Food and Drug Administration Amendments Act of 2007

BIOXCEL THERAPEUTICS, INC. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against BioXcel Therapeutics, Inc. (NASDAQ: BTAI)

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Tuesday, July 11, 2023
Psychiatry, LLP, Institutional review board, Dexmedetomidine, DSM-IV codes, Record, Food and Drug Administration Amendments Act of 2007, Dementia, District court, Patient, Advertising, Algorithm, Complaint, Defendant, Court, Artificial intelligence, Action Replay, FDA, Therapy, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry, Security (finance)

Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).

Key Points: 
  • Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).
  • If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc.
  • If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes

Retrieved on: 
Monday, July 10, 2023
Software, Research, General Health, Pharmaceutical, Technology, Infectious Diseases, Health Technology, Clinical Trials, Science, Biotechnology, FDA, Health, Diabetes, Psychology, Cognitive behavioral therapy, FRCP, De novo, DM, Overalls, FRCPE, Type 2 diabetes, PDT, Medicine, Better, Diabetes Technology Society, Food and Drug Administration Amendments Act of 2007, Digital health, HIV disease progression rates, Patient, Physician, Randomized controlled trial, Therapy, T2D, Food, Safety, Disease, Pharmaceutical industry, Diabetes Care

AspyreRx was reviewed through the FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices.

Key Points: 
  • AspyreRx was reviewed through the FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices.
  • “This De Novo authorization also provides a foundation for potential future growth opportunities.
  • AspyreRx is designed to address these barriers, leveraging technology to deliver an evidence-based therapeutic intervention to patients.
  • Investors and the general public may access a live webcast of the call by visiting https://edge.media-server.com/mmc/p/adggoags

The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of BioXcel Therapeutics, Inc. (BTAI) Investors

Retrieved on: 
Monday, July 10, 2023
Class Action Lawsuit, Professional Services, Legal, Institutional review board, Record, Law, Person, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, Patient, Court, Defendant, FDA, Therapy, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry

BioXcel investors have until September 5, 2023, to file a lead plaintiff motion.

Key Points: 
  • BioXcel investors have until September 5, 2023, to file a lead plaintiff motion.
  • On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
  • The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.

Biophytis has filed with the FDA for authorization to initiate SARA-31 phase 3 study in sarcopenia

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Monday, July 10, 2023
Tufts University, Partnership, Euronext Growth, Nutrition, CET, Adapted automobile, European Medicines Agency, COVID-19, Clinical trial, Ageing, NEPS, Woman, Patient, Doctor of Philosophy, Walking, EMA, Food and Drug Administration Amendments Act of 2007, Risk, Gait, FDA, Exercise, Notifiable disease, HGS, Food, Respiratory failure, Safety, MMD, Pharmaceutical industry, Sarcopenia, Physiology

The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022.

Key Points: 
  • The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022.
  • Based on the results of the previous study and feedback from the U.S. government agency, Biophytis is starting its Phase 3 program by filing the first ever Phase 3 application (SARA-31) in sarcopenia with the FDA.
  • The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability.
  • Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States.

BTAI CLASS ACTION NOTICE: The Law Offices of Frank R. Cruz Files Securities Fraud Lawsuit Against BioXcel Therapeutics, Inc.

Retrieved on: 
Saturday, July 8, 2023
Class Action Lawsuit, Professional Services, Legal, Institutional review board, Record, Law, Person, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, District court, Dementia, Patient, Court, Defendant, FDA, Therapy, News, Agitation, Food, Safety, Pharmaceutical industry

The Law Offices of Frank R. Cruz announces that it has filed a class action lawsuit in the United States District Court for the District of Connecticut captioned Martin v. BioXcel Therapeutics, Inc. et al (Case No.

Key Points: 
  • The Law Offices of Frank R. Cruz announces that it has filed a class action lawsuit in the United States District Court for the District of Connecticut captioned Martin v. BioXcel Therapeutics, Inc. et al (Case No.
  • 3:23-cv-00915) on behalf of persons and entities that purchased or otherwise acquired BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI ) securities between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).
  • Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
  • Investors are hereby notified that they have until September 5, 2023, to move the Court to serve as lead plaintiff in this action.

BTAI CLASS ACTION NOTICE: Glancy Prongay & Murray LLP Files Securities Fraud Lawsuit Against BioXcel Therapeutics, Inc.

Retrieved on: 
Friday, July 7, 2023
Class Action Lawsuit, Professional Services, Legal, Institutional review board, Record, Person, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, District court, Dementia, Investment, Patient, Court, Defendant, FDA, Therapy, GPM, News, Agitation, Food, Safety, Medical device, Pharmaceutical industry

Glancy Prongay & Murray LLP (“GPM”), announces that it has filed a class action lawsuit in the United States District Court for the District of Connecticut, captioned Martin v. BioXcel Therapeutics, Inc., et al., Case No.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), announces that it has filed a class action lawsuit in the United States District Court for the District of Connecticut, captioned Martin v. BioXcel Therapeutics, Inc., et al., Case No.
  • 3:23-cv-00915, on behalf of persons and entities that purchased or otherwise acquired BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI ) securities between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).
  • Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
  • Investors are hereby notified that they have 60 days from the date of this notice to move the Court to serve as lead plaintiff in this action.

Celltrion USA Launches Yuflyma® (adalimumab-aaty), a Humira® (adalimumab) biosimilar, in the United States

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Monday, July 3, 2023
Oncology, FDA, Health, Clinical Trials, General Health, Biotechnology, AIDS Drug Assistance Programs, University of Massachusetts, Ankylosing spondylitis, Nursing, Ulcerative colitis, Psoriasis, Juvenile idiopathic arthritis, Food and Drug Administration Amendments Act of 2007, Patient, PAP, Biosimilar, Celltrion, Food, Rheumatoid arthritis, Pharmaceutical industry, Adalimumab

Celltrion USA today announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, providing an alternative option for patients.

