National Health Regulatory Authority

Pixium Vision announces regulatory approval of remote rehabilitation system for patients in clinical trials

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Wednesday, August 3, 2022
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Pixium Vision has since established clinical sites and implanted its first patients in Germany, the UK and the Netherlands.

Key Points: 
  • Pixium Vision has since established clinical sites and implanted its first patients in Germany, the UK and the Netherlands.
  • Remote rehabilitation has been approved in France, Germany, Italy, Spain and the Netherlands for patients who have succesfuly completed their initial in-clinic rehabilitation sessions.
  • The remote rehabilitation sessions will take place between the patient and the rehabilitation specialists and will be of the same nature as the in-clinic rehabilitation sessions.
  • Given the age and lack of vision of the patients enrolled in the clinical studies, remote rehabilitation will make it simpler for patients to comply.

Valneva Receives Notice of European Commission’s Intent to Terminate COVID-19 Vaccine Purchase Agreement

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Monday, May 16, 2022
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Saint-Herblain (France), May 16, 2022 Valneva SE , a specialty vaccine company, today announced that it has received a notice from the European Commission (EC) of intent to terminate the advance purchase agreement (APA) for Valnevas inactivated whole-virus COVID-19 vaccine candidate VLA2001.

Key Points: 
  • Saint-Herblain (France), May 16, 2022 Valneva SE , a specialty vaccine company, today announced that it has received a notice from the European Commission (EC) of intent to terminate the advance purchase agreement (APA) for Valnevas inactivated whole-virus COVID-19 vaccine candidate VLA2001.
  • Thomas Lingelbach, Chief Executive Officer of Valneva, commented, the EC decision is regrettable especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases.

Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001

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Tuesday, March 1, 2022
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Saint Herblain (France), March 1, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valnevas inactivated, adjuvanted COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint Herblain (France), March 1, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valnevas inactivated, adjuvanted COVID-19 vaccine, VLA2001.
  • This authorization follows a rolling review process with the Bahraini NHRA and reflects the NHRAs initiative to support the authorization of COVID-19 vaccines.
  • As the only dual-adjuvanted, inactivated COVID-19 vaccine approved in Bahrain, VLA2001 will provide a differentiated vaccine option to the Bahraini population and medical community.
  • Valneva signed an advance purchase agreement with the Kingdom of Bahrain in December 2021 for the supply of one million doses of VLA2001.

Valneva’s Inactivated COVID-19 Vaccine Candidate Shown to Neutralize Omicron Variant

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Wednesday, January 19, 2022
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100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

Key Points: 
  • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant
    Saint Herblain (France), January 19, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valnevas inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.
  • All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant.
  • The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.

Emmaus Life Sciences Reports Third Quarter Financial Results and Business Highlights

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Friday, November 12, 2021
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TORRANCE, Calif., Nov. 12, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA),a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported financial results for the quarter and nine months ended September 30, 2021.

Key Points: 
  • TORRANCE, Calif., Nov. 12, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA),a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported financial results for the quarter and nine months ended September 30, 2021.
  • Asembia will provide a single point of contact for benefits investigation, financial and co-pay assistance, as well as patient and provider education.
  • Net revenues declined 6% compared to the second quarter of 2021 primarily due to lower bulk orders in the third quarter than in the second quarter.
  • Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease.

Quantum Genomics and its Partners Reach a New Stage of Development in Asia

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Thursday, October 7, 2021
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Jean-Philippe Milon, Chief Executive Officer of Quantum Genomics, added:

Key Points: 
  • Jean-Philippe Milon, Chief Executive Officer of Quantum Genomics, added:
    Starting the REFRESH study in Asia embodies our partnerships with DongWha (for South Korea) and Orient EuroPharma (for Taiwan, Southeast Asia, Australia and New Zealand), which finance the Asian stage of firibastats development.
  • The first patients should be recruited in the coming weeks, which will enable our partners to intensify their pre-marketing activities that are required before marketing.
  • Milestone payments from our partners related to the inclusion the first South Korean and Taiwanese patients are expected before the end of the year.
  • Quantum Genomics is a biopharmaceutical company specialising in the development of a new class of cardiovascular drugs, based on the Brain Aminopeptidase A Inhibition (BAPAI) mechanism.

Emmaus Life Sciences Announces Bahrain Temporary License of Endari®

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Tuesday, August 17, 2021
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TORRANCE, Calif., Aug. 17, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA),a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that on August 12, 2021, the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain approved a Temporary License for Importation of Pharmaceutical Product for Endari.

Key Points: 
  • TORRANCE, Calif., Aug. 17, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA),a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that on August 12, 2021, the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain approved a Temporary License for Importation of Pharmaceutical Product for Endari.
  • With a total population of 1.8 million, the incidence of sickle cell disease in the Kingdom of Bahrain is estimated at 2.1%.
  • Emmaus is in the process of applying for marketing authorization for Endari.
  • In addition, Emmaus continues collaborating with clinicians on providing Endari on a named-patient basis in the Bahrain and the wider MENA region."