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Type 2 diabetes patients who were physically active in the afternoon have greater reductions in blood sugar

Over 37 million Americans have diabetes, and 90-95% of that population are diagnosed with type 2 diabetes. Lifestyle interventions, such as a healthy diet and a regular physical activity program, are methods to manage diabetes. A new study from a collaboration of investigators at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, and Joslin Diabetes Center, part of Beth Israel Lahey Health, uses data from the Look AHEAD (Action for Health in Diabetes) study, a randomized controlled trial that compared an intensive lifestyle intervention with diabetes support and education in patients diagnosed with type 2 diabetes and overweight or obesity to track the development of cardiovascular disease over time. In the current study, the research team assessed whether physical activity at certain times of day was associated with greater improvement in blood glucose control. Their findings suggest patients with type 2 diabetes who were ...
- Source: drugdu
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- May 30, 2023
Restoring thought-controlled movement after spinal cord injury using a brain-computer interface

ONWARD Medical N.V., the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces a publication in Nature showing that a wireless brain-computer interface (BCI) can use thought to modulate ARC Therapy. Researchers reported that when paired with ARC Therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs. Dave Marver (CEO of ONWARD) said, “This publication shows the remarkable potential of ARC Therapy to be enhanced with the introduction of a BCI, facilitating more natural movement based on the thoughts of a person living with paralysis. We have positioned ONWARD as a leader in the BCI field with our unique understanding of spinal cord stimulation for people with SCI.” As a neuroscientist and professor, EPFL, and Co-author of the Nature Paper, Grégoire Courtine said, “The ...
- Source: drugdu
- 127
- May 30, 2023
Social vulnerability tied to higher assault-related firearm death rates for youth

States with restrictive gun laws have lower rates of assault-related firearm deaths among youths, but youths from socially vulnerable communities are disproportionately impacted across the spectrum of state gun laws, according to a study published online May 24 in JAMA Network Open. Eustina G. Kwon, M.D., M.P.H., from Seattle Children’s Hospital, and colleagues assessed the rate of death due to assault-related firearm injury by community-level social vulnerability and state-level gun laws. The Gun Violence Archive was used to identify all 5,813 assault-related firearm deaths among U.S. youths (aged 10 to 19 years) between Jan. 1, 2020, and June 30, 2022. The researchers found that the death rate in the low social vulnerability index (SVI) cohort was 1.2 per 100,000 person-years versus 2.5 in the moderate SVI cohort, 5.2 in the high SVI cohort, and 13.3 in the very high SVI cohort. Comparing the very high to the low SVI cohort, ...
- Source: drugdu
- 112
- May 30, 2023
European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract

Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
- Source: drugdu
- 118
- May 30, 2023
VarmX raises funds to seek IND approval for VMX-C001

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding. It also enables blood to clot normally in the presence of factor Xa blood clotting inhibitors. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing. The company’s first-in-human study will demonstrate the safety of VMX-C001 and provide clinical proof of concept. Enrolment for this study is completed. Full study results are expected to be announced later this year. Led by Sound Bioventures, the Series B2 financing round has also seen participation from another new investor, the European Innovation Council (EIC) Fund. Existing investors include EQT Life ...
- Source: drugdu
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- May 30, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
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- May 30, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
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- May 30, 2023
Merck’s Keytruda, Novartis’ Kisqali face their moment of truth in early-stage cancers

Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
- Source: drugdu
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- May 30, 2023
Medical row in France over unauthorised COVID trial

French medical bodies on Sunday called on authorities to punish researcher Didier Raoult for “the largest ‘unauthorized’ clinical trial ever seen” into the use of hydroxychloroquine to treat COVID-19. Raoult, the former head of the IHU Mediterranee research hospital, and his subordinates engaged in “systematic prescription of medications as varied as hydroxychloroquine, zinc, ivermectin and azithromycin to patients suffering from COVID-19… without a solid pharmacological basis and lacking any proof of their effectiveness,” a group of 16 research bodies wrote in an op-ed piece on daily Le Monde’s website. The drugs continued to be prescribed “for more than a year after their ineffectiveness had been absolutely demonstrated,” they added. Endorsement from respected tropical disease specialist Raoult helped push anti-malaria drug hydroxychloroquine into the public consciousness in the early days of the coronavirus pandemic, feeding into its promotion by former US President Donald Trump and Brazil’s then-leader Jair Bolosonaro. In April, ...
- Source: drugdu
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- May 30, 2023
FDA approves Lexicon’s heart-failure drug after defeat in diabetes

Nicole DeFeudis Editor The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi. The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday. The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end ...
- Source: drugdu
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- May 30, 2023

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