The Pioneer Antibody Discovery Platform is a new antibody discovery service specifically designed to develop best-in-class biologic candidates.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.

Indivior’s acquisition of Opiant grants them access to the company’s portfolio of investigational opioid overdose reversal agent, OPNT003.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.

The new Massachusetts facility will strengthen Cytiva’s cell culture services.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.

MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.

Under this deal, Merck, known as MSD outside of the United States and Canada, will select Veeva products for industry-specific software and data.

Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.

FDA keeps its user fees but fails to gain important reforms.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Content is king in publishing, but interpretation is imperator.

The winners of the 2022 CPHI Excellence in Pharma Awards were announced on Nov. 1, 2022 at an awards ceremony in Frankfurt, Germany.

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.

Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.