Key Points: 
  • Celltrion USA today announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, providing an alternative option for patients.
  • “We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the United States.
  • Patients who are uninsured or underinsured may be eligible to receive Yuflyma through the Celltrion CONNECT® Patient Assistance Program (PAP).
  • Celltrion is seeking an interchangeability designation from the U.S. FDA for Yuflyma, tentatively expected Q4 in 2024.

Icahn School of Medicine at Mount Sinai Dean and Researcher Receives Prestigious Award in Psychopharmacology

Retrieved on: 
Monday, June 26, 2023
Molecular biology, Science, Depression, DSM-IV codes, Genetics, Icahn School of Medicine at Mount Sinai, Schizophrenia, Anxiety, Fear, Psychopharmacology, Cancer, Donald Klein, Research, Mount Sinai, ASCP, Food and Drug Administration Amendments Act of 2007, National academy, Publication, Patent, MD, Patient, Attention deficit hyperactivity disorder predominantly inattentive, Neuroscience, Ketamine, Anne, Mount Sinai Health System, Society, Book, Food, Pharmaceutical industry, Medicine

NEW YORK,  June 26, 2023 /PRNewswire-PRWeb/ -- Dennis Charney, MD, the Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai and President for Academic Affairs of the Mount Sinai Health System, has received the prestigious Donald Klein Lifetime Achievement Award from the American Society for Clinical Psychopharmacology (ASCP). The award was presented to Dr. Charney during the ASCP's annual meeting on Wednesday, May 31.

Key Points: 
  • NEW YORK, June 26, 2023 /PRNewswire-PRWeb/ -- Dennis Charney, MD, the Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai and President for Academic Affairs of the Mount Sinai Health System, has received the prestigious Donald Klein Lifetime Achievement Award from the American Society for Clinical Psychopharmacology (ASCP).
  • The award was presented to Dr. Charney during the ASCP's annual meeting on Wednesday, May 31.
  • The award is presented annually to an individual who has made an outstanding contribution to the field of clinical psychopharmacology.
  • His work was fundamental not only in shaping the modern understanding of clinical depression, but also in defining the nature of clinical psychopharmacology trials.

PPMD Applauds FDA for Landmark Approval of First-Ever Gene Therapy Treatment for Duchenne for Patients Ages 4-5 Years Old

Retrieved on: 
Thursday, June 22, 2023
Interchange (road), Duchenne muscular dystrophy, Gene, Genetic distance, Nationwide Children's Hospital, Interchange, Policy, Becker muscular dystrophy, Initiative, Cardiac muscle, Research, Attention, Organization, Sarepta Therapeutics, Food and Drug Administration Amendments Act of 2007, Patient, EHR, PPMD, Knowledge, Hospital, Electronic health record, Exon, FDA, Conference, Therapy, Food, Vaccine, Pharmaceutical industry, Duchenne

WASHINGTON, June 22, 2023 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), heralded today's decision by the Food and Drug Administration (FDA) to approve the first-ever U.S. application for a gene therapy treatment for Duchenne patients ages 4-5 years old. ELEVIDYS (delandistrogene moxeparvovec-rokl) is the sixth approved therapy in Duchenne and the first therapy to replace the missing dystrophin protein by using a modified smaller version of the dystrophin gene, called micro-dystrophin, to produce a modified micro-dystrophin protein. ELEVIDYS will be made available and marketed in the United States by Sarepta Therapeutics.

Key Points: 
  • Despite the incredible advances made with five prior drug approvals for Duchenne, our community continues to have significant unmet needs.
  • Today's approval of a dystrophin replacement strategy further builds upon, and extends, the positive impact of Duchenne therapy development to date," said PPMD Founding President and CEO Pat Furlong.
  • PPMD has long been optimistic that gene therapy could be a potential treatment for Duchenne.
  • PPMD launched its Gene Therapy Initiative in 2017 as a long-term concept seeking to accelerate the potential of gene therapy as a therapeutic for Duchenne.

Mediso receives FDA approval for InterView™ nuclear medicine image processing software

Retrieved on: 
Wednesday, June 21, 2023
Tera, Central nervous system, Workflow, Human, Research, Lung, Nuclear medicine, SPECT, Food and Drug Administration Amendments Act of 2007, Molecular imaging, Kidney, Liver, FDA, Food, Software, Medical imaging, Mediso

BUDAPEST, Hungary, June 21, 2023 /PRNewswire/ -- Mediso has announced the Food and Drug Administration (FDA) clearance of the InterView™ FUSION and InterView™ XP multimodality (PET/SPECT/MRI/CT) image processing and reporting software which is specifically adapted for nuclear medicine and molecular imaging workflows.

Key Points: 
  • BUDAPEST, Hungary, June 21, 2023 /PRNewswire/ -- Mediso has announced the Food and Drug Administration (FDA) clearance of the InterView™ FUSION and InterView™ XP multimodality (PET/SPECT/MRI/CT) image processing and reporting software which is specifically adapted for nuclear medicine and molecular imaging workflows.
  • The vendor independent InterView™ software offers a complete solution for image visualization, post-processing and reporting specifically adapted for the routine nuclear medicine and molecular imaging workflow.
  • "Receiving the FDA nod for our image processing software marks the next step in marketing our clinical products in the USA," said Istvan Bagamery, founder and CEO of Mediso.
  • Mediso has a leader position in the clinical nuclear medicine market with over 1500 commissioned systems around the world.