Search Results for “EC” – Page 376 – media

Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

“This is a preliminary ruling in the case and Medtronic is confident that the full body of evidence, as the case moves ahead, will demonstrate that the claims have no merit. “Each patient seen at the Robert J. Dole VA Medical Center for a Peripheral Arterial Disease interventional procedure was referred by other doctors because of the patient’s medical condition. Moreover, the physicians performing these procedures used FDA-approved devices from a variety of manufacturers and the physicians were salaried and received no additional compensation for the procedures or using the devices. “Medtronic follows all applicable laws and policies to ensure our interactions with physicians are principled and appropriate.” Dive Brief Medtronic’s attempt to dismiss whistleblower accusations that it violated the False Claims Act has largely failed, with a court ruling on Thursday that most of the claims can advance. The whistleblower accused Medtronic of billing the government for unnecessary medical ...
- Source: drugdu
- 231
- August 17, 2023
Multimillion-dollar NIH grant awarded to develop advanced treatment for diabetic foot ulcers

A team of researchers from the Terasaki Institute for Biomedical Innovation (TIBI) and the University of Nebraska Medical Center (UNMC) has been awarded a multimillion-dollar grant from the National Institutes of Health to develop a superior, multi-pronged wound treatment for diabetic foot ulcers (DFUs). DFUs remain a significant complication resulting from dysregulated internal pathophysiological conditions in diabetic patients. The unresolved diabetic wounds affect patients’ quality of life and can result in amputations or death. More than 6.5 million individuals suffer from diabetic wounds worldwide. Therefore, efforts toward improving current treatment modalities via an innovative approach may promote rapid healing and increased quality of life in patients. Treatment options include growth factors, anti-bacterial agents, protease inhibitors, and anti-inflammatories. Unfortunately, currently available dressings with tiny pores limit granulation tissue formation, prevent cell migration, increase infection rates, and promote scar formation. Johnson V. John, Ph.D., TIBI scientist and principal investigator, said, “The microarchitecture ...
- Source: drugdu
- 119
- August 17, 2023
Researchers publish early results with new interleukin-targeting antibody

An academic group has published preclinical results with a new antibody that has greater activity and fewer side effects than existing biological therapies for inflammatory conditions. This could translate into a clinical benefit for patients living with rheumatoid arthritis (RA), psoriasis, or inflammatory bowel disease (IBD). Researchers from the University of Birmingham in the UK and the University of Naples Federico II in Italy revealed promising results after designing an antibody that targets a 20-long amino acid sequence in interleukin-17 (IL-17) – a protein important in inflammatory pathways. According to the team, they demonstrated for the first time that this sequence activates the release of cyto-chemokines. The antibody, which has been called Ab-IPL-IL-17, targets this sequence in both IL-17A and IL-17F. In cell studies, it demonstrated an ability to reduce the production of cyto-chemokines and white blood cell migration to inflammation-primed tissue. When the researchers compared it to existing therapies ...
- Source: drugdu
- 223
- August 17, 2023
UK government allocates £250m for more NHS hospital beds in England

The government has announced a fund of £250m to provide another 5,000 NHS England hospital beds this winter, to relieve pressure on hospitals and reduce waiting times. As part of the NHS Urgent and Emergency Care Recovery Plan, over 30 NHS organisations across England will benefit from the investment in urgent and emergency care services. Over 900 new hospital beds, including 60 intermediate care beds, should be ready by January 2024 to increase capacity on hospital wards and A&E to 100,000. The scheme will also improve assessment spaces and cubicles in A&E. Health and social care secretary, Steve Barclay, said: “Creating additional hospital capacity will support staff to provide the best possible care and treat patients more quickly, helping us to improve waiting times and cut waiting lists – one of the government’s top five priorities.” Trusts including Hull Royal Infirmary, James Cook University Hospital and Worthing Hospital will develop ...
- Source: drugdu
- 109
- August 17, 2023
Sandoz says its biosimilar matches Eylea in another threat to Regeneron’s blockbuster

