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WHO votes for a new leader of global health

World Health Organization member states began voting for the next director-general, with an Ethiopian candidate vying to be the first African to head the United Nations agency.

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FDA Voice Blog: FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis

“As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.” – Scott Gottlieb, M.D., Commissioner of Food and Drugs.

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UK competition watchdog accuses Merck of obstructing biosimilars

Britain’s competition watchdog has accused Merck & Co. of operating an unfair discount scheme for its medicine Remicade that it said was designed to restrict competition from so-called biosimilar copies.

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Biogen Spinoff Bioverativ Buying True North

Bioverativ is buying True North Therapeutics for an upfront payment of $400 million and up to $425 million in milestones.

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AstraZeneca asthma shot hits goal

AstraZeneca’s experimental injection for severe asthma cut substantially the need for patients to take problematic oral steroid drugs in a late-stage study.

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FDA Approves Kevzara for Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients

The U.S. FDA approved Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

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FDA approves first drug to specifically treat GCA

The U.S. FDA expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.

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FDA staff finds Puma Biotech’s cancer drug effective, shares soar

Shares of Puma Biotechnology Inc. surged about 80 percent after the U.S. Food and Drug Administration staffers concluded after a preliminary review that the company’s experimental breast cancer drug was effective.

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Celgene’s multiple sclerosis drug succeeds in late-stage trial

Celgene Corp. said its oral drug to treat relapsing multiple sclerosis met the main goal in a second late-stage study.

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Amgen Faces Setback as Osteoporosis Drug is Linked to Serious Heart Side Effects

Shares of Amgen fell after the company announced it does not anticipate its experimental osteoporosis drug Evenity will be approved by the U.S. Food and Drug Administration during 2017.

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