Drugs

Suit Seeks Info on Any Sharpless Drug Conflict

Is biotech G1 Therapeutics, which was cofounded by FDA acting commissioner Ned Sharpless, getting preferential treatment for its cancer drug trilaciclib? Progressive watchdog group Restore Public Trust says something smells fishy after the drug was recently given “breakthrough status” and company officials have reportedly been told by FDA to prepare a submission without having to conduct a Phase 3 trial.

The watchdog group has just filed a Freedom of Information Act (FOIA) lawsuit seeking responses to four FOIA requests for documents regarding any Sharpless contact with G1 Therapeutics including potential meetings and phone calls. “In the eleven years since its founding in 2008, G1 Therapeutics has never commercialized a single drug or made a single dollar in commercial revenue,” the group says. “But in five months with Sharpless as acting FDA commissioner, they’ve seen their lead drug candidate rapidly accelerate toward approval – twice – thanks to positive feedback from the federal agency their founder now leads. Something very swampy is going on at FDA and Americans deserve to know the extent to which FDA commissioner Sharpless worked to assist his former company in fast-tracking their drug, potentially using his position to enrich himself and his friends.”

According to Restore Public Trust, G1’s stock 12/2018 plummeted after trilaciclib failed to outperform placebo in a Phase 2 clinical trial. [Editor’s note: G1 notes that trilaciclib is being evaluated in four randomized Phase 2 clinical trials and it has reported positive results from all of these trials in 2018.] In April, the group says FDA explicitly told the company that their next step should be to file for approval and that further testing was never even mentioned in the FDA feedback. And on 8/7, G1 announced that trilaciclib was granted a breakthrough therapy designation, further expediting the development and review of the drug. “Just one day after the most recent news, G1 Therapeutics stock rose over 26%,” the group says.

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