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Medicago and GSK Announce the Approval by Health Canada of COVIFENZ, an Adjuvanted Plant-Based COVID-19 Vaccine
Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.
USP Developing mRNA Quality Guidelines to Help Bring Innovative Medicines to Market Faster
USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
MilliporeSigma Announces E&L Reference Library Collaboration with Waters
MilliporeSigma and Waters will work together to build an extractables and leachables (E&L) reference library.
Taconic Biosciences Launches Cage+ Contract Breeding Service
Taconic Biosciences Cage+ colony management service aims to offer comprehensive coverage for contract breeding services.
Lilly Launches Institute for Genetic Medicine and Invests in Boston Seaport Site
Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.
Valneva Awarded R&D Funding by Scottish Enterprise for Vaccine Development
Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.
Alvea to Develop New DNA Vaccine Against SARS-CoV-2 Variants
Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.
Moderna and Thermo Fisher Scientific Form Long-Term Strategic Manufacturing Collaboration
Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.
Sanofi and GSK to Seek Regulatory Authorization for COVID-19 Vaccine
Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.
Novavax Begins Shipping its COVID-19 Vaccine to European Union Member States
Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.
Center for Breakthrough Medicines and BioAnalysis LLC Form Partnership to Offer Novel Analytical Testing Services for CGT Clients
The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.
Semarion Raises £2.14 Million GBP ($2.89 Million USD) Seed Funding
Semarion raises £2.14 million GBP (US$2.89 million) seed funding to support the commercial development of Semarion’s SemaCyte cell assaying platform.
Hoffmann Neopac Partners with Saperatec for Recycling of Aluminum Laminate
Hoffman Neopac has signed a partnership with Saperatec to begin recycling aluminum laminate composites upon its opening in mid-2023.
European Medicines Regulatory Network Adopts EU Common Standard for Electric Product Information
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.
FDA Nixes Approvals Based Only on Foreign Data
FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.
Quotient Sciences Completes Integration of Drug Substance into Translational Pharmaceutics Platform
Quotient Sciences announces that it has integrated drug substance into its flagship Translational Pharmaceutics platform.
Recipharm Acquires Two Biologics CDMOs: Vibalogics and Arranta Bio
Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.
BioNTech Plans to Build Modular mRNA Manufacturing Facilities in Africa
The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.
Health Canada Authorizes Novavax COVID-19 Vaccine
Health Canada authorizes Novavax COVID-19 vaccine for individuals 18 years of age and older.
PETA Science Group Shares Goals With New FDA Commissioner
PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.
EC Approves AstraZeneca’s Lupus Drug
The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.
Moderna Plans Expansion in Europe
The company has announced plans to establish a commercial presence in six European countries.
FDA to Hold Public Symposium on Multi-Identification Biomarkers
FDA will hold a symposium discussing the identification of concepts and terminology for multi-component biomarkers from March 23–24, 2022.
Biogen and Xbrane Ink Agreement for Proposed Biosimilar
The commercialization and licensing deal will see Biogen commercialize Xbrane’s Xcimzane, a proposed biosimilar for CIMZIA (certolizumab pegol).
Thermo Fisher Scientific Invests $40 Million to Expand Bioprocessing Manufacturing Site
Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.
Intellia and ONK Therapeutics Enter Gene-Editing Partnership
ONK will receive non-exclusive rights to Intellia’s proprietary ex-vivo CRISPR/Cas9 technology in the development of five allogeneic NK cell therapies.
ImmunoGen Grants Lilly Exclusive Research, Development, and Commercialization License in $1.7+ Billion ADC Deal
ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.
FDA Grants Eli Lilly Drug EUA for Treatment of COVID-19
FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).
ProBioGen Inks License Agreement Deal with AstraZeneca
The deal between ProBioGen and AstraZeneca will allow AstraZeneca to use ProBioGen’s GlymaxX technology.
New Medicines Recommendations Up in 2021, EMA States
The agency recommended 53 new active substances in 2021, up 35% from 2020.