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While ElsaLys continues to work on the filing of marketing approval in Europe and the U S for
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OSE Immunotherapeutics Reports 2020 Financial Results and Provides Business Update
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OSE Immunotherapeutics and ARCAGY - GINECO Announce Initiation of a Randomized Phase 2 Clinical .
OSE ImmunotherapeuticsMarch 15, 2021 GMT This clinical trial will be sponsored and conducted by the French oncology cooperative group ARCAGY-GINECO and supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and OSE Immunotherapeutics.
The study will explore Tedopi®’s potential in an additional oncology indication with significant unmet medical need.
NANTES, France, March 15, 2021 (GLOBE NEWSWIRE) OSE Immunotherapeutics (FR0012127173) and the French cooperative group ARCAGY-GINECO today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic Committee (CPP) approved the initiation of a new Phase 2 clinical trial evaluating Tedopi® in patients with recurrent ovarian cancer (the TED
Early Access to BioCryst’s Berotralstat Granted for HAE Patients in France
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RESEARCH TRIANGLE PARK, N.C., March 11, 2021 (GLOBE NEWSWIRE) BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the French National Agency for Medicines and Health Products Safety (ANSM) has granted an Autorisation Temporaire d Utilisation de cohorte (cohort ATU), or Temporary Authorization for Use, for the use of berotralstat to prevent attacks of hereditary angioedema (HAE) in appropriate patients aged 12 and older.
This cohort ATU allows patients with HAE in France to receive treatment with berotralstat before the drug is granted marketing authorization by the European Commmission (EC).
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