Policy
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
FEATURED STORIES
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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BioSpace sat down with Sven Kili, 2022 ISCT Annual Meeting co-chair, to preview the event, which will focus on 4 key subject areas including launch and commercialization of cell and gene therapies.
David Sabatini has withdrawn his name for consideration for a faculty post at New York University Langone Health.
GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy.
Gongda Xue has been found guilty in a Philadephia courtroom of stealing trade secrets from GlaxoSmithKline. This comes after his sister, Yu Xue, was also convicted for a similar crime.
Teva announced that it had reached a deal with Lupin over Lupin’s Abbreviated New Drug Application (ANDA) for generic deutetrabenazine - an upcoming competitor to Hungtington’s drug Austedo.
The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.