PharmaFocus Today – Page 253 – media

Outclassed by Eliquis, Bayer Halts Atrial Fibrillation Study of Factor XIa Inhibitor

By Tristan Manalac Pictured: Bayer’s office in New Jersey Bayer on Sunday announced it was stopping the Phase III OCEANIC-AF study ahead of schedule due to the disappointing performance of its investigational factor XIa inhibitor asundexian. The decision to end OCEANIC-AF early is in line with the recommendation of an Independent Data Monitoring Committee, which during the ongoing surveillance of the study found that asundexian had “inferior efficacy” versus Bristol Myers Squibb’s and Pfizer’s Eliquis (apixaban). Bayer will take “appropriate measures” to close the study and will work with investigators to determine the next steps for patients. Bayer did not provide specific data from OCEANIC-AF in its news release, but said it will continue to analyze its results and publish the findings. Asundexian is an investigational inhibitor of the blood protein factor XIa, which is a key player in the coagulation cascade. The drug candidate is designed to be orally ...
- Source: drugdu
- 139
- November 22, 2023
What One Medicaid Insurer Looks for From Potential Health Tech Vendors

Digital health companies often start in the commercial market and thereafter target Medicaid plans. But not all startups are suited to serve the Medicaid population, according to Dr. Pooja Mittal, vice president and chief health equity officer at Health Net. That’s why Health Net created a vetting process to understand which companies have the potential to be the most effective with Medicaid members. The California-based insurer offers health plans for individuals, families and businesses and has three million members, including those who qualify for Medi-Cal or Medicare. Mittal noted that when the company started bringing in new vendors about four or five years ago, some were very successful working with its Medicaid population, while others struggled with engagement. “What we realized was that there were a lot of companies that didn’t have experience in the Medicaid space that were trying to enter into that space without a good understanding of ...
- Source: drugdu
- 106
- November 22, 2023
ChatGPT outperforms expert surgeon in answering rhinoplasty patient questions

In a new study, artificial intelligence in the form of ChatGPT outperformed an expert rhinoplasty surgeon in answering preoperative and postoperative patient questions related to nasal surgery. ChatGPT earned significantly higher ratings in accuracy, completeness, and overall quality, according to the study published in Facial Plastic Surgery & Aesthetic Medicine. Kay Durairaj, MD, and Omer Baker, from Pasadena, California , Dario Bertossi, MD, from University of Verona, Steven Dayan, MD, from University of Illinois, Chicago, Kian Karimi, MD, from Los Angeles California, Roy Kim, MD, from San Francisco, California, Sam Most, MD, from Stanford University, Enrico Robotti, MD, from Bergamo Italy, and Frand Rosengaus, MD, from Mexico City, reported that ChatGPT was overwhelmingly preferred over physician responses, with evaluators favoring ChatGPT in 80.95% of instances. Their findings are presented in the article titled “Artificial Intelligence Versus Expert Plastic Surgeon: Comparative Study Shows ChatGPT ‘Wins’ Rhinoplasty Consultations: Should We Be Worried?” ...
- Source: drugdu
- 106
- November 22, 2023
Q&A With William Ho, CEO of IN8bio

Mike Hollan Ho discusses how gamma-delta T cells can improve cancer treatments. Pharmaceutical Executive: Can you provide some background on gamma-delta T-Cells? William Ho: I’ve been in the biotech industry for over 22 years, and much of that was spent on the Wall Street side (investor banking, equity research, and as an investor). I co-founded the company together in 2016, and today we’re one of the leading companies developing gamma-delta T-Cells in oncology as a cellular therapy. Much of our work is based on Dr. Lamb’s lifetime of research on these t-cells. He was the first to describe them as being associated with better survival outcomes back in the 1990s. They were first identified in the mid 1980s. Dr. Lamb spent the better part of 25 years or so trying to figure out how to make that observation into a therapeutic. He needed to figure out how to manufacture, scale, ...
- Source: drugdu
- 109
- November 22, 2023
How Digital Health Can Support Suicide Prevention Among Adolescents

Engaging parents in their kids’ mental health treatment can improve health outcomes. With digital health, it’s easier to do this, according to one mental health executive. By MARISSA PLESCIA Involving parents in the mental health treatment of their kids can greatly improve health outcomes. But it’s not always easy for parents to get involved in a traditional brick-and-mortar setting, according to one mental health expert. That’s why digital health has the opportunity to support suicide prevention for younger populations. “Getting to a brick-and-mortar multiple times a week [is hard]. Parents have to show up, leave work early, go and drive for half an hour, battle traffic, try and figure out the flexibility of finding a therapist who can actually meet with you at a time that works for you before you get home to make dinner for your three other kids. It’s really stressful to be involved in treatment in ...
- Source: drugdu
- 113
- November 22, 2023
Almirall granted EC approval for Ebglyss in moderate-to-severe atopic dermatitis

Almirall has announced that its IL-13 inhibitor Ebglyss (lebrikizumab) has been approved by the European Commission (EC) to treat moderate-to-severe atopic dermatitis. The regulator has specifically approved the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy. Typically referred to as eczema, atopic dermatitis is a chronic, inflammatory disease of the skin characterised by recurrent inflammation associated with intense pruritus or itching. The incidence of atopic dermatitis appears to have increased in recent decades, currently affecting an estimated 4.4% of adults in the EU. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, is supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis, as well as data ...
- Source: drugdu
- 104
- November 22, 2023
NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 104
- November 22, 2023
Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 217
- November 22, 2023
FDA pushes back decision date on BMS, 2seventy bio’s Abecma in earlier line of treatment

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting. BMS revealed on Monday that the FDA’s Oncologic Drug Advisory Committee (ODAC) will meet to discuss data from the KarMMa-3 study. The United States regulator has not identified a date for the meeting, BMS said. BMS and its partner on the drug, 2seventy bio, said in the release that they expect the meeting has been called to review overall survival (OS) data, which is a secondary endpoint of the phase 3 study. The companies added that the meeting will not impact Abecma’s approval for multiple myeloma as a fifth-line treatment. This is another blow to the CAR-T medicine, ...
- Source: drugdu
- 99
- November 22, 2023
Stem-cell-derived brain cells hold promise for Alzheimer’s, Parkinson’s research

Researchers at the University of Wisconsin–Madison have identified a protein key to the development of a type of brain cell believed to play a role in disorders like Alzheimer’s and Parkinson’s diseases and used the discovery to grow the neurons from stem cells for the first time. The stem-cell-derived norepinephrine neurons of the type found in a part of the human brain called the locus coeruleus may enable research into many psychiatric and neurodegenerative diseases and provide a tool for developing new ways to treat them. Yunlong Tao, an investigator at Nanjing University in China who was a research professor at UW–Madison’s Waisman Center when the study was performed, and Su-Chun Zhang, a UW–Madison professor of neuroscience and neurology, published their work on the cells, which they call LC-NE neurons, today in the journal Nature Biotechnology. Norepinephrine neurons in the locus coeruleus regulate heartbeat, blood pressure, arousal, memory, attention and ...
- Source: drugdu
- 125
- November 21, 2023

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