Articles

GlaxoSmithKline will focus on vaccines and specialty medicines while spinning off consumer healthcare business.

GSK Announces Consumer Business Demerger

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EC Orders 150 Million Additional Doses of Moderna’s COVID-19 Vaccine

Centrient started production at its new statins API manufacturing unit in Toansa, India.

Centrient Pharmaceuticals Adds API Capacity

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

Ilya Pharma Receives Approval from Swedish Regulators for Phase II Study

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

FDA Advisory Committees Under Scrutiny

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

EMA Issues Positive Opinion for CrisBio Developed Vaccine, Validating the Platform

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

Vectura Signs Agreement with Incannex to Advance TBI Treatment

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

FDA Publishes Guidance on CMC Changes to an Approved Application 

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

FDA Gives Guidance on Development of Breast Cancer Drugs

Exscientia has entered into a binding agreement to acquire the artificial intelligence precision-based medicines company, Allcyte.

News