Industry News

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.

Naoki Okamura, Astellas’ current chief strategy officer, will take over the role from Kenji Yasukawa.

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.

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.

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

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.