In an ironic twist, FDA is asking APP Pharmaceuticals Inc. to let the agency know if any drug shortages will result from the need to take corrective action for GMP problems, in a warning letter dated the day after an agency press conference at which the company was praised for helping alleviate drug shortages.
Bayer Chief Worried About Innovation, Spanish Debts Bayer's chairman, Marijn Dekkers, calls for a greater appreciation of pharmaceutical inventors and brands, as the diversified Big Pharma reported group sales up 4% in 2011, and profits up 90% on lower charges.
The Biotechnology Industry Organization is critical of the timing and lack of specificity in the release of the draft version of PCORI’s national priorities and research agenda.
TAK-875’s Profile Emerges: Full results from a Phase II study show that Takeda’s novel GPR0 agonist stacks up to widely prescribed sulfonylureas, minus side effects like hypoglycemia.
“We do have to acknowledge some important, though sometimes difficult truths,” the FDA Commissioner tells GPhA annual meeting. While noting that shortages are problems for both brand and generic firms alike, she tells ANDA manufacturers that “perceptions are not always fair, but they still matter.”
During its fourth quarter and full-year 2011 earnings call Feb. 24, Idenix reported that it will begin a broad Phase IIb program testing its nucleoside polymerase inhibitor IDX184 in multiple interferon-free combinations of direct-acting antivirals for hepatitis C. The biotech also launched a Phase I safety and pharmacokinetics study of NS5A inhibitor IDX719 earlier this quarter.
