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J&J Megadyne Unit’s Electrode Pad Recall Labeled Class I over Burn Risk

Dive Brief Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries, the agency said in a Tuesday notice. Megadyne contacted customers last month after receiving reports of burns linked to its reusable electrode pads. The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths. The Class I recall covers 21,200 MEGA 2000 and MEGA Soft reusable electrodes sold in the U.S. In an emailed statement, a spokesperson for J&J wrote that the notification was not a product removal, and Mega Soft pads may continue to be used. Dive Insight Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment that makes tools used in electrosurgery, procedures that involve the use of electric current to heat or cut tissue or to stop bleeding. The ...
- Source: drugdu
- 134
- July 14, 2023
New Talking Therapy Shows Promise in Treating Depression

A new talking therapy for depression has shown encouraging early signs of being more effective and cheaper to deliver than the current best practice of Cognitive Behavioural Therapy (CBT). A pilot trial from the University of Exeter, funded by the National Institute of Health and Care Research (NIHR) and published in Lancet EClinical Medicine, has found Augmented Depression Therapy (ADepT) could be a significant advance in depression care. A core feature of depression is anhedonia (reduced interest or pleasure) and wellbeing deficits, but current depression psychotherapies like CBT fail to adequately target these components. ADepT has been developed to pay just as much attention to building wellbeing as it does reducing depressive symptoms. Professor of Clinical Psychology, Barney Dunn, from the University of Exeter led the trial and said: “Depression is widespread and a significant contributor to global disability, resulting in extensive social and economic costs. Only ...
- Source: drugdu
- 124
- July 14, 2023
Anti-inflammatory Drugs Do Not Lead to a Swifter Hospital Exit

Anti-inflammatory drugs may reduce deaths due to Covid-19, but they do not help speed up the recovery for those in hospital, according to a recent study. Results from s study, published in The Journal of the American Medical Association, demonstrated that giving abatacept, cenicriviroc, or Johnson and Johnson’s Remicade (infliximab) in addition to standard of care did not decrease time to recovery for patients hospitalised with Covid-19 pneumonia. The standard of care included in this study involved Gilead Sciences’ Veklury (remdesivir) and the corticosteroid dexamethasone. Patients who took either one of the three drugs recovered after a similar number of days compared to those who were on placebo. The investigators also measured mortality across the sub-studies by day 28 – which did show slight differences, though not statistically significant. Abatacept and Remicade led to a narrow decrease in patient deaths – a 4.1% and 4.4% difference respectively, whilst ...
- Source: drugdu
- 137
- July 13, 2023
GSK’s Jemperli Made Available to Endometrial Cancer Patients via UK’s Early Access Scheme

GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year. While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis. The positive scientific opinion from the Medicines and ...
- Source: drugdu
- 118
- July 13, 2023
FDA Rejects Xspray’s Would-Be Rival to Bristol Myers’ Sprycel on Dosing, Manufacturing Concerns

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
- Source: drugdu
- 207
- July 13, 2023
Moderna Mounts 2 New Patent Lawsuits Against mRNA Rivals Pfizer, BioNTech

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech.Seeking damages from Pfizer and BioNTech for alleged infringement, Moderna has lodged new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, European intellectual property outlet Juve Patent reported Tuesday. The Irish court, where Moderna is claiming infringement by Pfizer-BioNTech on a pair of Spikevax patents, is set to hear the case in early 2024, according to the publication. Less is known about the status of Moderna’s Belgian lawsuit, Juve points out. A spokesperson for Moderna didn’t immediately respond to a request for comment. The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus ...
- Source: drugdu
- 131
- July 13, 2023
UAE, Saudi Arabia Serve as Gateway to International Markets for Biopharma

Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
- Source: drugdu
- 151
- July 13, 2023
EMA Flags Potential Suicide Risk Tied to Novo’s Ozempic, Saxenda

The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide. The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide). A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda. The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN. This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as ...
- Source: drugdu
- 138
- July 13, 2023
Bruker Launches Portable MOBILE-IR II Spectrometer to Bring Laboratory-Grade FT-IR Analysis to the Field

Bruker Optics announces the launch of the MOBILE-IR II – a portable, battery-powered Fourier Transform Infrared (FT-IR) spectrometer that delivers the high spectral performance of a laboratory benchtop system. This powerful mobile spectrometer will enable users worldwide to bring routine and advanced FT-IR applications to the field. The MOBILE-IR II is intended to “mobilize” established use-cases of FT-IR spectroscopy, and also to enable new applications that demand mobility, flexibility, and spectral performance. Key application examples include the identification of illegal substances during police or border control operations, the characterization of recycled goods for sorting, the use in warehouses for mobile incoming goods inspection, or in mobile laboratories for the exploration of natural resources. Its IP65-class protection makes the MOBILE-IR II waterproof, dustproof and stable for field applications. A built-in battery powers the device during off-grid operations and safeguards it against power blackouts. The additional IP67 carry-case makes it ...
- Source: drugdu
- 138
- July 13, 2023
Medtronic Secures Medicare Coverage for MiniMed 780G Insulin Pump

Dive Brief Medtronic has received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump. The company said on Thursday that it has begun processing orders and will start shipping devices to patients with Type 1 diabetes who meet the eligibility criteria over “the next few weeks.” The coverage clears a barrier to patient access for a pump that is central to Medtronic’s plans to kickstart growth at its diabetes business after a tough period defined by regulatory problems. Dive Insight The U.S. Food and Drug Administration approved the 780G pump in April. Medtronic had aimed to bring the device to the U.S. market sooner, but its plans were delayed by a warning letter, hindering its ability to compete with Insulet and Tandem Diabetes Care in the insulin pump market. With the device now approved for use, Medtronic is working to ensure patients ...
- Source: drugdu
- 142
- July 13, 2023

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