News

The US Food and Drug Administration has approved Lumoxiti (moxetumomab pasudotox-tdfk), a new drug developed by AstraZeneca Plc for the treatment of refractory hairy cell leukaemia (HCL), a rare, slow-growing cancer of the blood.

Sanofi SA has continued its ongoing reorganisation under Chief Executive Olivier Brandicourt with a reconfiguration of two of its global business units. The current units include products for diabetes, cardiovascular disease and other legacy products. They will be altered to reflect the company’s geographical priorities.

A new primary care business unit will combine the product portfolios of Sanofi’s current diabetes, cardiovascular and mature products divisions to focus exclusively on mature markets.

Boehringer Ingelheim GmbH has exercised an option to acquire Austria-based ViraTherapeutics GmbH which is developing oncolytic virus vaccines to treat cancer. The transaction has been valued at €210 million.

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.

Two US institutions have taken steps to simplify the regulation of gene therapy, and bring the oversight of these technologies into the existing framework for monitoring experimental medicines. The shift in policy is described by Francis Collins, director of the National Institutes of Health, and Scott Gottlieb, commissioner of the Food and Drug Administration, in an article in the New England Journal of Medicine on 15 August 2018.

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.