PHARMA & MEDICAL UPDATES

Several breaking news stories this week, including the endorsement of Lilly’s donanemab for Alzheimer’s disease, FDA approvals for Ipsen’s Iqirvo and GSK’s Arexvy, and the European Commission’s approval of Roche’s Alecensa, among other developments.

LATEST NEWS

EU regulator mandates label updates on CAR-T cancer therapies: The European health regulator said on Friday makers of a class of cancer cell therapies known as CAR-T treatments will need to highlight the risk of secondary blood cancers in patients who use them. Read

Pfizer/Flagship’s drug discovery partnership to focus on obesity treatments: The first agreement under Pfizer and Flagship Pioneering’s strategic partnership has been initiated, with Flagship and Profound Therapeutics announcing an agreement to identify potential first-in-class therapies to treat obesity. Pfizer and Flagship first announced their collaboration worth $7bn in 2023 to accelerate the development of innovative medicines. As part of the agreement, Pfizer and Flagship aim to invest in and develop a new pipeline of up to ten programmes for areas including internal medicine, oncology, infectious diseases and immunology. Read

Researchers at the Francis Crick Institute, University College London (UCL) and AstraZeneca (AZ) have revealed why targeted treatment for non-small cell lung cancer (NSCLC) fails for some cancer patients. Published in Nature Communications, the study demonstrated how lung cancer cells with two genetic mutations are more likely to double their genome, withstanding treatment and developing resistance.Around 85% of all lung cancer cases are NSCLC, the most common type of lung cancer found in patients who have never smoked. Read

AbbVie and FutureGen Biopharmaceutical have announced a licence agreement worth $1.7bn to develop a pre-clinical therapy for inflammatory bowel disease (IBD).The deal gives AbbVie an exclusive global licence to develop, manufacture and commercialise the candidate, FG-M701. In exchange, FutureGen will receive $150m in upfront and near-term milestone payments and will be eligible to receive up to $1.56bn in clinical development, regulatory and commercial milestones, as well as tiered royalties. Read

The U.S. Food and Drug Administration classified a recall of Teleflex's inflatable devices that increase blood supply to the heart muscle as "most serious". The devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat those who have had heart failure or have acute coronary syndrome, a group of diseases in which blood flow to the heart decreases. Read

Organoids in Drug Discovery and Personalized Medicine: Organoid models have become key in the field of drug discovery and personalized medicine, offering a more physiologically relevant and predictive system than traditional 2D cell culture and animal models. These three-dimensional structures derived from stem cells replicate the structure and function of human organs, providing a more accurate environment for testing drug efficacy and toxicity. Read

Roche has entered into a strategic licence agreement with ALZpath , using its tau phosphorylated at amino acid 217 (pTau217) antibody, to develop and commercialise a diagnostic blood test for Alzheimer’s disease (AD) in its earliest stages.The diagnostic test could potentially be used to screen and help avert the clinical onset of the neurological condition when effective prevention therapies become available. Read

Sysmex Astrego AB, a subsidiary of Sysmex Corporation, has been awarded the UK’s Longitude Prize on Antimicrobial Resistance (AMR) for the development of its rapid antimicrobial susceptibility testing technology, the PA-100 AST System, to tackle the global threat of AMR.The system has been awarded £8m, which could implement significant change in antibiotic use by identifying the correct treatment for urinary tract infections (UTI) within 45 minutes. Read

Johnson & Johnson (J&J) has reached a $700m settlement with more than 40 US states over their investigation into the marketing of its talcum powder-based products, which have been alleged to cause cancer. The agreement resolves allegations that the company misled consumers in advertisements related to the safety of the products, including its baby powder.A tentative deal was originally announced in January and the settlement was led by the attorneys general of Florida, North Carolina and Texas. Read

Researchers at the Francis Crick Institute, University College London’s UK Dementia Research Institute and the VIB-KU Leuven Center for Brain and Disease Research have revealed how brain cell communication is linked to Alzheimer’s disease (AD) .Using mouse models with AD, the study published in Cell Reports shows how communication between support cells in the brain can disrupt signals between nerve cells. Read

Ipsen’s Iqirvo (elafibranor) has been granted accelerated approval from the US Food and Drug Administration (FDA) to treat adult patients with primary biliary cholangitis (PBC ).The oral, once-daily peroxisome proliferator-activated receptor agonist has been approved in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Read

Researchers from King's College London, with doctors at King's College Hospital NHS Foundation Trust, have successfully used a new robot system to improve treatment for a debilitating eye disease. The custom-built robot was used to treat wet neovascular age-related macular degeneration (AMD), administering a one-off, minimally invasive dose of radiation, followed by patients' routine treatment with injections into their eyes. Read

Merck is focused on second- and third-generation opportunities in the cardiometabolic drugs market, which includes weight-loss treatments, the company said on Tuesday. "We think more in terms of small-molecule orals, versus injectables. That's the preferred route," CEO Robert Davis said at the Goldman Sachs Global Healthcare Conference. Read

Researchers from the Johns Hopkins Kimmel Cancer Center and other institutions have developed and validated a liquid biopsy test using artificial intelligence (AI) to help identify lung cancer earlier. The new study published in Cancer Discovery demonstrated that the new blood test could help accelerate lung cancer screening while reducing death rates.Currently the leading cause of global cancer incidence and death worldwide, lung cancer accounts for an estimated two million diagnoses and 1.8 million deaths annually. Read

Eli Lilly’s amyloid-targeting Alzheimer’s disease (AD) drug has been unanimously endorsed by a US Food and Drug Administration (FDA) panel of experts. The Peripheral and Central Nervous System Drug Advisory Committee voted 11 to zero that the benefits of donanemab outweighed its risks and that trial data submitted by Lilly showed the drug was effective.The company is seeking approval of donanemab, administered intravenously, to treat AD patients who are presenting with mild cognitive impairment or mild dementia and have confirmed amyloid pathology. Read

GSK’s Arexvy has become the first respiratory syncytial virus (RSV) vaccine to be approved by the US Food and Drug Administration (FDA) for use in adults aged 50 to 59 who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD). The regulator’s decision comes just over a year after it approved Arexvy for use in adults aged 60 years and older.RSV is a common contagious virus affecting the lungs and breathing passages. Although most people can recover within a week or two, 13 million adults aged 50 to 59 years in the US have a medical condition that increases their risk of severe RSV outcomes. Read

Roche’s Alecensa (alectinib) has been approved by the European Commission (EC) as the first and only targeted adjuvant treatment for patients with anaplastic lymphoma kinase (ALK)-positive early-stage lung cancer. The regulator’s decision on the ALK inhibitor, which has been specifically authorised for use as a monotherapy in adults with non-small cell lung cancer (NSCLC) at high risk of recurrence, was based on positive results from the late-stage ALINA study.Alecensa was shown to reduce the risk of disease recurrence by an “unprecedented” 76% compared with platinum-based chemotherapy in patients with completely resected 1b to 3a ALK-positive NSCLC, Roche said. Read

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