In an era of ever-increasing change in regulation of medical devices, the 2021 draft regulatory proposal by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) might have seemed like an invitation to regulatory balkanization. However, MHRA said the responses to the draft proposal indicated widespread support for “international collaboration with like-minded regulators,” thus reassuring industry that their developmental devices won’t face an entirely new set of barriers to access to a market of more than 67 million.

The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.

Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a severe gunshot wound to the leg and the other was injured by shrapnel.

While the biopharma industry was widely praised for its fast response to the COVID-19 pandemic, moves are afoot to ensure that the world is better prepared in case another pandemic hits. Moderna Inc. was one of the companies that blazed a trail in the early stages of the pandemic with its revolutionary mRNA vaccine. Now the firm is investing in manufacturing and R&D in the U.K. to make good on a pledge to respond to the next global disease threat within 100 days of its detection.

Biocartis Group NV received CE-marking of its Idylla Gene Fusion lung cancer biomarker test. The automated panel is designed to detect chromosomal translocations that generate fusion genes and cause non-small-lung cancer (NSCLC). Mechelen, Belgium-based diagnostics company Biocartis recently reported results from a study that found the assay enables rapid screening with quicker turnaround and lower tissue requirements compared to standard methods.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches.

Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles.