Biotechnology

BrainTale Announces CE Marking of Its First Product for Brain Quantitative Measurement, brainQuant, And Its ISO:13485:2016 Certification

Thursday, April 2, 2020 - 8:00am

The company received ISO 13485:2016 certification, an international standard governing the requirements of a quality management system for medical devices and related company services.

Key Points: 
  • The company received ISO 13485:2016 certification, an international standard governing the requirements of a quality management system for medical devices and related company services.
  • The CE marking Conformite Europeenne certifies that the product meets European Union (EU) requirements for marketing in Europe.
  • BrainTale develops and commercializes accessible, effective and clinically-validated measurement and prognosis tools for brain injured patients.
  • This news is a major achievement allowing healthcare professionals to use our first product in compliance with EU requirements.

Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa

Thursday, April 2, 2020 - 7:00am

With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec's cell therapy discovery and development efforts.

Key Points: 
  • With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec's cell therapy discovery and development efforts.
  • Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners.
  • Integrating panCELLa's technology and cell lines into our ongoing proprietary research and development effortsstrengthens Evotec's position in cell therapy.
  • In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec's multimodality discovery and development platform."

SETi’s Violeds Technology Proves 99.9% Sterilization of Coronavirus (COVID-19) in 30 Seconds

Thursday, April 2, 2020 - 7:53am

Sensor Electronic Technology, Inc. (SETi), a leading global innovator of deep UV LED products and technology, announced that it has been successful in achieving 99.9% sterilization of coronavirus (COVID-19) in 30 seconds.

Key Points: 
  • Sensor Electronic Technology, Inc. (SETi), a leading global innovator of deep UV LED products and technology, announced that it has been successful in achieving 99.9% sterilization of coronavirus (COVID-19) in 30 seconds.
  • In the study by SETi and Seoul Viosys, Violeds technology is used to show just how strong the sterilization effect can be on COVID-19 when exposed to Violeds photons for 30 seconds.
  • The study also finds the coronavirus becomes even more sterile when placed closer to the photon with longer exposure time.
  • Violeds, compound semiconductor technology, is the brand name of technology that utilizes UV LED for sterilization and deodorization functions.

RELIEF THERAPEUTICS Holding SA Announces the Closing of its Share Exchange Agreement with Sonnet BioTherapeutics, Inc. for the Divestment of its wholly-owned Subsidiary Relief Therapeutics SA

Thursday, April 2, 2020 - 7:16am

RELIEF THERAPEUTICS Holding SA (SIX:RLF, "Relief Holding") announces today the closing of the binding Share Exchange Agreement (SEA) for the acquisition by Sonnet BioTherapeutics, Inc. (Sonnet), now a subsidiary of Sonnet BioTherapeutics Holdings, Inc. (formerly known as Chanticleer Holdings, Inc.) (Nasdaq:SONN, "Sonnet Holdings") of Relief Therapeutics SA (Relief SA), a subsidiary of Relief Holding signed August 12, 2019.

Key Points: 
  • RELIEF THERAPEUTICS Holding SA (SIX:RLF, "Relief Holding") announces today the closing of the binding Share Exchange Agreement (SEA) for the acquisition by Sonnet BioTherapeutics, Inc. (Sonnet), now a subsidiary of Sonnet BioTherapeutics Holdings, Inc. (formerly known as Chanticleer Holdings, Inc.) (Nasdaq:SONN, "Sonnet Holdings") of Relief Therapeutics SA (Relief SA), a subsidiary of Relief Holding signed August 12, 2019.
  • As a consequence, Sonnet acquires all outstanding shares of Relief SA that becomes a wholly-owned Geneva-based subsidiary of Sonnet.
  • In counterpart, Sonnet paid to Relief Holding shares of its common stock that converted into 757,933 shares of listed Sonnet Holdings common stock.
  • This divestment will allow Relief Holding to focus its resources to further develop its main asset Aviptadil for pulmonary affections.

NOXXON Announces Completion of Patient Recruitment for the First Dose Cohort in the Phase 1/2 Brain Cancer Study Of NOX-A12 Plus Radiotherapy

Thursday, April 2, 2020 - 7:00am

The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients in a Phase 1/2 clinical trial.

