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While Biocon intends to address the CRL, the company has not established a timeline for the resubmission of data and hopes that the FDA will rapidly review the BLA when it does submit the data.
The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Around 40% of Pfizer’s portfolio was realized through partnerships, and Monday, the pharma giant announced three more collaborative deals.
The results over the two-year evaluation period for its Phase III GENEr8-1 trial showed consistent clinical benefit from using valoctocogene roxaparvovec.
The planned acquisition will give Takeda full access to Adaptate’s antibody-based γδ T cell engager platform, which includes both pre-clinical and discovery assets.
Bayer and Mammoth Biosciences forged a strategic collaboration potentially valued at more than $1 billion. The partnership grants Bayer access to Mammoth’s CRISPR technology to develop in vivo gene-editing therapies.
The emerging generation of precision gene therapies addresses what has been one of this genre’s greatest challenges to date: the risk of unintended consequences.
BioSpace sat down with 12 executives who shared their thoughts on the coming year and decade.
California-based AN2 Therapeutics secured $80 million in a Series B funding round to help advance its novel nontuberculous mycobacterial lung disease program.
Biopharma companies are building momentum to carry them through the bulk of 2022. BioSpace takes a look at some of the recent announcements.
Scientists from the University of Pennsylvania developed a new approach to address fibrosis, a leading cause of heart disease.