Susan Haigney

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The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.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

The merger will create a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

Ahmed Youssef, senior manager, USP Process Development at Ascend, provides insight on tech transfer when developing and manufacturing emerging therapies and new modalities.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Pharmaceutical Technology Europe sat down with Joan Bassa, Human Health Business Unit Director at Bioiberica, to talk about the history of heparin, its uses in pharmaceuticals, and what heparinoids have to offer the industry.

Pharmaceutical Technology sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to talk about the session she is moderating at AAPS PharmSci 360 2024, Symposium: An Accelerated Development of Poorly Soluble Drugs Using Predictive Tool.

Through the global partnership, Colorcon will exclusively represent LOTTE’s AnyCoat Hypromellose products.

Pharmaceutical Technology® Europe sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery.

The winners of this year’s awards showcase achievements in pharma excellence.