Takeda inked a collaboration deal to develop and commercialize Portal's needle-free drug delivery device for use with some of Takeda's biologic medicines. Source: BioSpace
Bristol-Myers is initiating a Phase III clinical trial of BMS-986205 with nivolumab in patients with advanced melanoma. Source: BioSpace
The increased funding showcases investor confidence in Counsyl’s leading genetic screening products and business model. Source: BioSpace
The FDA cited an outsourcing drug compounder in Arkansas for failure to meet sterile production standards, according to a warning letter from the agency. Source: Drug Industry Daily
A federal judge ruled against a motion by three drugmakers to shut down antitrust litigation involving the Lidoderm pain patch. Source: Drug Industry Daily
Continuing education programs could be a useful tool for sponsors charged with providing training and education under a REMS, according to an agency feasibility study. Source: Drug Industry Daily
An FDA agreement to recognize good management practice reports from eight European countries, will allow the agency to reassign investigators to high-priority areas such as India and China, an official…
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Source: Drug…
Varian said it will replace linear accelerators in the oncology departments of Rigshospitalet and Herlev Hospital with 15 advanced Varian TrueBeam and Halcyon treatment machines and two ViewRay MRIdian MR-Guided…
Exicure announced it had closed on $11.2M in private financing. Source: BioSpace