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04.08.21 -- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021


04.08.21 Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
 
On this episode of the
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. ....

Niklas Sandler , Samsung Biologics , Satu Lakio , Oliver Stauffer , Josh Russell , Lee Allen , Fred Hines , Patrick Guertin , Megan Mason , Abdelaziz Toumi , Megan Kuikstra , Brad Larson , Lonza Biologics , Samuel Chia , Jim Springer , Steve Halpin , Jones Healthcare Group Packaging Services , Article Ajinomoto Bio Pharma Services , Automated Systems Of Tacoma Inc , Health Canada , Pharmaceutics International , Automated Systems , Professor Niklas Sandler , Richard Tree , Vlad Spehar , Jones Healthcare Group Packaging ,

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends


12.17.20 FDA FY2020 Drug Inspection Observations And Trends
 
ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
 
This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement. ....

Ted Tharp , Abdelaziz Toumi , Jessica Mueller Albers , Peter Poechlauer , Martin Gonzalez , Ian Whitehall , Lonza Biologics , Charles Ross , Gibco Efficientfeed , Jeff Tremain , Christine Banaszek , Qa Lonza Pharma , Andreas Stolle , Case Study Almac Group , Case Study Flow Sciences Inc , Poster Micromeritics Instrument Corporation , Case Study Asahi Kasei Bioprocess America Inc , Case Study Dec Group , Evonik Corporation , White Paper Alconox Inc , Pharma Services , Son Company , Thermo Fisher , Pfizer Centreone Contract , Dwayne Hull , Jon Best ,