Biopharma News

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.

The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

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.

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.

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.

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.

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.

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.

Under the collaboration between Vertex and Entrada, the companies will work on discovering and developing intracellular endosomal escape vehicle therapeutics for myotonic dystrophy type 1.

Amgen’s $27.8 billion acquisition of Horizon Therapeutics, an Irish biotechnology company, is one of the largest of 2022.

Generate Biomedicines published a preprint describing technology that can generate novel proteins towards desired functional or other properties.

PictorLabs, a digital pathology company developing an AI-powered virtual staining platform, formally announced its launch at the start of December.

The R&D analytical solutions will consist of analytical lab services that use USP’s in-house scientific expertise and state-of-the-art facilities at the USP Advanced Manufacturing Technology Lab in Richmond and the USP headquarters facility in Rockville, Md.

In addition, personnel, equipment, and facilities from the acquired companies will expand Reaction Biology’s presence in Germany while enabling its global customers to leverage Bioassay’s expansive portfolio of regulated clinical and commercial services.

Results from Eisai and Biogen’s Alzheimer's treatment, lecanemab, indicated significantly slowed cognitive decline in patients relative to placebo.

Merck will use BigHat’s AI/machine learning-enabled platform to design candidates for up to three drug discovery programs.