Food and Drug Administration

PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

Retrieved on: 
Monday, October 4, 2021
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VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread.

Key Points: 
  • VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread.
  • The first group has not been previously treated with a checkpoint inhibitor (CPI nave).
  • The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory).
  • As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more).

Cue Biopharma Announces Upcoming Scientific Presentations at the Society for Immunotherapy of Cancer’s (SITC) 36th Anniversary Annual Meeting

Retrieved on: 
Monday, October 4, 2021
Regulatory T cell, Food, Patent, Result, Oncology, Securities Act of 1933, SITC, Neoplasm, Translational research, Policy, Risk, Annual report, Gastrointestinal tract, Board of directors, NASDAQ, Hospital, Conversation, FDA, Cancer, Patient, HPV16, Division, Head, Infection, Board, Immunotherapy, Food and Drug Administration, Selective, Analysis, Society, Washington Convention Center, Science, COVID-19, Boston, Research, Hall, EST, Education, Forward-looking statement, Autoimmune disease, Walter, Securities Exchange Act of 1934, Government, Form 10-Q, GLOBE, Vaccine, Animal, Pharmaceutical industry

We believe the data demonstrated in these posters show great promise in selective and specific tumor targeting for the treatment of multiple cancers and other life-threatening diseases.

Key Points: 
  • We believe the data demonstrated in these posters show great promise in selective and specific tumor targeting for the treatment of multiple cancers and other life-threatening diseases.
  • The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules.
  • This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient.
  • The Society for Immunotherapy of Cancer (SITC) is the worlds leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Cassava Sciences, Inc. of Class Action Lawsuit and Upcoming Deadline – SAVA

Retrieved on: 
Sunday, October 3, 2021
Dementia, Publication, Delusion, News, Food, Neurodegeneration, National, Behavior, Person, NASDAQ, Logic, FDA, Patient, Cognition, Anomaly, Complaint, Court, Defendant, Food and Drug Administration, Company, District court, Trial of the century, Neuroscience, Plasma, Ext, Lists of action films, Anxiety, Securities Exchange Act of 1934, Agitation, Industry, GLOBE, Lists of schools in England, Private investigator, Pharmaceutical industry, Animal, Dietary supplement

To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.

Key Points: 
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Cassava is an Austin-based clinical stage biotechnology company engaged in the development of drugs for neurodegenerative diseases.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Cassava Sciences, Inc. of Class Action Lawsuit and Upcoming Deadline – SAVA

Retrieved on: 
Sunday, October 3, 2021
Publication, Delusion, News, Food, Neurodegeneration, National, Person, NASDAQ, Logic, FDA, Patient, Cognition, Anomaly, Complaint, Court, Defendant, Food and Drug Administration, Company, District court, Trial of the century, Neuroscience, Plasma, Ext, Lists of action films, Anxiety, Securities Exchange Act of 1934, Agitation, Industry, GLOBE, Lists of schools in England, Private investigator, Pharmaceutical industry, Animal, Dietary supplement

To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.

Key Points: 
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Cassava is an Austin-based clinical stage biotechnology company engaged in the development of drugs for neurodegenerative diseases.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

LeRoy Jones, MD and Ryan Owen, MD Join Signati Medical, Inc.'s Clinical Advisory Board

Retrieved on: 
Friday, October 1, 2021
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Providence, RI, Oct. 01, 2021 (GLOBE NEWSWIRE) -- Signati Medical, Inc. is pleased to announce that LeRoy Jones, MD and Ryan Owen, MD have joined their Clinical Advisory Board.

Key Points: 
  • Providence, RI, Oct. 01, 2021 (GLOBE NEWSWIRE) -- Signati Medical, Inc. is pleased to announce that LeRoy Jones, MD and Ryan Owen, MD have joined their Clinical Advisory Board.
  • He is also a Clinical Associate Professor at the University of Texas Health Science Center in San Antonio.
  • Previous academic appointments include The University of New Mexico Health Science Center and at the Baylor College of Medicine in Houston, Texas.
  • Signati Medical is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed.

Iovance Biotherapeutics to Present Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Cell Therapies Across Multiple Solid Tumors and Treatment Settings at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting

Retrieved on: 
Friday, October 1, 2021
Food, Poster, Perception, Risk, PSLRA, Annual report, Security (finance), Cervical cancer, Ministry of Education (Malaysia), NASDAQ, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, Cancer, Patient, Annual general meeting, Population, NSCLC, Food and Drug Administration, Life, Immunotherapy, Large-cell lung carcinoma, SAN, Society, COVID-19, Forward-looking statement, Safety, Combination therapy, SITC, GLOBE, TIL, Pharmaceutical industry, Animal

SAN CARLOS, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced oral and poster presentations of clinical and non-clinical data for tumor infiltrating lymphocyte (TIL) cell therapies in multiple solid tumors will be presented at the 36thAnnual Meeting of the Society for Immunotherapy of Cancer (SITC). The SITC 36th Annual Meeting will be held from November 12-14, 2021 in Washington, D.C. and virtually. Details of the oral presentation and posters are as follows:

Key Points: 
  • The SITC 36th Annual Meeting will be held from November 12-14, 2021 in Washington, D.C. and virtually.
  • ET)
    Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer.
  • The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors.
  • We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.

