PharmaFocus Today – Page 269 – media

NICE recommends Lilly’s tirzepatide to treat T2D

The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
- Source: drugdu
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- September 12, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 164
- September 12, 2023
analysts

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
- Source: drugdu
- 115
- September 11, 2023
Veracyte and Gustave Roussy announce partnership for cancer therapies

Veracyte has announced a multi-year partnership with Gustave Roussy to support biopharmaceutical companies in expediting the development of new cancer therapies. They will combine their abilities to offer new insights into the biology of metastatic tumours, helping to develop new cancer treatments. The collaboration will utilise Gustave Roussy’s extensive collection of tumour samples and related data, along with Veracyte’s Biopharma Atlas, a machine learning-powered, multi-omic solution aimed at enhancing the effectiveness and efficacy of clinical studies. Gustave Roussy’s department of therapeutic innovation and early clinical trials will deliver metastatic tumour samples and information for several cancer indications. These are derived from research projects, specifically for new immunotherapies. Veracyte intends to combine these resources with its multi-omics testing and machine learning capabilities, resulting in the development of a Veracyte Biopharma Atlas reference database for genomic and immunomic biomarkers. Using the comprehensive understanding of each tumour’s biology, especially its immune context, the ...
- Source: drugdu
- 141
- September 11, 2023
Janssen’s patient programme becomes latest victim of data breach

IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
- Source: drugdu
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- September 11, 2023
UK rejoins EU’s Horizon Europe science programme

The UK has re-joined the EU’s Horizon Europe science research programme after the country’s post-Brexit absence and long-stalled talks. British scientists will now be able to apply for grants and bids to take part in Horizon Europe projects, based on the UK Government’s 7 September announcement. As an EU member state at the time, the UK was part of the EU’s past Horizon 2020 research funding programme. This programme has since been succeeded by Horizon Europe, which uses its budget of €95.5bn to support research across the region. The programme not only offers funding for research but also provides a chance for collaboration across Europe and beyond such as Armenia, Israel, and New Zealand. “The UK’s decision to re-join the Horizon Europe funding programme will be welcomed warmly by researchers across the EU and Great Britain today,” said Dr. Harshil Patel, head of scientific development at Seqera Labs after the ...
- Source: drugdu
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- September 11, 2023
NYU Langone offers the highest-quality kidney and lung transplant programs in the nation, new U.S. data reveals

The NYU Langone Transplant Institute offers the highest-quality kidney and lung transplant programs in the nation, according to new federal quality data, while its heart and liver transplant programs hold the highest organ survival rates in New York. Data released this summer by the Scientific Registry of Transplant Recipients, a national quality tracker overseen by the U.S. Department of Health and Human Services, show NYU Langone’s kidney and lung transplant programs have achieved excellence in the most important triad of metrics: volume, transplant rate, and one-year survival. In 2022, NYU Langone transplanted 335 kidneys—the most of any center in New York State—while being the only high-volume program in the nation to achieve top-tier measures in both one-year organ survival and getting a deceased donor transplant faster. The kidney transplant program has the lowest mortality rate in New York City among those on the waitlist. Similarly, 81 lung transplants were performed ...
- Source: drugdu
- 102
- September 11, 2023
Wearable technology emerges as a potential game-changer in early detection of COVID-19 among athletes

In a groundbreaking study conducted by Florida State University, wearable technology has emerged as a potential game-changer in the early detection of COVID-19 among NCAA Division I female student-athletes. The research by FSU Professor Michael Ormsbee, Assistant Athletic Director of Sport Performance Elisa Angeles and doctoral candidate Liliana Rentería in the Institute of Sports Sciences and Medicine (ISSM) focused on the use of WHOOP bands, which use optical sensors to measure and predict how fast your heart beats, how often you breathe, how you sleep and then use that information to calculate your strain and recovery. The ISSM research team, which works closely with athletes, monitored 113 NCAA Division I female student-athletes in soccer, golf, softball, indoor volleyball, beach volleyball and tennis. The athletes were equipped with WHOOP bands over a 10-month period, from August 2020 to May 2021. The project started when Angeles, who is also the associate director ...
- Source: drugdu
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- September 11, 2023
CymaBay’s Liver Disease Candidate Hits Phase III Primary, Secondary Endpoints

By Connor Lynch Pictured: Illustration of a human body with the liver highlighted/iStock, magicmine CymaBay Therapeutics’ liver disease candidate, seladelpar, hit its primary and key secondary endpoints in the Phase III RESPONSE trial, the company announced Thursday. The clinical-stage biopharma was testing its selective PPARδ agonist in adult patients with primary biliary cholangitis (PBC), a disease in which the bile ducts in the liver are slowly destroyed. The year-long, double-blind study was looking at 193 PBC patients that either had an inadequate response or an intolerance to the main treatment for PBC, ursodeoxycholic acid. The study’s primary composite endpoint was related to serum alkaline phosphatase (ALP), a key indicator of liver damage and/or bone disorders. CymaBay said in Thursday’s announcement that 61.7% of patients met this endpoint, versus 20% of patients taking a placebo. The study also met a second primary endpoint of ALP normalization and another related to itching. ...
- Source: drugdu
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- September 11, 2023
Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 165
- September 9, 2023

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