Regulation of food and dietary supplements by the U.S. Food and Drug Administration

BPGbio Highlights AI-Developed Late-Stage Therapeutics Assets at 8th Annual INV€$TIVAL Showcase in Partnership with Jefferies

Retrieved on: 
Tuesday, November 7, 2023
Research, Technology, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Pancreatic cancer, GBM, Glioblastoma, Food, Netherlands Architecture Institute, Biomarker, Oak Ridge National Laboratory, Rare, Carcinoma, HPC, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SCC, Liver disease, Drug discovery, EB, Neurology, Parkinson's disease, Breast cancer, Partnership, Jefferies, Tumor microenvironment, AI, ORNL, TME, Epidermolysis bullosa, Sarcopenia, Medical device, Pharmaceutical industry, Frontier

BPGbio will present as part of the event’s Biotech Late Growth Stage track.

Key Points: 
  • BPGbio will present as part of the event’s Biotech Late Growth Stage track.
  • Last month, an independent medical advisory board recommended advancement into phase 2b trials for pancreatic cancer.
  • BPM31510 for pancreatic cancer has received orphan drug designation from the U.S. Food and Drug Administration.
  • This platform identifies targets, biomarkers, and drugs and assists the development team through both the developmental and clinical trial stages.

ROSEN, SKILLED INVESTOR COUNSEL, Encourages Brainstorm Cell Therapeutics Inc. Investors with Losses in Excess of 100k to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm - BCLI

Retrieved on: 
Saturday, November 4, 2023
Titan, FDA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Court, I-Space (Chinese company), Advertising, Plaintiff, Class, BLA, Cryptocurrency, Insurance, Tobacco

WHAT TO DO NEXT: To join the Brainstorm Cell class action, go to https://rosenlegal.com/submit-form/?case_id=19375 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Brainstorm Cell class action, go to https://rosenlegal.com/submit-form/?case_id=19375 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

ROSEN, A GLOBALLY RECOGNIZED FIRM, Encourages Integra LifeSciences Holdings Corporation Investors With Losses to Secure Counsel Before Important Deadline in Securities Class Action - IART

Retrieved on: 
Saturday, November 4, 2023
Titan, FDA, Food, Court, I-Space (Chinese company), Advertising, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PMA, Integra, Plaintiff, Class, Insurance, Tobacco

WHAT TO DO NEXT: To join the Integra class action, go to https://rosenlegal.com/submit-form/?case_id=19078 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Integra class action, go to https://rosenlegal.com/submit-form/?case_id=19078 or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

EQS-News: Reset Pharma Receives Notice of Safe to Proceed from FDA for Investigational New Drug (IND) Application for Oral Psilocybin RSTP1000

Retrieved on: 
Tuesday, November 7, 2023
FDA, IND, DSM-IV codes, Food, Safe, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CQD, Interim, Safety, Depression, Cancer, Anxiety, Patient, Mental health, Pharmaceutical industry

This action by the FDA allows the Company to conduct a Phase 2b trial with RSTP1000 in patients with cancer and demoralization syndrome.

Key Points: 
  • This action by the FDA allows the Company to conduct a Phase 2b trial with RSTP1000 in patients with cancer and demoralization syndrome.
  • The study is a multicenter, randomized, dose-ranging, double-blind, parallel-group study to investigate the preliminary efficacy, safety, and tolerability of a single dose of orally administered RSTP1000 for up to 6 months.
  • These patients have more difficulties with adherence to cancer therapy and are also more likely to have suicidal thoughts.
  • Oral psilocybin has shown promise as a novel, innovative treatment of demoralization in patients with cancer.1 2 3

Hearn Kirkwood Issues Safety Alert on Undeclared Soy and Milk in Various Croissant Sandwiches

Retrieved on: 
Monday, November 6, 2023
Allergy, Safety, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Milk, Allergen, Dietary supplement

No other products distributed by Hearn Kirkwood are being recalled.

Key Points: 
  • No other products distributed by Hearn Kirkwood are being recalled.
  • Hearn Kirkwood is working collaboratively with the U.S. Food and Drug Administration on this recall.
  • This led to products being sent to customers without properly identifying the allergens of soy and milk.
  • Hearn Kirkwood takes the safety and integrity of the products it distributes seriously.

