Coverage of COVID-19 vaccines was surprisingly displaced by this year’s astounding oncology and iconoclastic gene therapy “cures.”

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

The latest report from Clarivate has been published, highlighting 15 potential blockbusters to watch out for in 2023, the majority of which are personalized medicines.

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

Cell and gene therapies is unequivocally viewed as the biggest opportunity in the bio/pharma space.

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside 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.

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.

Takeda will purchase the rights to Nimbus Pharmaceuticals candidate, NDI-034858, which is currently being evaluated for treating multiple autoimmune diseases.

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.