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Brand manufacturer Acorda is fending off at least six different generic challenges filed in the last few weeks to its multiple sclerosis drug Ampyra. Read More
The FDA has rejected a citizen petition filed by health advocacy group Public Citizen calling for a black-box warning about cardiovascular risks on testosterone products. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More
Starting statin therapy earlier in people with lower risks of cardiovascular disease (CVD) could save thousands of lives and billions of dollars annually, according to guidance issued Friday from the UK’s healthcare costs regulator. Read More
AbbVie’s persistent courtship of Irish drugmaker Shire paid off with a roughly $54 billion merger that gives the U.S. company access to a promising rare disease drug pipeline and a more tax-friendly climate. Read More
Manufacturers reporting adverse events suspected to be caused by vaccines should submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor. Read More
The price of Gilead’s hepatitis C drug Sovaldi once again is drawing bipartisan fire from Capitol Hill, this time from two senators who are demanding answers as to how the company arrived at the product’s $1,000-a-pill price tag. Read More
Abbott Laboratories is sharpening its focus on devices and diagnostics, selling its developed markets generic drug business to Mylan for $5.3 billion in stock. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More