Shots:Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 AbsApproval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
Top 20 Life Sciences Deals of 2024 by Total Deal Value Shots: Life Sciences Dealmaking 2024 outlined a new genre of strategies for shaping global healthcare landscapes by targeting emerging technologies and addressing unmet needsIn 2024, Arrowhead’s global licensing and commercialization deal with Sarepta Therapeutics for $11.37B ranked first in the list, followed by…
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry.The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021.Additionally, last year in 2020, the US…

