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.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

Developments across the sector highlight a period of rapid acceleration and structural modernization.

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.

The author discusses analytical techniques associated with cleaning and disinfection; cleanroom operation; packaging component preparation; water-for-injection production; sterile product preparation; and aseptic filling, stoppering, and sealing.

The FDA's new era of proactive enforcement uses warnings to stop misleading GLP-1 ads and ensure a fair balance of drug risks and benefits.

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.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

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

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

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

Univar Solutions' Ingredients + Specialties division has been appointed as the distributor for Ingredion Pharma Solutions, creating an exclusive distribution channel for pharmaceutical starches within the United States and Canada.

Elisabeth Gardiner, PhD, CSO of Tevard Biosciences, explains some of the challenges associated with the development of treatments for rare diseases.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before uncertainty becomes late-stage risk.

In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, AI‑driven CDMOs, and focused specialization are now critical.

Industry experts discuss the benefits of utilizing contract development and contract research organizations in drug discovery and development.

Using patent intelligence data from the FounderNest platform, Gonzalez highlights where small-molecule synthesis, formulation, and manufacturing innovation is accelerating, and what it means for pharma competition this year.

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

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The multi-dose pen, designed to deliver a full month’s supply, could help alleviate device supply limitations and influence future distribution strategies.

PharmTech spoke with Andrew Mitchell, associate vice president of Business Development at BioVectra, about which 2025 trends will continue to impact the pharma industry and how CDMOs can offer solutions.