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Ipsen
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Pharmaceutical
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
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Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.
Latest News & Features of interest to Ipsen
Biotechnology
Important regulatory news last week included French pharma major Sanofi gaining approval from the US Food and Drug Administration (FDA) and the Chinese medicines authority for its blockbuster drug Dupixent as the first biologic for chronic obstructive pulmonary disease (COPD). Spanish epigenetics firm Oryzon Genomics announced that, with FDA feedback, it is preparing for a Phase III trial of its CNS drug candidate vafidemstat. Also, the FDA authorized Bristol Myers Squibb’s blockbuster drug Opdivo in a new lung cancer indication for patients with specific mutations such as EGFR or ALK. On the deal-making front, US biotech Arcus Biosciences has entered a collaboration with AstraZeneca to evaluate its casdatifan with the UK pharma major’s volrustomig in renal cell cancer. 6 October 2024
Pharmaceutical
A Spanish framework for medical cannabis usage is finally on the way, Cannabis Health reports. 4 October 2024
Biotechnology
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Pharmaceutical
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Pharmaceutical
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Biosimilars
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Biotechnology
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Pharmaceutical
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
Latest In Brief for Ipsen
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Latest Relevant Ones To Watch News
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 1 October 2024
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