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Can CorWave Fill Medtronic’s Shoes in the LVAD Market?

Medtronic’s exit from the left ventricular assist device (LVAD) market left a huge void. A small French company wants to fill it. A small French company has some mighty big shoes to fill in the left ventricular assist device (LVAD) market. When Medtronic pulled the plug on its embattled HeartWare ventricular assist device in 2021, the departure created a significant void in the LVAD market and highlighted the urgent need for innovation in the space to improve outcomes for end-stage heart failure patients. Abbott said it had the capacity and supply to effectively support the growing demand for mechanical circulatory support devices with its HeartMate 3 device, but Abbott and other LVAD makers suffer from limitations of using rotary pump technology, according to CorWave CEO Louis de Lillers. Clichy, France-based CorWave is developing an implantable heart pump for advanced heart failure patients that is based on a technology called ...
- Source: drugdu
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- July 15, 2023
Eisai, Biogen’s Leqembi May Face Rollout Hurdles Now, but Experts Still Like the Alzheimer’s Drug

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.The new Leqembi label carries a boxed warning about the risks of brain bleeding and swelling known as amyloid-related imaging abnormalities (ARIA). But two Alzheimer’s opinion leaders suggested the side effect is manageable typically by extensive monitoring in the first six months, Leerink Partners analysts said in a Wednesday note. But the two experts were split on whether they intend to treat patients with the ApoE ε4 genetic trait. The FDA label requires testing for that biomarker before initiating Leqembi to inform the risk of ARIA. While one expert felt comfortable giving Leqembi to APOE4 carriers as long as the patients are informed of the risk, the other ...
- Source: drugdu
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- July 15, 2023
Racial Discrimination Increases Risk for Childhood Obesity

Children who experience racial discrimination are more likely to later have a higher body mass index (BMI) and larger waistline, according to a new study published in JAMA Network Open. The findings illustrate that racial discrimination may be a risk factor for young people developing obesity—above and beyond other socioeconomic factors such as family income. “Exposure to racial discrimination must be acknowledged as both a social determinant of obesity and a significant contributor to obesity disparities among children and adolescents,” said Adolfo Cuevas, assistant professor of social and behavioral sciences at the NYU School of Global Public Health and the study’s lead author. Childhood obesity is a major public health issue in the U.S., affecting nearly one in five children and teens. Black and Hispanic youth experience even higher rates of obesity, which research shows may stem from factors such as poverty, neighborhood access to healthy foods, and single-parent households. ...
- Source: drugdu
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- July 14, 2023
Clinical Trial Set to Change Kidney Transplant Practice

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25%. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. The research was published in The Lancet. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood—instead of the usual practice of using normal saline (sodium chloride and water). “Of those study participants who received intravenous Plasma-Lyte 148, 30% needed dialysis after their transplants, compared to 40% for those given normal saline,” Professor Johnson said. “This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal Adelaide Hospital Nephrologist ...
- Source: drugdu
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- July 14, 2023
NVIDIA Doubles Down on AI Drug Discovery with $50M Recursion Investment

Clinical-stage biotech Recursion continues to go from strength to strength. After its recent acquisition of Cyclica and Valence, the company announced a partnership with—and $50 million investment from—NVIDIA on Wednesday. Under the agreement, the tech giant is giving Recursion a $50 million private investment in public equity. The two companies are looking to accelerate the development of Recursion’s AI foundation models to help the biopharma industry create improved patient therapies more quickly. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space,” Recursion CEO Chris Gibson said in a statement. Recursion has built a massive biological and chemical database via its Recursion OS, which exceeds 23 petabytes and has three trillion searchable compound and gene relationships. The company has been training machine-learning algorithms on this dataset to tackle the complex ...
- Source: drugdu
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- July 14, 2023
Takeda Withdraws Dengue Vaccine Application After FDA Request for More Data

Takeda has voluntarily withdrawn the Biologics License Application for its dengue vaccine candidate TAK-003 following discussions with the FDA regarding additional data collection, the Japanese pharma company announced Tuesday. According to Takeda, it will not be able to address the regulator’s concerns within the current BLA review cycle. The company is currently assessing its future options and plans for TAK-003, as well as evaluating the requirements for a potential BLA resubmission in the U.S., a spokesperson told Fierce Pharma. The FDA accepted Takeda’s BLA for TAK-003 in November 2022 and put the application under Priority Review, which typically results in a decision within six months versus the standard 10-month review period. “We will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.,” Gary Dubin, president of Takeda’s vaccines business unit, said in a statement. TAK-003 is a tetravalent live-attenuated vaccine ...
- Source: drugdu
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- July 14, 2023
BeiGene Signs $1.3bn Deal with DualityBio for Investigational Solid Tumour ADC

BeiGene has acquired an exclusive option for a global licence to one of DualityBio’s investigational, preclinical antibody-drug conjugates (ADC) for solid tumours. Though few details of the agreement were disclosed, it has been confirmed that DualityBio will receive undisclosed upfront payments from BeiGene and will be eligible to receive certain development, regulatory, and commercial milestone payments totalling up to $1.3bn. ADCs are a class of cancer therapies that combine the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. BeiGene’s global head of research and development, Lai Wang, said: “Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our ...
- Source: drugdu
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- July 14, 2023
EMA Concern Stirs over Suicide Risk with Weight Loss GLP-1RA Drugs

The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm. The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes. The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts. Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide. GLP-1RAs are a rapidly growing ...
- Source: drugdu
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- July 14, 2023
FDA Clears More Chemotherapy Imports from China’s Qilu Amid Shortage of Key Cancer Meds

As a shortage of key chemotherapy drugs continues to upend cancer treatment across the country, the FDA has resorted to securing some of the meds from China.After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Canada’s Apotex will distribute the drugs, which are expected to arrive this week, a company spokesperson told Fierce Pharma. Apotex is “very pleased” to aid in addressing the shortage, the spokesperson added. Cisplatin, along with fellow platinum-based chemotherapy carboplatin, are commonly used as a standard of care across many types of cancer. The newest import was first reported by Bloomberg. After the FDA flagged quality issues at a facility that produced the drug, a “ripple effect” ensued across the supply chain, the FDA’s Oncology Center of Excellence chief Richard Pazdur, M.D., told The Cancer ...
- Source: drugdu
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- July 14, 2023
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
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- July 14, 2023

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