Susan Haigney

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience.

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for the rest of 2026.

Campbell Bunce, chief scientific officer at Abzena, revisited his 2026 industry predictions on the direction of the biologics and bioconjugate market and gives an update on ADCs.

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market.

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.

PharmTech spoke with Gabriela Grasa Mannino, Senior Director, Advanced Supply Chain Solutions, US Pharmacopeia about the current state of the drug supply chain and what actions USP is taking to make supply more secure.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

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 episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.

The outsourcing company is adding commercial-scale capabilities to manufacture HPAPI and ADC payload-linkers.

The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain.

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.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

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.

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.

AI governance, nitrosamine risks, and surging US manufacturing investment reshape quality systems, deals, and workforce needs.

This week's headlines saw oncology investment; persistent pressure on supply chain resilience and drug availability; and the importance of operational readiness.

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

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.

Regulatory reform, patient access, and supply chain security were 3 of the key themes showcased this week on PharmTech.com.

EMA, AMA, and national regulatory authorities in Africa are working on potential clinical trial designs and medical treatments for the Ebola outbreak in the DRC and Uganda.