In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid-19, the FDA said its policy will compel generation of more evidence for these groups. Our roundup of regulatory news includes notable firsts for Alzheimer’s diagnosis and migraine treatment.
Despite achieving strong responses against influenza A, a Phase 3 test of a Pfizer and BioNTech flu and Covid-19 combination vaccine did not meet goals against less common influenza B. These results come two months after Moderna’s combination vaccine succeeded in its Phase 3 trial.
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Apple Tree Partners’ latest startup is Red Queen Therapeutics, developer of stapled peptide drugs that block viral fusion. Its lead program is on track for Phase 2 testing in immunocompromised Covid-19 patients; a preclinical pan-influenza program is in development under a BARDA contract.
GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company.
An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses.
The former Pfizer statistician worked on the clinical trial for the Covid-19 drug Paxlovid. A jury found the employee guilty of insider trading for transactions made before clinical data for the antiviral were publicly announced.
The home care industry is booming. As Baby Boomers age and more families seek in-home solutions for loved ones, demand for home care services is at an all-time high.
Contract development and manufacturing organizations cannot develop or distribute vaccines alone, but through partnerships, their infrastructure can provide the foundation for delivering life-saving tools swiftly and equitably when a new public health crisis emerges.
Pfizer lowered its revenue projections for 2023, a change it attributed to declining demand for its Covid-19 vaccine, Comirnaty, and antiviral drug, Paxlovid. Citing this revenue decline, Pfizer is implementing a companywide cost-cutting plan projected to save $3.5 billion.
New York, Florida, Texas and Minnesota terminated Medicaid coverage for some enrollees for “unallowable or potentially unallowable reasons” during the Covid-19 public health emergency, according to a recent Office of Inspector General report.
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
At a time when AI is reshaping pharma, Reverba Global CEO Cheryl Lubbert explained in an interview why empathy, context, and ethics still require a human touch.
In order to gain trust from communities, healthcare leaders will need more training on effective communication, said Dr. Vin Gupta, a pulmonologist and chief medical officer of Amazon Pharmacy. He made these comments last week during a panel at the AHIP 2023 conference in Portland.
While the U.S. did very well on the scientific front of Covid-19 with the production of vaccines, it needs to improve on the public health front, said Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases. He made these comments Tuesday at the AHIP 2023 conference in Portland.
Dr. Ala Stanford, founder of the Black Doctors Covid-19 Consortium, provided hundreds of thousands of Covid-19 tests and vaccines to Black and Brown people in Philadelphia's underserved neighborhoods during the pandemic. In her view, her work was impactful because she acted promptly and focused on community-based patient engagement.
Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical trial showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.
The Covid-19 public health emergency ended May 11, which will affect employer-sponsored insurance in several ways, said Jeff Levin-Scherz, population health leader of Willis Towers Watson. This includes the coverage Covid-19 tests and vaccines.