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Dive Brief: The Food and Drug Administration has temporarily halted an early-stage trial of an experimental Rocket Pharmaceuticals gene therapy for a rare and deadly heart condition known as Danon disease. The news came as somewhat of a surprise, as the agency didn t stop testing due to a new safety issue. Rather, the FDA asked Rocket to put additional risk mitigation methods into its clinical program, which executives on a conference call described as potential changes to enrollment criteria or drug regimens that would accompany treatment with the gene therapy. The clinical hold is the latest in a string of regulatory setbacks for gene therapies due to safety or manufacturing concerns. It also marks the first bump in the road for Rocket s Danon program, a key driver of the biotech s recent stock surge. Rocket believes, however, that it can resolve the issue with no more than a three-month delay to study enrollment. ....
You have worked in films in over five languages. Which film shoot process is the easiest to float with? The European film process is a lot more audition driven. There the casting is role specific, there are no personal equations, personal favours, it s a lot more simpler and effective as well. We over complicate our industry with drama and bitching. There s no need, and the power of working with a brand name and then marketing the top off of that, it isn t required. But it is done in leaps and bounds here. Filmmaking is about good stories, and characters. Marketing that story and character happens by default if you re efforts put at the initial stages of your production are honest enough. But in our land, filmstars are more about their looks and their camps. There is not enough emphasis put on the process of delving into characterisation, studying texts, applying your real world experience, casting appropriate people for the correct role. We need to become more authentic in ou ....
How Rocket Pharma quietly became one of gene therapy's high flyers biopharmadive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biopharmadive.com Daily Mail and Mail on Sunday newspapers.
Gurpreet Singh: Hands Against Racism campaign team sends a message of solidarity with Indian farmers straight.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from straight.com Daily Mail and Mail on Sunday newspapers.
Posted on 344 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today reports financial and operational results for the fourth quarter and year ended December 31, as well as guidance for anticipated 2021 milestones. “2021 is poised to be another exciting year for Rocket,” said Gaurav Shah, M.D., Chief Executive Officer of Rocket. “We anticipate clinical data from all five of our gene therapy programs, initiation of our first in-house AAV cGMP production from our new manufacturing facility, and continued strengthening of our organization, manufacturing capabilities and infrastructure. We look forward to continued validation of our gene therapy platforms with updated results from registrational studies in FA and LAD-I, longer term findings in Danon Disease and PKD, and clinical proof-of ....