AstraZeneca Plc’s biologic drug for respiratory disease, Fasenra (benralizumab), has failed a second Phase 3 trial in patients with chronic obstructive pulmonary disease (COPD). As a result, the company said it will not to make a regulatory submission for this indication.
The US Food and Drug Administration has approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose irises are completely missing or damaged due to aniridia, a congenital condition, or other damage to the eye.
The device, CustomFlex Artificial Iris, is made of thin, foldable medical-trade silicone and is custom-sized and coloured for each individual patient. It is implanted by a surgeon and held in place by the anatomical structures of the eye or, if necessary, by sutures.
With the introduction on 25 May of data protection regulations for companies inside the European Community and the outside companies that trade with Europe, a new entity called the European Data Protection Board (EDPB) began operations by holding a press conference in Brussels.
The data protection board consists of heads of national data protection agencies and has powers that are independent of the European Commission as it was created by an act of the European Parliament.
AstraZeneca Plc announced on 7 May that it will divest its legacy neuroscience product Seroquel by way of a sale to Luye Pharma Group Ltd, a Chinese investment holding company. The sale is part of AstraZeneca’s strategy of lightening up its portfolio to focus on three core therapy areas.
The core areas are oncology; treatments for cardiovascular, renal and metabolic diseases; and treatments for respiratory diseases. Seroquel was first approved by the US Food and Drug Administration in 2007; it started losing its patent protection in 2012.
An early clinical study of the monoclonal antibody daratumumab (Darzalex) in combination with the checkpoint inhibitor atezolizumab in patients with non-small cell lung cancer has been stopped early because of lack of efficacy as well as safety issues, Genmab A/S announced on 26 May.
Germany’s Medigene AG has raised €32.3 million in an oversubscribed private placement enabling it to expanded its ongoing clinical programme of prospective products for cancer using T cell receptor modified T cells.
The company issued 2.2 million new shares from its authorised capital on 24 May, representing approximately 10% of its outstanding share capital. The financing will increase the total number of registered shares of the company to 24,544,595.
A joint venture between Vifor Pharma Group and Fresenius Medical Care has entered into a licencing agreement with Cara Therapeutics Inc of the US to develop and commercialise a drug for treating severe itching associated with chronic kidney disease.
The drug, CR845 (difelikefalin), is a peripherally acting kappa opioid receptor agonist in development for the treatment of pruritus and pain.
Responding to renewed interest in cancer vaccines, Merck & Co Inc and Moderna Therapeutics Inc have expanded a 2016 collaboration to develop and commercialise novel personalised messenger RNA (mRNA) vaccines.
Avacta Group Plc of the UK has shown that it is possible to produce a therapeutic protein in mice by delivering DNA directly into the animal’s muscle tissue. Results of the preclinical proof-of-concept study were reported on 22 May.
A 2016 drug discovery alliance between Germany’s Medigene AG and bluebird bio Inc of the US has been expanded to raise the number of candidate compounds to be developed to six from four. The products are T cell receptor-modified T cell immunotherapies for the treatment of cancer.