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The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

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.

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.

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.

Agilent’s acquisition of Avida grants them access to high-performance enrichment workflows that enable NGS approaches for studying cancer.

Merck, known as MSD outside of the United States and Canada, will pay Kelun-Biotech up to $9l3 billion for seven early-stage oncology treatments.

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.

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

Sosei Heptares and Eli Lilly have entered a multi-target collaboration and license agreement in diabetes and metabolic diseases.

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

GSK and Wave Life Sciences have entered into a collaboration to drive drug discovery and development for novel genetic targets.

AbCellera and Rallybio are teaming up to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.

Catalent is set to expand its biologics analytical services with its new facility in Durham, NC.

Emmes’ new facility is designed to support clients conducting cell and gene therapy research worldwide.