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

Outlook Therapeutics® Provides Update on Type A Meetings with FDA

Retrieved on: 
Thursday, November 2, 2023
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The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD.

Key Points: 
  • The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD.
  • During the meetings, Outlook Therapeutics reached an agreement in principle with the FDA on a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of calendar year 2024, and subsequent approval around mid-2025, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial.
  • The FDA and Outlook Therapeutics also agreed on the approaches needed to resolve the CMC comments in the CRL and Outlook Therapeutics believes these efforts should be sufficient to support approval.
  • “We are confident that we can meet the additional requirements that the FDA is requiring for approval of ONS-5010.

Regeneron Reports Third Quarter 2023 Financial and Operating Results

Retrieved on: 
Thursday, November 2, 2023
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"Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Key Points: 
  • "Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.
  • These results were also presented at the 23rd EURETINA Congress in October 2023.
  • The Company announced that Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, will retire in February 2024.
  • Christopher Fenimore, current Senior Vice President, Head of Accounting and Controller at Regeneron, will succeed Mr. Landry as Chief Financial Officer upon his retirement.

Kymera Therapeutics Announces Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, November 2, 2023
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ET

Key Points: 
  • ET
    WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2023, and provided business updates on its pipeline of protein degraders.
  • Collaboration Revenues: Collaboration revenues were $4.7 million for the third quarter of 2023 compared to $9.6 million for the third quarter of 2022.
  • Net Loss: Net loss was $52.9 million for the third quarter of 2023 compared to a net loss of $43.0 million for the third quarter of 2022.
  • Cash and Cash Equivalents: As of September 30, 2023, Kymera had $435 million in cash, cash equivalents, and investments.

Tonix Pharmaceuticals’ Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

Retrieved on: 
Thursday, November 2, 2023
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CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.

Key Points: 
  • Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox).
  • The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response.
  • “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials.
  • NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates.

DBV Technologies to Present New Data at ACAAI 2023

Retrieved on: 
Thursday, November 2, 2023
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DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new data on the use of Viaskin™ Peanut (DBV712) 250 μg in peanut-allergic toddlers will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held Thursday, November 9 – Monday, November 13, 2023, in Anaheim, CA.

Key Points: 
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new data on the use of Viaskin™ Peanut (DBV712) 250 μg in peanut-allergic toddlers will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held Thursday, November 9 – Monday, November 13, 2023, in Anaheim, CA.
  • The presentation will be available on DBV’s website, www.dbv-technologies.com , following the conclusion of the meeting for those who are unable to attend.
  • In addition, DBV is a 2023 ACAAI Benefactor Level Corporate Council Member.
  • The Company will also host a booth in the ACAAI Exhibit Hall from Saturday, November 11 – Monday, November 13th.

Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in Adults

Retrieved on: 
Wednesday, November 1, 2023
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“Erosive GERD can be extremely painful and often has a significant impact on patients.

Key Points: 
  • “Erosive GERD can be extremely painful and often has a significant impact on patients.
  • VOQUEZNA 20 mg also demonstrated non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn free days over the healing period.
  • In addition, VOQUEZNA 10 mg was evaluated as a secondary endpoint for relief of heartburn in Erosive GERD patients and demonstrated non-inferiority to lansoprazole 15 mg over six months.
  • ET to discuss the FDA approval and the Company’s U.S. commercialization plans for Erosive GERD and H. pylori infection.

Nurix Therapeutics Announces Partial Clinical Hold For NX-2127 Phase 1 Trial

Retrieved on: 
Wednesday, November 1, 2023
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SAN FRANCISCO, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on U.S.

Key Points: 
  • SAN FRANCISCO, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on U.S.
  • Patients currently enrolled in the clinical study who are deriving clinical benefit may continue to receive treatment in accordance with the ongoing study protocol.
  • Nurix is working with the FDA to resolve the partial clinical hold as soon as possible.
  • The partial clinical hold follows the company’s communication to the FDA of its intention to transition to an improved manufacturing process.

Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD

Retrieved on: 
Wednesday, November 1, 2023
Eye, AMD, FDA, SPA, Axitinib, Patient, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SOL, Pharmaceutical industry

BEDFORD, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) --  Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced it had received written agreement regarding the overall design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (wet AMD), which the Company refers to as the SOL trial.

Key Points: 
  • BEDFORD, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) --  Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced it had received written agreement regarding the overall design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (wet AMD), which the Company refers to as the SOL trial.
  • The Company initiated the SOL trial in September 2023 and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye in the trial.
  • The SOL trial is designed to be a multi-center, parallel-group trial run primarily at U.S. sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on pre-specified criteria.
  • With the agreement under the SPA, the Company will begin enrolling patients in the SOL trial and expects to dose the first subject by year-end.

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

Retrieved on: 
Wednesday, November 1, 2023
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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

G1 Therapeutics Provides Third Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Wednesday, November 1, 2023
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Recognized $10.8 Million in Net COSELA Revenue: G1 recognized total revenues of $12.3 million for the third quarter of 2023.

Key Points: 
  • Recognized $10.8 Million in Net COSELA Revenue: G1 recognized total revenues of $12.3 million for the third quarter of 2023.
  • Vial volume grew 3% over the second quarter of 2023 despite the impact of an ongoing platinum-based chemotherapy shortage.
  • Ended the Third Quarter of 2023 with Cash, Cash Equivalents, and Marketable Securities of $94.4 Million.
  • Operating expenses for the third quarter of 2023 were $28.7 million, compared to $45.1 million for the third quarter of 2022.