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FDA product review fees may double or more

The cost to healthcare companies for U.S. regulatory review of their products would more than double under the Trump administration’s proposed 2018 budget.

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China Food and Drug Administration Approves Xeljanz

Pfizer China announced that it has received approval from the CFDA to market its oral Janus kinase inhibitor, Xeljanz (tofacitinib citrate), in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

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Patients left blind after paying for experimental stem cell treatment

Researchers are warning consumers to be wary of doctors who claim to be able to cure illness using stem cells after three women, at least two who thought they were enrolling in a government-registered trial, were left legally blind when the unproven therapy failed.

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U.S. government reports decline in Obamacare individual enrollment

Enrollment in the individual insurance plans created under Obamacare declined to 12.2 million Americans, the U.S. government said as Republican lawmakers and the Trump administration sought to repeal the healthcare law.

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GSK files for new Fluarix Quadrivalent indication

GlaxoSmithKline announces U.S. regulatory submission seeking expanded indication for Fluarix Quadrivalent (Influenza Vaccine) for infants 6 months and older.

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Americans Spent More Than $15 Billion On Aesthetic Procedures For The First Time Ever

The American Society for Aesthetic Plastic Surgery (ASAPS) reports that Americans spent more than $15 billion during 2016 on combined surgical and nonsurgical aesthetic procedures for the first time ever, accounting for an 11% increase over 2015 alone. Surgical procedures account for 56% and nonsurgical procedures account for 44% of the total.

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Higher rate of second heart attacks in patients who can’t tolerate statins

After a heart attack, taking one of the drugs known as statins can lower the risk of a second attack, but for people who go off statins because of side effects, that risk rises again sharply, researchers say.

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Catalyst’s neuromuscular drug succeeds in study

Catalyst Pharmaceuticals Inc.’s experimental drug to treat patients with a severe form of myasthenia gravis, a rare neuromuscular disease, met the main goals of a study.

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Despite Expansion Overall, Roche Diabetes Care Lays Off 157

Roche Diabetes Care announced that it plans to lay off 157 staffers as part of its U.S. Commercial Operations restructuring. Of those employees, 133 are full-time, 24 are contractors, and 42 are based in Indianapolis.

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Merck’s Keytruda wins FDA nod for treating blood cancer

Merck & Co. Inc. said it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer.

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