MFDS

Rznomics Inc. Secures Orphan Drug Designation from FDA for RZ-001 in Hepatocellular Carcinoma

Retrieved on: 
Friday, February 2, 2024

SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).

Key Points: 
  • SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).
  • This also may provide access to specialized regulatory assistance from FDA's Office of Orphan Products Development (OOPD).
  • "This FDA Orphan Drug Designation further underlines the potential of our pipeline to expeditiously address the current unmet medical needs of patients with Hepatocellular Carcinoma," said Seong-Wook Lee, CEO and founder of Rznomics.
  • Most recently, Rznomics has entered into an HCC clinical collaboration agreement with F.Hoffmann-La Roche Ltd (Roche) to study RZ-001, in combination with Roche's atezolizumab.

Rznomics Inc. Secures Orphan Drug Designation from FDA for RZ-001 in Hepatocellular Carcinoma

Retrieved on: 
Friday, February 2, 2024

SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).

Key Points: 
  • SEONGNAM, South Korea, Feb. 2, 2024 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Hepatocellular carcinoma (HCC).
  • This also may provide access to specialized regulatory assistance from FDA's Office of Orphan Products Development (OOPD).
  • "This FDA Orphan Drug Designation further underlines the potential of our pipeline to expeditiously address the current unmet medical needs of patients with Hepatocellular Carcinoma," said Seong-Wook Lee, CEO and founder of Rznomics.
  • Most recently, Rznomics has entered into an HCC clinical collaboration agreement with F.Hoffmann-La Roche Ltd (Roche) to study RZ-001, in combination with Roche's atezolizumab.

Natural Cycles receives approval from Health Canada for its birth control app

Retrieved on: 
Tuesday, January 9, 2024

NEW YORK, Jan. 9, 2024 /PRNewswire/ -- Natural Cycles, the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural Cycles app as a form of birth control. Previously sold in Canada as a fertility tracker, the Natural Cycles app is the first app of its kind to obtain a Class II Medical Device License from Health Canada and remains the only digital form of birth control on the market cleared by regulators in the United States (FDA), Europe (TÜV SÜD), Australia (TGA), Singapore (HSA), and South Korea (MFDS).

Key Points: 
  • NEW YORK, Jan. 9, 2024 /PRNewswire/ -- Natural Cycles , the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural Cycles app as a form of birth control.
  • "Our mission has always been to reach as many women as possible and with our latest regulatory clearance from Health Canada, the Natural Cycles app is now accessible to more than 380 million women globally," said Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl.
  • Natural Cycles currently has over three million registered users worldwide and the demand for its natural birth control option continues to increase, with many seeking an alternative to hormonal birth control or less effective fertility awareness methods.
  • As Natural Cycles is the only FDA Cleared birth control app on the market, it should be covered by all plans and issuers.

GC Cell's Promising AB-201 Cancer Treatment to Begin Phase 1 Trials Using Lunit AI Platform

Retrieved on: 
Monday, January 8, 2024

YONGIN, South Korea and SYDNEY, Jan. 8, 2024 /PRNewswire/ -- GC Cell, a fully integrated cell therapy pioneer, is proud to announce the approval from both the Australian Human Research Ethics Committee (HREC) and the Korean Ministry of Food and Drug Safety (MFDS) for a Phase 1 Investigational New Drug (IND) trial for its AB-201 cancer treatment, a HER2 targeted chimeric antigen receptor-natural killer (CAR-NK) cell therapy that shows great promise. Additionally, GC Cell is excited to reveal a strategic partnership with Lunit, the medical AI leader, to enhance precision and clinical intelligence of AB-201's efficacy evaluation by applying its advanced AI technology, in addition to traditional Immunohistochemistry (IHC) based assessments. After participating in the US White House's Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell's efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.

Key Points: 
  • After participating in the US White House's Cancer Moonshot initiative this past October, both accomplishments represent major milestones in GC Cell's efforts to revolutionize immunotherapy-based cancer treatment while harnessing AI and digital transformation to fight cancer.
  • "Our preclinical studies suggest the possibility that AB-201 causes complete cancer remission and tumor suppression," remarked James Park, CEO of GC Cell.
  • With such quantitative analysis, AI can help standardize the assessment of cancer target expression across different laboratories and geographical locations.
  • It's a pivotal step in GC Cell's journey towards a digital future, aligning with the broader healthcare industry's shift towards technology-enhanced solutions.

Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea

Retrieved on: 
Thursday, December 7, 2023

Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.

Key Points: 
  • Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
  • The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea (“IPK”), a Sosei Group company.
  • In South Korea, the Marketing Authorization of PIVLAZ™ is held by IPK and will become commercially available to patients in early 2025.
  • PIVLAZ™ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ”), also a Sosei Group company.

AriBio Co., Ltd. Announces Global Expansion of POLARIS-AD, A Phase 3 Early Alzheimer’s Disease Registration Trial

Retrieved on: 
Tuesday, November 14, 2023

AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.

Key Points: 
  • AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.
  • The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies.
  • AriBio is well positioned and adequately financed to execute on this global expansion”, stated Matthew Choung, Chairman and Chief Executive Officer (CEO) of AriBio.

Everest Medicines Announces Acceptance of Nefecon® New Drug Applications for the Treatment of Primary IgA Nephropathy in Adult Patients in South Korea

Retrieved on: 
Wednesday, November 29, 2023

Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China.

Key Points: 
  • Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China.
  • Everest expects to receive NDA approval in South Korea in 2024.
  • South Korea's MFDS granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® earlier this year.
  • The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value

Rznomics Inc. Secures Fast Track Designation from the U.S. FDA for RZ-001

Retrieved on: 
Friday, November 10, 2023

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs, thus enabling drugs to reach patients sooner.

Key Points: 
  • Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs, thus enabling drugs to reach patients sooner.
  • If relevant criteria are met, the drug with Fast Track Designation may also be eligible for Accelerated Approval and Priority Review.
  • GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies.
  • "We are proud to receive Fast Track Designation from the FDA," said Dr. Seong-Wook Lee, Chief Executive Officer of Rznomics.

Rznomics Inc. Secures Fast Track Designation from the U.S. FDA for RZ-001

Retrieved on: 
Friday, November 10, 2023

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs, thus enabling drugs to reach patients sooner.

Key Points: 
  • Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs, thus enabling drugs to reach patients sooner.
  • If relevant criteria are met, the drug with Fast Track Designation may also be eligible for Accelerated Approval and Priority Review.
  • GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies.
  • "We are proud to receive Fast Track Designation from the FDA," said Dr. Seong-Wook Lee, Chief Executive Officer of Rznomics.

Aeterna Zentaris Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023

TORONTO, ONTARIO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today reported its financial and operating results for the quarter ended September 30, 2023.

Key Points: 
  • - Ended the quarter with $38.8 million in cash, expected to fund operations and advancement of priority pipeline programs into 2025
    TORONTO, ONTARIO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today reported its financial and operating results for the quarter ended September 30, 2023.
  • Dollars
    The Company had $38.8 million in cash and cash equivalents at September 30, 2023.
  • Our total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period in 2022, representing an increase of $1.2 million.
  • For reference, the Company’s Management's Discussion and Analysis of Financial Condition and Results of Operations for the third quarter 2023, as well as the Company's unaudited consolidated interim financial statements as of September 30, 2023, will be available on the Company's website ( www.zentaris.com ) in the Investors section or at the Company's profile at www.sedarplus.com and www.sec.gov .