Hormones

Aeterna Zentaris Reports Second Quarter 2021 Financial Results and Provides Pipeline Program Updates

Retrieved on: 
Wednesday, August 4, 2021

TORONTO, ONTARIO, Aug. 04, 2021 (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 second quarter ended June 30, 2021. The Company also provided an update on its pre-clinical and clinical development programs.

Key Points: 
  • TORONTO, ONTARIO, Aug. 04, 2021 (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 second quarter ended June 30, 2021.
  • In consultation with The University of Sheffield, UK, selected AEZS-150 as the lead candidate in the Company's delayed clearance parathyroid hormone fusion polypeptides (DC-PTH) program.
  • In February 2021, Aeterna entered into an exclusive option agreement with Julius-Maximilians-University to evaluate a preclinical, potential COVID-19 vaccine developed at Julius-Maximilians-University.
  • The Company had $69.9 million cash and cash equivalents at June 30, 2021 (March 31, 2021 73.4 million).

FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

Retrieved on: 
Wednesday, July 28, 2021

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.

Key Points: 
  • Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.
  • Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes.
  • "This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs," said Acting FDA Commissioner Janet Woodcock, M.D.
  • The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

Dr. Gerald Shulman Joins Levels as Advisor

Retrieved on: 
Thursday, July 22, 2021

Levels , the first biowearable system to give real-time biofeedback on nutrition and lifestyle, today announced that Dr. Gerald Shulman, MD-PhD, has joined the company as an Advisor .

Key Points: 
  • Levels , the first biowearable system to give real-time biofeedback on nutrition and lifestyle, today announced that Dr. Gerald Shulman, MD-PhD, has joined the company as an Advisor .
  • In this role, Dr. Shulman will advise on our strategy and collaborate with Levels on research to understand better the physiologic drivers of insulin resistance and other metabolic dysfunction.
  • View the full release here: https://www.businesswire.com/news/home/20210722005815/en/
    Dr. Gerald Shulman Joins Levels as Advisor (Photo: Business Wire)
    Dr. Shulman is the George R. Cowgill Professor of Medicine and Professor of Cellular and Molecular Physiology at Yale.
  • Levels is currently running a closed beta program focused on product development and has a waitlist of over 115,000 people.

BioVie to Present Rationale for use of NE3107 for the Treatment of Alzheimer’s Disease at 2021 Alzheimer’s Association International Conference

Retrieved on: 
Thursday, July 22, 2021

The basis for the study design was also recently published in a peer-reviewed article in Neurodegenerative Disease Management ( https://doi.org/10.2217/nmt-2021-0022 ).

Key Points: 
  • The basis for the study design was also recently published in a peer-reviewed article in Neurodegenerative Disease Management ( https://doi.org/10.2217/nmt-2021-0022 ).
  • BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions.
  • In neurodegenerative disease, BioVie recently acquired the assets of NeurMedix Inc., including NE3107, that binds to ERK and selectively reduces neuroinflammation and insulin resistance.
  • Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained.

Xeris Pharmaceuticals Enters Into an Exclusive License and Supply Agreement with Tetris Pharma Limited to Commercialize Ogluo® in Europe

Retrieved on: 
Monday, July 19, 2021

Under the terms of the applicable agreements, Xeris will be responsible for product supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.

Key Points: 
  • Under the terms of the applicable agreements, Xeris will be responsible for product supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.
  • Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above.
  • The United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo (glucagon) injection on April 29, 2021.
  • Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

Basis for BioVie’s Phase 3 Clinical Trial of NE3107 in the Treatment of Alzheimer’s Disease Published in Neurodegenerative Disease Management

Retrieved on: 
Friday, July 16, 2021

NE3107 has demonstrated a favorable safety profile based on chronic dosing safety studies in rats and dogs and in human clinical trials to date.

Key Points: 
  • NE3107 has demonstrated a favorable safety profile based on chronic dosing safety studies in rats and dogs and in human clinical trials to date.
  • NE3107 has shown a low potential for drug-drug interactions, is not immunosuppressive, and has a nonclinical profile that facilitates the evaluation of clinically relevant hypotheses in patients with Alzheimers disease.
  • In neurodegenerative disease, BioVie recently acquired the assets of NeurMedix Inc., including NE3107, that binds to ERK and selectively reduces neuroinflammation and insulin resistance.
  • A Phase 2 trial of NE3107 in Parkinsons Disease is planned for later this year, and related compounds have additional potential to treat certain cancers.

Clarus Therapeutics Announces Comprehensive Settlement of Patent Litigation With Lipocine

Retrieved on: 
Thursday, July 15, 2021

These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Key Points: 
  • These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
  • Safety and efficacy of JATENZO in males less than 18 years old have not been established.
  • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

Insights on the Human Insulin Global Market to 2026 - by Product Type, Distribution Type, Disease Type and Region - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 13, 2021

The "Human Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Human Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.
  • The global human insulin market exhibited moderate growth during 2015-2020.
  • Looking forward, the publisher expects the market to grow at a CAGR of around 5% during the forecast period (2021-2026).
  • Human insulin (HI) is a form of synthetic insulin that is synthesized in laboratories for pharmaceutical use.

Royal Canadian Mint $2 Circulation Coin Marks the 100Th Anniversary of the Discovery of Insulin

Retrieved on: 
Tuesday, July 13, 2021

"The Mint has the unique privilege of creating lasting reminders of Canadian achievements through coins and it is proud that its newest $2 circulation coin celebrates the 100th anniversary of Canada's discovery of insulin," said Marie Lemay, the Mint's President and CEO.

Key Points: 
  • "The Mint has the unique privilege of creating lasting reminders of Canadian achievements through coins and it is proud that its newest $2 circulation coin celebrates the 100th anniversary of Canada's discovery of insulin," said Marie Lemay, the Mint's President and CEO.
  • The reverse of the $2 circulation coin commemorating the 100th anniversary of the discovery of insulin as a treatment for diabetes is designed by Kitchener-Waterloo, Ontario artist Jesse Koreck.
  • The words 'INSULIN'/ 'INSULINE' appear on the coin's outer ring, as do the years '1921' and '2021', highlighting the anniversary.
  • The Royal Canadian Mint is the Crown corporation responsible for the minting and distribution of Canada's circulation coins.

Royal Canadian Mint $2 Circulation Coin Marks the 100Th Anniversary of the Discovery of Insulin

Retrieved on: 
Tuesday, July 13, 2021

"The Mint has the unique privilege of creating lasting reminders of Canadian achievements through coins and it is proud that its newest $2 circulation coin celebrates the 100th anniversary of Canada's discovery of insulin," said Marie Lemay, the Mint's President and CEO.

Key Points: 
  • "The Mint has the unique privilege of creating lasting reminders of Canadian achievements through coins and it is proud that its newest $2 circulation coin celebrates the 100th anniversary of Canada's discovery of insulin," said Marie Lemay, the Mint's President and CEO.
  • The reverse of the $2 circulation coin commemorating the 100th anniversary of the discovery of insulin as a treatment for diabetes is designed by Kitchener-Waterloo, Ontario artist Jesse Koreck.
  • The words 'INSULIN'/ 'INSULINE' appear on the coin's outer ring, as do the years '1921' and '2021', highlighting the anniversary.
  • The Royal Canadian Mint is the Crown corporation responsible for the minting and distribution of Canada's circulation coins.