Policy
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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.
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Shares of AVEO Oncology plunged 45 percent Thursday trading after the Cambridge, Mass.-based company said it accepted the recommendation of the U.S. Food and Drug Administration to not seek regulatory approval of its kidney cancer drug, Tivozanib at this time.
The plan is aimed at providing new transparency to the prescription drug market and removing the veil of hidden rebates conducted between companies and pharmacy benefits managers.
MorphoSys AG announced today that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute.
Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, the FDA said it could not approve the application for the apomorphine sublingual film in its present form.
In November, Chinese researcher He Jiankui of the Southern University of Science and Technology of China announced he had used CRISPR to alter the embryos of seven couples to make them resistant to HIV. To date, a set of twins were born and there is another pregnancy. This was met by near-universal condemnation in the global scientific community.
The court documents in Massachusetts reveal not only how much the family made from sales of the opioid, but also the tactics used to promote sales.
As the trial against John Kapoor and other former executives at Insys Therapeutics continues, more sordid details of an aggressive campaign to boost sales of the company’s fentanyl-based sublingual spray for cancer pain are being brought to light.
The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices.
The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.