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Intellia Therapeutics and SparingVision Announce Strategic Collaboration to Develop Novel Ocular Therapies Using CRISPR/Cas9 Technology
The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.
INTERPHEX Keynote Sessions on the Innovation Stage
The Pharmaceutical Technology and BioPharm International editors host industry experts, highlighting trends and new technologies.
Avid Bioservices Expands into Viral Vector Development and Manufacturing Services
Avid Bioservices is building a viral vector development and manufacturing facility near its existing biologics manufacturing facility in California.
FDA Approves Rethymic for Pediatric Congenital Athymia
Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.
Element Strengthens US Presence with Nanosyn Acquisition
Element’s acquisition of Nanosyn is the latest in a series of moves made to strengthen the company’s North American presence.
Roche Submits Marketing Authorization Application for COVID-19 Treatment to EMA
Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.
EMA Ends Rolling Review of CureVac’s COVID-19 Vaccine Candidate
EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.
MHRA Awards ‘Innovation Passport’ to CellResearch for Stem Cell Therapy
MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.
Smiths Detection Confirms BioFlash Detects Multiple Airborne SARS-CoV-2 Variants
Smiths Detection has confirmed that the Bioflash air sampler can detect Beta, Gamma, Kappa, Delta, and Delta plus variants.
Pacira BioSciences Acquires Flexion Therapeutics for $630 Million
Pacira’s acquisition grants them access to Flexion’s pain management portfolio.
AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint
AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.
Supernus to Acquire Adamas Pharmaceuticals in $400 Million Deal
Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.
MilliporeSigma Licenses CRISPR-Cas9 Technology to Cellecta
MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, signed an agreement with Cellecta to license its genome-editing tool.
FDA Approves ChemoCentryx’s Tavenos
The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
FDA Grants AstraZeneca's Tezepelumab Orphan Drug Designation
AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.
Pfizer Agrees to License Agreement with Voyager Therapeutics
Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.
Pfizer, BioNTech Request EUA for COVID-19 Vaccine in Children Aged 5-11
Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.
Moderna to Select Site in Africa for $500 Million mRNA Facility
Moderna’s new facility is expected to produce 500 million vaccine doses per year.
FDA Grants Emergency Use Authorization for OTC COVID-19 Test
FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.
NIIMBL Invests $3 Million in Six Biopharmaceutical Manufacturing Products
The $3 million investment will go towards various projects investigating key product attributes for therapeutic proteins.
EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine
The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.
EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals
The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
Application for COVID-19 Treatment Submitted to EMA
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
MilliporeSigma Launches Excipient Platform for Protein-Based Therapies
New excipients for protein-based drug products reduce viscosity while maintaining protein stability.
Moderna Opens New Science Center in Cambridge, MA
Moderna’s new 462,000-ft² science center is expected to be completed by 2023.
Sunovion, Sumitomo Dainippon, and Otsuka Enter Development and Commercialization Collaboration
The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.
Luas Diagnostics Partners with Bond Digital Health to Launch Enhanced COVID-19 Immunity Test
The test developed by Luas Diagnostics and Bond Digital uses a smartphone app to enhance a 15-minute COVID-19 immunity test.
Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%
Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.
Certara Completes Acquisition of Pinnacle 21
Certara’s acquisition of Pinnacle 21 grants them access to their compliance validation software.
Selecta Biosciences and Takeda Announce Gene Therapy Platform Licensing Agreement
Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.
