Don Tracy, Associate Editor UCB executive speaks on recent FDA approval of Bimzelx. In an interview with Pharm Exec associate editor Don Tracy, Camille Lee, VP, head of US immunology, UCB, speaks about the company’s recent FDA approval for Bimzelx, a treatmemt for psoriasis. Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval 1 Play Video Pharm Exec: Generally speaking, how far does UCB’s work in psoriasis span? Lee: UCB started its research work in psoriasis over a decade ago. Through that work, we have two assets available. Most recently and most directly related to UCB’s work is our recent approval of Bimzelx. That approval has been specifically first and foremost in the area of psoriasis. It is the first and only approved treatment that is selectively targeted to directly inhibit the IL-17A and IL-17F, which are two key things causing the inflammation of psoriasis. That product has been ...
Dr. Wendaline VanBuren, a radiology chair at Mayo Clinic, thinks that AI is in the beginning stages of improving radiologists’ workflows. Some of the most developed radiology AI research projects at Mayo center on image segmentation and 3D printing, she said. In the future, she’s excited to see more tools that aid radiologists in triage and lesion measurement. By KATIE ADAMS Radiology, like most physician specialties, is dealing with a labor shortage driven by burnout and an aging workforce. AI is often heralded as something that can help solve these workforce problems, but a lot of AI deployment in radiology is still in its iterative phase, said Dr. Wendaline VanBuren, chair of the gynecological imaging section within the division of abdominal radiology at Mayo Clinic. Dr. VanBuren made this remark last week during an interview at RSNA 2023, the annual radiology and medical imaging conference in Chicago. While AI still ...
For many in America, especially people in the middle class, old age is a daily struggle to keep up with basic activities. For some, the trials of dementia add to the emotional and financial burden for loved ones and caregivers. Long-term care options — assisted living, home care, or full-time family care — are costly, complex, and often inadequate. Jordan Rau, KFF Health News senior correspondent, moderated a Zoom event Dec. 5 about “Dying Broke,” an investigative project undertaken with The New York Times and Times reporter Reed Abelson about America’s long-term care crisis. Panelists shared their lived experiences of caregiving. The event was hosted by KFF Health News and the John A. Hartford Foundation. Kaiser Health NewsThis article was reprinted from khn.org, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy ...
Our teenaged son never misses an opportunity to tease me when I do something he deems old-fashioned. “Hey Mom and Dad,” he’ll ask, “what was it like back in the 1900’s?” While our son’s question is rhetorical, it did get us thinking about how much has changed in our field of study: medicine. At the start of the 1900s, the practice of medicine was based on a “symptom model” where care was sought when patients felt poorly and would see a doctor who would try to make them feel better. Addressing symptoms is important, but in the 21st century, many major medical problems do not present symptoms before they cause trouble. No one has ever said, “I feel I may have a stroke soon,” or “I think I may break a hip.” So, what about age itself? Is aging symptomatic? Is aging a disease? Can aging be fixed? In cardiology, ...
IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. The case stems back to 2017 and has its roots in Novartis’ Tafinlar, a melanoma therapy that the company acquired from GSK after a 2015 asset swap. Daiichi’s former subsidiary Plexxikon, which makes melanoma treatment Zelboraf, alleged that GSK scientists only gathered the knowledge necessary to develop the rival drug after consulting with Plexxikon for talks about a partnership that never came to fruition. Plexxikon’s patents date back to 2005, while GSK filed its first patent application on the drug in 2008, Plexxikon said. In 2021, a Northern California jury ruled in favor of Plexxikon, determining that Novartis stepped on two of the Daiichi subsidiary’s patents. Novartis was ordered to pay Daiichi’s subsidiary 9% royalty payments on future Tafinlar sales until certain Zelboraf patents expire ...
Novartis’ Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disease affecting approximately ten to 20 people per million worldwide. PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has a significant unmet need, Novartis reports, with a large proportion of patients on anti-C5 treatment remaining anaemic and dependent on blood transfusions. Fabhalta is a factor B inhibitor of the immune system’s complement pathway and offers an alternative to therapies that need to be delivered by infusion or injection. Victor Bultó, president US, Novartis, described the approval as an “extraordinary moment” for the PNH community. “This new, effective oral medicine may ...
Direct-to-consumer telemedicine platform Hims & Hers launched a new weight loss program Monday that offers weight loss medications, educational content and digital tracking tools. San Francisco-based Hims & Hers is a health and wellness platform that provides support for sexual health, hair, skin, primary care, mental health and other areas. The launch of the new weight loss offering comes at a time when more people are battling obesity. About 42% of U.S. adults struggle with obesity, according to the Centers for Disease Control and Prevention. Compare that to more than 20 years ago when a little over 30% struggled with obesity. The company’s new program starts with a consultation with a licensed healthcare provider from Hims & Hers. If considered appropriate, the patient will then receive a personalized treatment plan that is based on several factors, including the person’s body, health history and goals. The treatment plans have three elements. ...
Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024. Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024. Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens. The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval. ImmunoGen reported $105.2m in ...
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.