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.
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Despite a decline over the past year of class-action lawsuits, life science companies remain a popular target for securities fraud litigation.
The government shutdown threw a wrench into several biotech company’s plans for initial public offerings (IPOs). Although the government is only guaranteed to stay open until February 15, several biotechs are working to get their IPOs launched in that window. Here’s a look.
FDA
The U.S. Food and Drug Administration approved the first treatment for acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi’s Cablivi was given the greenlight and will become a cornerstone of the company’s new rare blood disorders franchise.
After Health and Human Services Secretary Alex Azar, a former executive with Eli Lilly, unveiled a pricing reform that would allow pharma companies to end the rebate system and pass those savings directly to consumers, leaders from across the pharma industry are offering early support for the proposal.
Across the globe, pharma companies are making an impact. Last week BioSpace launched the first of a weekly roundup of international biotech and pharma news. Here’s the latest edition.
Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
During the president’s annual address to Congress and the nation, Trump said that as a result of his administration’s efforts to lower the costs of prescription drugs, “in 2018 drug prices experienced their single largest decline in 46 years.”
Investors are not happy after Austin, Texas-based Pain Therapeutics announced that it was no closer to seeing its drug candidate Remoxy ER, an abuse-deterrent, extended-release gel formulation of oxycodone, approved by the U.S. Food and Drug Administration.
Genentech, a Roche company, is flexing its litigation muscle this week. The South San Francisco-based company has filed 18 lawsuits over the past few weeks to block competitors from selling a generic version of a treatment for idiopathic pulmonary fibrosis, a fatal lung-scarring disease.
FDA
Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.