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Drugs often take more than a decade to move through the pipeline, and Sanofi is kicking off the process anew in immunology through a scientific exchange partnership with Stanford Medical.
“The journey of a drug is typically over 10 to 12 years. It’s a very long journey,” Frank Nestle, Sanofi’s global head of research and Chief Scientific Officer, said in an interview. The pharmaceutical industry knows how to make a molecule, but research such as Sanofi’s new collab with Stanford is crucial to understanding disease pathology…
Read MorePfizer’s COVID-19 vaccine scores FDA nod in adolescents, enabling a wider rollout
In a first for the U.S., the FDA has authorized the use of Pfizer’s BioNTech-partnered COVID-19 vaccine for use in adolescents between the ages of 12 and 15—months ahead of the upcoming school year in the fall. The FDA will amend the existing emergency authorization for the vaccine, which was first issued in December, the agency said. Pfizer’s vaccine…
Read MorePfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine
Dive Brief: Pfizer and BioNTech announced Friday they’ve initiated plans to seek a standard U.S. approval for their coronavirus vaccine, making the partners the first developers to try to transition from an emergency use authorization to full clearance from the Food and Drug Administration. The agency won’t set a decision deadline until all the documentation is in. However,…
Read MoreModerna says its Covid vaccine booster works well against variants
A third dose, given six to eight months after the first round, appeared to be effective against variants first found in Brazil and South Africa. Moderna’s variant-targeting booster shot appears to be protective against the strain of the virus first identified in South Africa, the company announced Wednesday. Interim data from Moderna’s Phase 2 clinical…
Read MorePatient Groups Support Giving Seniors Access to Life-Saving Medical Technologies Through MCIT
WASHINGTON, D.C. – A growing number of patient groups are expressing their support to the Centers for Medicare & Medicaid Services (CMS) of the Medicare Coverage of Innovative Technology (MCIT) rule that would allow Medicare to cover breakthrough medical technologies that treat chronic and debilitating conditions once the FDA approves or clears those treatments as safe and…
Read MoreHow Pfizer Makes Its Covid-19 Vaccine
Inside this facility in Chesterfield, Missouri, trillions of bacteria are producing tiny loops of DNA containing coronavirus genes — the raw material for the Pfizer-BioNTech vaccine. It’s the start of a complex manufacturing and testing process that takes 60 days and involves Pfizer facilities in three states. The result will be millions of doses of the…
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