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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submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor.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
Pfizer is facing at least three class action lawsuits alleging that the company went to extraordinary, fraudulent lengths to maintain exclusivity over its multibillion dollar arthritis pain drug Celebrex and keep generic competitors off the market. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More