Drug Development

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Articles

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine. 

Smart Inhalers Improve Patient Compliance

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Regeneron Halts Development of RSV Biologic

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.

Catalent Applied Drug Delivery Institute Appoints Jim Spavins to Advisory Board

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

Cambrex Adds HPAPI Capacity

FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.

FDA Extends Dynavax’s Hep B Vaccine Review

Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.

Merck KGaA and Baylor Partner on Vaccines for Neglected Diseases

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

Lonza Boosts Micronization Capacity with Acquisition

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline. 

Seattle Genetics Acquires Pharma Manufacturing Facility from BMS

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.


Congress Passes FDA User-Fee Reauthorization Bill

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

Formulation and Drug Delivery