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 […]
Neurological
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 […]
FDA to make decision on Corium’s transdermal patch for treating dementia next year
Corium (NSDQ:CORI) announced today that the FDA set a Prescription Drug User Fee (PDUFA) target action date for its Adlarity system. The FDA set the PDUFA target action date for Adlarity (donepezil transdermal system), a transdermal patch designed to treat dementia or Alzheimer’s disease, for March 11, 2022. If approved, Boston-based Corium’s once-weekly Adlarity patch […]
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. […]
Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic
Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of […]
Impel NeuroPharma prices $45M offering following FDA approval for migraine treatment
Impel NeuroPharma (NSDQ:IMPL) announced that it priced an underwritten public offering of common stock worth $45 million. The offering includes 3 million shares of common stock priced to the public at $15 per share, with gross proceeds set to total $45 million before deducting underwriting discounts and commissions and other offering expenses payable by Impel […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after […]
