Patrick Lavery

The inspection focused on fill/finish of ongoing commercial supplies of an adeno-associated virus viral vector biologics product for a major pharmaceutical client in the United States.

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

The report from Boston Consulting Group and Innovative Pharmaceutical Services Organization said the market in India is currently expanding at a 15% compound annual growth rate.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Previous domestic capital expansion commitments since 2020 had been made in Research Triangle Park and Concord, both in North Carolina; Kenosha County, Wisconsin; Lebanon, Indiana; and Lilly’s home city of Indianapolis.

Single-use solutions are the company’s focus this year, including tubing and custom-molded parts.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

With 2025 now in full swing, this article presents a review of the latest developments in outsourcing services, new facilities, and M&A activity thus far this year.

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

The transaction includes abelacimab, which is a late-stage medicine that is in development for prevention of stroke and systemic embolism in patients with atrial fibrillation.

Survey results show that being intellectually stimulated and getting assigned challenging projects are two key drivers of employee satisfaction, yet job training is lacking.

Intravenous administration of amivantamab is the currently approved route, but a Phase III trial showed that subcutaneous treatment was non-inferior.

In a peer-reviewed study, Lantern Pharma said its AI-driven approach successfully identified 82 promising ADC targets, and 290 target-indication combinations.

Prior to this announcement, Rentschler announced in September 2024 it would be launching an expanded service offering at its advanced therapies site in Stevenage, UK, which is now being shut down.

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

Kloxxado was approved by FDA in 2021 for emergency treatment of opioid overdose, and Emergent also distributes the FDA-approved over-the-counter treatment Narcan.

Although specifics about the milestone were not immediately provided, Scribe is eligible to receive more than $1.2 billion for certain research, development, regulatory, and commercial benchmarks.

The transaction adds a pipeline of early-stage drug candidates against high-value targets to Telix’s portfolio, along with other novel targets currently in the discovery stage.

This is the latest facility launch for BioDuro, following a kilogram laboratory and compound management center, both on the same site, in October 2024.

Bora said it will be involved in stages ranging from chemistry, manufacturing, and controls strategy through to clinical development.

The co-leaders of the financing were Novo Holdings and Bpifrance, with other investments from Invus, UI Investissement, Seroba Life Sciences, Fund+, Kurma Partners, Omnes Capital, and Turenne Capital.

CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

The transaction, which was first announced in September 2024, expands Phillips Medisize’s inhalation drug delivery capabilities.

The Cambridge-GSK Translational Immunology Collaboration builds on an existing scientific relationship between the biopharma company and the university, with the aim of improving outcomes for patients.

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.