FDA to Revise 20-Year-Old ICH Reproductive Risks Guideline
The FDA published an ICH-developed revision to its industry guideline on the detection of reproductive risks in new drugs. Source: Drug Industry Daily
FDA Finalizes Guidance on Evaluating Drug Effects on Driving Ability
The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle, saying reducing the incidence of accidents is a public…
PTAB Sides With Amneal on Obviousness of Purdue’s Oxycontin Patent
The PTO’s Patent Trial and Appeal Board ruled against a Purdue Pharma patent on OxyContin, agreeing with Amneal Pharmaceuticals on the patent’s obviousness. Source: Drug Industry Daily
FDA Expands ANDA Prioritization Policy
Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity…
Danes Shutter Drug Importer Over Quality Issues
Danish drug regulators have moved to shut down a drug importer and repackager due to its inadequate quality control systems, the Danish Medicines Agency said. Source: Drug Industry Daily
Siemens to Replace Healthineers CFO in Preparation for Listing
The public listing that is expected to value the business at around $46 billion. Source: BioSpace
GlaxoSmithKline Poaches New CSO From Google's Calico
Dr Barron was Executive VP, Head of Global Product Development, and CMO of Roche, responsible for all the products in the combined portfolio of Roche and Genentech. Source: BioSpace
Recipharm to End Operations at Two Swedish Facilities, 225 Employees Affected
The company will explore opportunity to close facilities during second half of 2019. Source: BioSpace
German Biotech InflaRx Snags $100M in IPO
The company announced the pricing of its initial public offering of 6,667,000 common shares at an initial public offering price of $15.00 per common share. Source: BioSpace
After $40M Financing, Exonics Therapeutics to Start Hiring for Cambridge Lab
The cash will allow the company to hire scientists to conduct preclinical research into a potential treatment for DMD. Source: BioSpace
- Go to the previous page
- 1
- …
- 263
- 264
- 265
- 266
- 267
- 268
- 269
- …
- 610
- Go to the next page