Dive Brief The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors. According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.” iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT. Dive Insight FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA ...
Tumors are composed of rapidly multiplying cancer cells. Understanding which biochemical processes fuel their relentless growth can provide hints at therapeutic targets. Researchers from Washington University in St. Louis have developed a technology to study tumor growth in another dimension -; literally. The scientists established a new method to watch what nutrients are used at which rates spatially throughout a tissue. By using this multidimensional imaging approach, they identified pathways whose activities are uniquely elevated in brain cancer, offering clues for potential treatment strategies. The study was published May 19 in Nature Communications. Gary Patti, Michael and Tana Powell Professor of Chemistry in Washington University in St. Louis, said, “We figured out how to infer the rate of biochemical reactions directly from discrete regions of tissue.” Patti, who is also a research member of the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, is senior author ...
Swiss pharma giant Roche is looking to put its biologics manufacturing facility in Vacaville, California, on the auction block or shutter it by 2029, Reuters reports. In a statement to Reuters, the company didn’t directly respond to the prospect of selling or closing the facility but said it no longer needs large volumes of the products being manufactured at the site. However, internal emails sent to employees and obtained by the news agency indicated that if a buyer weren’t identified, Roche would begin winding down operations at Vacaville and shutter the plant between 2028 and 2029, Reuters reports. The plant, which employs about 800 people, produces monoclonal antibodies, according to the news service. Roche is currently staving off challenges to its revenue flow thanks to biosimilar challengers to its big-selling cancer drugs Herceptin, Avastin and Rituxan. This has forced the company to rely on newer products to deliver growth. Roche ...
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. The probe into allegations that the company paid kickbacks between 2006 to 2015 has culminated in Greece’s Council of Misdemeanor Courts clearing four former Novartis executives and a former politician of bribery charges, Greece’s Kathimerini reports. Former Novartis Greece Vice President Konstantinos Frouzis, alongside three other Novartis execs and former Health Ministry adviser Nikos Maniadakis, couldn’t be charged of bribing nonpolitical individuals due to the expiration of the statute of limitations, according to the publication. Ten other politicians were investigated, but no evidence was found to prove passive bribery, according to Kathimerini. Meanwhile, 15 doctors who allegedly received financial benefits for prescribing Novartis drugs have been charged for passive bribery and money laundering, according to the publication. Novartis did not immediately reply to Fierce Pharma’s request for comment. ...
Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS). Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy. There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring. Until now, there has only been one approved biologic treatment for HS, with around half of patients potentially losing response to this. Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring. Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and ...
Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
Paul Schloesser Associate Editor Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus. The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024. Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.” Sandoz did not immediately respond to queries from Endpoints News. Novartis announced back in August that it planned to spin out Sandoz as its own independent company, which is set to be listed on the SIX Swiss Exchange. Amid concerns ...
Our skin contains specialized long-lived killer cells that protect against intruders. Researchers at Karolinska Institutet in Sweden have now identified how these cells are formed, and shown that high levels of memory killer cells in cancer tissue correlate with a better survival rate in people with melanoma. The study is published in the journal Immunity. Certain immune T cells called tissue-resident memory cells are formed locally in the skin and other tissue, and protect against infections that they have encountered before. Some of them express proteins that enable them to kill infected cells. These “memory killer cells” can also contribute to the inflammatory skin disorders vitiligo and psoriasis. Recent research has shown that they are also involved in the body’s immune response to various cancers. Varying responses to treatment The memory killer cells have been shown to respond to immunotherapy, a Nobel Prize-winning cancer therapy involving the tweaking/activation of the ...
Survival rate beyond 10 years in children with drug-resistant epilepsy (DRE) was highest after cranial epilepsy surgery and lowest when treated only with antiseizure medications, according to a study published in The Lancet Child and Adolescent Health. This large, retrospective study was the first to compare long-term survival in children with DRE among cohorts treated with medications only, vagus nerve stimulation plus medications, and cranial epilepsy surgery plus medications. Results show that risk of early death was reduced by over 80% after surgery and by 40% after vagus nerve stimulation, compared to medication-only treatment. People with epilepsy have increased mortality rates compared to the age-matched population. Epilepsy is one of the most common neurological conditions, affecting at least 3.4 million people in the United States. Among children with epilepsy, an estimated 20% have DRE. “We provide critical evidence for healthcare decision making for pediatric patients with drug-resistant epilepsy,” said senior ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.