Shots:The life science industry saw high deal activity in 2021 staying in the range of an even busier 2020.Fourth-quarter 2021 set the tone with Recursion’s development and commercialization deal with Roche and Genentech for a total value of $12.7B, followed by Poseida Therapeutics’ development and commercialization deal with Takeda for $3.73B.This article is based on the 2021…
The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industryThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021Additionally, last year in 2020, the US FDA…
The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industryThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021Additionally, last year in 2020, the US FDA…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012.The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…
The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose and treat the diseasesOur team…
The first quarter of 2019 has marked with major events in the pharma & biotech industries. We have gathered the key highlights of the quarter, which was starting with the blockbuster news, where Celgene had acquired BMS for $74B. Moving to the next news, acquisition of Loxo Oncology for $8B, in addition to Spark Therapeutics…

