Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.

Vitalli Bio Inc. terminated a potential $477 million licensing deal for autoimmune disease drug, DWP-213388, signed a year ago with Daewoong Pharmaceutical Co. Ltd., although Vitalli still retains option rights to two more dual inhibitor candidates that could fetch up to $941 million.

President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.

Despite government efforts to prop up biopharma and med-tech research toward creating women’s health products, companies must eventually reach out to the private markets to bring their inventions to the next stage of development. Anna Zornosa-Heymann, a women’s health investor, serves as a part-time contractor with the U.S. NIH’s SEED (Small business Education & Entrepreneurial Development) office, where she helps companies move from government to external funding. Government funds are “excellent to pay for research … but those funds don’t allow you to build a first-class team and to develop a sales apparatus,” she told BioWorld.

Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.

While women make up half the world’s population and own two out of every five businesses, there are substantial knowledge gaps about conditions affecting their health – mostly due to decades of research excluding women from clinical trials and investment decisions.

Sparian Biosciences Inc. has been awarded a $19.5 million, 5-year grant to fund development of SBS-226 from IND submission through phase I development. SBS-226 is a first-in-class dual μ-opioid receptor partial agonist and δ-opioid receptor full antagonist in development for opiate use disorder and opiate withdrawal syndrome.

While women make up half the world’s population and own two out of every five businesses, there are substantial knowledge gaps about conditions affecting their health – mostly due to decades of research excluding women from clinical trials and investment decisions.

PTC Therapeutics Inc.’s accelerated go-ahead from the U.S. FDA for Kebilidi (eladocagene exuparvovec-tneq), a recombinant adeno-associated virus serotype 2-based gene therapy to treat aromatic L-amino acid decarboxylase (AADC) deficiency, came with a priority review voucher (PRV) that the company intends to monetize.

Eko Health Inc. recently won a category III CPT code for its Sensora platform for cardiovascular disease detection. While a “cat III” CPT code hasn’t traditionally excited industry, the company is convinced that payers will respond because of the massive costs associated with cardiovascular disease.