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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.
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.
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.
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.
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.
Lonza and Singzyme Enter Bioconjugates Partnership
Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.
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.
Roquette Launches Next-Generation Direct Compression Solutions
Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.
Venture Capital Funding to Fuel Pharma Outsourcing
The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.
CSafe and BioLife Solutions Partnership Will Expand Supply Chain for Cell and Gene Therapies
The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.
FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
Pressure Mounts for FDA to Reform Accelerated Approval Program
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
Societal CDMO Signs Multiple CDMO Service Agreements
Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.
