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GenSight Biologics Reports Interim Financial Results for the First Half of 2021 and Provides Operational Update

GenSight Biologics Reports Interim Financial Results for the First Half of 2021 and Provides Operational Update
ATUs in France
in Europe in H1 2022
Successful refinancing in Q1 2021 secures mid-2023 runway
Multiple regulatory and clinical milestones expected in Q4 2021
Regulatory News:
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its interim financial results for the first half of 2021 and provided recent operational updates. The full interim financial report is available on the Company s website in the Investors section. The 2021 half-year financial statements were subject to a limited review by the Company s statutory auditors and approved by the Board of Directors on July 28, 2021. ....

United Kingdom , United States , James Palmer , Gensight Biologics Euronext , Gensight Biologics , Bernard Gilly , Thomas Gidoin , Guillaume Van Renterghem , Jeanene Timberlake , Research Tax Credit , European Medicines Agency , European Commission , Drug Administration , Access Program , Sales Marketing , Sight Biologics , North America , Chief Executive Officer , Leber Hereditary Optic Neuropathy , Year Financial , Chief Financial Officer , Temporary Authorization , French National Drug Safety Agency , Agence Nationale , Marketing Authorisation Application , Tax Credit ,

BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close

BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

United States , Sachsen Anhalt , Hank Fuchs , Klaus Mohnike , Asia Pacific , Debra Charlesworth , Carmen Alonso Alvarez , Autorisation Temporaire , Traci Mccarty , Health Products Safety , French National Agency For Medicines , European Commission , Drug Administration , Biomarin Pharmaceutical Inc , Exchange Commission , Worldwide Research , Professor Of Paediatrics At Magdeburg University Hospital , Committee For Medicinal Products Human Use , Biomarin Pharmaceutical , Medicinal Products , Human Use , C Type Natriuretic Peptide , Middle East , French National Agency , Temporary Authorization , President Worldwide Research ,

Gensight Biologics SA (via Public) / GenSight Biologics Appoints Country Leads for France, Germany and the UK in Preparations for LUMEVOQ® Commercial Launch

Gensight Biologics SA (via Public) / GenSight Biologics Appoints Country Leads for France, Germany and the UK in Preparations for LUMEVOQ® Commercial Launch
publicnow.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from publicnow.com Daily Mail and Mail on Sunday newspapers.

France General , United Kingdom , Neil Dugdale , Gensight Biologics Euronext , Gensight Biologics , Bernard Gilly , Sanofi Genzyme , Laurence Rodriguez , Robert Schupp , University Of Cologne , Business Administration University Of Cologne , Organization Leadership Program , Institute Of Marketing Diploma , Technical University Of Munich , University Of Cambridge , Harvard Business School , University Of Liverpoolb Sc , Sciences Po , European Medicines Agency , Market Access Management European Business School , Sight Biologics , Leber Hereditary Optic Neuropathy , Temporary Authorization , Chief Executive Officer , Marketing Manager , Sales Manager ,

Air Enforcement: Alabama Department of Environmental Management and Jackson County Secondary Aluminum Processing Facility Enter into Consent Order | Mitchell, Williams, Selig, Gates & Woodyard, P.L.L.C.

Scottsboro is stated to operate a secondary aluminum processing facility (“Facility”) in Jackson County, Alabama.
The Facility includes an aluminum scrap dryer operated pursuant to the authority of Air Permit No. 705-0030-X006 (“Permit”). Emissions from the aluminum scrap dryer are stated to be controlled by a baghouse.
ADEM is stated to have conducted an inspection of the Facility on September 29, 2020. The CO provides that Scottsboro was operating the aluminum scrap dryer without its associated baghouse and without temporary authorization to operate as required by certain provisions of the Permit.
Scottsboro is stated to have responded to an ADEM Notice of Violation indicating the Facility had operated the aluminum scrap dryer for a total of 289 hours without the associated baghouse and without temporary authorization to operate between June 27, 2020, and September 29, 2020. The scrap dryer was stated to have been shut down on September 29, 2020, and began op ....

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Advicenne Reports its Full-Year Financial Results to December 31, 2020 and Confirms its 2021 Outlook

Advicenne Reports its Full-Year Financial Results to December 31, 2020 and Confirms its 2021 Outlook
Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a French company specialized in the development of therapeutic products adapted to children and adults for treating nephrological and neurological orphan diseases, today reported its 2020 financial results.
2020 HIGHLIGHTS
Scientific developments
On March 10, 2020, Advicenne was authorized to make ADV7103 available within the framework of a Temporary Authorization for Use (TAU) scheme established by France s National Agency of Medicine and Health Products Safety (
Agence nationale de sécurité du médicament et des produits de santé (ANSM)). This authorization allows the exceptional use of coated 8 mEq and 24 mEq granules in sachets for the treatment of distal renal tubular acidosis (dRTA) in France. Its prescription is reserved for physicians specializing in nephrology. ....

United States , France General , Hege Hellstrom , Nicolas Merigeau , Dusan Oresansky , Peter Meeus , Advicenne Euronext , Emmanuel Huynh , David Solomon , Health Products Safety Agence , French Financial Markets Authority Autorit , France National Agency Of Medicine , Advicenne Inc , Sales Of The Company , European Investment Bank , Financial Communications , Regulatory News , Temporary Authorization , National Agency , Health Products Safety , Medicinal Products , Human Use , European Medicines Agency , Chief Executive Officer , State Guaranteed Loans , European Marketing Approval ,