Researchers at the University of Texas MD Anderson Cancer Center published two studies this week on a new approach that could improve treatment for patients with pancreatic cancer — a disease that an estimated 64,050 U.S. adults will be diagnosed with in 2023. The preclinical studies showed that combining immunotherapy with a KRAS inhibitor can lead to long-lasting tumor elimination in pancreatic cancer. The research explored the functional role of KRAS mutations in pancreatic cancer. KRAS belongs to a family of genes that encode proteins that participate in cell signaling, activating or deactivating to regulate the growth of cells. When KRAS are mutated, they cause the uncontrolled cell growth that occurs in cancer. The oncology community has known “for a while now” that KRAS mutations drive pancreatic cancer, but it has had a hard time figuring out a way to effectively drug these mutated genes, explained Dr. Raghu Kalluri, an ...
By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported, citing a source with knowledge of the matter. ThermoFisher is carrying out the filling of the Wegovy injection pens at its plant in Greenville, North Carolina, the source added. The publication quoted Novo Nordisk chief financial officer Karsten Munk Knudsen as saying in May 2023 that the company had hired a second contract manufacturer in the US, without revealing its identity. A spokesperson from Novo Nordisk declined to comment on the latest development. The company is currently working on increasing the drug output to meet the rising demand in the US, and due to manufacturing issues at a Catalent-operated plant in Brussels, Belgium. Catalent was engaged by Novo Nordisk as the first contract manufacturer for Wegovy production. In July 2023, the Brussels factory filling self-injection pens for Wegovy violated US sterile-safety ...
Data published in The New England Journal of Medicine has demonstrated that Novo Nordisk’s blockbuster weight loss drug Wegovy (2.4mg subcutaneous semaglutide) can reduce heart-failure-related symptoms in people with obesity. The results from a global Phase III trial funded by Novo Nordisk found significant symptom improvement in patients with preserved ejection fraction (HFpEF) – a condition that comprises roughly half of all heart failure cases. In the randomised, placebo-controlled trial (NCT04788511), Wegovy was administered as a 2.4mg weekly dose in 529 patients. After a year, it led to an estimated mean difference of 7.8 points in the Kansas City Cardiomyopathy Questionnaire clinical summary score – a patient-reported outcome for heart failure symptoms and limitations, compared to placebo. Along with leading to a larger reduction in body weight (13.3% versus 2.6%), Wegovy also vastly increased the distance patients were able to walk in six minutes compared to placebo – 21.5 metres ...
Enterome is planning to raise EUR100m ($108m) as part of its latest fundraising round to power its clinical studies, said CEO Pierre Belichard in an interview with Pharmaceutical Technology. The company has already started speaking to investors in Europe and plans to start contacting those in the US in early September, he said. The funding will go towards the company’s clinical trials, which include two new Phase II studies, said Belichard. Enterome’s E02463 is an off-the-shelf immunotherapy that is made of four bacterial peptides of B lymphocyte-specific lineage markers. These peptides are based on the company’s OncoMimics approach, which uses specific peptide combinations derived from bacteria in the gut microbiome. The company had previously raised EUR 46.3m as part of its Series E round, based on a June 2020 release, while Belichard added that Enterome has raised EUR 116m to date. While Enterome is not actively looking to go public ...
Danish pharma company Novo Nordisk has brought in Thermo Fisher Scientific as a second manufacturer as demand for its weight-loss drug Wegovy (semaglutide) soars and amid Catalent’s production problems at a factory in Brussels, Belgium, according to reporting Wednesday by Reuters. Thermo Fisher is reportedly filling Wegovy injection pens at its factory in Greenville, NC through its CDMO subsidiary Patheon. Reuters’ source declined to be named as the information was confidential, according to the news agency, which initially reported back in May that Novo had brought on a second, then-unnamed manufacturer. The news comes after reports of difficulties with Catalent, the first manufacturer contracted by Novo to produce Wegovy. Deliveries were halted in late 2021 only months after the drug’s launch, when the FDA found issues at the Brussels syringe-filling facility. The facility was shut down again in 2022 after another inspection by the regulator found lapses. Novo ended up ...
By Michelle Roberts Digital health editor Gut problems including constipation, difficulty swallowing and an irritable bowel may be an early warning sign of Parkinson’s disease in some people, a new study suggests. The findings in the journal Gut add more evidence to the idea that brain and bowel health are intimately linked. Understanding why gut issues happen might allow earlier treatment of Parkinson’s, say the researchers. Parkinson’s is progressive, meaning the brain disorder gets worse over time. What is Parkinson’s? People with Parkinson’s do not have enough of the chemical dopamine in their brain because some of the nerve cells that make it are damaged. This causes symptoms including involuntary tremor or shaking, slow, shuffling movements and stiff muscles. Although there is currently no cure, treatments are available to help reduce the main symptoms and maintain quality of life for as long as possible. Spotting the disease even sooner – ...
A new editorial paper was published in Oncoscience (Volume 10) on August 17, 2023, entitled, “Cancer drug development yesterday, today and tomorrow.” In this new editorial, researchers Elzbieta Izbicka and Robert T. Streeper from New Frontier Labs discuss the history of cancer drug development and how it has evolved over time. The editorial also highlights the current state of cancer drug development and what the future may hold. Editorial Introduction: The “war on cancer” began with the National Cancer Act, a United States federal law intended “to amend the Public Health Service Act so as to strengthen the National Cancer Institute in order to more effectively carry out the national effort against cancer” that was signed by President Richard Nixon on December 23, 1971. As the 50th anniversary is now two years gone, the war has not been necessarily a blitzkrieg. To paraphrase Charles Dickens, today “it is the best ...
The U.S. has much higher list prices for several weight loss drugs when compared to other peer countries, a new KFF report found. KFF’s analysis compares list prices from website searches for a month’s supply of Ozempic, Rybelsus, Wegovy and Mounjaro, which are all approved for diabetes or weight loss in the U.S. In some countries, these drugs are not available. Ozempic, which is approved for diabetes in the U.S., costs $936 for a month’s supply in the U.S., versus $169 in Japan, $147 in Canada and $144 in Switzerland. Rybelsus, also approved in the U.S. for diabetes, costs $936 for a month’s supply in the U.S., while it costs $203 in the Netherlands, $158 in Canada and $147 in Switzerland. Wegovy has been approved for weight loss and costs $1,349 for a month’s supply in the U.S., versus $328 in Germany and $296 in the Netherlands. Mounjaro, approved for ...
More than 1,300 oncology drugs are in the development pipeline, waiting to potentially embark on the long journey toward their commercial debut. This journey is usually an arduous one, made even more difficult by the mere 6% participation rate in clinical trials among adult cancer patients in the U.S. To help tackle this issue, OneOncology — a cancer center network that TPG and AmerisourceBergen bought for $2.1 billion in June — recently announced that it is deploying Verily’s clinical trial management software platform across 11 of its community oncology clinics. Verily’s platform, called SignalPath, was designed with the intention of making providers’ complex clinical research ecosystems more manageable. It does this by converting trial protocols from PDFs to automated workflows, enabling centralized site and study management, and facilitating communication across site stakeholders. SignalPath also produces real-time metrics on performance and finances that users can turn into actionable insights. “As a ...
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