A gene therapy for a rare, genetic eye disorder has been selected by the US Food and Drug Administration for its Regenerative Medicine Advanced Therapy Designation in recognition of the product’s potential to treat an unmet medical need.
The European Medicines Agency is restricting the use of two checkpoint inhibitor drugs as first-line treatments for urothelial cancer, or cancer of the bladder and urinary tract, because they may not work as well as chemotherapy in this group of patients. The drugs are Keytruda (pembrolizumab), the programmed cell death 1 (PD-1) inhibitor, and Tecentriq (atezolizumab), which inhibits the protein programmed cell death-ligand 1 (PD-L1). Both drugs are monoclonal antibodies that block a protective mechanism of cancer cells, allowing the immune system to destroy these cells.
The US Food and Drug Administration has approved the marketing of an artificial intelligence algorithm which is part of a diagnostic intended to help physicians detect wrist fractures. Called OsteoDetect, the product is a computer-aided detection and diagnostic software package that uses an artificial intelligence algorithm to analyse two-dimensional X-ray images for signs of distal radius fracture, a common type of wrist fracture. The software marks the location of the fracture on the image to assist the healthcare provider with detection and diagnosis.
Two Phase 3 trials of the candidate Alzheimer’s drug lanabecestat have been stopped for futility, Eli Lilly and Company and AstraZeneca Plc announced on 12 June. Lanabecestat is an inhibitor of the beta secretase cleaving enzyme (BACE), which plays a role in the production of the amyloid beta protein. The accumulation of this protein in the brain is believed to be a major cause of Alzheimer’s disease.
A short 18 months after its launch as a new company, Microbiotica Ltd has entered into a multi-year collaboration with Genentech, a member of the Roche group, to discover, develop and commercialise biomarkers, targets and medicines for inflammatory bowel disease (IBD). Microbiotica was spun out of the Wellcome Trust Sanger Institute in 2016 to research the human microbiome, a term used to describe the genomes of microorganisms in the gut, including at least 1,000 species of bacteria.
Hookipa Biotech AG has signed a licencing deal with Gilead Sciences Inc giving the US company exclusive rights to its technology platform to develop vaccines targeting the hepatitis B and the human immunodeficiency viruses. The agreement brings Austria-based Hookipa into a closer alliance with Gilead which invested an undisclosed amount of money in Hookipa’s €50 million Series C investment round in December 2017.
The European Medicines Agency has issued a positive opinion for Aimovig (erenumab), an antibody treatment for migraine prevention, only weeks after it was given approval by the US Food and Drug Administration. Both agencies highlighted the novelty of the drug which is the first preventive treatment for migraine.
It works by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
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.