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FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment
The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.
FDA Approves Interchangeable Biosimilar Insulin
FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
FDA Approves GSK’s Treatment for Chronic Rhinosinusitis with Nasal Polyps
GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.
FDA’s Pazdur Challenges Attack on Accelerated Approval Program
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.
FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.
18th Annual CPhI Pharma Awards to Take Place in Milan, Italy
Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.
FDA Grants Orphan Drug Designation to VICO Therapeutics for Huntington’s Disease Drug
VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.
New Drug Approvals on Track at FDA
In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Summa Equity Acquires Cleanroom Provider G-CON Manufacturing
Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.
