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Improving quality control for CAR T cell therapies

Drug Discovery World

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval.

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Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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Article FDA Thank You House legislators set to markup legislation related to rare diseases, pediatric oncology and HCT/Ps

Agency IQ

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. focuses on marketing exclusivity periods granted to orphan drugs. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),

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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand. Securities and Exchange Commission Regulation G.