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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A Reuters analysis of company documents reveals that Johnson & Johnson knew about levels of asbestos contamination in its talc products, but did not report it to the FDA.
FDA
The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
Fidelta Ltd is pleased to announce that it has signed an integrated drug discovery agreement with Galapagos based on Fidelta’s macrocyclic platform.
Axovant Sciences, announced that it has licensed exclusive worldwide rights for the development and commercialization of two novel gene therapy programs to address GM1 gangliosidosis and GM2 gangliosidosis from the University of Massachusetts (UMass) Medical School.
FDA
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
The rule could have allowed generic manufacturers to independently update safety data on drugs, which could have opened the companies to potential lawsuits over side effects.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
Earlier this week, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug Application to allow the company to initiate clinical studies with Xeno-Skin, a product designed to provide help for patients who have suffered from significant burns.
As we look back over the year, we noticed some stories just grabbed readers more than others. Here’s a look at the top 10 stories of the year, including job cuts, best-selling drugs, up-and-coming companies,scandals, clinical trials, and more.
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.