Galapagos NV has raised $300 million in a secondary offering on Nasdaq two days after the Belgian company and its partner Gilead Sciences Inc announced positive Phase 3 results for a new JAK1 inhibitor to treat rheumatoid arthritis.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc rejecting the company’s application for a third indication for mepolizumab (Nucala). The application was to use the drug as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD).
Announcing the rejection on 7 September, GSK said the FDA is requiring more data to support the proposed indication.
Nicox has begun a Phase 2 study of a candidate treatment for glaucoma designed to secure a position in global ophthalmology. The treatment, NCX 470, is being tested in patients with open-angle glaucoma, the most common form of glaucoma, accounting for about 90% of all cases.
As part of an ongoing out-licensing policy, AstraZeneca Plc has reached an agreement to transfer a candidate product for multiple system atrophy to Biohaven Pharmaceutical Holding Company Ltd of the US for further clinical development and commercialisation. The product, AZD3241, has completed a Phase 2a clinical study.
AstraZeneca Plc has announced that a Phase 3 trial of its proposed antibody treatment for systemic lupus erythematosus (SLE) failed to meet the trial’s primary endpoint of showing a statistically-significant reduction in disease activity as measured at 12 months by a responder index. Called TULIP 1, the trial was a double-blinded, 52-week placebo-controlled study evaluating the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.
Pfizer has stopped two clinical studies that were evaluating a proposed antibody treatment for Duchenne muscular dystrophy (DMD) because of lack of efficacy. The first study was a Phase 2 trial testing the treatment for safety and efficacy, while the second was an open-label extension study, the company announced on 30 August.
The glucagon-like peptide-1 (GLP-1) analogue semaglutide has demonstrated an ability to promote weight loss in people without diabetes, in some cases up to 13.8%, when combined with diet and exercise. The data comes from a Phase 2 trial comparing semaglutide with liraglutide, another GLP-1 analogue, and with placebo.
Roche’s Genentech has committed funding of $96 million to Affimed NV for rights to the German company’s biologics platform for the production of cancer therapies targeting natural killer (NK) cells in the innate immune system. The platform can generate antibodies directed against NK cells as well as against T cells of the adaptive immune system.
Novartis has reported positive Phase 3 data from a trial investigating a new treatment for breast cancer targeting a protein in the PI3K pathway, a signalling pathway for human cancers. The compound, BYL719 (alpelisib), showed an improvement in progression-free survival.
AstraZeneca Plc’s treatment for chronic obstructive pulmonary disease (COPD), Bevespi Aerosphere, has shown non-inferiority but not superiority, on one respiratory measure in a Phase 3b trial in which it was compared with a similar treatment from GlaxoSmithKline Plc.
On a second respiratory measure, it failed to show non-inferiority.