Dive Brief Boston Scientific on Thursday received approval from the Food and Drug Administration for a new heart ablation device to treat atrial fibrillation, according to a company announcement. The POLARx Cryoablation System can accommodate two balloon sizes in one catheter, which Boston Scientific said allows physicians to tailor care to individual patients. The device has been selling well in Europe and Japan, where it is cleared for use, CEO Mike Mahoney said in an earnings call last month. Boston Scientific has been competing with companies like Johnson & Johnson and Medtronic, which are also bringing new cardiac ablation devices to market. Dive Insight Cryoablation is a minimally invasive procedure that uses a balloon catheter to freeze tissue near the pulmonary vein. Scars then block irregular electric signals that can cause atrial fibrillation. Switching between two balloon sizes, clinicians can adjust the device to a patient’s anatomy during a procedure, ...
Patients often experience functional decline after an ischemic stroke, especially due to the brain’s resistance to regenerate after damage. Yet, there is still potential for recovery as surviving neurons can activate repair mechanisms to limit and even reverse the damage caused by the stroke. How is it triggered though? In a study published recently in Neuron, researchers from Tokyo Medical and Dental University (TMDU) provided new insights regarding this question by identifying a new mechanism. They discovered that neurons surrounding the area of cell death secrete lipids that can trigger brain-autonomous neural repair after ischemic brain injury. An ischemic stroke occurs when the blood supply to the brain is blocked and results in the death of brain cells. This condition is life-threatening, and patients will likely develop functional disabilities. Although the adult brain can self-repair, the underlying mechanisms need further clarification. Inflammation of the brain contributes to the effects of ...
By Tristan Manalac Pictured: Illumina signage at California office/iStock, Georgejason During its second-quarter earnings report on Wednesday, Illumina lowered its financial outlook for fiscal year 2023 and is now only expecting revenue growth of 1% compared to the previous forecast of 7% to 10%. The news comes as the DNA sequencing company grapples with an activist investor, leadership shake-ups and strong antitrust pushback over its acquisition deal with GRAIL. In the second quarter, Illumina generated $1.18 billion in revenue, representing a modest but nevertheless positive 1% increase from its earnings during the same period last year. Without taking exchange rates into consideration, Illumina’s revenue grew 3%. Illumina also reported financial results for GRAIL, which it moved to buy for $8 billion in September 2020. The cancer detection company made $22 million in the second quarter, up from $12 million during the same timeframe last year. Despite better revenues, Illumina is ...
BioNTech and Duality Biologics have expanded their existing agreement to include a third antibody-drug conjugate (ADC) for solid tumours. The companies announced the first deal covering two ADCs in April this year. Under the terms of the agreement, DualityBio would receive upfront payments totalling $170m and be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn. ADCs are a class of potent cancer therapies combining 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. Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said at the time of the first announcement: “Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as ...
AstraZeneca is often at the forefront when it comes to sustainability efforts among pharma companies. Now, the British drugmaker is doubling down on its clean energy commitments in Sweden. AstraZeneca and Stratkraft—Europe’s largest renewable energy producer—have entered into an agreement on wind power deliveries that will increase the supply of renewable electricity in Sweden based on the commissioning of new wind farms, the companies said Wednesday. Under the deal, AZ will purchase 200 gigawatt-hours per year for 10 years, the partners explained. That amount corresponds to roughly 80% of the company’s total electricity needs at its research facility in Gothenburg and its manufacturing plant in Södertälje. The wind farms for this project will be located in Strömstad and Årjäng, in the same region as AZ’s research and manufacturing facilities. Across its Swedish operations, AstraZeneca is also working to cut back on its electricity consumption. One way it’s meeting this goal ...
By Tristan Manalac Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies. SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT. Novo was trading approximately 11% higher in pre-market Tuesday following the data drop. The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk ...
Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug.Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. But PPD represents just a fraction of the total market Biogen and Sage were hoping to tap into. Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps. The dual approval and rejection was “more disappointing than good,” according to analysts ...
A new editorial paper was published in Oncoscience (Volume 10) on June 28, 2023, entitled, “Adenoid cystic carcinoma of the head and neck – treatment strategies of a highly malignant tumor with variable localizations.” In this new editorial, researchers Florian Dudde, Kai-Olaf Henkel and Filip Barbarewicz from the Army Hospital Hamburg discuss head and neck tumors, which are among the most common malignancies. In this anatomical region, squamous cell carcinoma (SCC) is the most common malignant entity. However, there are also other malignant tumors that, unlike SCC, originate in the salivary glands of the head and neck region, such as mucoepidermoid carcinoma or adenoid cystic carcinoma (ACC). In general, tumors originating from the minor salivary glands often show a higher degree of malignancy than tumors of the major salivary glands (parotid gland, submandibular gland, sublingual gland). Consequently, the ACC in particular is often localized in the area of the hard ...
Function and form are deeply intertwined in biology. Knowing how organisms grow, adapt and reproduce requires understanding their physical structures. Hence the transformative power of the microscope across the past four centuries of science. Microscopy, or the field of microscope use, can now reveal the tiniest of structures through techniques such as microcrystal electron diffraction, or MicroED. Instead of passing light through a cell like an optical microscope, MicroED bombards crystalline samples with a stream of electrons to produce detailed information about their atomic configuration. Brent Nannenga (Associate Professor, Chemical Engineering, Arizona State University) said, “The method was developed to reveal or ‘solve’ the structure of proteins. Then researchers started applying it to compounds for pharmaceuticals and small organic molecules. However, it had not been demonstrated for nucleic acids, and the scientific community was asking whether it would work for DNA.” Nannenga and colleagues just answered that question. A research ...
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