FDA Expands Bristol-Myers Squibb’s Opdivo Dosing Schedule
The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab). Source: BioSpace
Parexel International Taps New CEO Jamie Macdonald
After 35 years at the helm of Parexel International Corporation, co-founder Josef von Rickenbach is stepping down from his role as chief executive officer. Source: BioSpace
Best questions to ask in your next job interview
Job seekers typically focus on three things: the resume, the cover letter, and how to answer interview questions. But many candidates don't realize how important it is to have well-researched,…
Magenta Therapeutics and Heidelberg Pharma Team Up for Bone Marrow Transplants
Magenta Therapeutics is teaming up with Ladenburg, Germany-based Heidelberg Pharma to improve curative bone marrow transplantation. Source: BioSpace
Martin Shkreli Ordered to Forfeit $7.36 Million in Assets Ahead of Sentencing
Days before his sentencing for a criminal fraud conviction disgraced pharma entrepreneur Martin Shkreli has been ordered to forfeit $7.36 million. Source: BioSpace
Kath Chemicals Cited for Review, Testing and Cleaning Deficiencies
The FDA issued Kath Chemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies. Source:…
Health Canada Spells Out Risk Ratings for GMPs in Site Inspections
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Source:…
European Commission Clarifies Excipient Labeling Requirements
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Source: Drug Industry Daily
Oregon Bill on Drug Transparency Heads to Governor’s Desk
Oregon’s Senate advanced legislation that would introduce a drug cost and price transparency program, sending it to Gov. Kate Brown (D) for signature. Source: Drug Industry Daily
Dermira’s Acne Medication Olumacostat Glaseretil Tanks in Two Phase III Trials
Dermira plans to shutter the program and move on to more promising compounds. Source: BioSpace
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