Europe 1

Sutro Biopharma Announces Presentation of Data for Luveltamab Tazevibulin (luvelta) from the Phase 1 Dose-Expansion Study in Endometrial Cancers at ESMO 2023

Retrieved on: 
Sunday, October 22, 2023

SOUTH SAN FRANCISCO, Calif., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced initial results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel Folate receptor alpha (FolRα)-targeting ADC, in patients with endometrial cancer, in a mini oral presentation at the 2023 European Society For Medical Oncology (ESMO) Congress in Madrid, Spain.

Key Points: 
  • Advanced endometrial cancer is the only gynecologic malignancy with increasing incidence and mortality in both the US and Europe1.
  • Estimated incidence in the EU: 92,746 pts with 23,047 deaths (2022)2 and in the US: 66,000 pts with 13,030 deaths (2023)3.
  • “We are pleased to have the opportunity to present these encouraging early data at ESMO this year,” said Anne Borgman, M.D., Sutro’s Chief Medical Officer.
  • Consistent with previous reported luvelta safety results, the most common adverse event was neutropenia; no new safety signals were observed
    *2: European Cancer Information System (ECIS).

Oatly and Amazon Expand Relationship to Meet Growing Demand for Plant-Based Drinks Across Europe

Retrieved on: 
Thursday, August 3, 2023

Under the arrangement, Oatly will have the ability to list several of its popular Oat Drink lines across the markets including Oatly Barista Edition, Oatly Light, Oatly Semi, Oatly Whole, Oatly “No” Sugars and Mini Barista.

Key Points: 
  • Under the arrangement, Oatly will have the ability to list several of its popular Oat Drink lines across the markets including Oatly Barista Edition, Oatly Light, Oatly Semi, Oatly Whole, Oatly “No” Sugars and Mini Barista.
  • Amazon Prime members will be able to access Oatly products with next day and subscribe and save delivery options.
  • Oatly has formed a new pan-European business group to manage the Amazon relationship, which will be led by its General Manager of UK & Ireland, Bryan Carroll.
  • “We’re excited to build on the successful relationship we’ve had with Amazon in the UK and look forward to making more Oatly products available to more Amazon customers across Europe,” said Daniel Ordoñez, Chief Operating Officer at Oatly.

Sensorion Submits Clinical Trial Application for OTOF-GT, its Lead Gene Therapy Candidate, in Europe

Retrieved on: 
Wednesday, July 19, 2023

The CTAs submission follows extensive preclinical studies assessing the safety and efficacy of OTOF-GT and successful manufacturing of the gene therapy Drug Product for the clinical trial.

Key Points: 
  • The CTAs submission follows extensive preclinical studies assessing the safety and efficacy of OTOF-GT and successful manufacturing of the gene therapy Drug Product for the clinical trial.
  • Sensorion’s OTOF-GT dual AAV vector gene therapy development program aims to restore hearing in patients with mutations in OTOF who suffer from severe to profound sensorineural prelingual non syndromic hearing loss.
  • Géraldine Honnet, Chief Medical Officer of Sensorion, added: “We are excited to advance OTOF-GT, our first gene therapy program, to the clinic to address unmet medical need in the complex hearing space.
  • Hearing loss caused by mutations of the gene encoding for otoferlin is a debilitating disorder with currently no approved drugs.”

Sensorion Submits Clinical Trial Application for Lead Gene Therapy Candidate OTOF-GT in the UK

Retrieved on: 
Monday, July 10, 2023

The phase 1/2 clinical trial (Audiogene), aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of OTOF-GT, for the treatment of otoferlin gene-mediated hearing loss in pediatric patients aged up to 31 months.

Key Points: 
  • The phase 1/2 clinical trial (Audiogene), aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of OTOF-GT, for the treatment of otoferlin gene-mediated hearing loss in pediatric patients aged up to 31 months.
  • The CTA submission follows extensive preclinical studies assessing the safety and efficacy of OTOF-GT and successful manufacturing of the gene therapy Drug Product for the clinical trial.
  • Sensorion’s OTOF-GT dual AAV vector gene therapy development program aims to restore hearing in patients with mutations in OTOF who suffer from severe to profound sensorineural prelingual non syndromic hearing loss.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, commented: “This first gene therapy CTA filing is a major milestone for our OTOF-GT program and Sensorion’s broader gene therapy franchise.

Valbiotis Announces Positive Results in the Bioavailability and Mode of Action TOTUM•854 Clinical Study, Against High Blood Pressure

Retrieved on: 
Monday, January 30, 2023

Damage to the vascular wall is a major mechanism in the progression of high blood pressure.

