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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Adaptimmune Therapeutics plc today announced that it has entered into a definitive agreement with Matrix Capital Management Company
Company Anticipates NDA Resubmission by the End of September 2018
Oncolytics Biotech® Inc. today announced that it has entered into a Master Clinical Supply Agreement (Agreement) with F. Hoffmann-La Roche Ltd (Roche) to supply atezolizumab (Tecentriq®) for use in the company’s clinical development program.
The U.S. Food and Drug Administration is hoping to fill numerous vacancies at the regulatory agency. In June, the FDA laid out some of its hiring needs, as well as its approach to attracting top-quality talent in a report to Congress.
Although the dominant story in biopharma patent litigation was the federal appeals court backing the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University over the University of California (UC) on CRISPR patents, there have been other patent decisions of note today as well. Let’s take a look.
It was a win for the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University, as a federal court of appeals ruled against the University of California (UC) on CRISPR patents.
The University of Maryland School of Pharmacy (UMSOP), in partnership with the U.S. Food and Drug Administration (FDA), is hosting a medical devices workshop: Patient Engagement in Real World Evidence: Lessons Learned and Best Practices.
Amicus Therapeutics, headquartered in Cranbury, New Jersey, held a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its regulatory path for AT-GAA for Pompe Disease. The company released its plans for the drug.
José Baselga, chief medical officer at Memorial Sloan Kettering Cancer Center came under fire this weekend for his failure to disclose financial ties to various pharmaceutical companies when he published research papers in peer-reviewed journals.
Days after receiving a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Nucala (mepolizumab) as an add-on COPD treatment, GlaxoSmithKline released data that showed the same medication was a superior treatment in severe eosinophilic asthma in patients with similar blood eosinophil counts.