Drug Development

Ocrelizumab biosimilar for multiple sclerosis: Teva and Polpharma Biologics sign global deal covering intravenous and subcutaneous forms.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies.

Advances in personalized medicine, biopharma, and digital technologies are unlocking treatments for complex and rare conditions.

FDA approves a new IgA nephropathy therapy that targets two immune cytokines at once, offering a weekly, self-administered treatment option.

EMA starts phased review of daraxonrasib for metastatic pancreatic cancer, testing a faster assessment model under reformed EU pharma rules.

In a string of ADC acquisitions, Novartis agreed to acquire Myricx Bio for up to $1.5 billion, gaining an NMTi ADC payload platform designed to overcome resistance in solid tumor treatment.

FDA has approved Tregzi, the first regulatory T-cell therapy shown to reduce chronic GVHD and improve survival in blood cancer transplant patients.

The company’s thyroid eye disease treatment will be the first at-home subcutaneous disease-modifying treatment if approved.

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve standardization and efficiency were themes covered on PharmTech.

The agency approved palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer.

The FDA's revised draft guidance updates master protocol recommendations on randomization, control groups, blinding, and regulatory submissions for multi-drug trials.

Merck is collaborating with Versant Ventures to establish a portfolio of treatments for rare genetic cardiomyopathies. The company also announced the winners of its 2026 Future Insight Prize and its 2026 North American Advance Biotech Grant.

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

AbbVie acquires Apogee Therapeutics for $10.9 billion, gaining zumilokibart, a long-acting injectable targeting atopic dermatitis and asthma with once-quarterly dosing potential.

PharmTech Europe's June 2026 issue reflects the convergence of compliance burden, cost pressure, analytical complexity, and patient access.

Kristin Ciriello Pothier, KPMG US, discusses why pharma dealmaking slowed in early 2026, but how AI partnerships, manufacturing acquisitions, and oncology are driving a second-half rebound.

Kristin Ciriello Pothier, KPMG US, explains why supply chain resilience and platform technology diligence are reshaping biopharma M&A valuations globally.

Kristin Ciriello Pothier, KPMG US, discusses biopharma dealmaking shifting toward strategic precision, with oncology, GLP-1s, and manufacturing complexity reshaping M&A valuations in 2026.

The FDA priority review granting of AstraZeneca’s ravulizumab reinforces the commercial and scientific rationale for sustained investment in complement biology platforms.

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems.

GSK's momelotinib receives US and EU orphan drug designations for VEXAS syndrome, a rare myeloid disorder with 30–40% five-year mortality and no approved treatments.

Tom Sellig, Adare, discusses 3D-printed tablets, US reshoring investment, FDA timeline pressures, and workforce development strategies driving CDMO growth.

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies.

GSK boosts oncology pipeline with Nuvalent acquisition, advancing FDA-designated ROS1/ALK inhibitors for NSCLC and expanding kinase inhibitor drug development in lung cancer.