The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. Friday, Danco asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone. “The risks and confusion that result from the Fifth Circuit’s decision are not ones that women, teenage girls, and the public health system should be forced to bear without this Court’s review,” Danco’s lawyers wrote in a legal filing. “Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team continued, adding that the case is of “indisputable importance.” Mifepristone remains unrestricted until the Supreme Court weighs in on the case. Medication abortion makes up the majority ...
Researchers at The Institute of Cancer Research (ICR), London, have discovered a way to use a simple, non-invasive MRI scan to determine whether an experimental approach to enhance treatment for breast cancer is effective. New research from the study, funded by Cancer Research UK, could help doctors visualise tumours and speed up the development of targeted therapies for breast cancer. If successful, these drugs could enhance the effectiveness of other drugs administered in combination. Common features of breast cancer include excessive connective tissue, which consists of cells and fibres that provide a scaffold, known as the extracellular matrix (ECM), where tumours can grow. Hyaluronic acid, which works by absorbing water, is naturally present inside the tumour ECM and causes cancer tumours to swell, making it challenging for drugs to penetrate, reach and destroy cancer cells. Researchers are able to use experimental drugs that target and degrade a chemical called hyaluronic ...
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 According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise.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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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.