Press release content from Globe Newswire. The AP news staff was not involved in its creation.
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple .
SanofiApril 19, 2021 GMT European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies
Sarclisa combination therapy was associated with undetectable levels of multiple myeloma (MM) in nearly 30% of patients with relapsed MM
Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory MM
Press release content from Accesswire. The AP news staff was not involved in its creation.
CureVac Swiss AG Initiates Rolling Submission Process for mRNA-based COVID-19 Vaccine Candidate, CVnCoV, with Swissmedic
April 19, 2021 GMT
Review process started with submission of first CVnCoV data package
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 19, 2021 / The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced initiation of a rolling submission for CVnCoV, the company’s mRNA based COVID-19 vaccine candidate, for the use in Switzerland. The application for authorization was submitted to Swissmedic, the country’s authority responsible for the authorization and supervision of therapeutic products including vaccines.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium .
Avadel Pharmaceuticals plcApril 17, 2021 GMT
Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PD
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Ehave Prepares to Launch Ketamine Clinical Trials Using Brain Scientific’s Brain Mapping Technology
EhaveApril 16, 2021 GMT
MIAMI, April 16, 2021 (GLOBE NEWSWIRE) Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today plans to launch brain mapping ketamine clinical trials using Brain Scientific technology later this year. The clinical trial will establish the statistical correlation between the ketamine treatment and patient improvement from the disorders.
The trial, which is designed to enroll 35 patients, is expected to start in the second half of 2021. Ehave is currently completing the necessary preclinical studies necessary to begin enrolling patients in the trial. The average drop out ratio of clinical trials is around 15 % and Ehave will need at least 25-30 patients’ egg data to es
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
New England Journal of Medicine publishes exploratory study showing signals of positive .
COMPASS Pathfinder Ltd.April 15, 2021 GMT
London, UK, April 15, 2021 (GLOBE NEWSWIRE) COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, welcomed a study published in the New England Journal of Medicine (NEJM) yesterday, which showed signals of positive activity in COMP360 psilocybin compared with the standard antidepressant escitalopram, for major depressive disorder (MDD).
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The study was designed and conducted by a research team at Imperial College London, using COMPASS’s COMP360 psilocybin.