseases and disorders of the ear, is initiating more job cuts as well as planning to divest one of its assets.

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Azar says drug pricing a top priority

Alex Azar – a former drug industry exec who Republicans nominated to run the Department of Health and Human Services – promised to lower drug prices that he said are too high, saying he would look at abuse of patent laws that delays generic competition.

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Auris Abandons Hearing-Loss Drug After Phase III Flop, Stock Sinks

Auris Medical Holding’s HEALOS Phase III clinical trial of AM-111 for acute inner ear hearing loss failed to meet its primary endpoint.

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UK approves world’s first OTC Viagra

Pfizer’s big-selling erectile dysfunction drug Viagra was given a green light for sale without a prescription in Britain, the first country to grant it over-the-counter status.

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Tens of thousands dying from $30 billion fake drugs trade, WHO says

One in 10 drugs sold in developing countries is fake or substandard, leading to tens of thousands of deaths with many of them of African children given ineffective treatments for pneumonia and malaria, health officials said.

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Merck KGaA, Pfizer’s immunotherapy fails in gastric cancer trial

Germany’s Merck KGaA suffered a setback in the development of the company’s key cancer immunotherapy Bavencio, which failed in a trial to prolong lives in gastric cancer patients when compared with standard chemotherapy.

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Takeda moves ahead in Zika race with launch of vaccine trial

Japan’s Takeda Pharmaceutical moved ahead in the race to develop a vaccine for the mosquito-borne Zika virus, with the start of a clinical trial program backed by the U.S. government.

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Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab’s Biologics License Application

Kyowa Hakko Kirin Co. Ltd. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for mogamulizumab to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.

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Europe’s HIV epidemic growing at alarming rate, WHO warns

The number of people newly diagnosed with HIV in Europe reached its highest level in 2016 since records began, showing the region’s epidemic growing “at an alarming pace,” health officials said.

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Merck Plots 950-Job R&D Hub in London

Merck & Co. plans to move its European clinical operations to central London and bring in 150 new scientists and 800 additional staff.

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