BioPharm International Editors

The University of Southern California and Amgen have teamed up to provide researchers access to two of Thermo Fisher Scientific’s cryo-EM instruments.

A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.

Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

Promega will demonstrate applications of bioluminescence tools at Discover Glo 2021.

BioAgilytix, a US-based contract research laboratory focused on large-molecule drug development, has agreed to purchase 360biolabs, an Australia-based contract research organization specializing in virology and immunology.

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.

Todos Medical has completed validation of its cPass neutralizing antibody blood test to monitor COVID-19 immunity.

Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.

Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.

The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).

A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.