PharmaFocus Today – Page 301 – media

The past, present, and future of cancer drug development

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 ...
- Source: drugdu
- 116
- August 28, 2023
Weight Loss Drugs Cost Significantly More for Americans than Peer Countries

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 ...
- Source: drugdu
- 195
- August 22, 2023
Why OneOncology Is Adopting Verily’s Clinical Trial Management System

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 ...
- Source: drugdu
- 137
- August 22, 2023
Pfizer, Moderna Target Emerging Variants with Updated COVID-19 Shots

By Tristan Manalac Pictured: Healthcare worker administering a vaccine into a patient’s arm/iStock, Tirachard Moderna on Thursday announced that its updated COVID-19 vaccines can induce neutralizing antibodies against the emerging EG.5 and FL.1.5.1 variants of the virus, dubbed Eris and Fornax, respectively. Pfizer, along with German partner BioNTech, also said on Thursday that its updated shots elicited strong neutralizing activity against the Eris subvariant in a mouse study, reported Reuters. These updated vaccines come just in time for the fall vaccination season, for which the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June unanimously recommended using a monovalent vaccine focusing on the Omicron XBB.1.5 subvariant. According to data from the CDC, XBB.1.5 was the most dominant Omicron subvariant in the U.S. throughout most of 2023, accounting for 73.5% of cases in the latter half of April and 64.5% in the first half of May. In the last ...
- Source: drugdu
- 200
- August 22, 2023
Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed, Regeneron said in its Friday release. Chaple disease is caused by mutations of the complement regulator CD55 gene, which can lead the compliment system to attack the body’s own cells. Enter Veopoz, a fully human monoclonal antibody that targets a protein involved in complement system activation called compliment factor C5. It’s approved for patients 1 year of age and older and comes with a $34,615 price tag per single-use vial, a Regeneron spokesperson said in an emailed statement. The injection was tested in ...
- Source: drugdu
- 128
- August 22, 2023
Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

Ipsen’s Sohonos (palovarotene), a drug treatment for fibrodysplasia ossificans progressive (FOP), has been approved by the US Food and Drug Administration (FDA). FOP is a rare muskuloskeletal condition that progressively transforms muscles and tendons into bone, affecting the movement of the body. As a rare disease, FOP is estimated to Impact around 900 people globally. Sohonos has been approved as a treatment for adults and paediatric patients with FOP – for females 8 years and older and for males 10 years and older – to mediate the interactions between the receptors, growth factors and proteins within the retinoid signaling pathway to reduce new abnormal bone formation. The drug has particular selectivity for the gamma subtype of retinoic-acid receptors, which are an important regulator of skeletal development and ectopic bone in the retinoid signaling pathway. “The first treatment for FOP has been proven to reduce the volume of new abnormal bone ...
- Source: drugdu
- 134
- August 22, 2023
Boehringer Ingelheim advances weight loss drug to Phase III trials

Boehringer Ingelheim could soon stake a claim in the lucrative obesity treatment market after the pharma company said it has advanced a candidate into three Phase III trials following promising data. Survodutide, the company’s glucagon/glucagon-like peptide 1 (GLP-1) receptor dual agonist co-developed with Zealand Pharma, demonstrated up to 19% weight loss after 46 weeks of treatment in a Phase II dose escalation trial investigating the drug in patients living with obesity without type 2 diabetes (T2D). In a statement announcing the plans, Boehringer Ingelheim said that insights from previous studies will be used to inform the design of the three Phase III trials which will investigate the efficacy and safety of survodutide. Enrolment of patients is planned before the end of 2023, with the company saying that study details will be unveiled nearer to trial commencement. Survodutide has previously received a US Food and Drug Administration (FDA) fast track designation ...
- Source: drugdu
- 115
- August 22, 2023
AbbVie achieves win for migraine prevention drug Aquipta in Europe

The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement. In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in ...
- Source: drugdu
- 134
- August 22, 2023
Meta-analysis reports global prevalence of MAFLD of 38.8% in adults

Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects up to 30% of adults in the general population. It is characterized by the accumulation of fat in the liver. It is often associated with other conditions, such as obesity, type 2 diabetes, and metabolic syndrome. The new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed in 2020. MAFLD is diagnosed based on hepatic steatosis (fatty liver) and at least one of three metabolic risk abnormalities: overweight/obesity, type 2 diabetes, or evidence of metabolic dysregulation. A recent meta-analysis led by Ming-Hua Zheng from the First Affiliated Hospital of Wenzhou Medical University has reported a global prevalence of MAFLD of 38.8% in adults. MAFLD can progress to cirrhosis and promote the development of some critical extrahepatic diseases, such as cardiovascular disease and chronic kidney disease. MAFLD is a severe condition that can lead to cirrhosis and other health ...
- Source: drugdu
- 194
- August 21, 2023
Severe COVID-19 may cause long-term changes to innate immune system

Severe COVID-19 may cause long-lasting alterations to the innate immune system, the first line of defense against pathogens, according to a small study funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. These changes may help explain why the disease can damage so many different organs and why some people with long COVID have high levels of inflammation throughout the body. The findings were published online today in the journal Cell. Researchers led by Steven Z. Josefowicz, Ph.D., of Weill Cornell Medicine in New York City examined immune cells and molecules in blood samples from 38 people recovering from severe COVID-19 and other severe illnesses, as well as from 19 healthy people. Notably, the researchers established a new technique for collecting, concentrating and characterizing very rare blood-forming stem cells that circulate in the blood, eliminating the need to extract such cells from ...
- Source: drugdu
- 190
- August 21, 2023

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