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 ...
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?” ...
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, ...
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 ...
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 ...
This year’s European Antibiotic Awareness Day (EAAD) focuses on the targets outlined in the 2023 Council Recommendation to step up efforts in the European Union (EU) against antimicrobial resistance in a One Health approach. Those recommendations formulate the 2023 goal to reduce total antibiotic consumption (community and hospital sectors combined) by 20%, using consumption data from 2019 as baseline. Consumption of antibiotics in the community accounts for around 90% of the total use. This means, that a substantial and consistent decline in the use of antibiotics in this sector will be key on the way towards reaching the set goals for 2030 which aim at preventing and reducing antimicrobial resistance overall. During the first year of the COVID-19 pandemic, data from the European Union (EU)/European Economic Area (EEA) showed an unprecedented 18.5% decrease in community consumption of antibiotics in 2020 compared with the 2019 baseline. This drop has been related ...
By Tristan Manalac Pictured: Merck Research Laboratories building in California The FDA on Thursday approved Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Thursday’s label expansion is Keytruda’s seventh approval in gastrointestinal cancer and its 38th indication overall in the U.S., according to Merck’s announcement. This latest approval covers patients with HER2-negative cancers and authorizes the use of the PD-1 blocker in combination with fluoropyrimidine- and platinum-containing chemotherapy. Previously, Keytruda was indicated for gastric cancer only in patients who had progressed after at least two prior lines of systemic therapy, including fluoropyrimidine- and platinum-containing chemotherapy. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, in a statement called Keytruda’s label expansion an “important milestone” in the care of gastric or gastroesophageal junction adenocarcinoma. Data from the Phase ...
The National Medical Products Administration (NMPA) of China granted conditional approval to biotech Apollomics for the commercialisation of its non-small cell lung cancer (NSCLC) treatment. Velbretinib (APL-101) is an orally bioavailable small molecule that treats NSCLC patients with MET exon 14 skipping alterations by inhibiting c-Met. This is a protein that is key in the tumour growth pathway. MET exon 14 skipping mutations occur in approximately 3% of cases of NSCLC. This condition is most diagnosed in adults aged over 70 with a smoking history. China’s NMPA grants conditional approvals to treatments for diseases that are severely life-threatening and there is no effective treatment method. Under the terms of an agreement, the company’s Chinese partner, Avistone, holds the drug’s exclusive rights in China, Hong Kong and Macau. Apollomics holds the rights for the US and all other countries. California-headquartered Apollomics is also in active discussions with the US Food and ...
In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
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