Taking place from 18 to 24 November 2023, World antimicrobial resistance (AMR) Awareness Week will focus on the theme “Preventing Antimicrobial Resistance Together” to combat resistance and improve antimicrobial use in humans around the world. This AMR Awareness Week, leaders and communities across several sectors will work to preserve antimicrobials and protect the health of people, animals, plants and the environment. Designated as one of the top ten global public health threats facing humanity by WHO, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Estimated to cost the world’s economy $100trn by 2050 if left unresolved, AMR contributes to approximately five million bacterial infection-related deaths annually. Currently, the misuse and overuse of antimicrobials is one of the biggest drivers of AMR. When antibiotics and other antimicrobial treatments become ineffective, infections become more challenging or impossible to treat, increasing the risk of disease spread, severe ...
The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs. The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi. Specifically, the FTC argues “improper” listings in the FDA’s “Orange Book” can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case. In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices ...
After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
By Tristan Manalac Pictured: NASDAQ Stock Exchange headquarters Carmot Therapeutics on Friday filed for an initial public offering (IPO), banking on its pipeline of GLP-1 agonists and the multibillion-dollar potential of the obesity market. Carmot did not disclose how many shares of its common stock will be put up for sale or its projected earnings from the planned offering. The company expects to wrap up its IPO before the year closes, after which it will trade on Nasdaq under the proposed ticker CRMO, according to a Nov. 17 SEC filing. The California-based biotech is advancing a pipeline of “life-changing therapeutics for people living with metabolic diseases,” particularly obesity and diabetes, per the SEC filing. One of its most mature candidates is CT-868, a dual agonist of both the GLP-1 and GIP receptors, both of which play crucial roles in the regulation of insulin secretion, appetite and weight. CT-868 is being ...
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 ...
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 ...
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 ...
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 ...
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