Drugs

Galena Updates Federal False Claims Act Probe

Galena Biopharma says it faces greater risks as it learns more about a 12/16/15 subpoena from the U.S. Attorney in New Jersey for records relating to the company’s marketing and promotional practices for Abstral (fentanyl), which it sold in the fourth quarter of that year. The company says in an SEC filing that prosecutions under healthcare fraud and abuse and false claims laws and regulations have increased in recent years and the company may become subject to such prosecutions or related litigations under those laws and could face substantial penalties if it has not fully complied with the laws.

The notice also says that a federal investigation of two of the high-prescribing doctors for Abstral has resulted in their criminal prosecution for alleged violations of the False Claims Act and other laws in a trial that began 1/4. The company says it has received a trial subpoena for documents relating to that investigation and has been in contact with the Alabama U.S. Attorney. It says it is cooperating in producing the documents.

Galena further reports there have been federal and state investigations of a company that has a product that competes with Abstral in the same therapeutic class and says it has learned that FDA and other government agencies are investigating Abstral promotion practices.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome