Drug Development

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 quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

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.

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.

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.

In this exclusive Drug Digest video, Adi Kaushal from Lonza summarizes the current state of the oral solid dosage market, identifies the main challenges to drug developers, explains how CDMOs are leveraging expert techniques to improve OSD bioavailability, and looks into the future of advancements in drug delivery.

Jamie Baumgartner, Jonathan Grinstein, and John Wilkerson go behind the headlines to discuss the implications of personalized gene-editing therapies, more HHS policy and funding updates, and the latest tariff-related investments.

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.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

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.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.