ADMA Biologics Announces Presentation on Respiratory Viral Infections at IDWeek 2021

Retrieved on: 
Friday, October 1, 2021
Infection, Protein, Influenza and Other Respiratory Viruses, Immunity, Feinberg School of Medicine, FDA, Immunodeficiency, Patient, University, Food and Drug Administration, Bacteria, Virus, Marketing, MS, United States, IVIG, Disease, Risk, Plasma, COVID-19, Organ transplantation, Johns Hopkins, Hepatitis B virus, USF, ADMA, Doctor of Philosophy, Nasdaq, Organ, PIDD, RSV, GLOBE, Vaccine

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA or the Company), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced an exclusive educational event at IDWeek 2021 on respiratory viral infections, presented by nationally recognized clinical experts Dr. Michael Ison from Northwestern University and Dr. Jolan Walter from the University of South Florida and Johns Hopkins All Childrens Hospital.

Key Points: 
  • RAMSEY, N.J. and BOCA RATON, Fla., Oct. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA or the Company), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced an exclusive educational event at IDWeek 2021 on respiratory viral infections, presented by nationally recognized clinical experts Dr. Michael Ison from Northwestern University and Dr. Jolan Walter from the University of South Florida and Johns Hopkins All Childrens Hospital.
  • Two leading experts in the management of respiratory syncytial virus (RSV) and other respiratory viruses in immunocompromised patients will discuss todays key clinical challenges and emerging treatment strategies.
  • Information about ADMA Biologics and its products can be found on the Companys website at www.admabiologics.com.
  • ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida.

Nabriva Therapeutics Appoints Dr. Christine Guico-Pabia, M.D., as Chief Medical Officer

Retrieved on: 
Friday, October 1, 2021
McKesson Corporation, Food, Infection, Therapy, Tablet, Urinary tract infection, NASDAQ, Private Securities Litigation Reform Act, Metagenics, Johns Hopkins Bloomberg School of Public Health, Patient, Wyeth, Bronchopneumonia, Business, Merck, Food and Drug Administration, CMO, Pyelonephritis, University, MPH, Johns Hopkins University, COVID-19, Public health, MBA, Drug development, Fosfomycin, Cuties, SEC, GLOBE, Pharmaceutical industry

Christine Guico-Pabia, M.D., MBA, MPH as Chief Medical Officer (CMO) effective October 1, 2021.

Key Points: 
  • Christine Guico-Pabia, M.D., MBA, MPH as Chief Medical Officer (CMO) effective October 1, 2021.
  • Christine brings a well-rounded profile to the CMO role, with extensive experience across several therapeutic areas from clinical development through to the post-marketing support of multiple commercial stage products over the course of her notable career, said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.

NIHC Makes Policy Statement on Delta-8 THC

Retrieved on: 
Thursday, September 30, 2021
THC, Food, NASDA, Policy, Food and Drug Administration, National Association, Congress, Solution, Sale, FDA, Multimedia, Cannabidiol, New York State Department of Agriculture and Markets, CDC, Public health, Centers for Disease Control and Prevention, Leadership, National Association of State Departments of Agriculture, Center, Industry, Dietary supplement

The safety profile of Delta-8 THC products is questionable, and we believe that they should not be sold or marketed as hemp-derived products.

Key Points: 
  • The safety profile of Delta-8 THC products is questionable, and we believe that they should not be sold or marketed as hemp-derived products.
  • Such a clarification in statute would unequivocally prevent the sale of products containing unsafe concentrations of Delta-8 THC as hemp.
  • The NIHC Government Affairs committee continues to have conversations and look at more intricate policy solutions on Delta-8 THC.
  • offers opportunities for NIHC members, industry stakeholders, and regulators to actively engage with each other in person on how to regulate Delta-8 THC.

NIH/NINDS Awards AnaBios With $1.7M Grant to Develop Novel Analgesic for Mixed Inflammatory, Neuropathic Pain States

Retrieved on: 
Thursday, September 30, 2021
Food, Gabapentin, SBIR, Initiative, Chronic pain, Food and Drug Administration, Research, National, Pain management, Investigational New Drug, NINDS, Patient, Itch, Pain, Lists of diseases, SAN, Cros, Risk, Standard electrode potential, Degenerative disease, National Institute, Fortune 500, Neuropathic pain, NIH, Pregabalin, Sodium, Safety, National Institute of Neurological Disorders and Stroke, GLOBE, Neuron, Pharmaceutical industry

AnaBios is developing ANB-504, a lead small molecule dual inhibitor of two sodium channels specifically expressed in sensory neurons and implicated in numerous forms of chronic pain.

Key Points: 
  • AnaBios is developing ANB-504, a lead small molecule dual inhibitor of two sodium channels specifically expressed in sensory neurons and implicated in numerous forms of chronic pain.
  • ANB-504 shows potent, dose-dependent inhibition of action potentials in human sensory neurons in a variety of pathological states and is intended for the treatment of mixed inflammatory and neuropathic pain.
  • "AnaBios appreciates NIH's support in our continued effort to bring a potential new, non-addictive pain therapy to market," said Dr. Andre Ghetti, Chief Executive Officer of AnaBios.
  • Located in San Diego, California, AnaBios aims to establish the safety and efficacy of novel compounds through its advanced, human-focused translational technologies.