Formulation and Drug Delivery

Merck & Co.’s Application for Ebola Vaccine Accepted by FDA and Granted Priority Review

September 19, 2019

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

Colorcon Launches $50 Million Venture Capital Fund

September 18, 2019

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

Acura and Catalent Team Up for LTX-03 Advancement

September 17, 2019

The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.

Lundbeck to Acquire Alder BioPharmaceuticals in Deal Worth Up to $1.95 Billion

September 16, 2019

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

PPF Acquires Stake in Autolus Therapeutics, Expands Cell Therapy Pipeline

September 16, 2019

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

Nephron, UofSC Researchers Collaborate on Automation

September 16, 2019

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

Generics: Getting Beyond “File First, Figure it Out Later”

September 15, 2019

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

Collaboration Aims to Drive Commercialization of Next-Generation Therapies

September 13, 2019

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

GSK Announces First Biologic for the Treatment of Eosinophilic Asthma in Pediatric Patients

September 13, 2019

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

Grünenthal, Mesoblast Partner on Innovative Cell Therapy for Chronic Low Back Pain

September 13, 2019

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.