Robotic drug delivery technology developer Bionaut Labs announced today that it closed a Series B financing round worth $43.2 million. Los Angeles-based Bionaut Labs uses microscale robots to deliver drugs for treating central nervous system (CNS) diseases and disorders. Through magnetic propulsion, the company’s Bionauts can navigate the human body and deliver drugs locally. The […]
Neurological
Corium launches transdermal patch for treating Alzheimer’s
Corium (Nasdaq:CORI) today announced the availability of Adlarity (donepezil transdermal system) for prescription use in the U.S. Adlarity, a once-weekly patch, delivers consistent doses of donepezil through the skin. It treats patients with mild, moderate, or severe dementia of the Alzheimer’s type. It holds FDA approval — the first and only — for 5 mg/day […]
Pulmatrix completes patient dosing for inhaled migraine treatment
Pulmatrix (Nasdaq:PULM) announced today that all subjects completed dosing in a trial of its orally inhaled migraine treatment. Lexington, Massachusetts-based Pulmatrix is evaluating PUR3100 in a Phase 1 trial using the patented iSperse technology. All subjects completed dosing of the novel orally inhaled formulation of dihydroergotamine (DHE). The company expects Phase 1 data in the […]
FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures
Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus, or prolonged seizures. Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Rafa’s Midazolam 10mg autoinjector received FDA indication for […]
Acorda Therapeutics COO resigns
Acorda Therapeutics (Nasdaq:ACOR) announced today that Chief Operating Officer Lauren Sabella will resign next month. Pearl River, New York-based Acorda develops therapies designed to restore function and improve the lives of those with neurological disorders. The therapies are delivered via inhalation through the company’s Arcus pulmonary delivery system. Sabella’s resignation will be made effective Sept. […]
Study backs Corium’s transdermal Alzheimer’s dementia treatment
Corium (NSDQ:CORI) announced that studies support its once-weekly Adlarity transdermal treatment for Alzheimer’s dementia. Adlarity (donepezil transdermal system) demonstrated the ability to maintain equivalent daily exposure of donepezil when compared to oral formulations of donepezil, along with a favorable overall gastrointestinal (GI) side effect profile. The treatment uses Corium’s proprietary Corplex technology, delivering continuous, controlled, […]
Better Therapeutics completes trial for type 2 diabetes treatment, will submit to FDA
Better Therapeutics (Nasdaq:BTTX) announced today that it completed the pivotal trial for its BT-001 digital therapeutic for diabetes. San Francisco-based Better Therapeutics designed its nutritional cognitive behavioral therapy (nCBT) platform to address the root causes of cardiometabolic diseases. It designed its investigational, first-in-class BT-001 prescription digital therapeutic (PDT) to use nCBT to treat type 2 […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound to […]
Data shows cost benefits with Pear Therapeutics digital therapeutic for opioid use disorder
Pear Therapeutics (Nasdaq:PEAR) today shared real-world data highlighting low costs with its reSET-O prescription digital therapeutic (PDT). Boston-based Pear Therapeutics’ reSET-O represents the only FDA-authorized PDT for the treatment of opioid use disorder (OUD). According to a news release, results from a 12-month, real-world data study of reSET-O demonstrated reduced healthcare resource utilization and associated […]
Pear Therapeutics reports positive real-world data for chronic insomnia treatment
Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT). Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up. Boston-based Pear Therapeutics presented results at the […]