The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended two antivirals, one biosimilar and two cancer meds for approval at its June meeting.
A publication in Science Translational Medicine shows that Roche has a rising star in the 15 million patient market of age-related macular degeneration (AMD). In a Phase II trial, US and German researchers showed efficacy in geographic atrophy, an advanced stage of AMD, which has currently no treatment.
German oncologists have unveiled that market-approved inhibitors of DNA methyltransferases (DMNTi) and histone deacetylases (HDACi) act through expression of cancer neoantigens. They already have a biomarker test to identify responders.
Following shrinking sales for its wet AMD drug Lucentis, Novartis is back with convincing Phase III results of its anti-VEGF-A singe chain antibody fragment brolucizumab. In two pivotal studies the drug proved to be non-inferior to Regeneron/Bayer’s Eylea (aflibercept).
Evotec and co-investors support Dutch Facio Therapies BV with €4.8m to push development of Dux4 inhibitors to treat facioscapulohumeral dystrophy (FSHD), one of the most common forms of muscular dystrophy.
Belgian Asit Biotech S.A. (formerly Biotech Tools) has announced that its grass pollen allergic rhinitis immunotherapy gp-ASIT+ did reach the primary efficacy endpoint in a Phase III trial but needs confirmation through an additional Phase III study. Market access is receding into the distance.
After today’s completion of the acquisition of Actelion Ltd by J&J for US$30bn in cash, equivalent to US$280 per share, through the US company’s Swiss subsidiary, Janssen Holding GmbH, Actelion will become part of Janssen Pharmaceuticals.
Boehringer Ingelheim has presented detailed pivotal double-blinded Phase III data, which prove comparability of its biosimilar candidate BI695501 to Humira in patients with moderate to severe Rheumatoid Arthritis.
Novartis and Alphabet/Google asset Verily Life Sciences LLC has co-invested into the late stage fund designed to finance programmes with up to €25m post clinical proof of concept.
Germany’s Constitutional Court has stopped the government from ratifying the EU’s Unitary Patent Package. At the time of the announcement, The German Bundestag and Council of Federal states had already adopted and signed the legislation.