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Thermo Fisher Expands Hematology Oncology NGS Portfolio
Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.
CHMP to Assess Extended Indication of Kineret for COVID-19
Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.
EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
ERS Genomics Adds Japan SLC to List of Partners
ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.
Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies
Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.
Summa Equity Acquires Majority Stake in Axion BioSystems
Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.
908 Devices and Transcenta Partnership Leads to Workflow Innovations
Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.
Artificial Intelligence Facilitates Empty Well Detection
Through a partnership with the University of Hertfordshire, Ziath discovers means of using AI to detect empty wells in sample tube racks.
J.T.Baker Robotic Tips from Avantor Offer Precision Workflow
Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.
FDA Under Pressure to Restore “Normal” Drug Inspections
FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.
Cytiva and Pall Investing $1.5 Billion into Manufacturing Expansion
Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.
Sciex’s New ZenoTOF 7600 Mass Instrument System Offers Increased Analytical Precision
Sciex’s recently launched accurate mass instrument, the ZenoTOF 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.
FDA Approves Merck’s 15-Valent Pneumococcal Vaccine
Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.
Nexus Opens New Wisconsin Manufacturing Facility
Nexus Pharmaceuticals celebrated a new manufacturing facility in Pleasant Prairie, Wis.
FDA Approves Amneal’s Generic Version of TobraDex
Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.
Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data
Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.
PerkinElmer to Acquire BioLegend in $5.25-Billion Deal
PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.
EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents
The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.
Kadmon Pharmaceuticals Partners with Oncology Pharmacy for New Chronic Graft-Versus-Host Disease Therapy
Kadmon Pharmaceuticals selects Onco360 to be a specialty pharmacy partner for Rezurock (belumosudil).
Pfizer and Arvinas to Develop and Commercialize Estrogen Receptor Targeting Breast Cancer
The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.
Johnson & Johnson Finalizes National Opioid Settlement Agreement
J&J to contribute up to $5 billion to the settlement agreement to resolve opioid-related claims and litigation in the United States.
Aenova Announces Plans for New Production Line
Aenova has announced plans to open a new new can and bottle filling production line in Cornu, Romania.
Summa Equity Acquires Cleanroom Provider G-CON Manufacturing
Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.
Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.
Catalent Biologics Launches New Cell Line Expression Technology
Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.
Sinovac’s Eupolio Vaccine Gains Market Authorization in China
Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.
Exscientia and GT Apeiron Form Strategic R&D Collaboration Agreement
Exscientia and GT Apeiron Therapeutics have entered into a strategic R&D oncology collaboration agreement.
Advanz Pharma Launches Generic Lanreotide in Germany
Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.
Catalent Invests $100 Million to Expand European Biologics Manufacturing Capabilities
Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.
EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA
The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.
