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FDA Moves Forward with State Drug Import Plans
FDA once again is taking steps to facilitate the import of less costly prescription drugs.
Thermo Fisher Scientific and LabShares Partner to Support Emerging Boston Biotechs
Through the Thermo Fisher Scientific and LabShares Newton partnership, life science startups can accelerate early-stage discovery and development with shared lab spaces.
PerkinElmer Introduces Ultrarapid Whole Genome Sequencing
PerkinElmer has expanded its genomics testing services with the launch of its ultrarapid whole genome sequencing.
PAMM Foundation Outsources Laboratory Activities to Eurofins
Eurofins partners with PAMM to strengthen laboratory services for the Dutch healthcare system.
Biograd Diagnostics Adopts Autoscribe Informatics’ Matrix Gemini LIMS
Biograd Diagnostics has chosen the Matrix Gemini system by Autoscribe Informatics as its laboratory information management system for managing COVID-19 test samples.
Foxx Life Sciences and Thomas Scientific Partner to Simplify Media Bottle Ordering
Foxx Life Sciences and Thomas Scientific collaborate to simplify online ordering access to Foxx’s media bottle assembly offerings.
FDA Approves Sanofi’s and Regneron’s Dupixent to Treat Eosinophilic Esophagitis
Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.
Lonza, IBF Collaborate to Support Development and Manufacturing of Biologics and Small Molecules
Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.
AGC Biologics Adds Viral Vector Suspension Technology at New US Campus
AGC Biologics is investing in viral vector suspension technology at its new Longmont, Colo., facility.
Lubrizol Launches Apisolex Technology
Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.
AbbVie and Cugene Form Autoimmune Disease Collaboration
AbbVie and Cugene have reached an exclusive license option agreement for CUG252, Cugene’s lead therapeutic candidate.
Sferalp to Use Fluid Air Technology for Laboratory Research
Sferalp will use Fluid Air’s PolarDry technology for powder processing.
New Guidelines Aim to Advance Pediatric Drug Development
A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.
Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA Recommends Approval of Niemann-Pick Disease Types A/B and B Therapy
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
Pandemic Science Hub Launches at University of Edinburgh
Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.
AstraZeneca and RQ Biotechnology Sign License Agreement for Monoclonal Antibodies
AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.
PTC Therapeutics Receives Positive Opinion for Upstaza
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
FDA Issues Labeling Guidance
The final guidance addresses safety aspects of container and carton labeling design.
FDA Stresses Risk Management Plans
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity in US Facility
Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.
FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.
Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC
The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.
Avacta Establishes New Therapeutics Headquarters
Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.
Pfizer to Acquire Biohaven Pharmaceuticals for $11.7 Billion
Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.
Avantor and Cytovance Biologics Partner on Plasmid DNA Development
Through a collaboration, Avantor and Cytovance Biologics will accelerate plasmid optimization and sourcing services for viral vectors and mRNA-based vaccines and therapeutics.
PCI Pharma Services Invests $100 Million in Bedford, NH Manufacturing Facility
PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.
Natoli Announces Tablet Press & Tooling Training Schedule at Company Headquarters
The “Tablet Press & Tooling: Applied Learning Experience” session will be held from June 14-16 at Natoli’s global headquarters in St. Charles, Mo.
FDA Launches Accelerated Rare Disease Cures Program
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.
