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Ascletis expands production of ritonavir oral tablets & oral direct-acting antiviral R&D pipeline to treat SARS-CoV-2 infection

Ascletis Pharma Inc. announces the expansion of the production of ritonavir oral tablets and oral direct-acting antiviral R&D pipeline for the treatment of SARS-CoV-2 infection. The company’s Covid-19 pipeline currently includes (i) ritonavir oral tablet (100 mg), an authorized...

Amyris and Immunitybio Complete Joint Venture for Next Generation Covid-19 RNA Vaccine

Amyris, Inc., a leading synthetic biotechnology company accelerating the world to sustainable consumption through its Lab-to-Market operating platform, and ImmunityBio, a clinical-stage immunotherapy company, today announced the completion of a previously announced joint venture agreement to accelerate the commercialization...

Valneva Announces Positive Lot-to-Lot Consistency Trial Results for its Single-Shot Chikungunya Vaccine Candidate

Valneva SE, a specialty vaccine company, announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent...

Pfizer and BioNTech Receive U.S. FDA EUA of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

Pfizer Inc. and BioNTech SE announced that the U.S. FDA has expanded the EUA of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage...

REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

REGENXBIO Inc. announced the U.S. FDA granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal...

EC grants marketing authorisation to GSK-Virs Xevudy for Covid-19

The European Commission (EC) has granted marketing authorisation to GlaxoSmithKline (GSK) and Vir Biotechnology’s Xevudy (sotrovimab) to treat Covid-19 in the early stage. The therapy is intended to be used to treat Covid-19-infected adult as well as and adolescent individuals...

ViiV Healthcare announces US FDA approval of Apretude, the first and only long-acting injectable option for HIV prevention

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, announced that the US Food and Drug Administration (FDA) approved Apretude, the first and only long-acting...

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