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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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BTG’s pulmonary embolism device work faster and at lower doses in study

British pharmaceutical firm BTG said its EKOS combination therapy device for pulmonary embolism (PE) was effective using smaller drug dosages and shorter treatment periods than the current standard.

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AstraZeneca Offloads Heart Drugs to Recordati in $300 Million Deal to Pump Up R&D

AstraZeneca PLC sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati S.p.A. for $300 million.

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Trimbow is the first triple combination in a single inhaler for the treatment of COPD to receive positive opinion from the CHMP in Europe

Chiesi Group announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for the extrafine triple combination ICS/LABA/LAMA, under the brand name Trimbow, for the first time in a single inhaler for the treatment of Chronic Obstructive Pulmonary Disease.

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CHMP backs Novartis’ Zykadia for first-line use

Novartis’ push to win approval for Zykadia as an initial treatment for a type of lung cancer got a lift with a positive recommendation from the EMA’s CHMP.

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5 Biotechs Releasing Highly Anticipated Data

A look at five biotech companies in the cancer market and their upcoming releases at the 2017 American Society of Clinical Oncology (ASCO).

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Two NIH Sources Reveal President Trump is Considering New Cuts to Biomedical Research

All eyes will be on the White House Is President Donald Trump is expected to release his full budget proposal–which reportedly still contains deep cuts to the National Institutes of Health (NIH).

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Apple CEO Spotted Wearing a Prototype Glucose-Tracker on the Apple Watch

Apple continues to delve into the medtech world. Chief Executive Officer Tim Cook was seen wearing a new device that monitors his blood sugar levels and tracks how those levels respond to things such as diet and exercise.

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Novartis to Shed Another 500 Jobs, Add 350 High-Tech Jobs

Novartis AG is shaking up its operations by terminating approximately 500 production and development positions in Switzerland, but adding an additional 350 jobs to its growing biotech business, Matthias Leuenberger said in a posting on the company’s Swiss site.

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FDA Approves Keytruda for Bladder Cancer

Merck’s Keytruda (pembrolizumab) received FDA approval for two new indications for certain patients with locally advanced or metastatic urothelial carcinoma, including first-line treatment in patients ineligible for cisplatin-containing chemotherapy.

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Kieran Walsh Appointed President of Greater Than One Inc.

Greater Than One Inc. (GTO) announced the appointment of Kieran Walsh as President of its US operations. Walsh is responsible for leading the GTO staff and offices in New York and San Francisco, and for providing oversight on all US-based accounts.

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