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The Senate is taking its first steps toward considering new Medicare drug price negotiating authority for the federal government with a hearing scheduled for Jan. 11.
Australian biotechnology company Giaconda said that the European Patent Office has granted it a patent for Ibaconda, its combination therapy for irritable bowel syndrome (IBS).
The FDA approved abbreviated new drug applications filed by six generic drugmakers, allowing them to market generic versions of Merck's cholesterol treatment drug Zocor.
Congressional Democrats' plan to reduce Medicare costs through government-run drug-price negotiation falls short of expectations and is an empty gesture that fails to give the government the leverage it needs, sources say.
Plaintiffs are asking the Supreme Court to review the dismissal of a case to determine the legality of reverse payment agreements, where brand drugmakers pay generic rivals to keep their low-cost versions of prescription products off the market.
Generic firms Barr Pharmaceuticals and Dr. Reddy's Laboratories won FDA approval to market ondansetron, a generic version of GlaxoSmithKline's Zofran ODT indicated for the prevention of nausea and vomiting associated with cancer chemotherapy.
The biotechnology industry considers Democrats' push for government negotiation of Medicare drug prices to be its biggest threat and is actively lobbying lawmakers against the move, a leading industry expert says.
Reliant Pharmaceuticals has filed a lawsuit against Par Pharmaceutical in response to Par's plan to market propafenone HCl capsules, a generic version of Rythmol SR extended-release capsules.
Generic drug firm Barr Pharmaceuticals is seeking FDA approval to market thalidomide, a generic version of Thalomid, a skin defect drug manufactured by Celgene, Barr announced Dec. 26.
Presumptive House Speaker Nancy Pelosi's (D-Calif.) plan to prevent Republicans from offering alternatives to her Medicare direct negotiation legislation is not discouraging industry critics, who are still working to defeat the proposal.