Prevailing after an initial complete response letter from the FDA, Chiasma Inc. on June 26 has finally secured U.S. approval for Mycapssa, the first oral formulation of the acromegaly medicine octreotide to get a regulatory green light. Octreotide has until now only been available by injection. The drug was approved for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, both somatostatin analogues (SSAs).
DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13.
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
Ekso Bionics Holdings Inc. has received a green light from the U.S. FDA to market its Eksonr robotic exoskeleton for use with patients with acquired brain injury (ABI). The company said it is the first exoskeleton product to receive the agency's nod for rehabilitation use with ABI, allowing a broader patient population to access the device. This is good news for Richmond, Calif.-based Ekso, which, like many other device companies, saw its earnings off during the first quarter.
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder.
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