Search Results for “Clinical Trial” – Page 96 – media

Medivis Snags $20M to Enhance Surgical Navigation With Augmented Reality

Gone are the days when augmented reality’s primary use cases centered on gaming and entertainment. Investors are now betting on the technology’s promise to enhance surgical navigation. This shift is evidenced by Medivis’ recent funding round — the New York City-based medical augmented reality (AR) company raised $20 million in Series A financing on Tuesday. The round, which takes Medivis’ total funding to $25 million, was led by Thrive Capital. Other investors included Mayo Clinic, Initialized Capital, Disney CEO Bob Iger and NBA star Kevin Durant. Medivis was founded in 2016 by neurosurgeon Osamah Choudhry, who serves as CEO, and radiologist Christopher Morley, who serves as president. Their mission has always been to establish AR as the new standard in surgical navigation, Choudhry shared in a recent interview. “Traditionally, surgeons have relied on 2D flat images, requiring them to mentally reconstruct their patient images into a 3D representation. However, with ...
- Source: drugdu
- 113
- June 17, 2023
AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
- Source: drugdu
- 108
- June 17, 2023
Phastar’s DIA 2023 Global Inspire Award for Community Engagement winner to present at this year’s conference

A statistics manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement. Stephen Corson said it was a ‘fantastic bonus’ to be recognized by the DIA community and says it is already privilege enough to share his knowledge. The award recognizes outstanding contribution of DIA Community Chairs who ‘consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the membership community’. He said: “The DIA Community is such a constructive, collaborative space with everyone inspired by their work which can really benefit people. It already feels a privilege to be able to share what knowledge I can bring to the table, so it is a fantastic bonus to be recognized by the DIA community. “Education around data science is crucial to making clinical trial processes more efficient and I get such a buzz from working ...
- Source: drugdu
- 130
- June 17, 2023
AHA Flags CV Risk With Lead, Cadmium, and Arsenic Exposure

Megan Brooks Mounting evidence supports that chronic environmental exposure to low levels of lead, cadmium, and arsenic contribute significantly to cardiovascular disease (CVD), the American Heart Association (AHA) says in a new scientific statement. “In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, told theheart.org | Medscape Cardiology. “For the most part, as cardiologists, we are used to risk factors, we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida. The statement addressing contaminant metals as CV risk factors was published online June 12 in the Journal of the American Heart ...
- Source: drugdu
- 117
- June 16, 2023
Bayer needs ‘midsize acquisition’ to reach $10B oncology sales goal, exec says

Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities. “We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology’s 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.” Roth agreed ...
- Source: drugdu
- 112
- June 15, 2023
GSK Awaits Approval for Myelofibrosis Hopeful

The FDA’s final action date this week is for GSK’s investigational drug, momelotinib, which the company is proposing to treat myelofibrosis patients with anemia. The decision is set to be released by June 16. According to GSK, momelotinib works through a differentiated mechanism of action that involves the inhibition of three signaling pathways: the JAK1 and JAK2 cascades, as well as the activin receptor type I (ACVR1) pathway. By disrupting JAK1 and JAK2 signaling, momelotinib induces improvements in patient constitution and symptoms of splenomegaly. Meanwhile, its ACVR1 activity could decrease levels of hepcidin, which contribute to anemia in myelofibrosis. Data from the pivotal Phase III MOMENTUM trial supported momelotinib’s FDA bid. In December 2022, GSK reported 48-week results from MOMENTUM at the 64th American Society of Hematology (ASH) Annual Meeting. Momelotinib achieved its primary efficacy endpoint of an at-least 50% reduction in Total Symptom Score after 24 weeks. GSK’s myelofibrosis ...
- Source: drugdu
- 103
- June 14, 2023
Eisai, Biogen’s Alzheimer’s disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
- Source: drugdu
- 109
- June 13, 2023
Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
- Source: drugdu
- 118
- June 12, 2023
Sanofi, AstraZeneca’s RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
- Source: drugdu
- 160
- June 10, 2023
Study may help advance data on oncolytic adenovirus mediated double suicide-gene therapy for high-grade brain tumors

Researchers in the Hermelin Brain Tumor Center at Henry Ford Health are leading a Phase I clinical trial studying the maximum tolerated dose of an oncolytic adenovirus, a mutated virus engineered to selectively replicate in and destroy cancer tissue, in combination with fractionated stereotactic radiosurgery among patients who are undergoing resection of a recurrent high-grade astrocytoma brain tumor. Tobias Walbert (M.D., Ph.D., principal investigator of the study and co-director of the Hermelin Brain Tumor Center at Henry Ford Health) said, “The participants in this study have progressive high-grade astrocytoma as well as glioblastoma, and are scheduled to undergo repeat surgery. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose of the injected adenovirus, which is engineered to selectively replicate ...
- Source: drugdu
- 104
- June 10, 2023

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