Industry News

The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.

Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

Vetter significantly increases its sustainability ranking by achieving gold status in EcoVadis ranking.

The guidance provides examples of required and recommended information in the Dosage and Administration section.

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

Ipsen’s $952 million acquisition of Albireo is designed to bolster the company's rare disease portfolio.

Sartorius and RoosterBio will work together to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies.

Getinge is launching Livit Flex, a bioprocess control system designed to help pharmaceutical and biotech products get to market faster.

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

Astrea Bioseparations has acquired Delta Precision, a manufacturer of chromatography columns for biomanufacturing.

Avantor and Catalent have entered into a multi-year supply and services agreement.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

She also mentioned the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) launching at the same time to help energize the clinical research area of the EU.

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.