Hospira has voluntarily suspended shipments of two drugs – Propofol, an anesthesia, and Liposyn, a fat emulsion for low birth weight babies – to address manufacturing concerns raised by FDA in a recent warning letter.
Since being acquired and then spun back out by Merck in the past decade, Aton Therapeutics has staked out a very distinct business approach – in-licensing and marketing mature products for ophthalmic and orphan conditions. With its acquisition of Parkinson’s disease drug from Bristol-Myers Squibb April 26, however, the specialty pharma appears to be broadening its therapeutic focus.
FDA's Anti-Infective Drugs Advisory Committee meets April 29 to discuss the World Health Organization's NDA for artesunate rectal suppositories for the initial treatment of patients with acute malaria.
U.S. Supreme Court rules that investors filed a timely securities class action against Merck alleging the company knowingly misrepresented the heart attack risks associated with Vioxx. The court said the clock on the statute of limitations for filing a suit begins to run once the plaintiff actually discovered or reasonably would have discovered the facts of a violation.
AstraZeneca finalizes its $520 million settlement with the Department of Justice to resolve an investigation of its Seroquel (quetiapine) sales and marketing practices. Attorney General Eric Holder and HHS Secretary Kathleen Sebelius announced the settlement at a press conference in Washington, D.C. April 27.
