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InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

By Tristan Manalac InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during a planned dose selection, safety and futility analysis that cobitolimod is “unlikely” to meet the study’s primary endpoint, according to the company’s announcement. At the same time, InDex noted that the committee’s advice to discontinue the study was not due to any safety concerns. InDex CEO Jenny Sundqvist in a statement called the committee’s recommendation “surprising and disappointing,” adding that cobitolimod’s failure in CONCLUDE highlights the “complexity of the disease” and points to the need for more research to address the “high unmet medical need” in ulcerative colitis. The company’s stock was trading approximately 59% lower on Wednesday morning in ...
- Source: drugdu
- 141
- November 24, 2023
Cosmic radiation and microgravity linked to erectile dysfunction in astronauts

During missions into space, astronauts are exposed to high levels of galactic cosmic radiation and weightlessness. Simulation experiments in male rats indicated that these aspects of spaceflight can negatively affect vascular tissues relevant to erectile dysfunction, even after a period of long-term recovery. The research, which is published in The FASEB Journal, indicated that vascular alterations are induced by relatively low doses of galactic cosmic radiation and to a lesser extent simulated weightlessness, primarily through increases in oxidative stress. Treatment with different antioxidants could counter some of these effects. Justin D. La Favor, PhD, corresponding author of Florida State University, said, “With manned missions to outer space planned for the coming years, this work indicates that sexual health should be closely monitored in astronauts upon their return to Earth. While the negative impacts of galactic cosmic radiation were long-lasting, functional improvements induced by acutely targeting the redox and nitric oxide ...
- Source: drugdu
- 99
- November 24, 2023
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes

Dive Brief The Food and Drug Administration voiced concerns in a Monday letter that Cardinal Health failed to sufficiently mitigate the risk of incompatibility between its syringes and certain pumps in its communication to healthcare providers. Cardinal wrote to its customers in September to explain that some lots of Monoject Luer-lock tip syringes are incompatible with certain infusion pumps, leading to a Class I recall notice covering the device correction. The recall affects more than 32 million syringes. Days after posting the Class 1 notice, the FDA revised recommendations for healthcare providers. It said the dimensional changes made to Cardinal Health’s Monoject syringes, when used with syringe pumps or patient-controlled analgesia (PCA) pumps, may result in issues that include overdose, underdose, or delays in therapy or occlusion alarms. Dive Insight On Monday, the FDA moved to clarify the advice for healthcare providers in a notice titled “Do Not Use Cardinal ...
- Source: drugdu
- 100
- November 24, 2023
Investigating Industry Involvement in Modern Clinical Trials

Don Tracy, Associate Editor Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are. In a study published earlier this month by JAMA, the authors aimed to discover how the pharmaceutical industry gets involved in the most influential modern clinical trials and how they fare in terms of transparency. Crediting the major impact of these clinical trials on medical practice, the authors believed that it was important to evaluate the extent of industry involvement and the use of transparency practices in such studies published in the last few years. In order to find a sufficient answer, the study relied on a meta-research assessment consisting of 600 randomized and nonrandomized clinical trials published in 2019 or later. Trials that attracted the highest number of number of citations in Scopus as of December 2022 were selected for analysis, occurring from March to ...
- Source: drugdu
- 108
- November 24, 2023
Another medtech reports a cybersecurity incident

BY JIM HAMMERAND The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations. “Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.” “The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued. LivaNova said it expects continued disruption of its operations, and can’t yet determine “the extent of the impact from such event on its business, results of operations, cash flows or financial condition.” Earlier this year, the SEC launched new ...
- Source: drugdu
- 99
- November 24, 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment

The European Commission (EC) has approved pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer in patients who have responded to first-line platinum-based chemotherapy. The PARP inhibitor, which has been authorised for use in all advanced ovarian cancer patients regardless of their BRCA mutation status, was previously approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage ATHENAMONO trial. Results showed that, as a first-line maintenance treatment, Rubraca significantly improved investigator- assessed progression-free survival compared with placebo in advanced ovarian cancer patients, regardless of BRCA mutation status. The safety profile observed in the ATHENAMONO trial was also consistent with ...
- Source: drugdu
- 102
- November 24, 2023
Merz strengthens its global footprint with botulinum approval in Australian market

With approval granted from the Australian Therapeutic Goods Administration (TGA), Merz Therapeutics’ Xeomin (incobotulinumtoxinA) enters the Australian market as the first and only neurotoxin treatment for chronic sialorrhea or excessive drooling in adults and children. Xeomin, a botulinum toxin type A with accessory proteins, is designed to block the release of neurotransmitter acetylcholine, thereby inhibiting signal transduction and incapacitating the body’s ability to contract voluntary muscles. Sialorrhea is a common symptom associated with Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), stroke, and acquired brain injuries. The TGA approval follows a series of greenlights by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug, which is currently approved for adults and children in the US, was originally granted approval in the EU to treat chronic sialorrhea in adults in 2019. The EMA approval was awarded based on data from the Phase III SIAXI ...
- Source: drugdu
- 94
- November 24, 2023
To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic. Novo and the European Medicines Agency (EMA) divulged (PDF) the move in a letter to healthcare professionals, warning of a growing shortage of both medicines that is set to intensify during the rest of the fourth quarter. With the shortage of Victoza expected to continue into the second quarter of next year, the EMA has instructed healthcare providers not to start new patients on the drug until then. While Victoza (liraglutide) and Ozempic (semaglutide) are both GLP-1 drugs, the former—which was originally approved in 2010—is not used for weight loss. Intermittent shortages of Ozempic are expected to persist throughout 2024, though the overall supply situation should improve in the first quarter of next year, according ...
- Source: drugdu
- 152
- November 24, 2023
Novartis drops subpoena request in trade-secret spat with Takeda

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
- Source: drugdu
- 110
- November 24, 2023
Why 1 Health System Is Embedding Genomics Into Primary Care

When people think of genomics, they typically don’t visualize the primary care setting — but Northshore–Edward Elmhurst Health is trying to change that. Genomics is a key part of the health system’s approach to personalized care delivery, said Kristen Murtos, its chief innovation and transformation officer, in a recent interview. NS-EEH, the third largest health system in Illinois, was created in January 2022 when NorthShore University HealthSystem and Edward-Elmhurst Health completed their merger. “Several years ago, NorthShore leaned heavily into the power of genomics and integrated that as part of primary care practice — unlocking the opportunity to more holistically understand predisposition to certain diseases, to tailor care plans and to be able to give proactive and preventative care versus waiting until disease manifests and just being treated after that,” she explained. At NS-EEH, all patients are offered genetic testing as part of their primary care visit, Murtos pointed out. ...
- Source: drugdu
- 106
- November 23, 2023

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