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Regeneron and Cytomx Announce $2 Billion Oncology Collaboration
The collaboration will see the companies develop investigational next-generation bispecific immunotherapies for cancer.
Gelomics and Rousselot Biomedical Announce 3D Cell Culture Kits Based on Gelatin Methacryloyl
Rousselot Biomedical will supply Gelomics with its gelatin methacryloyl, a photo cross-linkable extracellular matrix, for use in Gelomics’ LunaGel 3D Tissue Culture System.
Bio-Rad Introduces Pioneer Antibody Discovery Platform for Therapeutic Development
The Pioneer Antibody Discovery Platform is a new antibody discovery service specifically designed to develop best-in-class biologic candidates.
FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes
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.
FDA Committee Recommends Ardelyx Kidney Disease Drug
Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.
Biotech Startup Raises $5.4M to Develop AI-Designed Protein Machines and Cell Factories
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’s New Air Treatment Testing Facility Supports Indoor Space Public Health Air Quality
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 and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate
CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.
Sanofi and Insilico Medicine Ink $1.2 Billion Drug Development Deal
The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.
Indivior Acquires Opiant for $145 Million
Indivior’s acquisition of Opiant grants them access to the company’s portfolio of investigational opioid overdose reversal agent, OPNT003.
ReiThera Expands Viral Vector Production Capabilities with Opening of New Manufacturing Facility
The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.
Avantor Opens New Distribution Center in Dublin, Ireland
Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland.
Salipro Biotech Enters into Collaboration with Sanofi
Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.
Cytiva Opens Cell Culture Center of Excellence
The new Massachusetts facility will strengthen Cytiva’s cell culture services.
Major FDA Reform Unlikely in Closely Divided Congress
The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.
UK MHRA Expands Cosentyx License
The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.
FDA Publishes Draft Guidance Concerning Sameness in ANDAs
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.
Shimadzu and UMG Göttingen Enter Analytics Collaboration
The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.
MGI and Imperial College London Establish Overseas Customer Experience Center in the UK
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 Biological Services Opens San Antonio Biologics Facility
Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.
Trial Decline
Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.
Gerresheimer and Nelson Labs NV Announce E&L Partnership
Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.
Merck and Veeva Ink 10-Year Partnership Agreement
Under this deal, Merck, known as MSD outside of the United States and Canada, will select Veeva products for industry-specific software and data.
J&J to Acquire Abiomed for $16.6 Billion
Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.
FDA User Fees Reauthorized
FDA keeps its user fees but fails to gain important reforms.
Steriline Showcases Filling Equipment at CPHI 2022
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.
Conference Time Brings Gifts
Content is king in publishing, but interpretation is imperator.
CPHI 2022 Award Winners Announced
The winners of the 2022 CPHI Excellence in Pharma Awards were announced on Nov. 1, 2022 at an awards ceremony in Frankfurt, Germany.
Voice of Regulators
Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.
Lonza and Singzyme Enter Bioconjugates Partnership
Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.