Phase

FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

Retrieved on: 
Friday, February 16, 2024

People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).

Key Points: 
  • People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).
  • Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens.
  • Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
  • About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies, based on estimates for 2024.

FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies

Retrieved on: 
Friday, February 16, 2024

People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance").

Key Points: 
  • People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance").
  • Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens3.
  • Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
  • "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."

First Patient Randomized in AskBio Phase II Gene Therapy Trial for Congestive Heart Failure

Retrieved on: 
Friday, February 16, 2024

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).

Key Points: 
  • Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
  • “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
  • “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
  • AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Areteia Therapeutics Announces Appointment of Daniel Becker, M.D., Ph.D. To Board of Directors

Retrieved on: 
Thursday, February 15, 2024

Areteia Therapeutics, Inc. (“Areteia”) today announced the appointment of Daniel Becker to the Areteia Board of Directors, effective immediately.

Key Points: 
  • Areteia Therapeutics, Inc. (“Areteia”) today announced the appointment of Daniel Becker to the Areteia Board of Directors, effective immediately.
  • Dr. Becker will serve as a member of the audit committee of the board.
  • View the full release here: https://www.businesswire.com/news/home/20240215803782/en/
    “I am excited that Dan has been appointed to our board,” said Jorge Bartolome, President and Chief Executive Officer of Areteia.
  • and Ph.D. (Cellular and Molecular Biology) degrees from the University of Michigan and received his B.S.

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

Retrieved on: 
Thursday, February 15, 2024

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Antibe Reports Q3 2024 Interim Financial and Operating Results

Retrieved on: 
Wednesday, February 14, 2024

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to target pain and inflammation, has filed its financial and operating results for the fiscal quarter ended December 31, 2023.

Key Points: 
  • Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to target pain and inflammation, has filed its financial and operating results for the fiscal quarter ended December 31, 2023.
  • “The results of November’s successful PK/PD study have empowered us to make considerable enhancements to the Phase II trial,” commented Dan Legault, Antibe’s CEO.
  • General and Administrative Expenses: General and administrative expenses were $2.3 million, compared to $2.2 million in fiscal Q3 2023.
  • The Company’s unaudited fiscal Q3 2024 condensed interim financial statements and MD&A are available on SEDAR.

GC Biopharma Presents Updates on its LSD Treatments at the WORLDSymposium 2024

Retrieved on: 
Wednesday, February 14, 2024

YONGIN, South Korea, Feb. 14, 2024 /PRNewswire/ -- GC Biopharma (CEO, Eun-Chul Huh), a South Korean biopharmaceutical company, announced on Feb. 14th that it has presented the development updates on its LSD (Lysosomal Storage Diseases) medicines at the WORLDSymposium 2024 held on Feb. 4th-9th, 2024 in San Diego, USA.

Key Points: 
  • YONGIN, South Korea, Feb. 14, 2024 /PRNewswire/ -- GC Biopharma (CEO, Eun-Chul Huh), a South Korean biopharmaceutical company, announced on Feb. 14th that it has presented the development updates on its LSD (Lysosomal Storage Diseases) medicines at the WORLDSymposium 2024 held on Feb. 4th-9th, 2024 in San Diego, USA.
  • WorldSymposium 2024 is an international forum for Lysosomal Diseases experts to share and exchange insights for researching better treatment of the disease.
  • In 2012, GC Biopharma succeeded in developing the world's second treatment for Hunter syndrome, "Hunterase" solely using domestic technology.
  • GC Biopharma, together with Hanmi Pharmaceutical, is developing GC1134A/HM15421, a long-acting alpha-galactosidase that can be administered subcutaneously once a month to improve patient convenience.

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Retrieved on: 
Tuesday, February 13, 2024

PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

Key Points: 
  • PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).
  • This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
  • “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen," said Christelle Huguet, EVP and Head of Research and Development, Ipsen.
  • In the clinical trial, diarrhea was managed following institutional guidelines and appropriate antidiarrheal medications.9
    *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

First patient randomized in AskBio Phase II gene therapy trial for congestive heart failure

Retrieved on: 
Tuesday, February 13, 2024

Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media

Key Points: 
  • Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media
    Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
  • “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
  • “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
  • AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.