Zachary Zubulake

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.

FDA has granted priority review to AstraZeneca's Datroway for the first-line treatment of metastatic TNBC treatment.

EMA recommends Kygevvi for rare thymidine kinase 2 deficiency. It is the first authorized treatment for this disease.

EMA recommends Rezurock (belumosudil) for chronic graft-versus-host disease, with the drug. Meetings unmet needs via conditional authorization.

This week's coverage discusses the M&A report, $50B+ investments, automated cell therapy, vaccine approvals, and risks from the US leaving the WHO.

M&A report claims that pharma is now targeting vertical integration and manufacturing control in radiopharma, GLP-1s, and ADCs to secure the supply chain.

Vetter's €1.5 billion expansion adds German commercial and Illinois clinical sites to support global sterile injectable drug supply.

The ROSS CDA-200 optimizes viscous pharmaceutical batches via independent agitation, vacuum, and thermal control.

Halo Pharma becomes a standalone drug product CDMO after the sale of Noramco’s API assets, adding sterile services by H2 2026.

WuXi Biologics and HanchorBio partner to accelerate multi-functional fusion protein translation via end-to-end CMC and GMP services.

Laine Mello, director of Marketin, Ecolab, details how AI, continuous manufacturing, and Pharma 4.0 drive bioprocessing efficiency and cost savings.

Raj Puri, CCO, Argonaut Manufactoring, provides key insight on navigating tariffs, supply redundancy, and the risks of compressed timelines.

Mirum Pharmaceuticals acquires Bluejay Therapeutics, adding a Phase 3 antibody for chronic hepatitis delta virus to its pipeline.

In a 2026 industry outlook interview, Laine Mello, Ecolab Life Sciences, explains how next-gen therapies, digitalization, and partnerships drive pharma agility.

This week's coverage discusses pharma advances in sustainable packaging and digital standards amid trade risks from Greenland tariffs and falling workforce morale

The United States Pharmacopeia is developing digital standards for digital-first workflows and regulatory confidence.

ACG’s new SuperPod reduces blister size and boosts efficiency and sustainability for moisture-sensitive drug products.

The three firms offer a pre-verified platform for large-volume subcutaneous delivery of biologics to enable home self-administration.