Regulation & Policy

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.

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.

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.

The US Food and Drug Administration has requested permanent injunctions against stem cell clinics in two regions of the country to prevent them from administering unapproved stem cell treatments to patients with cancer and other diseases. The move comes nearly 10 months after it issued warning letters to the clinics.

Novartis has received a new cancer indication for its chimeric antigen receptor T (CAR-T) cell therapy Kymriah (tisagenlecleucel) enabling the gene therapy to be administered to a broader group of patients. The new indication is for large B cell lymphoma, including diffuse large B cell lymphoma (DLBCL).

Subject to approval from US regulators, Bayer AG hopes to conclude its $66 billion takeover of Monsanto Co in the second quarter. The transaction would be the third merger of its kind in just under 12 months, illustrating the global consolidation of the agrochemical and seed businesses. This is being enabled by biotechnology, which makes it possible for crops to be engineered to resist insects, and digital technology which gives farmers new tools for managing their fields.

If everything goes according to plan, member states of the European Union will in future use a common methodology to decide whether a new medicine or medical device is clinically effective, relative to certain benchmarks, and therefore be considered for reimbursement. This is the scenario envisioned by the European Commission under a proposed Regulation on Health Technology Assessment, which was unveiled earlier this year.

With new evidence showing that the biological changes associated with Alzheimer’s disease start earlier than expected, the European Medicines Agency has revised its guideline for companies developing drugs for the disease.