Artificial intelligence's processing power creates more accurate reports for improved drug safety.

Harnessing Technology to Ensure Drug Safety

Harmonization of global regulations fosters innovation and ensures quality medicines.

Convergence in the Global Regulatory Village

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

Topic

Mike Hennessy Jr. is the President and CEO of 

Articles

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

Governance of  Future Pandemics

Feliza Mirasol is the science editor for 

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials 

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, discusses the state of the biopharma supply chain, movements in the patent industry, and more.

Investigating the Pharmaceutical Ingredients Industry with Myrna Wilson (DCAT Week 2023)

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA Eyes Advisory Committee Reform to Enhance Credibility

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA Approves Topical Gene Therapy for Treating Wounds Associated with Rare Genetic Skin Disorder

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.

FDA Approves Blueprint Medicines’ Rare Blood Disorder Treatment

Editor of Pharmaceutical Technology Europe

The UK’s National Institute for Health and Care Excellence has recommended dapagliflozin (Forxiga) from AstraZeneca as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.

AstraZeneca’s Chronic Heart Failure Drug Gets Nod from NICE

Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.

Quality Systems

Harnessing Technology to Ensure Drug Safety

Convergence in the Global Regulatory Village

Shining a Light on Junior Pharmaceuticals