Zachary Zubulake

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.

Gazyva phase III MAJESTY study met its primary endpoint, showing superior complete remission in primary membranous nephropathy.

EMA recommends withdrawing levamisole from the EU market due to serious leukoencephalopathy risks that outweigh clinical benefits.

JIN-A02 is a fourth-gen EGFR inhibitor targeting EGFR C797S resistance in lung cancer, showing brain activity and tumor regression.

Fujifilm’s £400m (US $547m) Teesside expansion adds 19,000L single-use capacity and an innovation center to boost global biopharma development.

IMA Group acquired ProSys to expand its global aseptic and containment portfolio for biopharmaceutical manufacturing.

Márcio Temtem, Hovione, discusses how to tackle pharma complexity via regional growth in the US, Ireland, and Portugal, using digital tools to accelerate development.

Merck KGaA optimized cooling by 21% at its Darmstadt site using autonomous AI, aiding sustainability without system changes.

Márcio Temtem, Hovione, discusses how his company integrates modular hardware and modeling software to accelerate pharmaceutical R&D and optimize manufacturing processes.

Takeda and Iambic partner to use digital tools for discovery. NeuralPLexer helps move oncology candidates toward clinical trials.

Fresenius Kabi and Phlow partner to onshore US epinephrine production, securing the domestic supply chain for essential medicines.

FDA granted priority review for Pfizer’s Marstacimab, a weekly subcutaneous anti-TFPI to treat pediatric and inhibitor hemophilia.

Marcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing.

ACG’s Shirwal site is the first pharmaceutical packaging site in the WEF Lighthouse Network, using digital tools to cut defects and boost sustainability.