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
- Source: drugdu
- 139
- August 17, 2023
Stada in ‘exploratory talks’ about possible sale, CEO says, but nothing is certain

Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company’s second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company’s investors “have no pressure to sell,” the CEO pointed out. “What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, ...
- Source: drugdu
- 107
- August 17, 2023
Peripheral tumor biomarkers to guide treatment for HPV-associated malignancies

A new review paper was published in Oncotarget’s Volume 14 on August 10, 2023, entitled, “Peripheral surrogates of tumor burden to guide chemotherapeutic and immunotherapeutic strategies for HPV-associated malignancies.” With the rapid adoption of immunotherapy into clinical practice for HPV-associated malignancies, assessing tumor burden using “liquid biopsies” would further our understanding of clinical outcomes mediated by immunotherapy and allow for tailoring of treatment based on real-time tumor dynamics. In their new review, researchers Meghali Goswami, Jeffrey Schlom and Renee N. Donahue from the National Cancer Institute examine translational studies on peripheral surrogates of tumor burden derived from peripheral blood in HPV-associated malignancies, including levels and methylation of circulating tumor DNA (ctDNA), miRNA derived from extracellular vesicles, circulating tumor cells (CTCs), and HPV-specific antibodies and T cell responses. “We review their utility as prognostic and predictive biomarkers of response to chemotherapy and radiation, with a focus on how they may inform ...
- Source: drugdu
- 121
- August 16, 2023
NHS England to offer millions of children flu vaccines from September

The NHS has announced that millions of children in England will be offered a flu vaccine as of September 2023 as part of its “life-saving” vaccination programme to protect the country against deadly viruses ahead of winter. School-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the NHS’s winter flu and COVID-19 vaccination programme to provide protection to those eligible from developing serious illnesses and minimise hospitalisations during the winter months. Professor Sir Stephen Powis, NHS England medical director, said: “Vaccinations are our best defence against flu and COVID-19 ahead of what could be a very challenging winter.” By prioritising flu vaccinations for children, the NHS aims to “break the chain of transmission” to the wider population. Earlier this month, ...
- Source: drugdu
- 206
- August 16, 2023
Novartis acquires Chinook for $3.2bn to boost kidney disease pipeline

Novartis has acquired Chinook Therapeutics for more than $3.2bn in a move to bolster its portfolio of drugs targeting kidney disease. With reported sales of $13.62bn in Q2 2023, Novartis is looking to expand its drug portfolio. Just last month, the company acquired DTx Pharma for $1bn for its small interfering RNA (siRNA) treatment portfolio for rare diseases. As part of Chinook’s acquisition, its shareholders would receive $40 per share, totalling $3.2bn. The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. The acquisition comes at a significant inflection point with two high-profile drugs, atrasentan and zigakibart, in Phase III development for the treatment of IgA nephropathy (IgAN). A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023. IgAN is a chronic kidney disease, in which immunoglobulin A (IgA) is trapped in the glomeruli of the ...
- Source: drugdu
- 109
- August 16, 2023
Arcturus JV scored $115M in Japanese grants to boost mRNA manufacturing

Right after Daiichi Sankyo picked up Japan’s first mRNA vaccine approval, a potential rival has revealed substantial financial backing from the Japanese government. The Japanese government awarded two grants totaling $115 million to Arcalis to support the production of mRNA vaccines and therapeutics. Arcalis is an mRNA-focused CDMO joint venture by Arcturus Therapeutics and Japanese drug discovery service provider Axcelead. The money was granted in December 2021 and October 2022 to support the construction of Arcalis’ vaccine factory in the Japanese city of Minamisoma and to support the manufacturing of mRNA drug substance and final drug product, respectively, an Arcturus spokesperson told Fierce Pharma. Arcalis completed construction of the drug substance part of the plant at the end of July. The facility occupies an area of 1,933 square meters (nearly half an acre) and boasts total floor space of 7,252 square meters (more than 78,000 square feet). The company plans ...
- Source: drugdu
- 226
- August 16, 2023

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