Ipsen and Skyhawk Therapeutics have signed an exclusive worldwide collaboration to discover and develop novel small molecules that modulate RNA for rare neurological diseases. The agreement includes an option pursuant to which Ipsen would acquire exclusive license for the worldwide rights to develop successful development candidates (DC). Following successful DC nomination, Ipsen will be responsible for all activities. Skyhawk’s unique platform accelerates building RNA-targeting small molecules across several therapeutic areas, including rare neurological diseases. “We are delighted to join f ..read more

Ochre Bio has formed a partnership with Boehringer Ingelheim focused on the discovery and development of novel, first-in-class regenerative treatments for chronic liver diseases (CLDs), such as late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. Within the partnership, Ochre Bio will utilise its proprietary discovery platform combining machine learning with human big data, including advanced imaging and deep genomic phenotyping, as well as in-house RNA chemistry, and the unique ability to employ proprietary ex-vivo human-organ perfusion models. This will enable ..read more

The U.S. Food and Drug Administration (FDA) has approved Takeda’s ENTYVIO (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO. The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen). The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, ra ..read more

The European Commission (EC) has approved a Type II variation for Janssen-Cilag International NV’s (a Johnson & Johnson company) CARVYKTI (ciltacabtagene autoleucel; cilta-cel). This latest approval is for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. Cilta-cel is an innovative chimeric antigen receptor T-cell (CAR-T) therapy directed a ..read more

Evotec and Variant Bio have announced a collaboration agreement to identify a best-in-class treatment for diseases caused by fibrosis. Fibrosis is characterised by marked and pathogenic build-up of the tissue matrix, leading to tissue degeneration in organs, including the liver and lungs. Fibrotic disease contributes substantially to global mortality and morbidity. Despite the chronic nature of fibrotic conditions, widespread impact on various organs, and substantial disease burden, there is currently no curative treatment for these conditions. The strategic partnership leverages Variant Bio ..read more

Ferring Pharmaceuticals and SK pharmteco have forged an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA). Adstiladrin® was approved by the FDA in December 2022 for adult pat ..read more

Ipsen has opened its new UK headquarters in Paddington, London. The site, which will serve as one of Ipsen’s three global hubs, will house 300 employees. It is located at the heart of a growing life sciences community in Paddington, where several other pharmaceutical and technology companies as well as Imperial College London are based. David Loew, Ipsen CEO, and Ioana Parsons, General Manager of Ipsen UK and Ireland, welcomed Rosalind Campion, Director of the Office for Life Sciences, Dr. Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, and other ke ..read more

Essential Pharma has completed the acquisition of Reminyl® oral capsules from Janssen Pharmaceutica NV, a Johnson & Johnson company. Reminyl®, a cholinesterase inhibitor, is an established central nervous system (CNS) drug indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. Under the terms of the acquisition, Essential Pharma has acquired rights to Reminyl® oral capsules in the EEA, Thailand, South Korea and all other current markets for that product, excluding UK and Ireland, Japan and Latin America. As well as being an important addition to Essential ..read more

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, Lexeo Therapeutics’ AAVrh.10hFXN-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA) cardiomyopathy. LX2006 is designed to deliver a functional frataxin gene to promote frataxin protein expression and restore mitochondrial function in myocardial cells. Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical need. This designation was granted based on available preclinical data ..read more

Medincell has formed a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. It will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization. Christophe Douat, M ..read more