Pharmaceutical Technology Editors

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.

CPHI China and P-MEC China has opened its online partnering platform after China experienced gains in the CPHI Pharma Index.

UK researchers have discovered a gene involved in chronic pain, which has created a new treatment target.

The draft ICH Q9(R1) document details the importance of quality risk management principles.

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

Yourway intends to construct a new manufacturing facility in the Dublin Airport Logistics Park.

The deal will see Spectrum market and distribute ANGUS’ biologics grade buffers in the United States and Canada.

Precision BioSciences has released clinical trial data on CAR T therapy candidates PBCAR0191, PBCAR19B, and PBCAR269A.

Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.

REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

The Rockwell Experience Center will teach ARMI members how to increase delivery speeds by leveraging smart manufacturing in the scaling of regenerative medicine products.

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

Bio-Rad’s SEQuoia Express Stranded RNA Library Prep Kit is designed to construct efficient RNA sequencing workflows.

Axol Bioscience’s CiPA-validated ventricular cardiomyocytes can be used as a robust cardiotoxicity measurement tool.

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

The acquisition grants Bristol Myers Squibb access to the company's oncology pipeline and lead candidate, repotrectinib.

Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

Pfizer will invest $120 million to produce COVID-19 oral treatment in the US.

Sanofi will grant Regeneron worldwide exclusive license rights to Libtayo, a treatment for non-small cell lung cancer.

Astellas and GO Therapeutics will work together to develop novel antibodies for immuno-oncology.