Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication.
The FDA told Provention Bio Inc. that its BLA under priority review for teplizumab needs some work but the May 27 advisory committee meeting to discuss the application in full is still on the calendar.
“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
DUBLIN – Imcyse SA has successfully parlayed a research collaboration it entered with Pfizer Inc. in 2017 into a license agreement, under which it will finalize preclinical development of a drug candidate for rheumatoid arthritis (RA) based on its Imotope technology in return for an undisclosed up-front payment, equity investment and up to $180 million in milestones, as well as tiered royalties on product sales.
A consequence of one of President Joe Biden’s first executive orders (EOs) is that some low-income patients may have to wait at least two more months to get the out-of-pocket relief they were promised for insulin and injectable epinephrine.
LONDON – Remynd NV has extended its series B, raising a further €12 million and bringing the total for the round to €24 million (US$29 million). The new money will fund clinical proof-of-concept trials in the diverse indications of Alzheimer’s disease and diabetes.
Evoq Therapeutics LLC, a Michigan-based company developing a new technology for treating autoimmune disease, has signed a new license and collaboration agreement giving Amgen Inc. exclusive rights to selected programs in the area, undisclosed in number and indication. Valued at more than $240 million in up-front and milestone payments, the deal also includes potential royalties on sales of resulting therapies, Evoq said.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
RSS
