The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

Empty pharmaceutical capsules provider ACG aims to merge science and art with its new art competition worth $5000.

Catalent invests $5 million in hot melt extrusion capabilities at Somerset, NJ facility.

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

Sterling Pharma Solutions has acquired the US arm of complex chemistry solutions provider, CiVentiChem, which is based in Cary, North Carolina, USA.

3M Drug Delivery Systems UK organization has revealed that it is relocating its R&D team to the Charnwood Campus, which is an officially designated Life Sciences Opportunity Zone in Loughborough, United Kingdom

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

The company’s Quantum peristaltic pump uses a patented single-use cartridge technology and is applicable to downstream bioprocessing.

Pharma industry exhibition and conference to convene in Chicago on April 30–May 2, 2019.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

The company will add a cGMP packaging line and a new filler on its existing packaging line at its Mirabel, Québec, Canada, site.

The BioContinuum Buffer Delivery Platform offers streamlined buffer management and delivers “contiGuous” bioprocessing.

The Kimble GLS 80 Media Bottle and Multiport Cap System from DWK Life Sciences, showcased at INTERPHEX 2019 in New York City, is capable of performing a multitude of laboratory applications.

ITT Engineered Valves presented its new EnviZion hygienic valve technology at INTERPHEX 2019 in New York City.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

The acquisition is expected to expand CURE Pharmaceutical’s technology platform in oral drug delivery.