Topic:
Regulatory
Latest Headlines
Latest Headlines
Amgen to pay $25M to wrap up Aranesp kickbacks case
Amgen has inked another marketing settlement with the U.S. government. The biotech giant agreed to pay $24.9 million to wrap up allegations that it used kickbacks to induce long-term care pharmacies to use more of its Aranesp anemia drug--and not only for patients with anemia caused by chronic kidney failure, the drug's officially approved use.
Baxter warned for marketing infusion pump minus PMA
The FDA cited Baxter Healthcare for selling an infusion pump without premarket approval. As a result, the company's SIGMA Spectrum Infusion Pump with Master Drug Library is also misbranded, regulators allege in an April 1, 2013, warning letter addressed to Baxter CEO Robert Parkinson, Jr.
Vivus revs up new Qsymia sales plan after FDA removes a roadblock
The FDA has agreed to take down one of the big hurdles hampering U.S. sales of Vivus' newly approved weight drug Qsymia, but plenty more remain.
FDA halts generic OxyContin, handing Purdue a victory
For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic version of the highly addictive OxyContin on the market vs. consumers with pain issues having access to cheaper meds.
FDA denies inhaled migraine drug from Allergan
The U.S. regulator handed Allergan, which picked up the migraine therapy Levadex in its $958 million buyout of Map Pharmaceuticals last year, a complete response letter for its application for marketing approval, denying approval on concerns about manufacturing.
Compounders' recalls come as Hamburg faces tough questions
Even as she prepared to face tough questioning, the FDA was issuing more recalls of sterile products from a number of the 30-high risk compounders the agency has been inspecting during a crash campaign this year.
Sarepta slips as FDA seeks more data on eteplirsen
Sarepta Therapeutics has kept hopes alive for gaining accelerated approval for its lead drug eteplirsen for Duchenne muscular dystrophy.
Supreme Court questions validity of Myriad's gene patents
Early indications are that the U.S. Supreme Court may jeopardize the future of Myriad Genetics' patents regarding two cancer-related genes, at least in their current form.
Report slams FDA's response to CRO's fraudulent study data
The FDA is feeling the sting from defunct Cetero Research's fraudulent drug trial data nearly three years after investigators raided the CRO's Houston labs. ProPublica has written a critical report on the agency's response to the fraudulent findings from Cetero's labs, citing sources that call out the regulator for acting slowly and keeping the public in the dark.
All eyes on Supreme Court as it weighs Myriad's gene patents
In August, Myriad Genetics won an appeals court affirmation of its rights to patent isolated genes related to cancer, but today the Supreme Court will take up the issue of whether intellectual property stretches all the way to the genetic code.
