Drugs

Merck Scraps Covid Therapy on Data Request

Merck says it is stopping development of MK-7110 (formerly known as CD24Fc) for treating hospitalized patients with Covid-19 due to additional FDA data requests. Merck received the therapy in a 12/2020 acquisition of OncoImmune. Previously, the company and the U.S. government penned a $356 million deal to supply the U.S. with 60,000 to 100,000 doses of MK-7110.

After taking over the drug development, Merck received FDA feedback that additional data, beyond a study conducted by OncoImmune, would be needed to support a potential Emergency Use Authorization submission. “Based on the additional research that would be required – new clinical trials as well as research related to manufacturing at scale – MK-7110 would not be expected to become available until the first half of 2022,” the company says. Stopping the development program means Merck will shift resources to focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s Covid-19 vaccine, it adds.

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

Read more

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