Citryll BV has closed an €85 million (US$89.8 million) series B, enabling it to take CIT-013, an antibody designed to block pathological neutrophil extracellular traps that drive a wide range of immune-mediated inflammatory diseases, into phase IIa development.
The European Commission approved Novo Holding A/S’ acquisition of Catalent Inc., a global contract development and manufacturing organization expected to help Novo Nordisk A/S keep up with increasing demand for its GLP-1 drug, Wegovy (semaglutide).
Tubulis GmbH has sealed a potential $415 million option and licensing deal under which it will apply proprietary technologies to discover an antibody-drug conjugate (ADC) against a solid tumor target for Gilead Sciences Inc.
South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
The U.K.’s leading bioethics body is calling for a new law to regulate the generation of stem cell-derived human embryo models and ensure that research does not cross ethical red lines. Currently, there is no statute governing the oversight of these models. In particular, bioethicists say there should be a statutory ban on the transfer of embryo models into the reproductive tract of humans and animals, with legal penalties for contraventions.
The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
Rising from a $51 million series A round a year ago to a $1.1 billion acquisition, Kate Therapeutics Inc. has stepped under the umbrella of Novartis AG, which gains preclinical adeno-associated virus-based gene therapies for neuromuscular diseases.
“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.
Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based immunotherapies for treating bacterial vaginosis, a cause of preterm birth and other pregnancy complications.
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
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