Zachary Zubulake

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

The FDA approves icotrokinra, the first targeted oral peptide blocking the IL-23 receptor, for moderate-to-severe plaque psoriasis with Phase III data across 2,500 patients.

SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like Alzheimer's and Parkinson's.

The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how existing therapies trigger immune response.

The FDA will evaluate tildrakizumab-asmn for psoriatic arthritis. A 2026 decision is expected based on Phase III clinical trial data.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses PDX models preserving tumor architecture and heterogeneity, yielding clinically relevant data for more accurate radiopharmaceutical translation.

Rare disease drugs are forecast to exceed $400B by 2032, driven by policy shifts and pipeline growth, despite competition from large-indication products.

groninger will present innovations in equipment lifecycle programs, RTU platform flexibility, and earlier format alignment at INTERPHEX NYC, 2026.

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers.

Japan's largest pharma event returns May 2026 with 320 sessions spanning manufacturing, quality, CMC, and digital transformation.

FDA approves leucovorin for cerebral folate deficiency, signaling how literature-based evidence can support rare disease approvals without clinical trials.

FDA vaccine chief Dr. Vinay Prasad is leaving for the second time in a year amid controversies that disrupted multiple drug and vaccine development programs.

Teclistamab plus daratumumab gains FDA approval for relapsed/refractory multiple myeloma, showing 83% reduction in disease progression versus standard care.

Norgine invests £23 million in Wales site to modernize production and boost resilience for UK and European medicine supply chains.

AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.

Sartorius' new engineered host cell line triples productivity and doubles expression titers while maintaining long-term genetic stability.

Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for global markets by 2028.

EMA's Feb 2026 meeting resulted in the recommendation of 12 medicines, including a combined flu/COVID vaccine among the six biosimilars and six therapeutic extensions.

Think you know the ins and outs of pharma development and outsourcing? See how you did on the quiz!

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty pharmaceutical platform.

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic benefits for 82 million patients.

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

SCOTUS struck down IEEPA tariffs. Pharma duties under Section 232 persist as they fall outside the ruling's scope.

FDA commissioner warns US trial startup delays may cede early drug development to China, urging IND and IRB process reforms amid global competitions.

A $1 Billion Pennsylvania cell therapy site investment bolsters domestic manufacturing, creating 500 skilled biomanufacturing jobs.

Eli Lilly & CSL seal a deal for clazakizumab partitions rights to maximize lifecycle value. CSL retains ESKD focus as Lilly prioritizes commercialization.

The European approval for GSK's depemokimab joins recently announced data on vaccine efficacy and progress on 4-month viral treatments.

FDA has accepted the NDA for BMS's Iberdomide, an oral agent targetting relapsed/refractory multiple myeloma.