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The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

GSK’s position is raising concerns as it continues working towards its separation of businesses.

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.

Technology advances foster new therapies.

The acquisition gives PerkinElmer access to Nexcelom Bioscience’s complementary cell counting and analysis capabilities and enhances its QA/QC capabilities.

PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).

The Discovery Labs has signed a foundational lease with the University of Pennsylvania Gene Therapy Program to build a new life sciences cluster in King of Prussia, Pa.

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

CMA has launched an anti-competition investigation into AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals.

MilliporeSigma has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

The new line can fill prefilled syringes, cartridges, and vials using ready-to-use components.

Evonik has introduced the EUDRACAP, a portfolio of easy-to-handle capsules to fast-track speed to market for oral drug products in the early development stage.

Almac Sciences is investing in the expansion of its continuous flow chemistry equipment as an additional project to its previously announced £5-million (US$7-million) laboratory expansion.

The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.

The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

The Committee for Medicinal Products for Human Use of the European Medicines Agency presented a positive opinion of bluebird bio’s SKYSONA (elivaldogene autotemcel, Lenti-D), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy, an X-linked metabolic disorder.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.