Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Source: Drug…
The U.S. Food and Drug Administration stunned the company with a Refusal to File letter regarding its New Drug Application (NDA) for multiple sclerosis treatment ozanimod. Source: BioSpace
Gene-editing company Inscripta, formerly known as Muse Biotechnologies, will be able to expand its research capabilities and increase hiring after the company closed a Series C funding round of $55.5…
Today, on this 11th World Rare Disease Day, life science companies, organization and activists have come together to raise awareness about these diseases and the needs of therapies for patients.…
Reata Pharmaceuticals has updated the timing of coming data announcements for two ongoing mid-stage trials for rare renal diseases. Source: BioSpace
PharmaCyte Biotech recently discussed its options and plans for a Phase IIb clinical trial of its Cell-in-a-Box technology in pancreatic cancer. Source: BioSpace
Galera Therapeutics has initiated its Phase I/II clinical trial of GC4419 in locally advanced pancreatic cancer (LAPC). Source: BioSpace
After a huge dry spell in M&A, 2018 is shaping up to be a great year for deal making. Source: BioSpace
The FDA hit Indian API manufacturer Alchymars ICM SM with a warning letter after an investigation found the firm falsified laboratory data, failed to thoroughly investigate complaints and improperly maintained…
More states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the Pew…