Policy
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
FEATURED STORIES
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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A closer look at legal action against executives from the company formerly known as JHL Biotech who recruited scientists from Genentech to steal trade secrets related to several cancer drugs.
Sir Mene Pangalos said the company was considering not submitting it to the FDA if it finds it is “banging its head against a brick wall indefinitely.”
U.S. and Chinese regulators are edging toward a cooperation plan on Chinese companies that have stock listed on U.S. stock exchanges.
Alexion will pay Chugai $775 million in the second quarter of 2022 in exchange for the Japanese firm withdrawing the patent infringement lawsuits it filed in Europe, Japan and the U.S.
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
Alnylam is suing Moderna and Pfizer over patent infringements related to its lipid techQnology that have been foundational to the success of the mRNA-based COVID-19 vaccines.
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
On Wednesday, the World Health Organization indefinitely postponed the evaluation of Russia’s Sputnik V COVID-19 vaccine due to the ongoing conflict in Ukraine.
In his new book, Warp Speed, Paul Mango said the realization that many healthcare workers didn’t want the vaccine, for instance, was shocking.