Page 2 - Authorisation Application News Today

Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants…

Partnership offers treatment access to hundreds of patients across several European countries - News - PharmaTimes

01.12.2022 - Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination scheduleHigher antibody levels were observed in the three-dose vaccination schedule versus the two-dose ...

New submission date for Day 120 responses: October 2022 Restart of validation batches in Q3 2022 Committee for Medicinal Products for Human Use (CHMP) opinion expected by Q3 2023 Regulatory

Orphazyme A/SCompany announcement        No. 24/2021Inside informationCompany Registration No. 32266355 Progress made in understanding potential...

  The Q1 operating loss of $3.4M includes the impact of non-cash items including amortisation, depreciation and the impact of share-based compensation expenses. Adjusting for these non-cash items, the Company delivered $9.9M of EBITDA 3 for the quarter. 2  Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($10.7M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($1.0M), depreciation and amortisation (...

Investegate announcements from Amryt Pharma plc, Amryt Reports Record Q1 2021 Financial and Operating Results

REPUBLIC OF SOUTH AFRICA OR JAPAN. NEITHER THIS ANNOUNCEMENT NOR ANYTHING CONTAINED HEREIN SHALL FORM THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR COMMITMENT WHATSOEVER IN ANY JURISDICTION.   THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU AS IT FORMS PART OF THE LAW OF ENGLAND AND WALES BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018. IN ADDITION, MARKET SOUNDINGS WERE TAKEN IN RESPECT OF THE MATTERS CONTAINED ...