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Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

Theranexus and the Beyond Batten Disease Foundation, have announced receipt of approval from the Food and Drug Administration for the design and primary and secondary endpoints of the pivotal Phase III trial for Batten disease CLN3, at a meeting with the Division of Rare Diseases and Medical Genetics held in mid-April.

Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease Read More »

Biophytis has Requested a Pre-Submission Meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the Treatment of COVID-19

Biophytis SA announced that it has filed for a pre-submission meeting request with the European Medicine Agency to discuss filing for conditional Marketing Authorisation in Europe for Sarconeos in the treatment of severe form of COVID-19.

Biophytis has Requested a Pre-Submission Meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the Treatment of COVID-19 Read More »

Zion Pharma Announces Global Agreement with Roche to Develop and Commercialize a Blood Brain Barrier Penetrant Oral HER2 Tyrosine Kinase Inhibitor

Zion Pharma Limited, a Chinese biotechnology company focused on the development of brain-penetrable compounds, announced that Roche has acquired the global rights to Zion’s lead program, ZN-A-1041.

Zion Pharma Announces Global Agreement with Roche to Develop and Commercialize a Blood Brain Barrier Penetrant Oral HER2 Tyrosine Kinase Inhibitor Read More »

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