Impel NeuroPharma (Nasdaq:IMPL) announced today that it changed its name to Impel Pharmaceuticals as part of a corporate rebrand. Seattle-based Impel develops proprietary Precision Olfactory Delivery (POD) technology to treat patients suffering from diseases across a range of areas in addition to the central nervous system. The company’s Trudhesa nasal spray for treating migraine in […]
Neurological
FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic
Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate. Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. Get the full story at our […]
Pear Therapeutics joins Epic App Orchard to enable monitoring of its digital therapeutics
Pear Therapeutics (Nasdaq:PEAR) announced today that its PearConnect platform is now available in the Epic App Orchard Gallery. By making PearConnect available to healthcare providers through the Epic App Orchard Gallery, the providers who implement the application will be able to access PearConnect within Epic’s electronic health record (EHR) platform, allowing them to monitor patients […]
Pear Therapeutics to develop digital therapeutic for sleep/wake disorder in Japan
Pear Therapeutics (Nasdaq:PEAR) announced today that it entered an agreement to develop a Japanese-language digital therapeutic. Boston-based Pear struck a deal with SoftBank, a Japan-based communication and information technology service provider, to develop the digital therapeutic for the treatment of sleep/wake disorders on the Japanese market. Pear Therapeutics markets the Somryst prescription digital therapeutic (PDT) […]
Pear Therapeutics says new data backs its prescription digital therapeutic for insomnia
Pear Therapeutics (Nasdaq:PEAR) today announced data from two studies that highlight the effectiveness of its chronic insomnia treatment. Boston-based Pear Therapeutics designed its Somryst prescription digital therapeutic (PDT) to address the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), training the body to sleep. The nine-week PDT can be used […]
European regulators approve Janssen’s twice-yearly schizophrenia treatment
Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate. Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found […]
Better Therapeutics completes enrollment in type 2 diabetes study
Better Therapeutics (NSDQ:BTTX) announced that it completed patient enrollment in a study of its digital therapeutic in treating diabetes. San Francisco-based Better Therapeutics’ BT-001 prescription digital therapeutic delivers a novel cognitive-behavioral therapy to patients with uncontrolled type 2 diabetes. According to a news release, the trial for BT-001 exceeded its enrollment target, bringing in 662 […]
Pasithea launches in-home ketamine infusion platform in U.S.
Pasithea Therapeutics (NSDQ:KTTA) announced that it commenced clinical operations with its in-home intravenous ketamine therapy. Miami Beach, Florida-based Pasithea’s wholly-owned subsidiary, Pasithea Clinics, offers in-home IV ketamine therapy to patients suffering from treatment-resistant mental health issues. The company will offer the treatment initially in New York City, Los Angeles, San Diego and San Francisco, with […]
FDA gives Bexson pre-IND guidance for ketamine formulation delivered by wearable pump
Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy. Santa Barbara, California-based Bexson develops the patented BB106 formulation, a ketamine therapy delivered through a wearable, subcutaneous patch pump in development with Stevanato Group. According to a news release, having reached the milestone of pre-IND guidance, […]
Corium touts study results for once-daily ADHD capsule
Corium (NSDQ:CORI) today announced clinical data demonstrating the strong performance of its once-daily ADHD capsule. Boston-based Corium’s Azstarys oral capsule for treating ADHD symptoms (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) received FDA approval in March as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients […]