BioPharm International Editors

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.

Vertex’s $320 million acquisition of ViaCyte will give the company complementary capabilities for its Type 1 diabetes therapy program.

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

Bio-Rad’s CFX Opus Deepwell Real-Time PCR Detection System is designed to support researchers in developing nucleic acid detection assays.

Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.

Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.

Ipsen will acquire Epizyme, who recently had their lead medicine Tazverik (tazemetostat) approved by FDA for treatment of relapsed or refractory follicular lymphoma.

Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.

MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.

Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.

The European Commission has approved Xenpozyme as the first treatment for ASMD.

The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.

MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

Lonza will produce drug product for Pierre Fabre’s monoclonal antibody W0180.

The partnership between Echosens and Novo Nordisk is intended to increase awareness and early diagnosis of non-alcoholic steatohepatitis (NASH).

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.

GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.