PharmaFocus Today – Page 277 – media

Wegovy can reduce heart failure symptoms in obese patients, study shows

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 ...
- Source: drugdu
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- August 28, 2023
Microbiome company Enterome plans $108m raise to fund Phase II cancer trials

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 ...
- Source: drugdu
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- August 28, 2023
Reuters

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 ...
- Source: drugdu
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- August 28, 2023
Gut problems may be early sign of Parkinson’s disease

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 – ...
- Source: drugdu
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- August 28, 2023
VC funding in medtech ticks up, raising hopes that slump has bottomed

Dive Brief Venture capital investment in medtech startups increased sequentially in the second quarter, in both volume and value, according to the financial database PitchBook. Activity remains down from last year, and well down from the highs hit in 2021, but the PitchBook analysts think funding bottomed out in the first quarter and will “inch upwards over the rest of the year.” The analysts also speculated that M&A activity could pick up now that large companies “have worked through their numerous spinoff and spinout plans.” On Wednesday, wound care device maker Sanuwave Health announced it plans to go public through a $127.5 million merger agreement with SEP Acquisition, a special purpose acquisition company, or SPAC. Dive Insight VC investment in medtech fell across 2022, and the downward trend in deal value continued in the first quarter of 2023. The second quarter brought potential signs that a recovery is starting. Deal ...
- Source: drugdu
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- August 28, 2023
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 ...
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- 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
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- 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
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- 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
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- 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
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- August 22, 2023

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