Industry News

Pharmaceutical Technology® sat down with Adam Sherlock, CEO of Qinecsa, to discuss the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

Pharmaceutical Technology® spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

Winners in this year's Pharmapack Awards include both commercial products and innovations that are shaping the future of pharmaceutical packaging.

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Brian Feth, Jonathan Grinstein, PhD, Beth Willers, and Laks Pernenkil go behind the headlines to discuss major news announcements made during the JP Morgan Healthcare Conference, a wave of new Medicare drug price negotiations, and more.

Pharmapack identifies biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow as drivers for a record year in 2025.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss their ‘wish list’ for the progression of trends in the bio/pharmaceutical industry.

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss 2024’s biggest trends in the pharmaceutical industry, as well as the unforeseen outcomes that took us by surprise.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow. Here are the CDMOs and service providers that are poised to make the biggest impact on the pharmaceutical industry.

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

The PharmTech Group editors present our most popular technical articles from 2024.

The PharmTech Group editors present our most popular interviews from 2024.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.

The company is voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials due to misleading labeling and its status as an unapproved drug.

A pilot program to explore creation and testing of ePIs in regulatory procedures shows positive results.

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

The first CPHI Middle East event will be held Dec. 10–12, 2024 at the Riyadh Front Exhibition & Convention Center Riyadh in Saudi Arabia and is expected to be host to 30,000 pharma professionals.

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.

A new platform allowing market authorization holders to report drug shortages has gone live.