Key Points: 
  • The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients in a Phase 1/2 clinical trial.
  • Under the approved protocol, it is planned that each patient is treated with NOX-A12 for up to six months.
  • The combination of NOX-A12 and radiotherapy has so far been well-tolerated by the patients that participated in this clinical trial.
  • In September 2019 the company initiated an additional trial with NOX-A12 in brain cancer in combination with radiotherapy.

Sensorion Reports Full-year 2019 Financial Results and Business Update

Thursday, April 2, 2020 - 6:30am

As part of this consortium, Sensorion will receive up to 5.6 million over the duration of the project contingent on milestones completion.

Key Points: 
  • As part of this consortium, Sensorion will receive up to 5.6 million over the duration of the project contingent on milestones completion.
  • SENS-111 (Seliforant) was safe and well tolerated in a Phase 2 proof-of-concept study for the treatment of acute unilateral vestibulopathy (AUV).
  • However, it did not meet the primary endpoint of vertigo intensity and Sensorion stopped all development activities for SENS-111.
  • On the 13th of March, Sensorion made an update on timelines for the ongoing Phase 2 study of SENS-401 to treat Sudden Sensorineural Hearing Loss (SSNHL).

As Part of a Global Partnership with Nestlé Health Science, VALBIOTIS Initiates the Pivotal Late Stage Development Phase of TOTUM-63, a Plant-Derived Active Substance With Clinically Demonstrated Metabolic Health Benefits in People With Prediabetes

Thursday, April 2, 2020 - 6:35am

This last phase of the clinical development was co-designed with Nestl Health Science's medical and regulatory teams and consists of one pivotal Phase II/III clinical study, called REVERSE-IT.

Key Points: 
  • This last phase of the clinical development was co-designed with Nestl Health Science's medical and regulatory teams and consists of one pivotal Phase II/III clinical study, called REVERSE-IT.
  • It will be entirely funded by the partnership signed in February 2020 with Nestl Health Science.
  • Murielle CAZAUBIEL, Head of Development and Medical Affairs, states: The REVERSE-IT study results from the combined expertise of VALBIOTIS and Nestl Health Science.
  • In 2020, VALBIOTIS has signed a global and long-term partnership with Nestl Health Science for the development and worldwide commercialization of TOTUM-63.

RECELL® System Data Accepted to 52nd Annual American Burn Association Meeting Available Online

Thursday, April 2, 2020 - 1:35am

AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin.

Key Points: 
  • AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin.
  • AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018.
  • The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older.
  • The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury.

Dicerna Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Wednesday, April 1, 2020 - 9:30pm

The stock options approved under the Inducement Grants were issued pursuant to Dicernas 2016 Inducement Plan and have an exercise price per share equal to $17.33, the fair market value on the grant date.

Key Points: 
  • The stock options approved under the Inducement Grants were issued pursuant to Dicernas 2016 Inducement Plan and have an exercise price per share equal to $17.33, the fair market value on the grant date.
  • The stock options have a 10-year term and are subject to the terms and conditions of the applicable stock option agreements.
  • The Company granted the stock options and RSUs as inducement materials to the new employees entering into employment with Dicerna Pharmaceuticals, Inc. in accordance with Nasdaq listing Rule 5635(c)(4).
  • This press release includes forward-looking statements pertaining to continued service of employees and future vesting of inducement grants.

Medical Professionals Across Merck & Co., Inc., Pfizer Inc., and Eli Lilly and Company Activate to Support Health Systems, First Responders and Patients Amid COVID-19 Pandemic

Wednesday, April 1, 2020 - 9:00pm

Merck will support its employees around the world who are uniquely qualified to provide medical services and wish to aid communities affected by the COVID-19 pandemic.

Key Points: 
  • Merck will support its employees around the world who are uniquely qualified to provide medical services and wish to aid communities affected by the COVID-19 pandemic.
  • Pfizer has created a new Global COVID-19 Medical Service Program that empowers medical colleagues to provide diagnostic, treatment, and public health support in the battle against COVID-19.
  • Lilly is deploying its medical professionals to staff a free drive-through COVID-19 testing facility at its corporate headquarters in Indianapolis.
  • Forward-Looking Statement of Eli Lilly and Company, Indianapolis, Ind., USA
    This release contains forward-looking statements regarding Lillys efforts in regard to the novel coronavirus.