WASHINGTON – With yet another deadline looming this week, a congressional conference committee has come to terms on a "minibus" bill that includes a 2012 budget for the FDA of nearly $3.8 billion.
Both the FDA and Salix Pharmaceuticals Inc. will be looking to members of the Gastrointestinal Drugs Advisory Committee Wednesday for answers on designing a clinical trial to demonstrate the safety and efficacy of an antibiotic intended to be used intermittently to treat a chronic condition.
In lieu of a much-promised and oft-delayed guidance on social media, biopharma has been told to apply existing guidance on drug promotion to online communication. But in many instances, that's like trying to fit a square peg into a round hole.
The match Tranzyme Pharma Inc. struck with Bristol-Myers Squibb Co. (BMS) two years ago will continue to spark the discovery of potential new macrocyclic drug candidates – at least for an additional six months.
WASHINGTON - Fiscal 2011 produced a bumper crop of new drug approvals with historic breakthroughs in a number of areas. But the yield on biologics actually dropped.
If successful, efforts to reduce the 12 years of data exclusivity granted under the Affordable Care Act for innovative biologics could prove to be costly for patients, payers and the companies that make the drugs.Reducing data exclusivity to seven years, as the president and a number of lawmakers have proposed, would be disruptive to the marketplace as it would encourage at-risk launches of biosimilars and lead to unnecessary patent litigation, said Dave Fox, former associate chief counsel for drugs at the FDA and a partner at Hogan Lovells.
Amylin Pharmaceutical Inc. lost its preliminary bid to block Eli Lilly and Co. from jointly promoting diabetes drugs Byetta and Tradjenta, but its underlying challenge to Lilly's marketing strategy has yet to get its day in court.A U.S.
WASHINGTON – In trying to identify the culprit for the drug shortage crisis facing the nation, the Department of Health & Human Services (HHS) had only to look to the marketplace. But finding a solution isn't as easy.Patent expirations, a rush to generic drugs, manufacturing capacity limitations, pricing issues and expanding use of oncology drugs have combined to create a record number of shortages in off-patent sterile injectables, according to a new report from the Office of the Assistant Secretary for Planning and Evaluation at HHS.
