With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
Dariohealth Corp. agreed to acquire Psyinnovations Inc. (dba Wayforward), a behavioral health digital platform, for $30 million. The deal represents Dario's second of 2021, following the acquisition of the digital musculoskeletal company Upright Technologies Ltd. in January. The Wayforward transaction calls for $25 million at closing, with $6 million of that in cash and $19 million in shares of Dario common stock valued at $21.09 per share. In addition, Wayforward will receive another $5 million, if behavioral health revenues exceed a certain threshold in 2022.
Restoring blood flow to limbs is a challenging goal, given the minuteness of the peripheral vasculature. But there is a huge unmet need for patients with chronic limb-threatening ischemia (CLTI) – a severe form of peripheral artery disease in which patients face major amputation. Now, Limflow SA reports one-year data from the PROMISE I study shows its Percutaneous Deep Vein Arterialization System (pDVA) led to sustained amputation-free survival and wound healing in CLTI patients treated with the device.
The FDA’s November 2019 two-day hearing regarding the use of metals in medical devices generated at least one actionable recommendation, namely that manufacturers disclose all materials used in devices in product labels. The agency has reacted to that recommendation in the form of a discussion paper that proposes to require that product labels provide a deep level of detail regarding the materials found in the device, a notion that received the backing of industry during the November 2019 hearing.
PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.
Collectively, lysosomal storage disorders (LSDs) are caused by malfunctions in metabolic enzymes in the lysosome system. Depending on which enzyme is missing, toxic metabolites accumulate. While the LSDs are highly heterogenous – even within one disease, presentation can vary widely – neurodegeneration is a common feature in these disorders.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anthem, Clinical Enterprise, Diversa, Edwards Lifesciences, Eurofins, Grupo Suprimed, Humacyte, Indica Labs, Inspire MD, Inspire Medical Systems, Mdxhealth, Neovasc, Novacyt, Sanuwave, Viracor.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Ito.
RSS
