Regulation of tobacco by the U.S. Food and Drug Administration

Elevar Therapeutics and Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC

Retrieved on: 
Tuesday, October 17, 2023

Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.

Key Points: 
  • Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.
  • In May 2023, a new drug application (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC.
  • In January 2023, the combination was approved in China as a first-line treatment for uHCC.
  • Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Jiangsu Hengrui Pharma and Elevar Therapeutics Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC

Retrieved on: 
Tuesday, October 17, 2023

Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.

Key Points: 
  • Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.
  • Rivoceranib, under the name apatinib (brand name: Aitan®), is developed by Hengrui Pharma in China.
  • Elevar and Hengrui Pharma presented CARES-310 study results at the September 2022 ESMO Congress and published them in The Lancet on July 24, 2023.
  • Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Late CMV Infection and Disease

Retrieved on: 
Tuesday, October 17, 2023

The CHMP has also recommended the approval for extending dosing for PREVYMIS from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease.

Key Points: 
  • The CHMP has also recommended the approval for extending dosing for PREVYMIS from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease.
  • The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU) and a final decision is expected this year.
  • In June 2023, the FDA approved PREVYMIS for prophylaxis of CMV disease in adult kidney transplant recipients at high risk, and in August 2023, the FDA approved extended 200-day dosing for PREVYMIS for CMV prophylaxis in HSCT recipients at risk for late CMV infection and disease.
  • The CHMP opinion for use of PREVYMIS for CMV disease prophylaxis in adult kidney transplant recipients was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869 ) in 589 adult kidney transplant recipients at high risk (CMV D+/R-).

FloBio Receives FDA's Breakthrough Device Designation for Bleeding Risk Diagnostic Test

Retrieved on: 
Tuesday, October 17, 2023

PHILADELPHIA, Oct. 17, 2023 /PRNewswire/ -- FloBio, a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. FloBio's test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs). This information would help emergency and critical care clinicians make informed treatment decisions about drug reversal to reduce serious bleeding, a major cause of preventable complications and death in US hospitals.

Key Points: 
  • PHILADELPHIA, Oct. 17, 2023 /PRNewswire/ -- FloBio , a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test.
  • The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
  • FloBio's test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).
  • This makes it difficult to  adequately prevent or manage bleeding in the face of trauma, invasive surgeries, stroke, and other medical conditions.

Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA and Solidifies Plans to Initiate the Registrational Program for BNC210 in Social Anxiety Disorder

Retrieved on: 
Monday, October 16, 2023

“We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.

Key Points: 
  • “We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.
  • “The FDA meeting outcomes provide external and independent validation of our position on the strength and Phase 3-enabling nature of the PREVAIL dataset.
  • BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder and in a panic model, was recently significantly enhanced by the positive results in Post-Traumatic Stress Disorder.
  • The Company anticipates beginning the Phase 3 program in Q1’24.

Kirby McInerney LLP Reminds Investors That a Class Action Lawsuit Has Been Filed on Behalf of Kenvue Inc. (KVUE) Investors and Encourages Investors to Contact the Firm Before December 8, 2023

Retrieved on: 
Thursday, October 12, 2023

Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On November 12, 2021, Johnson & Johnson announced the creation of Kenvue as a wholly owned consumer health subsidiary.
  • On May 3, 2022, Johnson & Johnson and Kenvue jointly announced that the price of Kenvue’s IPO would be $22 per share.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.

T2 Biosystems Announces FDA 510(k) Submission to Expand the Pathogen Detection on its FDA-Cleared T2Bacteria Panel to Include Detection of Acinetobacter baumannii

Retrieved on: 
Thursday, October 12, 2023

A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.

Key Points: 
  • A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.
  • In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of 34.0% to 43.4%.
  • “We are excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel to include the detection of A. baumannii,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.

Data Demonstrating Financial Impact of INPEFA® (Sotagliflozin) to be Presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting

Retrieved on: 
Wednesday, October 11, 2023

THE WOODLANDS, Texas, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that findings from two studies on the cost-effectiveness and budget impact of INPEFA® (sotagliflozin) will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting on October 16-19, 2023, in Orlando, Florida.

Key Points: 
  • Studies address cost-effectiveness and budget impact of INPEFA, an inhibitor of SGLT2 and SGLT1
    THE WOODLANDS, Texas, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that findings from two studies on the cost-effectiveness and budget impact of INPEFA® (sotagliflozin) will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting on October 16-19, 2023, in Orlando, Florida.
  • Both posters will be on display Tuesday, October 17, 2023, from 4:00 – 7:00 p.m.
  • ET during the Opening Night Reception at the Orlando World Center Marriott, Expo Hall, Cypress 1 and 2, and will be included in the meeting’s first session of poster presentations on Wednesday, October 18, 2023, from 11:00 a.m. – 12:30 p.m.
  • ET in the same location.

Aquestive Therapeutics Provides Business Update

Retrieved on: 
Monday, October 9, 2023

WARREN, N.J., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided a business update on its lead pipeline programs and base business results.

Key Points: 
  • WARREN, N.J., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided a business update on its lead pipeline programs and base business results.
  • The Company recently received comments from the U.S. Food and Drug Administration (FDA) on its pivotal Phase 3 pharmacokinetic (PK) clinical study protocol for Anaphylm™ (epinephrine) Sublingual Film.
  • Anaphylm is a polymer matrix-based epinephrine prodrug administered as a sublingual film that is applied under the tongue for the rapid delivery of epinephrine.
  • Anaphylm comes in a highly portable package with the durability to withstand many of the norms of daily life.

Tonix Pharmaceuticals Provides Overview of TNX-2900 Program for the Treatment of Prader-Willi Syndrome at the Foundation for Prader-Willi Research Family Conference

Retrieved on: 
Monday, October 9, 2023

The presentation highlights preclinical data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors.

Key Points: 
  • The presentation highlights preclinical data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors.
  • TNX-2900 has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of PWS.
  • Tonix plans to submit an investigational new drug (IND) application to the FDA in the fourth quarter of 2023.
  • Tonix licensed the technology to treat PWS from Inserm Transfert, the private subsidiary of Inserm (the French National Institute of Health and Medical Research).