Drug Development

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

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

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

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.

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.

Donald Ingber, MD, PhD; Miguel Forte, MD, PhD; Ali Pashazadeh, MRCS, MBA; and Adam Inche, PhD, MBA go behind the headlines to examine the fast-changing landscape of manufacturing re-shoring, tariffs, NIH budget cuts, and the outlook for cell and gene therapies.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about how the political landscape may impact the pharmaceutical industry.

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.