SK pharmteco’s Tatiana Nanda, chief technical officer of SK pharmteco Viral Vector North America discusses what gene therapy sponsors must account for sooner rather than later when preparing for GMP manufacturing.
Inclusion of the patient perspective is currently an “optional” part of the rare disease drug development process, CBER Director Karim Mikhail told BioSpace. Mikhail, along with his CDER counterpart Michael Davis and other agency rare disease leaders, is trying to change that.
FDA’s new rare disease framework aims to leverage patient voices for better innovation Read More »
The CEO change was unexpected and prompted a stock selloff Friday, analysts said, but the new chief executive is prepared for the role.
While Moderna preps an entry to the oncology market next year with a personalized cancer vaccine, COVID sales are holding steady with several other vaccine launches underway around the world.
Moderna enjoys stable vaccine sales thanks to global COVID uptake Read More »
Regulators have expanded powers to revoke providers’ Medicare certification, including for parent companies that violate federal rules.
New CMS rule ties Medicare billing privileges to owners’ misconduct Read More »
The company is rebranding the unit as Olyrian Diagnostics and plans to set it up as a standalone business by mid-2028.
Siemens Healthineers to rebrand and separate its IVD business Read More »
Regulators finalized a rule Wednesday that would slash payments for drugs in the controversial 340B program and equalize some payments between care sites. Hospitals railed against the rule.
Medicare will cut billions from 340B, expand site-neutral payments in 2027 Read More »
A federal judge agreed with brokers’ arguments that the moratorium, instituted by the CMS to combat fraud on the exchanges, would cause irreparable harm to agents. The injunction paves the way for new brokers to begin training and facilitating enrollments immediately.
Judge sides with ACA brokers, lifts moratorium on new registrations Read More »
The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide.
Forge’s Piteri-Molina on AI, Ohio and what’s next for gene therapy manufacturing Read More »
Jeannette Bankes will take over the role from John Sheridan, who will retire at the end of the year after leading the company since 2019.
