News

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.

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

Under the terms of the agreement, Thermo Fisher will construct and operate a 44,000-ft2 cell therapy development, manufacturing, and collaboration center on UCSF's Mission Bay campus.

USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.

Bristol Myers Squibb has entered into a definitive agreement with Agenus for a global exclusive license to Agenus’ proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target.

Univercells will introduce the intermediate capacity scale-X carbo system to NIBRT’s facility for hands-on demonstration and training in CGT.

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

VectorY, a Netherlands-based biotechnology company, has been selected as the European winner of MilliporeSigma’s 2021 Advance Biotech Grant Program.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

BD’s new high-tech manufacturing facility in Zaragoza, Spain, will create up to 600 jobs by 2030.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

Charles River plans to enhance its gene therapy capabilities through the acquisition of Vigene Biosciences.

WuXi Biologics and WuXi STA have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates.

The expansion in Le Mans, France will support growth in clinical and commercial manufacturing.

The expansions will add peptide manufacturing capacity.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.