News

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.

Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland.

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.

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

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.

Metrics from the CPHI Annual Survey suggest that confidence in the global pharma market has risen significantly in the past year.

Purolite and Repligen have extended their existing ligand partnership through 2032.

Lonza has launched a new capsule to deliver acid-sensitive APIs to the intestine.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany.

Thermo Fisher Experts will demonstrate its various capabilities at CPHI Frankfurt 2022.