Drug Development

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.

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.

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.

Inobrodib is being developed as a first-in-class oral cancer drug that the company says will be able to treat not only multiple myeloma, but other specific cancers as well.

The LP.8.1 variant of the SARS-CoV-2 virus differs from the JN.1 family that previous vaccines had been designed to target, and has surpassed JN.1 as the variant circulating most widely worldwide.

Researchers say they have discovered the first drug mechanism that binds to the pyrin domain to block NLRP3 and prevent a series of reactions resulting in inflammation.

According to the White House, the order builds on actions taken in the president’s first term to reduce price disparities domestically.

Poor API quality may often lead to delays in production and a shortage of supply.

Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

The AbYlink technology enables a seamless, reproducible conjugation of payloads to antibodies or ADCs.

Under the partnership, Pharmaron will validate and promote the application of CN Bio’s PhysioMimix technology and will integrate OOC technologies into its R&D platform.

The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the future of M&A in the bio/pharmaceutical industry and the struggle small biotech companies face raising funds.

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the impact of the changing political landscape on the pharmaceutical industry.

Mike Exton, Andrew Thomson, Konstantinos Tsioris, and Cheryl Barton go behind the headlines to discuss the advancement of neuroscience, weight-loss drugs, and the evolving political climate’s impact on the industry.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.