The U.K. Medicines and Health Care Products Regulatory Agency provided an update of its guidance for clinical investigations for medical devices and is offering a temporary waiver of the fees for registration of clinical studies to small manufacturers.

Newco Tecregen AG has raised CHF10 million (US$12.5 million) to advance a novel way of regenerating the thymus in order to boost T-cell production and stimulate recovery of the immune system following stem cell transplants and chemo- and radiotherapy.

Newco Tecregen AG has raised CHF10 million (US$12.5 million) to advance a novel way of regenerating the thymus in order to boost T-cell production and stimulate recovery of the immune system following stem cell transplants and chemo- and radiotherapy.

Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available.

There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.

It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.

As widely expected, GSK plc and Ionis Pharmaceuticals Inc. reported positive findings from two pivotal trials testing bepirovirsen in chronic hepatitis B, showing the antisense oligonucleotide therapy achieved a statistically and clinically meaningful functional cure rate, indicating a potential transition in CHB treatment beyond the current viral suppression-focused standard of care.

Amgen Inc. has swooped on two European cancer specialists, buying Dark Blue Therapeutics Ltd. for up to $840 million plus royalties, and sealing a $618 million license agreement with Disco Pharmaceuticals GmbH for rights to a novel cancer cell surface target.

Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.