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FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

This new monoclonal antibody therapy is designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in neonates and infants born during or entering their first RSV season. RSV disease is the leading cause of infant hospitalization in the U.S. Key results from the CLEVER trial include: A 60.5%

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Merck’s ENFLONSIA Receives ACIP Recommendation for Protecting Infants from Severe RSV

The Pharma Data

CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program. Dr. Richard M.

Vaccine 52
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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

Vaccine 130
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Gene therapy startup emerges with green light for first-of-its-kind trial

BioPharma Drive: Drug Pricing

Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.

Therapies 278
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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. This press release features multimedia.

Trials 69
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RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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NHS staff sign up to Covid-19 sniffer dog trial

The Pharma Data

Medical detection dogs Bramble (left) and Lexi during a visit to Kettering General Hospital. NHS staff are taking part in a trial to see if dogs can sniff out Covid-19 – even in people who are asymptomatic. If the trial is successful, the dogs could be used at UK airports to screen people arriving from abroad.

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