Susan Haigney

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.

The company has expanded its NeoFlex coated plungers with new sizes for large-volume auto-injectors and wearable devices.

Pharmaceutical Technology® Europe sat down with Álvaro Nocete Díaz, Pharma Division Manager at HTBA, about the benefits of flavonoids and their use in the pharmaceutical industry.

The CDMO will be launching its EnzeneX 2.0 continuous manufacturing for biologics technology during CPHI Milan, which is being held Oct. 8–10, 2024 in Milan, Italy.

Pharmaceutical Technology sat down with Erica Schlesinger, vice president of technical development at Serán Bioscience, to talk about her upcoming presentation at AAPS PharmSci 360 2024, “High Dose Subcutaneous Delivery of Protein Therapeutics.”

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

The company will be introducing its new low-substituted hydroxypropyl cellulose and its improved polyplasdone LN superdisintegrant at the October 2024 events.

The Almac Group is planning a £11 million (US$14.7 million) investment to expand the company’s existing analytical laboratories.

Pharmaceutical Technology sat down with Anna Jenks, director of Pharmaceutical Operations for Merck & Co., Inc. in Rahway, NJ, USA to talk about her prologue presentation for AAPS PharmSci 360 2024.

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

The two companies are partnering to provide logistics and manufacturing services to biotechnology and pharma companies.