FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
|Articles|March 30, 2022
Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in India
Author(s)BioPharm International Editors
Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.
Advertisement
Novavax, a vaccine development and commercialization company, and Serum Institute of India, the world’s largest vaccine manufacturer by volume, announced on March 22, 2022 that Novavax’ COVID-19 vaccine has been granted emergency use authorization (EUA) for adolescents aged 12–18 by the Drugs Controller General of India (DCGI). The protein-based vaccine is currently manufactured in India and marketed under the brand name Covovax.
The EUA for Covovax was initially granted for adults aged 18 years and over in India in December 2021. It is the first protein-based vaccine authorized for the age group of 12–18 in India.
"We're proud of this first approval in adolescents given the efficacy and safety that our data show in this population, and that our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India," said Stanley C. Erck, president and CEO of Novavax, in a press release. "We hope that this authorization of our COVID-19 vaccine in adolescents is the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades."
"The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, CEO of Serum Institute of India, in a press release. "We are proud to deliver a protein-based COVID-19 vaccine with a favorable safety profile to the adolescents of our nation."
Source:
Advertisement
Related to this article
FDA granted RMAT and Fast Track designations to AbelZeta’s anti-CD20/CD19 CAR-T therapy prizlon-cel for relapsed or refractory large B-cell lymphoma. The company plans US studies after prior CAR-T therapy and in the second-line setting.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5