Recurrence

DEINOVE to present data on DNV3837 at the ESCMID/ASM conference in Dublin

Retrieved on: 
Wednesday, October 5, 2022

Preclinical and clinical data show that the prodrug DNV3837 is rapidly converted to DNV3681 in vivo and that the active drug mostly concentrates in the GI tract.

Key Points: 
  • Preclinical and clinical data show that the prodrug DNV3837 is rapidly converted to DNV3681 in vivo and that the active drug mostly concentrates in the GI tract.
  • The diarrhea episodes improved after 6 days of treatment and came back to normal 10 days after treatment after a transient constipation period.
  • Georges Gaudriault, Chief Scientific Officer of DEINOVE who attended the ESCMID/ASM conference in Dublin specifies: The use of DNV3837 is a potential paradigm shift.
  • Located at the heart of the Euromedecine park in Montpellier, DEINOVE has been listed on EURONEXT GROWTH (ALDEI - code ISIN FR0010879056) since 2010.

Personalis Forms Research Collaboration to Better Predict Immunotherapy Response for Gastroesophageal Cancer

Retrieved on: 
Tuesday, October 4, 2022

Personalis, Inc. (Nasdaq: PSNL) has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer.

Key Points: 
  • Personalis, Inc. (Nasdaq: PSNL) has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer.
  • Gastroesophageal cancer is the fourth most common cancer worldwide, with nearly 50% of patients having developed unresectable or metastatic disease at the time of diagnosis.
  • Fortunately, pembrolizumab, an immunotherapeutic targeting PDL1/PD1, has been approved by the FDA for use in patients with chemorefractory gastroesophageal cancer.
  • Personalis, Inc. is a leader in advanced cancer genomics, enabling the next generation of precision cancer therapies and diagnostics.

Cue Biopharma Granted FDA Fast Track Designation for CUE-101 for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Tuesday, October 4, 2022

We are very pleased to have received Fast Track designation from the FDA for CUE-101.

Key Points: 
  • We are very pleased to have received Fast Track designation from the FDA for CUE-101.
  • Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need.
  • A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidates development plan.
  • Therapeutic candidates with Fast Track designation may be eligible for accelerated approval and priority review if supported by clinical data.

Data presented at the International Bladder Cancer Network (IBCN) meeting demonstrate a reduction in the risk of recurrence with the use of BLC

Retrieved on: 
Tuesday, October 4, 2022

The IBCN meeting brings together international Bladder Cancer Experts and scientists, with the mission to improve the diagnosis, prevention, and treatment of bladder cancer.

Key Points: 
  • The IBCN meeting brings together international Bladder Cancer Experts and scientists, with the mission to improve the diagnosis, prevention, and treatment of bladder cancer.
  • A significant decrease in risk of recurrence following BLC utilization compared to WLC alone (HR, 0.70, p=0.005) was also determined.
  • Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall.NMIBC remains in the inner layer of cells lining the bladder.
  • Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients.

Galderma and National Breast Cancer Foundation Announce Continued Partnership to Launch Campaign Elevating Skin Stories of Breast Cancer Survivors

Retrieved on: 
Monday, October 3, 2022

These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Key Points: 
  • These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products.
  • Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete.
  • Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area.

ZetrOZ Strives for Increased Recognition in Prioritizing the Critical Healing and Repair Process that Continues After Pain Subsides

Retrieved on: 
Friday, September 30, 2022

Noncompliance due to patients doing too much too soon can prevent soft tissue from fully healing, resulting in chronic instability, chronic pain, and scar tissue.

Key Points: 
  • Noncompliance due to patients doing too much too soon can prevent soft tissue from fully healing, resulting in chronic instability, chronic pain, and scar tissue.
  • ZetrOZ Systems , developers of the sam ultrasound device, is pushing for improved education for this critical repair process that can ensure healing beyond the patient's experience with pain as a result of the injury.
  • Adherence to a sam regimen across the repair phase is a necessary and safe intervention to ensure patients avoid chronic, recurring injuries.
  • ZetrOZ Systems produces UltrOZ, samSport, and samPro 2.0 to provide safe and effective treatment options for prevalent conditions such as arthritis.

Cytokinetics Presents New Data From REDWOOD-HCM OLE in Late Breaking Clinical Trial Session at the HCM Society Scientific Sessions

Retrieved on: 
Friday, September 30, 2022

Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM).

Key Points: 
  • Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM).
  • Cytokinetics expects to start a Phase 3 clinical trial of aficamten in patients with obstructive HCM in Q4 2021.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Propanc Biopharma Targets Pancreatic & Ovarian Cancers for PRP Clinical Studies with Combined Markets to Reach Over $14.3 Billion by 2027

Retrieved on: 
Thursday, September 29, 2022

Overall, proenzymes appeared to exert significant effects against more aggressive, less differentiated tumor types, like pancreatic and ovarian tumors.

Key Points: 
  • Overall, proenzymes appeared to exert significant effects against more aggressive, less differentiated tumor types, like pancreatic and ovarian tumors.
  • Patients from the compassionate use study suffering from cancers of the GI tract, or endocrine tumors, such as pancreatic and ovarian cancers, benefited most from treatment.
  • In addition, assays revealed that the migration capacity of ovarian, pancreatic, melanoma and colon cancer cells was suppressed after incubation with PRP.
  • In the case of pancreatic and ovarian cancers, 2 from 4 pancreatic cancer patients and 4 from 7 ovarian cancer patients significantly exceeded life expectancy.

Axsome Therapeutics Announces Plans to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting

Retrieved on: 
Thursday, September 29, 2022

Based on the FDA feedback, the Company will include new CMC information, including stability data on newly manufactured commercial scale batches of AXS-07, in its resubmission package.

Key Points: 
  • Based on the FDA feedback, the Company will include new CMC information, including stability data on newly manufactured commercial scale batches of AXS-07, in its resubmission package.
  • The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review.
  • No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA.
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options.

FDA Authorizes an Extension of the In-Use Period for UroGen Pharma’s JELMYTO® Admixture to 96 Hours Following Reconstitution

Retrieved on: 
Wednesday, September 28, 2022

This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations.

Key Points: 
  • This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations.
  • UroGen encourages healthcare providers to consult the new Prescribing Information and speak to their UroGen representative about this extended in-use period to optimize flexibility when treating patients with JELMYTO.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.