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U.S. approves first drug for psychosis linked to Parkinson’s

Acadia Pharmaceuticals Inc’s drug for psychosis linked to Parkinson’s disease was approved in the United States on Friday, becoming the first treatment for the condition to get a nod in the country. The U.S. Food and Drug Administration, however, asked Acadia to include a black-box warning, its strictest warning, on the drug’s label for an […]

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Gadavist approved as first contrast agent for MRA use of supra-aortic arteries

Bayer announced U.S. FDA approval of Gadavist (gadobutrol) injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease.

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Shire jumps as Vyvanse drug helps it to beat earnings forecast

Strong demand for Shire’s top-selling Vyvanse drug helped to lift the company’s first-quarter earnings by better-than-expected 12 percent.

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Abbott Tries to Back Out of $5.8B Alere Deal, But Alere Says It’s Still On

The announcement that Abbott was acquiring St. Jude Medical for about $25 million cast doubts on Abbott’s acquisition of Alere for $5.8 billion.

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Biogen, AbbVie multiple sclerosis drug wins EU green light

A once-monthly injection for multiple sclerosis from Biogen and AbbVie has been recommended for approval by European regulators, paving the way for its launch in the coming months.   The European Medicines Agency said on Friday its experts had endorsed Zinbryta, or daclizumab, for the treatment of relapsing forms of multiple sclerosis (MS), adding a […]

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Medivation Says No! to Sanofi’s $9.3 Billion Hostile Bid

\   April 29, 2016By Mark Terry, BioSpace.com Breaking News Staff   San Francisco-based Medivation (MDVN) announced today that its board of directors had unanimously decided to reject Sanofi’s unsolicited bid for the company. On March 25 and April 3, Olivier Brandicourt, chief executive officer of Sanofi (SNY), discussed on the phone with David Hung, […]

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FDA Sued for Not Disclosing More Info on the Experts Determining the Fate of Drugs and Devices

  April 29, 2016 By Alex Keown, BioSpace.com Breaking News Staff   WASHINGTON – A consumer group, the Public Citizen Foundation, Inc., filed a lawsuit against the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services to force the agencies to disclose more information about the people on advisory committees […]

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AstraZeneca cuts costs and doubles down on cancer drugs

AstraZeneca is to cut costs by $1 billion and increase its focus on cancer treatments after underlying earnings, hit by drug patent expiries, fell 12 percent in the first quarter, broadly in line with analyst expectations.   Chief Executive Pascal Soriot said on Friday he would sharpen the prioritization of investments and increase spending in […]

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Sanofi launches $9.3 billion fight for U.S. cancer firm Medivation

French drugmaker Sanofi went public with a $9.3 billion offer to buy Medivation, setting up what could be a lengthy takeover battle after the U.S. cancer firm rebuffed its approaches.

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Diabetes drug test results boost Novo Nordisk

Novo Nordisk said on Thursday a late-stage trial showed its new once-weekly diabetes drug significantly reduced patients’ cardiovascular risks, boosting the company’s hopes of maintaining its lead in the fast-growing diabetes market.   Shares in the Danish drugmaker rose as much as 3.5 percent on the news. The trial, dubbed SUSTAIN 6, showed the drug […]

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