News

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

The contest, which aims to accelerate the development of recombinant protein-based oncology therapies, will culminate at CPHI Frankfurt in October 2025.

Chrysalis lists among its partners early-stage biotechnology companies, contract research organizations, top-10 pharmaceutical firms, and various other life sciences stakeholders.

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, ahead of BIO 2025 to find out what’s new in pulmonary drug delivery.

The collaboration will focus on identifying pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.

The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

The agreement has been designed to offer a turnkey service to companies seeking faster time to market.

Elkedonia will develop first-in-class Elk1 inhibitors for treatment-resistant depression, targeting neuroplasticity without psychedelic side effects.

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.

The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.

Most of the company’s new additions, if not already online, will be scheduled for commissioning, validation, or qualification before the fourth quarter of 2025.

Smart technologies, such as digital and laser printing, incorporated into manufacturing equipment are helping manufacturers align with sustainability goals, according to Sheikh Akbar Ali, general manager and head of Development and Technology for ACG Packaging Materials.

The company describes the compact system as ergonomically designed, providing precision dosing and production floor flexibility.

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.

Jon Ellis and Simon Vanstone, PhD, go behind the headlines to explore the latest M&A activity and what tariffs and funding changes could mean for mRNA and beyond.

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

EMA has published recommendations to address potential radiopharmaceutical shortages.

The grant encompasses $100,000 each from the Life Sciences Entrepreneurship Center and Berkeley SkyDeck, with SkyDeck having the option to invest an additional $100,000.

As a result of the decision, Shilpa will not be eligible to receive FDA approval for its lenvatinib mesylate generic until February 2036.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.

Both companies viewed the early end to the PIVOT-PO trial as a positive development, with GSK saying it would work with US regulatory authorities to move the treatment forward in 2025.

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Christy Eatmon of Thermo Fisher Scientific reviewed her company’s experience at CPHI Americas 2025 and discussed recent industry trends that are driving strategic partnerships.

MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.