The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication of Boehringer Ingelheim’s Spevigo (spesolimab) injection for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo originally received a European Commission approval for the infusion in December 2022, for the treatment of GPP flares in adults as a monotherapy. However, this approval would offer younger patients the chance to use Spevigo to prevent flare-ups. Spevigo attaches to the interleukin-36 receptor (IL-36), which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. GPP is a rare, severe type of psoriasis where patients suffer from widespread pustules on red skin, often accompanied by systemic symptoms like fever and fatigue. It is distinct from other forms of psoriasis, as it can become life-threatening due to complications ...
The Scottish Medicines Consortium (SMC) has accepted Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for use within NHS Scotland to treat adult patients living with chronic kidney disease (CKD). The regulator has indicated the therapy for adult CKD patients who are receiving optimised standard care, including angiotensin converting enzyme inhibitors or angiotensin 2 receptor blockers, with either an estimated glomerular filtration rate (eGFR) of 20ml/min/1.73m2 up to 45ml/min/1.73m2 or an eGFR of 45ml/min/1.73m2 up to 90ml/min/1.73m2. Additionally , patients in Scotland in the 45ml to 80ml group will now be eligible to receive Jardiance if they have a urine albumin-to-creatine ratio of 22.6mg/mmol or more or type 2 diabetes (T2D) mellitus. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition that is caused by decreased kidney function and is often triggered by diabetes, hypertension and glomerulonephritis. Already approved in the EU and US, Jardiance is an oral, ...
Boehringer Ingelheim has unveiled promising results from a Phase II trial of survodutide, demonstrating a notable improvement in liver fibrosis among patients. The sub-analysis indicated that up to 64.5% of adults with moderate to advanced scarring (fibrosis stages F2 and F3) experienced an improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% with placebo after 48 weeks of treatment. The findings, presented at the European Association for the Study of the Liver Congress (EASL) 2024 and published in The New England Journal of Medicine, also showed that up to 52.3% of adults treated with survodutide achieved a significant improvement in liver scarring across stages F1 to F3, versus 25.8% with placebo. Dr. Arun Sanyal, Professor of Medicine at Virginia Commonwealth University School of Medicine and Principal Investigator of the trial, said: “I am particularly excited about the findings of the phase 2 trial in survodutide, which demonstrate the potential ...
As the burden of documentation and various other administrative duties has increased, physician burnout has reached historical levels. In response, EHR vendors are embedding generative AI tools to aid physicians by drafting their responses to patient messages. However, there is a lot that we don’t yet know about these tools’ accuracy and effectiveness. Researchers at Mass General Brigham recently conducted research to learn more about how these generative AI solutions are performing. They published a study last week in The Lancet Digital Health showing that these AI tools can be effective at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight. For the study, the researchers used OpenAI’s GPT-4 large language model to produce 100 different hypothetical questions from patients with cancer. The researchers had GPT-4 answer these questions, as well as six radiation oncologists who responded manually. Then, the ...
Chronic liver disease and associated cirrhosis account for one million deaths every year Boehringer Ingelheim and Ochre Bio have partnered to discover and develop novel, first-in-class regenerative treatments for chronic liver disease (CLD), including late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. The partnership aligns with Boehringer’s drive to improve outcomes for patients living with interconnected cardiovascular, renal and metabolic diseases. Accounting for approximately one million deaths per year, CLD and associated cirrhosis cause significant morbidity, loss of health-related quality of life and economic burden. As CLD progresses, the liver’s natural ability to regenerate and repair diminishes, resulting in serious complications such as liver failure or liver cancer. Under the terms of the agreement, Ochre will receive up to $35m in upfront and near-term research-based milestone payments, as well as possible milestones for clinical, regulatory and commercial success plus tiered royalties, with an overall deal value with the potential to exceed $1bn. ...
The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. By Frank VinluanThe liver is the only organ in the human body capable of regenerating itself. Boehringer Ingelheim has begun a research alliance with a startup to see if its technology can produce new therapies that tap into the liver’s capacity for regeneration and repair. Boehringer is committing to pay Ochre Bio to up to $35 million to begin the partnership, which is focused on identifying, characterizing, and validating multiple novel regenerative targets for chronic liver diseases. Specific targets were not disclosed, but Monday’s announcement describes the deal as a multi-target, multi-year collaboration. Ochre develops RNA medicines for chronic liver diseases. The Oxford, U.K.-based startup hasn’t disclosed details about its internal pipeline, but the company ...
Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, ...
SHANGHAI RAAS and Boehringer Ingelheim, one of the world’s leading biopharmaceutical companies, announced today that they have entered into a major collaboration: Boehringer Ingelheim BioPharmaceuticals (China) Ltd. will provide process transfer and clinical manufacturing services for SHANGHAI RAAS’s innovative hemophilia drug, SR604 injection. Boehringer Ingelheim China Biopharmaceutical (“Boehringer Ingelheim China Biopharmaceutical”) will provide process transfer and clinical manufacturing services for SR604 injection, an innovative hemophilia drug under Shanghai Lacey, which will be transformed into a high-quality end-product through the international first-class CDMO platform, helping Chinese innovations to go overseas to benefit patients worldwide. SR604 injection is a humanized monoclonal antibody that binds human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. Recently, the State Drug Administration (SDA) has officially approved SR604 injection. Recently, the State Drug Administration formally approved an application for a clinical phase I trial of SR604 injection, to ...
Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025. By FRANK VINLUANAntipsychotic medications used to treat schizophrenia don’t work for all patients, and even when they do, side effects lead many people to stop taking them. Sosei Heptares is developing a novel drug that could bring patients better efficacy along with fewer side effects, and that potential has caught the interest of Boehringer Ingelheim. The German pharmaceutical company has inked a deal for an exclusive option on Sosei Heptares’s schizophrenia drug candidate, which is in early clinical development. Under deal terms announced Monday, Boehringer is paying its new partner €25 million up front. Sosei Heptares’s schizophrenia research address a G protein-coupled receptor (GPCR) called GPR52. This particular receptor is highly expressed in the brain, making ...
Canada-based Phenomic AI has landed two strategic collaborations this week with Boehringer Ingelheim and Astellas-owned cell therapy biotech Xyphos Biosciences to develop cancer therapies. Phenomic and Boehringer have teamed up on a target identification collaboration, announced on 29 November. Under the deal, Phenomic will receive an upfront payment of $9m and may be entitled to up to $500m in research funding and milestones. The Canadian company hasn’t disclosed the financial terms of the deal with Astellas, but the companies aim to develop cell therapies with an antibody directed at a novel target of the tumour stroma, utilising Phenomic’s scTx platform. The company singled out colorectal and pancreatic cancers as being stroma-rich, which would be amenable to being targeted by Phenomic’s platform. These developments mark the first deals announced by Phenomic in three years since the company launched in 2020 with $6m in seed funding. Phenomic’s scTx is a single-cell RNA ...
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