The Munich-based startup JenaValve is a bit like the tortoise, with a slow and steady approach to transcatheter aortic valve replacement (TAVR) device development. At the Transcatheter Cardiovascular Therapeutics (TCT) conference today, Dr. Vinod Thourani, co-principal investigator of the ALIGN-AR study, jokingly compared the company’s approach to a “nice bottle of wine” that gets better […]
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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time. FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the […]
Intrommune extends scope of Phase 1 trial for peanut-allergy-treating toothpaste
The food-allergy-focused biotech Intrommune Therapeutics is announcing that it is extending the duration of the ongoing Phase 1 OMEGA clinical trial of INT301 in adults with peanut allergy. The alteration will lengthen the study duration to 48 weeks to include a maintenance period. The study duration was previously 26 weeks. The New York City–based company […]
FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5
In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines […]
How psychedelics could address unmet need in mental health
Interest in the therapeutic potential of psychedelics is booming, given their therapeutic potential for treating depression and other conditions. It is telling that psychedelics were among the hottest topics at the World Economic Forum (WEF) meeting this year in Davos, Switzerland, prompting mockery from late-night comics. Although the field remains embryonic, part of the reason for the […]
BD to purchase pharmacy automation firm Parata Systems
BD (Becton, Dickinson and Company) (NYSE:BDX) has partnered with the private equity firm Frazier Healthcare Partners to acquire Parata Systems, a provider of pharmacy automation solutions. The purchase price of the acquisition is $1.525 billion. Founded in 2006, Parata Systems offers a range of products and services, including medication adherence packaging technology and perpetual inventory […]
Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise
Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. Get the full story from our sister site, Drug Discovery […]
FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said […]
Massachusetts is competing for ARPA-H biomedical research center
The U.S. government is planning to establish the Advanced Research Projects Agency for Health (ARPA-H) to accelerate biomedical research. The new federal research agency will not be based alongside its NIH parent in Bethesda, Maryland. After winning authorization to create the agency, Sen. Edward J. Markey (D-Mass.) and several colleagues in Massachusetts are asking the […]
Moderna’s new CFO leaves after former employer discloses investigation
Moderna (Nasdaq:MRNA) CFO Jorge Gomez is gone from his new job effective immediately, the COVID-19 vaccine maker said today. Cambridge, Massachusetts–based Moderna said the departure comes after Gomez’s former employer, Dentsply Sirona (Nasdaq: XRAY), announced an “ongoing internal investigation into certain matters, including financial reporting,” Moderna said in a news release. Get the full story […]
Pfizer to shell out $11.6B for migraine drugmaker Biohaven
Pfizer (NYSE:PFE) today announced that it has entered into an agreement to acquire Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), which is best known for Nurtec ODT (rimegepant), a dual-acting migraine therapy. Pfizer will pay $148.50 per share in cash to acquire Biohaven, totaling approximately $11.6 billion. Get the full story from our sister site, Pharmaceutical […]
