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As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.
Leading generic firm Teva Pharmaceutical will have partial marketing exclusivity privileges once it launches rabeprazole sodium, a generic version of Eisai’s acid-pump inhibitor drug, Aciphex.
A little more than week after Ranbaxy Laboratories launched generic Lipitor in Denmark, Pfizer won a preliminary injunction blocking its sale, a Pfizer spokesman said.
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.
A pathway for creating and marketing generic biologics could help health plan sponsors and patients save $71 billion over the next 10 years, according to an Express Scripts report.
The U.S. Patent and Trademark Office rejected claims in a key patent covering Genentech’s respiratory treatment drug, Synagis, the company said, noting that it is contemplating challenging the decision.
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 last week.
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.
The UK’s National Health Service’s (NHS) drug price regulation scheme should be changed to a value-based system that focuses more on patients and providing better benefits, an Office of Fair Trading (OFT) report recommended.
Shire Laboratories’ plan to acquire a smaller specialty drug manufacturer, giving it full control of the marketing and manufacturing of the attention-deficit/hyperactivity disorder (ADHD) drug Vyvanse, could put it in the same market as generic Adderall XR, according to a company source.