The European Medicines Agency accepted into its PRIME priority medicines program Ignyta's entrectinib, which is being developed to treat adult and pediatric patients with NTRK-positive, locally advanced or metastatic solid tumors with disease progression after previous treatment and those with no other acceptable therapeutic options.
Suven Life Sciences received a Singapore product patent to develop treatments for patients with neurodegenerative diseases such as Parkinson's, schizophrenia, Alzheimer's, Huntington's and attention-deficit/hyperactivity disorder.
The FDA approved a Phase IIb study of MiMedx's investigational new drug Amniofix for osteoarthritis of the knee. The company anticipates the 318-patient clinical trial to start next quarter.
A permanent junction was entered by the US District Court for the Northern District of California against Custompax, ordering the company to stop selling products because it violated the FDA's current good manufacturing regulations for dietary supplements. The agency said Custompax failed to adequately establish component specifications used in the manufacturing of dietary supplements that will ensure the products meet specifications for strength, purity and composition.
Malvern, Pa.-based Neuronetics reached an agreement with Teijin Pharma Limited to exclusively distribute Neuronetics' NeuroStar Advanced Therapy system in Japan. The system, which recently received Shonin approval, is designed to treat major depressive disorder using transcranial magnetic stimulation.
COFEPRIS, Mexico's regulatory authority, gave Viveve approval to market its Viveve system, which is intended to be used as a nonsurgical treatment for postpartum vaginal introitus laxity. The system is also indicated to improve sexual function.
Allergan subsidiary Vitae Pharmaceuticals granted Syndax Pharmaceuticals exclusive global rights to menin-MLL fusion oncogene inhibitors to treat patients with acute leukemia who have chromosomal rearrangements in the MLL gene. The deal grants Allergan $5 million upfront plus milestones and royalty fees.
Takeda Pharmaceutical agreed to collaborate with HemoShear Therapeutics to discover, explore and develop targets for the possible treatment of liver diseases, including nonalcoholic steatohepatitis. The deal gives Takeda exclusive access to HemoShear's REVEAL-Tx platform for fatty liver diseases and grants HemoShear undisclosed upfront payments and research funding, plus $470 million in milestone payments and royalties.
A follow-on funding raised $80 million for Abeona Therapeutics. The company has an ongoing Phase I/II study of its mucopolysaccharidosis IIIA candidate ABO-102 and plans to initiate a late-stage study of EB-101 for the treatment of recessive dystrophic epidermolysis bullosa by next year.
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