Bio/Pharma News
Lilly to Invest $2.1 Billion in New Indiana Manufacturing Facilities
Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.
Pfizer to Invest $120 Million in COVID-19 Oral Treatment Production
Pfizer will invest $120 million to produce COVID-19 oral treatment in the US.
Sanofi Grants Regeneron Worldwide Exclusive License Rights to Libtayo
Sanofi will grant Regeneron worldwide exclusive license rights to Libtayo, a treatment for non-small cell lung cancer.
Astellas and GO Therapeutics Enter into Immuno-Oncology Research and License Agreement Worth Up to $783 Million
Astellas and GO Therapeutics will work together to develop novel antibodies for immuno-oncology.
Thermo Fisher Scientific and Qatar Genome Program Partner to Advance Precision Medicine
Thermo Fisher Scientific and Qatar Genome Program will use custom genotyping arrays to accelerate genomic research in Qatar.
Cambrex Acquires Irish Storage Company Q1 Scientific
Cambrex’s acquisition of Q1 Scientific expands the company’s storage services in the European market.
GSK Acquires Affinivax for $2.1 Billion
GSK’s acquisition of Affinivax will give the company access to their portfolio of next-generation pneumococcal vaccines.
Agenus Enters into Three New Clinical Collaborations
Agenus has entered into three new deals with Targovax, Oxford BioTherapeutics, and Immunogenesis, respectively, doubling its current number of clinical collaborations.
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.
AbbVie and Cugene Form Autoimmune Disease Collaboration
AbbVie and Cugene have reached an exclusive license option agreement for CUG252, Cugene’s lead therapeutic candidate.
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.
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.
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.
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.
Lonza and Integral Molecular Enter Biotherapeutics De-Risking Collaboration
Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.
FDA Limits Use of Janssen COVID-19 Vaccine
FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.
Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer
Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.
FDA Grants Quanterix Plasma Test Breakthrough Device Designation
FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.
Migraine Treatment Granted Marketing Authorization by European Commission
VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.
Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children
Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.
ENHERTU Granted Breakthrough Therapy Designation in US
ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.
FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
USPTO Issues Malaria Vaccine Patent to GeoVax
GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.
Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
