FDAnews Drug Daily Bulletin
Oct. 17, 2012 | Vol. 9 No. 204
The FDA has approved a new indication for Roche’s Actemra to treat adults with moderately to severely active rheumatoid arthritis (RA) who have responded poorly to one or more disease-modifying anti-rheumatic drugs.
An upcoming FDA final guidance on risk-based monitoring of clinical investigations will include more specifics for drugmakers on developing monitoring plans, as industry has requested.
The Supreme Court has left intact existing precedents that allow OTC-drug makers to be sued for failing to place warnings on their products that are more robust than the OTC monograph requires.
Abbott Laboratories said its experimental hepatitis C drug regimen cured 99 percent of patients in a midstage study with the most common and hardest-to-treat type of the disease.
Two more drugs created by the pharmacy linked to a nationwide meningitis outbreak are suspected of contamination and may have caused meningitis and another type of fungal infection, the FDA said.
Aegerion Pharmaceuticals rose after a U.S. regulatory staff report said a plan to manage the risks of the company’s drug supports its approval in adults with the most life-threatening forms of severely high cholesterol.
Daclizumab, a biologic drug targeting the interleukin-2 pathway, showed sustained efficacy in the second year of a Phase II trial in multiple sclerosis, but serious autoimmune issues also emerged, researchers said.
ArQule, Daiichi Sankyo Reach Agreement With FDA on Special Protocol Assessment for Phase III Trial of Tivantinib in Hepatocellular Carcinoma
ArQule announced a Special Protocol Assessment agreement with the FDA for the design of a pivotal Phase III trial of tivantinib in patients with hepatocellular carcinoma.
The FDA has given Eli Lilly’s Alimta (pemetrexed injection) its Paragraph IV certification.
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