A new class of cholesterol-lowering medicines from Pfizer Inc. and Amgen Inc. may struggle to meet sales projections, as latest treatment guidelines suggest doctors should prescribe only drugs proven to help the heart.
U.S. regulators won’t require Amgen Inc., Sanofi, Pfizer Inc. and other companies developing the next class of cardiovascular medicines to prove the therapies prevent heart attacks and death before they’re approved.
GlaxoSmithKline Plc’s Avandia, the best-selling diabetes pill that was pulled off the market in Europe and tightly restricted in the U.S. because of its heart risks, will undergo another regulatory review.
Cheryl Barcomb, a school-district clerk in Pittsford, New York, never wanted to start taking Shire Plc’s Replagal medicine for her rare genetic illness. Now, after more than two years, she doesn’t want to give it up.
Pfizer Inc. may get a reprieve from generic competition to its $11 billion Lipitor cholesterol pill as Ranbaxy Laboratories Ltd. fights regulatory breaches that threaten to derail its push to produce the first U.S. copies.
Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts. A scandal over leaking breast implants made in France may make the argument harder.
Gilead Sciences Inc., the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.
U.S. drug approvals in 2012 reached their highest level in 15 years, led by 11 new cancer therapies, including Ariad Pharmaceuticals Inc.’s Iclusig and Pfizer Inc.’s Bosulif, both aimed at forms of leukemia.
Pfizer Inc. will withdraw its blood cancer drug Mylotarg after 10 years on the U.S. market because studies didn’t prove it works and the treatment was linked to deaths from liver and lung complications.