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GSK’s three-in-one inhaler gets positive opinion from EU agency

GlaxoSmithKline said a European Medicines Agency (EMA) panel recommended for approval the company’s three-in-one inhaled lung drug.

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Prostate cancer drug clears late-stage trial

Pfizer Inc. and Astellas Pharma Inc. said their drug to treat a type of prostate cancer met the main goal of improving overall survival in a late-stage trial.

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Aspen to buy remaining AstraZeneca anesthetic rights

AstraZeneca agreed to sell the U.S. rights to a portfolio of anesthetics to South Africa’s Aspen Group.

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Interim Analysis from Phase 3 Open-Label Extension Study Shows Sustained Benefits of Soliris Treatment for Patients with Refractory Generalized Myasthenia Gravis

Alexion Pharmaceuticals Inc. announced results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris (eculizumab) for the treatment of patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.

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Teva to sell women’s health assets to CVC Capital Partners: report

Teva Pharmaceutical Industries Ltd. is close to a deal to sell its women’s health assets outside the United States to private equity firm CVC Capital Partners, the Fly reported, citing Bloomberg.

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‘Impressed’ FDA panel unanimously recommends GSK shingles vaccine

A U.S. Food and Drug Administration advisory panel voted 11-0 that the safety and efficacy of GlaxoSmithKline’s Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.

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A healthy heart can also help keep the mind sharp

Many of the same things people should do for a healthy heart – such as exercising, eating well and avoiding cigarettes – can also help protect the brain from cognitive decline and dementia, according to the American Heart Association and the American Stroke Association.

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Discrepancy between trial goals, results may mask treatment risks

Scientists often fail to publicly register plans for clinical trials or to publish the results, and the outcomes they do share may mask instances when new treatments are unsafe or ineffective, a small study suggests.

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Biotechs Ramp up Clinical Trial Programs as FDA Looks at More Efficient Drug Development Programs

The hope of new measures for the FDA to advance the regulatory path for drug development is forging ahead incorporating relatively swift pivotal data in seeking accelerated approvals.

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Otonomy Slashes Staff After Failed Phase III Study

Otonomy is cutting jobs and slashing operations in order to stay in business.

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Bay Area Startup BridgeBio Quietly Snags $135 Million From a Bunch of Wall Street Firms

BridgeBio Pharma, which was founded in 2015, recently closed on a $135 million series C round that was co-led by Viking Global Investors and KKR. They were joined by Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital, and Janus Funds.

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Dupixent Takes Another Step Toward Blockbuster Status

On Sept. 11, 2017, Regeneron Pharmaceuticals and Sanofi announced positive data for its Phase III LIBERTY ASTHMA QUEST trial of Dupixent (dupilumab) in asthma. Investors and analysts do not seem to agree on whether dupilumab is on its way to being one of the biggest blockbuster drugs in the last two years, or if it’s the most overhyped drug on the market.

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Amicus Ends Lead Rare Disease Drug Program

Amicus Therapeutics terminated a late-stage wound-treatment therapeutic after it failed to meet primary and secondary endpoints in a Phase III trial.

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Purohit Navigation hires new VP, Brad Sherrill, for West Coast development

Purohit Navigation, a full-service healthcare communications and advertising agency, hired Brad Sherrill as Vice President of Account Services.

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Progress on global poverty and disease at risk, Gates says

Proposed United States budget cuts could put in jeopardy great progress in reducing global poverty and disease and lead to 5 million more deaths from AIDS alone, the philanthropist Bill Gates warned.

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Key U.S. senators reach deal on funding children’s health program

Leaders of the U.S. Senate Finance Committee said they reached an agreement to finance a federal insurance program for millions of lower-income children and pregnant women that was due to expire at the end of September 2017.

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Mylan says Allergan misusing tribal sovereignty in patent dispute

Generic drugmaker Mylan NV alleged in a court filing that rival Allergan Plc is trying to take advantage of Native American sovereignty to shield its patent for the blockbuster dry-eye treatment Restasis.

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Texas calls in U.S. Air Force to counter post-storm surge in mosquitoes

Texas launched aerial attacks on mosquitoes swarming coastal regions of the state and threatening to spread disease and hinder disaster recovery in the aftermath of Hurricane Harvey.

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Vertex Ends Phase II CF Trial

Vertex Pharmaceuticals reportedly terminated a long-acting trial combining a recently acquired therapy with the company’s cystic fibrosis drug Kalydeco.

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Sage’s seizure drug fails key trial

Sage Therapeutics Inc.’s shares tumbled 23 percent after its drug to treat a life-threatening seizure disorder failed to meet the main goal of a key trial.

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