Drugs

FibroGen Paying $1.25 Million to SEC

The Securities and Exchange Commission (SEC) says it has accepted an offer from FibroGen to resolve a cease-and-desist order covering false and/or materially misleading statements about the results of certain cardiovascular safety analyses of the firm’s anemia drug roxadustat. A commission order details how the firm’s former chief medical officer “reverse engineered” the initial Phase 3 trial results between 2019 and 2021 to show that roxadustat was superior to epoetin alfa, when in fact the data showed that the two drugs were comparable at best.

The SEC says that between 2019 and 2021, the company raised about $5.6 million in proceeds from its employee stock purchase plan. When a 4/6/2021 company news release disclosed that its previously reported trial results had been based on post-hoc changes to stratification factors, the company’s stock fell by some 41%.

The filing says FibroGen violated provisions of the SEC law and regulations that prohibit fraudulent statements in the offer or sale of securities and in connection with the purchase or sale of securities.

“In determining to accept the [Fibrogen] offer,” the SEC says, “the commission considered FibroGen’s cooperation with the staff’s investigation and agreement to cooperate in a commission investigation and related enforcement action and its remedial efforts.”

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