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Home » Topics » Drugs » Vaccine

Vaccine
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Enflonsia

Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

June 10, 2025
By Lee Landenberger
No Comments
With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb) will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024.
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Canceling claims not an appropriate sanction, USPTO says

June 9, 2025
By Mari Serebrov
No Comments
Absent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, according to the acting director of the U.S. Patent and Trademark Office (USPTO).
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 4, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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US Fed Circuit rules in favor of Moderna in patent squabble

June 4, 2025
By Mari Serebrov
No Comments
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
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HHS terminating Moderna’s $590M grant for flu vaccines

May 29, 2025
By Jennifer Boggs
No Comments
The funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
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Kennedy welcomes end of COVID-19 vaccines for healthy kids

May 27, 2025
By Mari Serebrov
No Comments
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
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US FDA rethinks COVID-19 boosters

May 20, 2025
By Mari Serebrov
No Comments
Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
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Elderly person receiving shot

With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rules

May 19, 2025
By Randy Osborne
No Comments
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
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3D illustration and light micrograph of lung cancer.
Immuno-oncology

mRNA-based cancer vaccine targeting mutated EGFR shows antitumor efficacy

May 9, 2025
No Comments
Drug resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, occurring via secondary mutations or bypass pathways, is frequent among non-small-cell lung cancer patients.
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Immuno-oncology

Preclinical results from a new HPV16/18 mRNA-based vaccine presented

May 8, 2025
No Comments
Metis Pharmaceuticals Inc. recently presented a novel mRNA-encoded human papillomavirus (HPV) 16/18 therapeutic vaccine for HPV-driven malignancies.
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