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FDA Updates Sotrovimab Emergency Use Authorization
FDA has revised the Emergency Use Authorization for sotrovimab.
AstraZeneca and Neurimmune Collaborate on Treatment for Transthyretin Amyloid Cardiomyopathy
AstraZeneca and Neuroimmune have closed an exclusive global collaboration and license agreement to develop and commercialize NI006.
BioMed X Institute and Boehringer Ingelheim Start New Research Project in Brain Sensor Development
BioMed X and Boehringer Ingelheim have announced the start of a new research project in brain sensor development.
Hovione Appoints Jean-Luc Herbeaux as New CEO
Hovione has announced that Jean-Luc Herbeaux will take over for Guy Villax as CEO on April 1, 2022.
UCB Announces Extension of Tender Offer to Acquire Zogenix
UCB has announced that it is extending its tender offer to acquire Zogenix.
EMA Recommends Granting Market Authorization in EU for New Medicine for Rare Type of Eye Cancer
EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.
EMA Recommends Approval of Spikevax for Children Aged 6 to 11
EMA has recommended approval of Spikevax for children aged 6 to 11.
Johnson & Johnson Confirm Advancement of Nationwide Opioid Settlement Agreement
Johnson & Johnson has confirmed advancement of the nationwide opioid settlement agreement.
EMA Issues Positive Opinion on Pfizer and BioNTech COVID-19 Vaccine Booster in Adolescents 12 Through 17 Years of Age in EU
Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.
FDA Approves Treatment for Wider Range of Patients with Heart Failure
FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.
FDA Licenses Certara’s Immunogenicity Simulator
FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.
AstraZeneca Progresses Ambition Zero Carbon Program with Honeywell Partnership to Develop Next-Generation Respiratory Inhalers
AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers as part of AstraZeneca’s Ambition Zero Carbon program.
Thermo Fisher Scientific Introduces New Portfolio of Chromatography and Mass Spectrometry Consumables
A new portfolio of chromatography and mass spectrometry consumables launched by Thermo Fisher Scientific is designed to meet higher performance requirements while remaining economical.
Inhaled Niclosamide Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2
TFF Pharmaceuticals announces findings that inhaled niclosamide significantly inhibits viral replication of the Omicron variant of SARS-CoV-2.
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.
Remix Therapeutics Collaborates with Janssen to Advance Small Molecule Therapeutics
Janssen will pay upwards of $1 billion for exclusive rights to use Remix’s RNA-based drug discovery platform on three specific targets.
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.
Taconic Biosciences Launches Cage+ Contract Breeding Service
Taconic Biosciences Cage+ colony management service aims to offer comprehensive coverage for contract breeding services.
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.
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.
Consultation on Proposals for the Future of UK Clinical Trial Legislation
MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.
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.
Noema Pharma Announces First Patient Dosed in Study Evaluating Efficacy of NOE-101 for Trigeminal Neuralgia
Noema Pharma announces first patient dosed in its Phase IIb clinical trial of mGluR5 inhibitor NOE-101 in trigeminal neuralgia.
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.