Policy
In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
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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Nearly two months ahead of the planned PDUFA date, the U.S. Food and Drug Administration approved two new HIV-1 treatments developed by Merck. The FDA gave the go ahead for Delstrigo, a once-per day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor.
The U.S. FDA announced a new pilot program aimed at stimulating the use of complex innovative clinical trial designs for drugs and biologics. Announced on Wednesday, August 29, the pilot program will continue through September 30, 2022.
Recently, Milton Packer, a renowned cardiologist at Baylor Scott & White Health, wrote a criticism of the Orphan Drug Act and the resulting problems caused by the biopharma industry. John LaMattina, formerly president of Pfizer Global Research and Development and a current senior partner at PureTech Ventures, responded to the editorial in Forbes. Let’s take a look.
The U.S. Food and Drug Administration (FDA) warned four online networks that operate 21 websites selling opioids online. The warning indicates they were “illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol.
As President Donald Trump attempts to revise the North American Free Trade Agreement (NAFTA) between the U.S., Mexico and Canada, generic drugmakers have expressed concern over some of the negotiating points.
Citing safety concerns, a watchdog organization is calling on the National institutes of Health to halt enrollment in a clinical trial evaluating a treatment for sepsis that the organization said is risky and flawed.
As August rolls into September, BioSpace takes a look back at some key decisions made by the FDA. First are some of the draft guidance documents outlined by the FDA.
The United Kingdom’s government-funded health service isn’t being so nice to Gilead Science’s CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.
Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
A spending bill passed in the U.S. Senate includes provisions taking aim at the high cost of prescription medicines by requiring pharmaceutical companies to disclose the cost of medications in television advertisements.