Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
Dive Brief: Medtronic agreed to buy EOFlow, a company based in South Korea that makes a tubeless, disposable insulin pump on a patch. The company will make a public tender offer to acquire all of EOFlow’s outstanding public shares for 971 billion South Korean won ($738 million). The purchase will allow Medtronic to compete with Insulet, which has gained market share with its tubeless insulin pumps, and Tandem Diabetes Care, which agreed last year to buy patch pump-maker AMF Medical. Dive Insight: Medtronic, with a warning letter recently lifted from its U.S. diabetes business, aims to bring new products to market. The company plans to integrate its new insulin dosing algorithm, which is used in the 780G pump, with EOFlow’s pump. “We’ve never lost faith in our technology,” Medtronic CEO Geoff Martha said on a Thursday earnings call, adding that “the patch segment is a good segment and we ...
As the United States’ opioid epidemic rages on, health officials are busy looking for ways to help with the response. Now, right on the heels of the FDA’s approval for a new overdose rescue medication, the agency has cleared Braeburn’s Brixadi (buprenorphine) for use in patients with moderate to severe opioid use disorder. The long-acting injectable features weekly and monthly dosing options for patients who are already being treated with a transmucosal (administered in the mouth) buprenorphine-containing product. Brixadi’s active ingredient is buprenorphine, an old medicine used to treat pain and opioid dependence, according to the National Institutes of Health. Braeburn’s CEO and president Mike Derkacz called the approval “a significant step forward” in the fight against opioid use disorder. “Over the last three years the U.S. experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially ...
Swansea University researchers have found that a drug commonly used to treat type 2 diabetes can potentially be used in the treatment of autoimmune disorders. Academics at the University’s Faculty of Medicine, Health and Life Science have found that the drug, canagliflozin (also known as Invokana), could be used to treat autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus as it targets T-cells, which form an essential component of the immune system. Canagliflozin is a drug that controls blood sugar levels in people with type 2 diabetes, however researchers have found an unexpected role for the drug involving the human immune system. Existing research has reported that targeting T-cell metabolism in autoimmunity can lead to therapeutic benefits. T-cells are a type of white blood cell that help the body fight infections and diseases, but in autoimmune diseases they have been observed to attack healthy tissues. The new study, ...
Dive Brief The U.S. Food and Drug Administration and the Veterans Health Administration have signed an agreement to increase medical product manufacturing capacity and flexibility in times of crisis. The agencies will create “digital stockpiles” to improve the resilience of domestic supply chains during emergencies, shortages and pandemics. The digital stockpiles will store electronic plans, instructions and methods to make and test medical products to enable trusted suppliers to quickly scale up production when needed, according to the agencies. Dive Insight The COVID-19 pandemic exposed the shortcomings of existing supply chains. When the crisis struck, the U.S. and other countries struggled to meet demand for personal protective equipment and other medical devices used in the response to the coronavirus. The experience led officials to consider how to make supply chains more resilient and able to cope with crises. Now, the FDA has signed a memorandum of understanding with the VHA. ...
By Tristan Manalac Pictured: Hundred dollar bills/courtesy of Nomad_Soul/Adobe Stock On Wednesday, ElevateBio closed a $401 million Series D financing round, making it biotech’s largest private fundraising haul this year. The Massachusetts-based company will use the money to improve further the company’s gene editing, RNA, cell, vector engineering, protein and induced pluripotent stem cell technologies. ElevateBio will funnel these funds into BaseCamp, the company’s end-to-end genetic medicine cGMP manufacturing and process development business. Beyond advancing its platforms, ElevateBio will also use its Series D raise to broaden its geographic reach and increase its manufacturing capacity to satisfy the needs of its industry and academic partners. Wednesday’s funding round follows ElevateBio’s $525 million Series C in May 2021, one of biotech’s largest fundraises of that year. Since then, the company has further solidified its presence in the gene therapy space. In October 2021, ElevateBio bought biotech start-up Life Edit Therapeutics, whose ...
By Heather McKenzie https://www.biospace.com/ Pictured: Sarepta logo on a building/courtesy of Sarepta Therapeutics Those in the Duchenne muscular dystrophy and gene therapy spaces hoping for a milestone decision by May 29 will have to wait approximately three more weeks as the FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease. The FDA told the company Wednesday “it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions,” according to Sarepta’s announcement. The company went on to say that the FDA indicated it is “working toward potentially granting an accelerated approval for SRP-9001” for DMD patients aged 4-5 years. If approved, SRP-900 would be the first FDA-authorized gene therapy for DMD. Sarepta’s shares were down 14% in pre-market trading Wednesday.
A trial of a new vaccine against meningococcal disease, a cause of meningitis and blood poisoning, has found that it is safe and induces a strong immune response across five strains of meningococcal bacteria: A, C, W, Y and X. The phase 3 trial compared the immune response generated by the new pentavalent vaccine NmCV-5 against that of the licensed quadrivalent MenACWY-D vaccine in 1,800 healthy participants aged 2–29 in Mali and The Gambia. After 28 days, across all ages, the immune responses generated by a single dose of NmCV-5 were generally higher than those generated by MenACWY-D. In addition, NmCV-5 induced a strong immune response to the emerging meningococcal X strain for which there is currently no licensed vaccine. The trial found no safety concerns with NmCV-5. The study, led by a team including researchers from the Medical Research Council (MRC) Unit, The Gambia, at the London School of ...
Sudden infant death syndrome (SIDS) is a case where the death of an apparently healthy infant before their first birthday remains unexplained even after thorough investigation. Death generally seems to occur when infants are sleeping. While rare, it is the leading post-neonatal infant death in the United States today, occurring in 103 out of 100,000 live births a year. Despite the initial success of national public health campaigns promoting safe sleep environments and healthier sleep positions in infants in the 1990s in the United States, rates of cases have remained the same over the last three decades. Researchers here collected tissue from the San Diego Medical Examiner’s Office related to infant deaths between 2004 and 2011. They then examined the brain stems of 70 infants who died during the period and tested them for consistent abnormalities. They found that the serotonin 2A/C receptor is altered in sudden infant death cases ...
Fever was found to be the most common non-respiratory feature of infection with SARS-CoV-2, the virus that causes COVID-19, according to research published at the ATS 2023 International Conference. The finding held true regardless of which COVID variant patients had, and whether or not they were fully vaccinated or not fully vaccinated. The researchers, who also looked at mortality risk, found that patients who were not fully vaccinated had a higher risk of dying when infected with either the Omicron or Delta variant. The study was based on the examination of the University of California Health Covid Research Data Set’s (UC CORDS) medical records of 63,454 patients who had been treated in a University of California medical center for COVID-19. The scientists applied statistical tests to determine the relationship between non-respiratory features, vaccination status and differences in mortality between infection with the Omicron and Delta variants. We determined that we ...
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