Key Points: 
  • Damage to the vascular wall is a major mechanism in the progression of high blood pressure.
  • This first-in-human evidence confirms the relevance of TOTUM•854's positioning in the early stages of the disease and bodes well for the ongoing Phase II/III clinical efficacy studies in high blood pressure."
  • Mode of action tests also revealed a reduction in angiotensin I-converting enzyme (ACE1) activity, an enzyme well known in the pathophysiology of high blood pressure.
  • 3The fraction of blood remaining after all blood cells (red blood cells, leukocytes, platelets) and fibrinogen (a protein involved in coagulation) have been removed.

Sensorion receives Orphan Drug Designation for OTOF-GT for the treatment of otoferlin gene-mediated hearing loss from the US Food and Drug Administration

Retrieved on: 
Wednesday, November 30, 2022

Sensorions OTOF-GT dual vector AAV gene therapy development program aims to restore hearing in people living with otoferlin deficiency.

Key Points: 
  • Sensorions OTOF-GT dual vector AAV gene therapy development program aims to restore hearing in people living with otoferlin deficiency.
  • Patients with mutations in OTOF suffer from severe to profound sensorineural prelingual non syndromic hearing loss.
  • Otoferlin deficiency is responsible for up to 8% of all cases of congenital hearing loss, with around 20,000 people affected in the US and Europe1.
  • In September 2022, the Company received a positive opinion on an application for Orphan Drug Designation (ODD) from the European Medicines Agency (EMA).

MilliporeSigma Announces the Expansion of Hands-On Science Education Program with Kick-off of Global Curiosity Cube® Mobile Lab

Retrieved on: 
Wednesday, May 18, 2022

"At the Life Science business of Merck KGaA, Darmstadt, Germany, our purpose is to positively impact life and health with science.

Key Points: 
  • "At the Life Science business of Merck KGaA, Darmstadt, Germany, our purpose is to positively impact life and health with science.
  • "With our Curiosity Cube, we're making science interactive and fun, building confidence and capabilities for the next generation of scientists."
  • The design of the Curiosity Cube mobile science lab connects students of all backgrounds, including underrepresented populations in STEM, with high-quality, technology-driven scientific learning experiences.
  • To learn more about the Curiosity Cubemobile science lab and view the complete 2022 tour schedule, visit TheCuriosityCube.com and follow the Curiosity Cube on Instagram @curiositycube_milliporesigma.

Specific Diagnostics Announces First French Tender Award and LIS Connectivity

Retrieved on: 
Tuesday, February 15, 2022

SAN JOSE, Calif., Feb. 15, 2022 /PRNewswire-PRWeb/ --Specific Diagnostics today announced its first French tender award for the Reveal Rapid AST Blood Culture Gram-Negative Sensor Panel.

Key Points: 
  • SAN JOSE, Calif., Feb. 15, 2022 /PRNewswire-PRWeb/ --Specific Diagnostics today announced its first French tender award for the Reveal Rapid AST Blood Culture Gram-Negative Sensor Panel.
  • "A group of our early adopter sites are working together to generate clinical impact data driven by rapid AST.
  • As a result, we designed the Reveal system and software with functionality and flexibility for broad LIS connectivity," said Elias Fayad, VP Software Engineering.
  • Specific is based in San Jose, CA, with subsidiaries in Ireland, France and the UK.

Biogen Reaches Agreement with Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 billion

Retrieved on: 
Thursday, January 27, 2022

This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade.

Key Points: 
  • This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade.
  • We are thankful to Samsung Biologics for a productive collaboration since 2012, said Michel Vounatsos, Chief Executive Officer at Biogen.
  • We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen.
  • Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture.

Leading Edge Materials Reports Fiscal 2021 Results

Retrieved on: 
Wednesday, January 26, 2022

During the year ended October 31, 2021, 493,109 options and 63,571 warrants were exercised for gross proceeds of $95,348 and $6,357 respectively.

Key Points: 
  • During the year ended October 31, 2021, 493,109 options and 63,571 warrants were exercised for gross proceeds of $95,348 and $6,357 respectively.
  • In addition, during fiscal 2020 the Company issued 800,000 common shares on the exercise of warrants for $80,000.
  • These developments continue to support Leading Edge Materials business strategy to establish more secure and sustainable supply alternatives of critical raw materials.
  • 2021 turned out to be a pivotal year as many of the fundamental drivers underpinning the strategy of Leading Edge Materials materialized in force.