Lancet

Final Results From PATHFINDER Study of GRAIL’s Multi-Cancer Early Detection Blood Test Published in The Lancet

Retrieved on: 
Friday, October 6, 2023

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced that detailed findings from the PATHFINDER study of its multi-cancer early detection (MCED) blood test have been published in The Lancet.

Key Points: 
  • GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced that detailed findings from the PATHFINDER study of its multi-cancer early detection (MCED) blood test have been published in The Lancet.
  • "The PATHFINDER study was a pilot non-randomized study to evaluate how patients and clinicians would respond to a blood test to screen for multiple cancer types.
  • The screening test identified a cancer signal in 1.4% of participants, 0.5% of whom were confirmed to have cancer.
  • This study demonstrates the feasibility of screening for multiple cancers using a blood test and lays the foundation for large, controlled trials necessary to establish clinical utility and cost-effectiveness."

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)

Retrieved on: 
Friday, October 13, 2023

TOKYO, Oct. 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.4 VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.5,6  

Key Points: 
  • "Today's positive CHMP opinion marks another significant milestone for both fezolinetant and women's health.
  • We are excited to be another step closer to potentially providing a novel and important treatment option to individuals in Europe suffering from moderate to severe VMS associated with menopause."
  • The positive CHMP opinion is based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 3,000 individuals across Europe, the U.S. and Canada.
  • Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending March 31, 2024.

Alimentiv Inc. Announces New Scientific Advisors Leading Research In GI-Related Therapeutics

Retrieved on: 
Friday, October 13, 2023

LONDON, ON, Oct. 13, 2023 /PRNewswire/ - Alimentiv Inc. ("Alimentiv"), a leading Contract Research Organization focused on GI-related therapeutics, is pleased to announce the addition of new scientific advisors to its scientific advisory board.

Key Points: 
  • LONDON, ON, Oct. 13, 2023 /PRNewswire/ - Alimentiv Inc. ("Alimentiv"), a leading Contract Research Organization focused on GI-related therapeutics, is pleased to announce the addition of new scientific advisors to its scientific advisory board.
  • The advisors are internationally recognized experts in designing and conducting clinical research in Inflammatory Bowel Disease.
  • Their contributions to the field have been essential in progressing the development of novel therapies in IBD and improving patient outcomes.
  • He holds the Crohn's Colitis Canada Endowed Research Chair in Inflammatory Bowel Disease and is an executive member of the IOIBD.

Alimentiv Inc. Announces New Scientific Advisors Leading Research In GI-Related Therapeutics

Retrieved on: 
Friday, October 13, 2023

LONDON, ON, Oct. 13, 2023 /PRNewswire/ -- Alimentiv Inc. ("Alimentiv"), a leading Contract Research Organization focused on GI-related therapeutics, is pleased to announce the addition of new scientific advisors to its scientific advisory board.

Key Points: 
  • LONDON, ON, Oct. 13, 2023 /PRNewswire/ -- Alimentiv Inc. ("Alimentiv"), a leading Contract Research Organization focused on GI-related therapeutics, is pleased to announce the addition of new scientific advisors to its scientific advisory board.
  • The advisors are internationally recognized experts in designing and conducting clinical research in Inflammatory Bowel Disease.
  • Their contributions to the field have been essential in progressing the development of novel therapies in IBD and improving patient outcomes.
  • He holds the Crohn's Colitis Canada Endowed Research Chair in Inflammatory Bowel Disease and is an executive member of the IOIBD.

World Sight Day is October 12, 2023 - HCP Cureblindness Shines Light on Avoidable Blindness and Its Mission to Help Individuals in Underserved Countries Retain and Regain Their Sight

Retrieved on: 
Thursday, October 5, 2023

Held the second Thursday each October, World Sight Day is an annual day of awareness to focus global attention on blindness and vision impairment.

Key Points: 
  • Held the second Thursday each October, World Sight Day is an annual day of awareness to focus global attention on blindness and vision impairment.
  • 90% of these individuals live in low-to-middle income countries, where poor nutrition and limited access to eye care can mean a life limited by needless blindness.
  • "This World Sight Day, HCP is shining a light on why avoidable blindness can – and must – be overcome," said K-T Overbey, HCP's Chief Executive Officer.
  • "This World Sight Day, everyone should learn the easy steps to help the millions who are blind or who have moderate-to-severe vision impairment."

The long road to a new malaria vaccine, told by the scientists behind the breakthrough – podcast

Retrieved on: 
Tuesday, October 3, 2023

In this episode of The Conversation Weekly podcast, we find out why it’s been so hard to find a malaria vaccine – and hear from the scientists behind the new breakthrough.

Key Points: 
  • In this episode of The Conversation Weekly podcast, we find out why it’s been so hard to find a malaria vaccine – and hear from the scientists behind the new breakthrough.
  • In 2021, 619,000 people died from malaria, the majority of them children.
  • The search for a vaccine has been underway for decades, but it’s particularly difficult due to the complexity of the malaria parasite.
  • “It begins with a mosquito bite,” says Faith Osier, co-director of the Institute of Infection at Imperial College London.

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Tuesday, October 3, 2023

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.