Pfizer’s oral HER2 inhibitor Tukysa looks poised to find a new role as first-line maintenance therapy for HER2-positive metastatic breast cancer, based on now-revealed data from the HER2CLIMB-05 study. The results, presented at the SABCS conference, show that the combination of Tukysa (tucatinib), trastuzumab, and pertuzumab reduced the risk of disease progression or death by…
Telehealth company Hims & Hers has launched its direct-to-consumer weight-loss therapy channel in the UK, offering GLP-1 agonists like Novo Nordisk’s Wegovy at a starting price of £149 per month. The move also marks the launch in the UK of the Hers part of the Hims & Hers business, which until now has focused mainly…
After pushing for restrictions on vaccines for COVID-19 and hepatitis B, the Trump administration seems to be turning its attention to recently approved shots that protect infants against respiratory syncytial virus (RSV). According to a Reuters report, the FDA has launched an investigation into the safety of antibody-based preventative medicines – Sanofi/AstraZeneca’s Beyfortus (nirsevimab) and…
Fondazione Telethon ETS’ Waskyra has become the first gene therapy in the US for patients with Wiskott-Aldrich syndrome (WAS), a rare and life-threatening inherited disease. The Italian non-profit company’s cell-based gene therapy has been cleared by the FDA for use in patients with WAS who are aged six months and older, are healthy enough to…
The UK government has confirmed that the rebate rate for newer medicines supplied to the NHS under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) will be 14.5% next year, following the recent announcement of the UK-US pharma trade agreement. That is a big reduction on the record 22.5% due from pharma manufacturers…
The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to market more quickly and easily. In line with its deregulatory stance under new Commissioner Marty Makary, the US regulator has launched TEMPO – Technology-Enabled Meaningful Patient Outcomes – that will take the…
Shares in Praxis Medicines rose more than 28% today after the company said it was halting a trial of its experimental therapy for rare childhood epilepsies early and preparing to file for approval. The EMBOLD study of relutrigine (also known as PRAX-562) was testing the oral drug in patients with SCN2A and SCN8A developmental and…
Bristol Myers Squibb has taken CAR-T therapy of blood cancers into new territory, after getting FDA approval for Breyanzi as a treatment for relapsed or refractory marginal zone lymphoma (MZL). CD19-targeted therapy Breyanzi (lisocabtagene maraleucel) can now be used to treat adults with MZL – a rare and form of non-Hodgkin lymphoma (NHL) – who…
A court in Munich has granted a preliminary injunction that will prevent MSD from distributing the subcutaneous version of its cancer immunotherapy Keytruda in the German market. The verdict is the latest twist in patent litigation between MSD and Halozyme, in which the latter is claiming that Keytruda SC (pembrolizumab and berahyaluronidase alfa) – which…
Seven digital health technologies (DHTs) that can be used to support people recovering from cardiovascular diseases have been recommended for use by the NHS in England and Wales. In final draft guidance (PDF), reimbursement authority NICE has backed the use of the DHTs for an initial three-year period, during which evidence on their long-term effectiveness…