Clinical medicine

National Kidney Foundation Publishes 23 Recommendations to Move Thousands of Patients from Dialysis to Transplant

Tuesday, July 27, 2021 - 1:04pm

Today, while nearly 100,000 people are on the waitlist for a kidney transplant , only 22,817 Americans received a kidney transplant in 2020.

Key Points: 
  • Today, while nearly 100,000 people are on the waitlist for a kidney transplant , only 22,817 Americans received a kidney transplant in 2020.
  • Research recommendations developed by the panel center on seven key priorities:
    Improve management and readiness of the kidney waitlist.
  • Hispanic or Latino people are 1.3 times more likely than non-Hispanic or non-Latino people to have kidney failure.
  • The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org .

ForwardVue Pharma Appoints Bob Katz as Chief Executive Officer

Tuesday, July 27, 2021 - 1:03pm

BOSTON, July 27, 2021 /PRNewswire/ --ForwardVue Pharma names Bob Katz as Chief Executive Officer to advance the pre-clinical development of potent long-acting anti-angiogenic molecules directed against diabetic eye disease and neovascular age related macular degeneration.

Key Points: 
  • BOSTON, July 27, 2021 /PRNewswire/ --ForwardVue Pharma names Bob Katz as Chief Executive Officer to advance the pre-clinical development of potent long-acting anti-angiogenic molecules directed against diabetic eye disease and neovascular age related macular degeneration.
  • Bob Katz is a seasoned life science executive bringing broad, multi-disciplinary expertise in early-stage technology development, clinical applications and successful fundraising.
  • Most recently, Katz was CEO and President of ContraMed where he directed the company from the pre-clinical stage to a successful Phase 3 Clinical Trial and exit.
  • Prior to ContraMed, Katz has held multiple C-level positions at venture-backed startups.

BioHarvest Sciences Inc. Appoints Two Top Ranked Law Firms in the US and Canada to Pursue Regulatory Approvals of Its Upcoming Cannabis and Hemp Products

Tuesday, July 27, 2021 - 1:00pm

Dr. Applebaum, who joined BioHarvest in November 2020 as a senior consultant, is now expanding her role to head all the Cannabis regulatory affairs in North America.

Key Points: 
  • Dr. Applebaum, who joined BioHarvest in November 2020 as a senior consultant, is now expanding her role to head all the Cannabis regulatory affairs in North America.
  • Lewis Retik, a partner at GOWLING WLG, said: "In recent years, BioHarvest has emerged as a major disruptor in the global nutraceutical and Cannabis sectors.
  • With our technology, we believe we can help meet the demand for high quality, consistent and sustainable medicinal and wellbeing products.
  • As BioHarvest gets closer to full scale-up, and subsequently the commercialization of its Cannabis and hemp products, regulatory compliance is key."

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

Tuesday, July 27, 2021 - 1:00pm

SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company’s lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.

Key Points: 
  • Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases.
  • Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy.
  • Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia.
  • Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression.

Rhythm Pharmaceuticals to Report Second Quarter 2021 Financial Results on Tuesday, August 3, 2021

Tuesday, July 27, 2021 - 1:00pm

ET on Tuesday, August 3, 2021 to report its second quarter 2021 financial results and provide a corporate update.

Key Points: 
  • ET on Tuesday, August 3, 2021 to report its second quarter 2021 financial results and provide a corporate update.
  • A webcast of the call will also be available under Events & Presentations in the Investor Relations section of the Rhythm website at ir.rhythmtx.com.
  • Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity.
  • Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity.

Infinity Pharmaceuticals Presents Updated Data from Phase 2 MARIO-275 Trial in Urothelial Cancer (UC) and Phase 2 MARIO-3 Trial in Triple Negative Breast Cancer (TNBC)

Tuesday, July 27, 2021 - 12:31pm

These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.

Key Points: 
  • These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.
  • These results are consistent with the results from MARIO-275, which show the similar translation of disease control into a meaningful survival benefit for patients.
  • For patients with TNBC, the potential to extend progression free survival, regardless of PD-L1 status, would be a transformational breakthrough.
  • MARIO-275 is a global, randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

Verastem Oncology Announces Updated Phase 1/2 FRAME Study Data in Low Grade Serous Ovarian Cancer Selected for a Mini Oral Presentation at the European Society of Medical Oncology Congress 2021

Tuesday, July 27, 2021 - 12:00pm

Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.

Key Points: 
  • Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.
  • The company-sponsored, registration-directed Phase 2 RAMP 201 study is well underway, with top-line results from the selection phase expected during the first half of 2022.
  • The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC.
  • Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma.

LifeSignals receives FDA 510 (k) Approval for LifeSignals LX1550 Multiparameter Remote Monitoring Platform

Tuesday, July 27, 2021 - 12:00pm

FREMONT, Calif., July 27, 2021 /PRNewswire/ -- LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform. This follows recent CE marking and is further validation of LifeSignals' drive to create innovative wireless platforms which can be used by clinicians for the continuous collection of patient physiological data at home and in healthcare settings.

Key Points: 
  • FREMONT, Calif., July 27, 2021 /PRNewswire/ -- LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform.
  • Clinicians and Care Providers can access the cloud-based remote monitoring dashboard to view patient physiological data and manage alert settings.
  • The Remote Monitoring Platform is designed to enable healthtech companies to rapidly enhance their product and service portfolios to provide vital sign monitoring to the widest possible patient base, from any location.
  • Our focus now is to rapidly introduce low-cost remote vital sign monitoring to US healthtech companies looking to expand their services and improve patient care."

Global Medical Marijuana Market to 2027 - ResearchAndMarkets.com

Tuesday, July 27, 2021 - 11:15am

The "Global Medical Marijuana Market to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Medical Marijuana Market to 2027" report has been added to ResearchAndMarkets.com's offering.
  • Increase in awareness regarding various medical applications such as appetite enhancement, pain management, and reducing eye pressure is the key driving factor which is expected to boost the global medical marijuana market growth.
  • However, Medical marijuana is not approved by USFDA (Food and Drug Administration) for the treatment of cancer which is major restraining factor which is expected to hamper the global medical marijuana market growth.
  • Global Medical Marijuana Market is segmented into route of administration such as Oral, Inhalation, and Topical.

Merck Announces Phase 3 KEYNOTE-355 Trial Met Primary Endpoint of Overall Survival (OS) in Patients with Metastatic Triple-Negative Breast Cancer Whose Tumors Expressed PD-L1 (CPS ≥10)

Tuesday, July 27, 2021 - 11:45am

These new overall survival results confirm that KEYTRUDA in combination with chemotherapy represents an important treatment option for certain patients with metastatic TNBC.

Key Points: 
  • These new overall survival results confirm that KEYTRUDA in combination with chemotherapy represents an important treatment option for certain patients with metastatic TNBC.
  • The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).