Susan Haigney

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 company will be showcasing its injection blow molded bottles and five-layer blown film at the packaging event in Paris on Jan. 22–23, 2025.

Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.

AbbVie has completed its acquisition of Aliada Therapeutics which includes Aliada’s disease-modifying therapy for Alzheimer’s disease.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

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The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.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

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

Ascend is partnering with EW Healthcare Partners to expand capabilities in the United States.

Pharmaceutical Technology® caught up with Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, after AAPS PharmSci 360 to talk about the challenges and quality requirements involved in the development and manufacture of peptide-based oral dosage forms.

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.

The companies will work to create climate-friendly pMDIs using Orbia’s low global warming potential propellant.

A genetic medicines customer has selected the company’s binders for commercial development of the customer’s product.

The merger agreement is valued at approximately $1.1 billion.

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

WHO and its partners are providing support to countries dealing with mpox outbreaks.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

The report highlights international regulators’ plans for the development and availability of vaccines to prevent and drugs to treat mpox.

Merck is acquiring the Yale-spinout, which develops direct DNA modification-enabled cancer treatments.

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses how facilities used for solid dosage manufacturing may be retrofitted into sustainable cell and gene therapy production facilities.

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.