Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian Nordic, Ensysce Biosciences, Longboard Pharmaceuticals, Vanda Pharmaceuticals, Xspray Pharma.
By treating mice with antifibrotic drugs, researchers were able to stave off functional decline of the ovaries. Six weeks of systemic treatment with the antifibrotic pirfenidone, which is approved for the treatment of idiopathic pulmonary fibrosis, in early middle age improved both the morphology and the endocrine function of the animals’ ovaries at 1 year of age.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
What comes down must go up seems to be the rule of thumb these days, even for U.S. FDA fees. The cost of using a priority review voucher (PRV) to shave four months off an FDA standard 10-month drug review has dropped drastically over the past several years. But come Oct. 1, biopharma companies will have to pay nearly 89% more than on the previous day to use a PRV.
Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the serious gastric emptying condition for which there has been no new treatment in 40 years. The complete response letter (CRL) issued on the Sept. 18 PDUFA date for the neurokinin-1 receptor antagonist, which Vanda licensed from Eli Lilly and Co. in 2012, requested additional studies that the company said are not in line with the advice of experts in the field.
After disclosing data from the phase II Herald study, Aligos Therapeutics Inc. may sign a partner to help advance ALG-055009, a thyroid hormone receptor (THR) beta agonist, in subjects with metabolic dysfunction-associated steatohepatitis (MASH, formerly nonalcoholic steatohepatitis, or NASH).
Positive data from two studies boosted Edgewise Therapeutics Inc.’s market share and elevated analyst enthusiasm for the company and its treatment of obstructive hypertrophic cardiomyopathy. Top-line data from the phase I and phase II studies of EDG-7500 in treating the genetic disease that results in thickened heart muscles showed the therapy was well-tolerated in healthy volunteers and produced meaningful improvements in those with the disease.
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