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Results For "license"

409 News Found

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline
Biotech | October 18, 2021

Ipsen enters exclusive worldwide tie-up with Accent for its pre-clinical R&D oncology pipeline

Ipsen obtains an exclusive license to develop, manufacture and commercialize a pre-clinical stage METTL3-inhibitor programme


Resilience and Harvard announce five-year R&D alliance
News | October 18, 2021

Resilience and Harvard announce five-year R&D alliance

First anticipated spinout from the alliance, Circle Therapeutics, to develop novel muscle stem cell therapies for a variety of skeletal muscle disorders


Lancet Respiratory Medicine publishes Phase 2 data of Medigen Covid-19 vaccine
News | October 16, 2021

Lancet Respiratory Medicine publishes Phase 2 data of Medigen Covid-19 vaccine

The interim analysis showed that the MVC-COV1901 vaccine has a good safety profile and elicits promising neutralising antibody titres


ASU drug manufacturing licence goes online
Policy | October 09, 2021

ASU drug manufacturing licence goes online

The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence


Sanofi says positive results from flu vaccine with mRNA booster study
Biotech | October 08, 2021

Sanofi says positive results from flu vaccine with mRNA booster study

The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older


CDSCO approves Syntellix implants
News | October 08, 2021

CDSCO approves Syntellix implants

This opens up a huge market for the company’s Magnezis implants in India


Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy
Biotech | October 01, 2021

Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy

Takeda to exclusively commercialize JR-141 outside the U.S. (except Japan and certain other Asia-Pacific countries) upon regulatory approval


Thermo Fisher launches SpeciMAX saliva collection kit
Medical Device | September 29, 2021

Thermo Fisher launches SpeciMAX saliva collection kit

The kit preserves viral nucleic acids in a non-hazardous stabilization solution that inactivates common respiratory viruses for safer sample collection