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Neurological

European regulators offer positive opinion on Janssen’s schizophrenia treatment

September 17, 2021 By Sean Whooley

Updated Janssen logo

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. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: Janssen Pharmaceuticals, Johnson & Johnson

Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic

September 16, 2021 By Sean Whooley

Pear Therapeutics

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Patient Monitoring, Pharmaceuticals Tagged With: Pear Therapeutics

Impel NeuroPharma prices $45M offering following FDA approval for migraine treatment

September 10, 2021 By Sean Whooley

Impel Neuropharma logo updated

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Neurological, Otolaryngology Ear, Nose & Throat, Pharmaceuticals Tagged With: Impel NeuroPharma Inc.

FDA approves Impel NeuroPharma’s nasal spray for treating migraines

September 3, 2021 By Sean Whooley

Impel Neuropharma logo updated

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Otolaryngology Ear, Nose & Throat, Pharmaceuticals, Regulatory/Compliance Tagged With: FDA, Impel NeuroPharma Inc.

Bexson Biomedical aims to extend its wearable drug delivery device to psychoactive drugs

August 11, 2021 By Sean Whooley

Bexson Biomedical Ketamine Pump

Bexson Biomedical announced today that it launched an R&D initiative to develop subcutaneous formulations of psychoactive therapeutics. Santa Barbara, Calif.-based Bexson’s effort will apply its existing subcutaneous formulation technology to build several psychoactive drug scaffolds for treating mental health indications, including post-traumatic stress disorder (PTSD) and depression. Formulations developed through the R&D initiative are designed […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Research & Development Tagged With: Bexson Biomedical

Satsuma launches Phase 3 trial for acute migraine combination product

July 28, 2021 By Brian Buntz

satsuma-pharmaceuticals

Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have […]

Filed Under: Clinical Trials, Drug-Device Combinations, Neurological Tagged With: DHE, dihydroergotamine, Satsuma Pharmaceuticals, STS101, SUMMIT

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

July 19, 2021 By Sean Whooley

Nevro Senza

Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Neurological, Pain Management, Regulatory/Compliance Tagged With: FDA, Nevro

Pear Therapeutics touts 9-month data for reSET-O

July 14, 2021 By Sean Whooley

Pear Therapeutics

Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). According to a news release, results from the nine-month real-world data analysis demonstrated a continued long-term reduction in costly healthcare […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Patient Monitoring, Pharmaceuticals Tagged With: Pear Therapeutics

Europe approves Roche’s Enspryng subcutaneous NMOSD treatment

June 28, 2021 By Sean Whooley

Roche logo - updated

Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Approval comes for the treatment as a monotherapy or for use in […]

Filed Under: Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: European Commission, Roche

Pear Therapeutics to go public via merger with SPAC

June 22, 2021 By Sean Whooley

Pear Therapeutics

Prescription digital therapeutics pioneer Pear Therapeutics announced today that it will go public by merging with a SPAC called Thimble Point Acquisition Corp. Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Initial Public Offering (IPO), Mergers & Acquisitions, Neurological, Patient Monitoring, Pharmaceuticals, Wall Street Beat Tagged With: Pear Therapeutics, peartherapeutics, Thimble Point Acquisition Corp.

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