In a patent case centered on two rival hemophilia medicines, Roche’s Genentech unit has scored its second straight win. After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda’s Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling. In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation.” In this case, Baxalta’s patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn’t amount to undue experimentation. But the circuit court shot down this argument, supporting the decision that the patent should be invalidated. ...
German group Merck has announced two new drug discovery collaborations with BenevolentAI and Exscientia to harness artificial intelligence (AI)-driven design and discovery capabilities to accelerate drug discovery. The partnerships are expected to generate several new clinical development drug candidates in key therapeutic areas of oncology, neurology and immunology. Under the terms of the agreements, three potential targets have been selected to initiate each partnership, with the potential of identifying and nominating additional targets in the future. The collaborations will focus on advancing small-molecule development candidates, which Merck will select for further preclinical and clinical development. As part of the agreements, both UK-based companies will receive upfront payments from Merck and will be eligible for future milestone payments plus tiered royalties based on net sales. Exscientia will receive an upfront payment of $20m and up to $674m in milestone payments if all three projects meet their objectives. Meanwhile, BenevolentAI is set ...
A new Massachusetts Institute of Technology (MIT) study has revealed a potential explanation as to why certain immunotherapies for cancerous tumours do not always work as predicted. If validated in clinical trials, the findings could help doctors identify cancer patients who would benefit the most from drugs known as checkpoint blockade inhibitors. Checkpoint blockade inhibitors work by stimulating immune cells to destroy tumours in the body’s T cell response. In previous studies, findings have shown that these drugs work effectively in patients whose tumours have a large number of mutated proteins. However, 50% of patients who received the US Food and Drug Administration-approved checkpoint blockade inhibitor, pembrolizumab, did not respond well or only showed short-lived responses, despite their tumours showing high mutational burden. In a study of mice, the researchers revealed that measuring the diversity of mutations within a tumour generated a more accurate prediction as to whether immunotherapy treatment ...
Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated. By MARISSA PLESCIA After determining an issue in the way many states were handling Medicaid and CHIP redeterminations, the U.S. Department of Health and Human Services (HHS) announced Thursday that coverage will be reinstated for nearly 500,000 children and other individuals.“Thanks to swift action by HHS, nearly half a million individuals, including children, will have their coverage reinstated, and many more will be protected going forward. HHS is committed to making sure people have access to affordable, quality health insurance – whether that’s through Medicare, Medicaid, the Marketplace, or their employer,” said HHS Secretary Xavier Becerra in a statement. “We will continue to work with states for as long as needed to help prevent anyone eligible ...
Short-term exposure to air pollution may be linked to an increased risk of stroke, according to a meta-analysis published in the September 27, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. Short-term exposure was defined as occurring within five days of the stroke. Ahmad Toubasi, MD, study author, University of Jordan in Amman, said, “Previous research has established a connection between long-term exposure to air pollution and an increased risk of stroke. However, the correlation between short-term exposure to air pollution and stroke had been less clear. For our study, instead of looking at weeks or months of exposure, we looked at just five days and found a link between short-term exposure to air pollution and an increased risk of stroke.” The meta-analysis involved a review of 110 studies that included more than 18 million cases of stroke. Researchers looked at pollutants such as ...
Merck KGaA has announced two new strategic partnerships with Benevolent AI and Exscientia to support its artificial intelligence (AI)-driven drug discovery plans. Benevolent and Exscientia plan to leverage Merck KGaA’s expertise in oncology and neuroinflammation under the collaboration. As part of the agreement, the companies have collectively selected three potential first-in-class and best-in-class targets. The partnership will focus on finding viable small molecule candidates for development that Merck KGaA will choose for further preclinical and clinical development. In this deal, announced on 20 September, BenevolentAI will be eligible for payments of up to $594 million, including a low double-digit million-dollar immediate payment. Further payments will be made according to future discovery, development and commercial milestones. Also, the London, UK-based company could receive tiered royalties on net sales of any commercialised products. BenevolentAI is already collaborating with AstraZeneca and Eli Lilly for AI-driven drug discovery. In May, BenevolentAI announced intentions to ...
By Connor Lynch Pictured: FDA sign in its headquarters/iStock, Grandbrothers Taysha Gene Therapies has decided to drop its lead experimental AAV-based gene therapy candidate after the FDA reiterated calls for the company to put the treatment through a randomized, double-blind placebo-controlled trial. The Dallas-based company announced on Tuesday that it would no longer be developing its TSHA-120 treatment for giant axonal neuropathy (GAN) based on the FDA’s Type C meeting feedback regarding the therapy’s potential pathway. “FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120,” the company said in a statement. Taysha noted in the announcement that the FDA “provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.” CEO Sean Nolan said in a statement that the ...
CSL Seqirus has unveiled new data highlighting the potential impact of influenza vaccines on reducing the burden seasonal flu has on hospitals and broader healthcare systems. The analyses were presented at this year’s European Scientific Working Group on Influenza (ESWI) Conference. Seasonal flu is an acute respiratory infection caused by influenza viruses, which circulate in all parts of the world. Although most people can recover within a week without requiring medical attention, the flu can cause severe illness among high-risk groups such as young children, older adults, pregnant individuals and those with serious medical conditions. In France, approximately 2 to 6 million people are affected by influenza every year, leading to over 20,000 hospitalisations and 10,000 excess deaths, 90% of which occur in older adults. According to findings from a dynamic transmission model, standard-dose quadrivalent flu vaccines for older adults could reduce hospitalisations by 11.1% to 30.0% and cut ICU ...
The treatment is the first oral GPCR receptor antagonist class recommended for NHS use The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults. The recommendation marks Vydura as the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as treatment for the condition. Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated. It is also recommended after prior use of nonsteroidal anti-inflammatory drugs, such as ibruprofen and aspirin, and paracetamol didn’t work well enough. Triptants are a group of medicines used to treat a migraine or headache. The recommendation was based on clinical trial evidence, which showed that Vydura is more likely to reduce pain in patients within 2 ...
Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
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