This week, we highlight big news from Roche, BMS, GSK, J&J, and Lilly, as well as well as key insights from industry experts.

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.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

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

In part three of this four-part series regarding rare diseases, the authors examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation.

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.

This week, we highlight AI efficiency, modular hardware, onshoring, Alzheimer's DMTs, and the impact of women in STEM leadership.

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.

Suzanne Jansen, MSc, PharmD, ICON, says early-phase clinical success depends on flexible, simple formulations that support wide dose ranges, matching placebos, and robust stability.

New disease-modifying agents are being evaluated in the clinic that could change the course of treatment for Alzheimer’s disease patients.

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.

Dr. Jennifer Levin Carter, CEO and founder of Medzown, shares her experience as a CEO in the biotech industry and gives insights on how women can succeed in the pharmaceutical industry.

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

PharmTech spoke with women working in the pharmaceutical industry about the innovations they are seeing in bio/pharma and the role women play in the development of critical treatments for patients.

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.

PharmTech spoke with Klaudia Lechowska, Business Development Specialist at Mabion Biologics CDMO, about how women working in STEM fields bring unique perspectives to the important work of rare disease treatment.

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.

This week, we look at a cross-industry shift toward integrated automation, domestic resilience, and a critical focus on the human talent pipeline.

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs.

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