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Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
Federal policymakers should ensure the FDA has adequate resources to review and approve follow-on biologics in a timely and effective manner, according to American Enterprise Institute (AEI) Research Fellow Scott Gottlieb.
Schering-Plough and Merck have announced an agreement to jointly develop a fixed-dose cholesterol drug that will combine Zetia and atorvastatin, which sold by Pfizer under the brand name Lipitor.
Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
A new Medicaid rule being proposed by the Centers for Medicare & Medicaid Services (CMS) could discourage generic drug use and should be amended to reflect actual acquisition costs for retailers that fill prescriptions with generic drugs, a pharmacist group said.
Sales of buproprion hydrochloride extended-release are expected to continue for two more months, according a new agreement aimed at resolving patent litigation brought by Biovail to block generic versions of its antidepressant drug, Wellbutrin XL.
Ranbaxy may have joined the bidding war for Merck KGaA’s generic drugs division, according to a company source that confirmed reports of the generic firm’s interest in acquiring the billion-dollar division.
Generic drug firms operating in the European Union (EU) should work closely with state agencies to mitigate drug approval delays caused by bureaucratic overload, the European Generic medicines Association (EGA) said at an industry conference in February.
Despite lower fourth-quarter income due to generic competition for one of its top products, Savient Pharmaceuticals saw significant earnings in 2006, according to financial results released by the company.