Industry News
FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence
The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.
Rising Demand Drives Drug Shortages
FDA struggles to track shortages caused by a rise in demand.
GSK, Sanofi, and Takeda Partner With Singapore to Boost Biologics Innovation
The partnership will see the pharma giants partner with researchers from A*STAR and various Singapore universities.
ACS-Grade Reagents’ Database Launched
The complete online database of ACS Reagent Chemicals is now available.
Catalent Completes Expansion of Clinical Supply Facility
Catalent has completed the expansion of its clinical supply facility located in Shanghai, China.
Pfizer, Merck KGaA, and Immutep Enter into Second Clinical Trial Collaboration Agreement
The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.
Etihad Cargo Achieves IATA CEIV Pharma Recertification for Pharmaceutical Logistics
Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.
Sartorius BIA Separations and Exopharm Sign Joint Research Agreement
The agreement aims to develop integrated technology for large-scale exosome production.
Regeneron and Cytomx Announce $2 Billion Oncology Collaboration
The collaboration will see the companies develop investigational next-generation bispecific immunotherapies for cancer.
MilliporeSigma Invests $286 Million in US Drug Safety Testing Capacity
The $286 million investment ability is designed to elevate MillioporeSigma’s ability to conduct biosafety testing and analytical development services.
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.
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.
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.
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.
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.
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.
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.
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.
Terumo Pharmaceutical Solutions Expands CDMO Services
The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.
Purolite and Repligen Announce Ligand Partnership
Purolite and Repligen have extended their existing ligand partnership through 2032.
Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program
FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.
FDA Embroiled in Reproductive Rights Debate
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.
FDA User Fees Reauthorized
FDA keeps its user fees but fails to gain important reforms.
