Drugs

Pfizer, BioNTech Positive Data on Covid Vaccine Program

Pfizer and BioNTech have announced positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program. The data are available on an online preprint server at medrxiv. The data demonstrated the ability of BNT162 to elicit high SARS-CoV-2 neutralizing titers, the companies say, adding that specific antibody and T cell responses by the vaccine against the coronavirus receptor binding domain suggest a “potential for multiple beneficial protective mechanisms against Covid-19.”

Local reactions and systemic events after injection with the vaccine at all dose levels were “transient, generally mild to moderate, with occasional severe events (Grade 3) of flu-like symptoms and injection site reactions,” the companies say. No serious adverse events were reported, and there were no withdrawals due to adverse events related to the vaccine, they say.

Pfizer and BioNTech say the data will be used to determine a dose level and select the vaccine candidates to advance to a Phase 2b/3 safety and efficacy trial. The trial may involve up to 30,000 healthy participants and is expected to begin later this month, if regulatory approval is received.

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