BioPharm International Editors

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 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.

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.

Thermo Fisher Scientific’s new facility in Hangzhou, China, is designed to boost biologics and sterile development and manufacturing capabilities in the Asia-Pacific region.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

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

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

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 guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

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.

The partnership will see the pharma giants partner with researchers from A*STAR and various Singapore universities.

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.

Catalent has completed the expansion of its clinical supply facility located in Shanghai, China.

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.

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

AstraZeneca inked a deal worth up to $320 million to purchase Neogene Therapeutics, a biotech start-up focused on T-cell receptor therapies.