FDAnews Drug Daily Bulletin

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 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.