GW Pharma, Otsuka Satvex Deal Terminated
As a result, GW has now reacquired full ownership of the development and commercialization rights to the product in the U.S. market. Source: BioSpace
Daichi Sankyo Abandons Deal With Nektar Therapeutics After Drug Tanks in Europe
Daiichi Sankyo informed Nektar that it was terminating a collaboration and licensing deal, effective Feb. 4, 2018. Source: BioSpace
Roche Gets in on Bay Area Allakos' $100M Funding Round
The round was led by NEA and included Redmile Group, Partner Fund Management, Rock Springs Capital, LifeSci Venture Partners, Samsara BioCapital, and a large institutional investor. Source: BioSpace
Why Bluebird Bio Investors Aren't Singing the Blues
bluebird bio stock has been on an upswing for most of the year, having recently taken a spike after positive news at the ASH Annual Meeting. Source: BioSpace
Why Pfizer's 2017 Was Mediocre at Best
Pfizer's 2017 wasn't horrible. Just ho-hum. Source: BioSpace
Besties Regeneron, Sanofi Show Off Phase II Skin Cancer Data
The positive results are spurring the companies to begin seeking approval for the checkpoint inhibitor. Source: BioSpace
Korean Manufacturer Warned for GMP, Quality Violations
The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit. Source: Drug Industry Daily
ANSM Creates New Unit to Handle Early Stage Clinical Trials
France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials. Source: Drug Industry Daily
Whistleblower Says Drugmaker Fired Him for Raising Concerns About CMO
A newly unsealed whistleblower lawsuit claims Regeneron fired a manager for raising concerns about the drugmaker’s manufacturing process. Source: Drug Industry Daily
FDA Spells Out ‘Refusal to File’ Scenarios for NDAs and BLAs
The FDA issued draft guidance on when CDER may refuse to file new drug applications and biologics license applications, outlining errors or omissions that can lead them to classify the…
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