A Phase 3 trial of a prospective triple combination therapy for advanced melanoma failed to meet its primary endpoint of progression free survival, Novartis announced on 22 August. The trial was testing the experimental checkpoint antibody spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib), both approved products, in patients with melanoma with a BRAF V600 mutation.
BioMarin Pharmaceutical Plc has received a complete response letter (CRL) from the US Food and Drug Administration saying it can’t approve the company’s gene therapy for haemophilia A without further data on its durable effect. The therapy, valoctocogene roxaparvovec, is intended as a one-time treatment for the blood clotting disorder.
Johnson & Johnson Inc is to significantly expand its presence in drugs for autoimmune diseases with the acquisition of Momenta Pharmaceuticals Inc in an all cash transaction valued at approximately $6.5 billion. Momenta’s lead product, nipocalimab, is in Phase 3 for the treatment of a rare autoimmune disorder called warm autoimmune haemolytic anaemia.
An application from Gilead Sciences Inc to market filgotinib, a candidate treatment for rheumatoid arthritis, has been turned back by US Food and Drug Administration with a request for further safety data, the company announced on 19 August. Filgotinib, a JAK1 inhibitor, was discovered by Galapagos NV and is being jointly developed with Gilead.
Germany-based CureVac NV, which is developing a messenger RNA (mRNA) vaccine against Covid-19, has closed its initial public offering of shares on the US Nasdaq market, raising a gross $245.3 million, including the full exercise of the underwriters’ share options. The stock was priced at $16 per share.
Sanofi SA is to acquire Principia Biopharma Inc of the US and its pipeline of Bruton’s tyrosine kinase (BTK) inhibitors in a deal valued at approximately $3.36 billion. The two companies have been collaborating since 2017 and the merger is expected to trigger increased investment across the BTK inhibitor class of molecules.
A new therapy has been approved by the US Food and Drug Administration to treat a rare central nervous system (CNS) disorder known as neuromyelitis optica spectrum disorder – the third drug to be authorised for this indication in a little over a year. The drug, Enspryng (satralizumab), is a monoclonal antibody developed by Chugai Pharmaceutical Co Ltd, a member of the Roche group.
Bayer AG has taken steps to expand its portfolio of medicines for gynaecological diseases with the acquisition of UK-based KaNDy Therapeutics Plc and its non-hormonal compound, NT-814, for the treatment of the symptoms of menopause. The acquisition complements Bayer’s existing portfolio of birth control treatments, as well as therapies for management of the menopause.
KaNDy Therapeutics was founded in 2017 with financial support Advent Life Sciences, Forbion Capital Partners and OrbiMed, among others. NT-814, the company’s main asset,
A candidate antibody therapeutic for atopic dermatitis has met its primary endpoint in a Phase 2a study using a novel treatment strategy. The therapy, KY1005, targets the OX40-ligand, a key regulator of the immune system. In the study, the compound showed a clinically meaningful improvement in disease activity compared with placebo, according to the developer Kymab Ltd.
The Swedish specialty pharmaceutical company Calliditas Therapeutics AB has reached an agreement to acquire a controlling 62.7% interest in Genkyotex SA of France whose lead product candidate, setanaxib, is in clinical development for primary biliary cholangitis (PBC), a fibrotic orphan disease. The deal is the first step towards a full acquisition of the company whose total consideration is approximately €32 million, not including potential milestones of up to €55 million for regulatory approvals of setanaxib.