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Giant leap for innovation: Bharat Biotech after DCGI approval to Covaxin

Bharat Biotech on Sunday said the approval for emergency use of its Covid-19 vaccine --Covaxin -- is a giant leap for innovation and novel product development in India. The Hyderabad-based vaccine maker expressed its delight after Drug Controller General of...

Treating brain disorders with new nanoparticle drug delivery system

A new nanoparticle drug-delivery system could help scientists overcome the long-standing problem of delivering therapeutics across the blood-brain barrier and into the brain. Progress has been made over the past few decades in identifying biological pathways that lead to neurodegenerative...

Forge Biologics receives US FDA approval to initiate phase 1/2 trial of AAV gene therapy, FBX-101 to treat Krabbe disease

Forge Biologics Inc., a gene therapy manufacturing and development company, announced that the company has received FDA clearance of the Investigational New Drug (IND) to initiate a phase 1/2 clinical trial evaluating its novel, first-in-human AAV gene therapy, FBX-101,...

Pfizer, OPKO One Step Closer to Approval of Pediatric Growth Hormone Deficiency Drug

Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency (GHD) drug, somatrogon, after the U.S. FDA recently accepted the companies’ regulatory submission for the therapy. The FDA accepted for filing...

Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. “Today’s authorization is a landmark moment in our company’s history...

RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that preliminary top-line data from its U.S. Phase 2 study with orally-administered opaganib (Yeliva®, ABC294640)1 in patients hospitalized with COVID-19 pneumonia demonstrated positive safety and efficacy signals. The randomized, double-blind, placebo-controlled U.S....

CEPI Partners with Biological E. Limited to advance Development and Manufacture of COVID-19 Vaccine candidate

CEPI, the Coalition for Epidemic Preparedness Innovationsand Biological E Limited, India (Bio E), a Hyderabad-based vaccines and pharmaceutical company, today announced a collaboration to advance the development and manufacture of Bio E’s COVID-19 subunit vaccine candidate. CEPI will initially...

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