As Europe’s growing biomanufacturing and bioprocessing industries develop, now a crucial time for the small-molecule and biopharma industries to integrate in order to facilitate growth. / read more /
Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy. / read more /
GlaxoSmithKline has issued a voluntary recall of three lots of respiratory inhalers in the United Kingdom, including preventer and emergency relief inhalers. / read more /
The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials. / read more /
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections. / read more /
A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead’s Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned. / read more /
The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility. / read more /
Industry lessons from a fast-track technology transfer of a soft-gelatin capsule are multifold. This case study reviews the success factors for effective execution of the technology transfer / read more /
Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform. / read more /
This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products. / read more /
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities. / read more /
Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