MacroGenics Provides Update on Corporate Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 6, 2023
Research, Sale, IND, Half-life, Acute myeloid leukemia, Enoblituzumab, Bispecific monoclonal antibody, Food, Therapy, RPF, Telephone, Docetaxel, Macrogen, B7, HEAT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Prostate cancer, Gilead Sciences, CD123, Syndrome, ADC, ID, Webcast, Cancer, Conference call, Patient, Cytokine release syndrome, Monoclonal antibody, D, Fine chemical, Pharmaceutical industry, Vaccine, Conference

ET

Key Points: 
  • ET
    ROCKVILLE, Md., Nov. 06, 2023 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended September 30, 2023.
  • Revenue: Total revenue was $10.4 million for the quarter ended September 30, 2023, compared to total revenue of $41.7 million for the quarter ended September 30, 2022.
  • R&D Expenses: Research and development expenses were $30.1 million for the quarter ended September 30, 2023, compared to $48.2 million for the quarter ended September 30, 2022.
  • SG&A Expenses: Selling, general and administrative expenses were $12.4 million for the quarter ended September 30, 2023, compared to $15.4 million for the quarter ended September 30, 2022.

Day One Reports Third Quarter 2023 Financial Results and Corporate Progress

Retrieved on: 
Monday, November 6, 2023
Priority review, FDA, Research, Report, Ageing, Food, MAPK, Data, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, D, MEK, Clinical trial, VRK1, New Drug Application, NDA, Cancer, Investment, General counsel, Patient, Pharmaceutical industry, PDUFA

BRISBANE, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its third quarter 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • In October 2023, Day One announced that the FDA accepted its NDA for Priority Review.
  • Day One presented two case reports at the 2023 Connective Tissue Oncology Society Annual Meeting in November 2023, documenting fusion-driven sarcoma case reports from the FIREFLY-1 and FIRELIGHT-1 studies.
  • R&D Expenses: Research and development expenses were $33.2 million for the third quarter of 2023 compared to $22.0 million for the third quarter of 2022.
  • G&A Expenses: General and administrative expenses were $18.3 million for the third quarter of 2023 compared to $17.7 million for the third quarter of 2022.

Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
Priority review, Neoplasm, Research, 27th Construction Company (U.S. Army Air Service), Food, Phase 1, ID, KRYS, New Drug Application, Data monitoring committee, Marketing, CGMP, Sale, Netherton syndrome, NCT, Lung, Form, PRV, DEB, IL-12, Immunology, Investment, Patient, Cohort, Financial result, Medicines and Healthcare products Regulatory Agency, Immunotherapy, Clinical trial, Medicaid, AATD, Society, CF, Survival, FDA, IND, Genotype, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inhalation, ASTRA, Pharmaceutical industry, Vaccine, Clothing, Bookkeeping, Rolling (metalworking), Reinsurance, Security (finance), Cryptocurrency, EU

Financial results for the quarter ended September 30, 2023:

Key Points: 
  • Financial results for the quarter ended September 30, 2023:
    Cash, cash equivalents, and investments totaled $598.6 million on September 30, 2023.
  • For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
  • For additional information on the Company’s financial results for the nine months ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
  • Krystal Biotech will host a conference call to discuss its third quarter 2023 financial results and business highlights today, November 6, 2023, at 8:30 a.m.

Insider information: Faron Initiates Phase 2 Part of BEXMAB Study of Bexmarilimab in HMA-failed MDS

Retrieved on: 
Monday, November 6, 2023
Principal, Patient, FDA, Helsinki University Central Hospital, Standard of care, AIM, Food, Trial of the century, MDS, Nasdaq First North, Associate professor, Bone marrow, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Syndrome, HMA, Quality of life, Optimus, Majesty of the Seas, RDE, Faron Pharmaceuticals, Immunotherapy, ORR, SOC, Safety, Pharmaceutical industry, Vaccine, Dietary supplement, Fårö

TURKU, Finland and BOSTON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that based on guidance from the U.S. Food and Drug Administration (FDA), hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) has been selected as the initial indication to advance to Phase 2 in the BEXMAB study investigating bexmarilimab in combination with standard of care (SoC).

Key Points: 
  • The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with SoC in patients with aggressive myeloid leukemias.
  • The Phase 2 part of the BEXMAB trial will enroll a total of 32 patients with HMA-failed MDS.
  • Patients will be randomized 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3 extension of the study.
  • Post selection of final dosing Faron intends to discuss a potential registrational study plan with the FDA.

Cabaletta Bio Receives FDA Clearance of CABA-201 IND Application for Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Monday, November 6, 2023
GMG, Steroid, FDA, IND, Respiratory failure, Food, Enzyme inhibitor, Myositis, MG, Lupus, Autoantibody, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Disease, Clinical trial, Acetylcholine receptor, Risk, Neurology, Neuromuscular junction, Autoimmune disease, Scleroderma, NMJ, Patient, Investigational New Drug, Rheumatology, Fatigue, Pharmaceutical industry

PHILADELPHIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG. Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.

Key Points: 
  • Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.
  • The announcement of our fourth CABA-201 IND clearance is also our first IND clearance for the product candidate in a predominantly autoantibody mediated disease.
  • Generalized MG affects approximately 85% of the between 50,000 and 80,000 estimated MG patients in the United States.
  • Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which often provide modest clinical effect and require chronic administration, increasing the risk of serious long-term side effects.