Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
FEATURED STORIES
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.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Last week HHS floated a plan that would allow companies to pass rebates of 26 to 30 percent of a drug’s list price directly to patients in order to be reflected in what consumers pay at the pharmacy counter.
Almost three months to the day after an FDA advisory committee overwhelmingly rejected Alkermes’ major depressive disorder treatment, ALKS-5461, the company received word that the regulatory agency will not approve the medication.
Although bioterrorism doesn’t get the kind of attention more traditional bombings and shootings receive, the biotech industry and the federal government are paying attention and actively funding and developing countermeasures to potential bioterror, military and public health emergencies.
Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
You have to give San Diego-based Gossamer Bio credit for the way it’s adapted its plans for an initial public offering (IPO) to deal with the government shutdown.
Four months after getting the green light in the U.K. for treatment of children with acute lymphoblastic leukemia (ALL), Novartis’ CAR-T treatment Kymriah, known as Tisagenlecleucel in the U.K., has gained approval for treatment of adults with diffuse large B-cell lymphoma (DLBCL).
Recently, in the U.S., there has been a shortage of an anti-anxiety drug, buspirone. The American Society of Health-System Pharmacists (ASHP) lists shortages, and as of Jan. 31, 2019, noted shortages of buspirone tablets manufactured by Accord Healthcare, Mylan and Teva Pharmaceutical.
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.