Search Results

Collaborative project involving researchers from King’s College London and University College London looks to develop therapeutic strategies for amyotrophic lateral sclerosis and frontotemporal dementia. < Back Researchers Secure £3.9M Grant to Explore Early Axonal Dysfunction in ALS and FTD Collaborative project involving researchers from King’s College London and University College London looks to develop therapeutic strategies for amyotrophic lateral sclerosis and frontotemporal dementia. Researchers from King’s College London (KCL) and University College London (UCL) have received a £3.9 million grant from the Medical Research Council (MRC) and the Motor Neurone Disease (MND) Association to investigate axonal dysfunction in amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The project seeks to develop therapeutic strategies to address these neurodegenerative diseases at their early stages. ALS and FTD are devastating conditions that cause progressive nerve cell degeneration. ALS, a fatal type of MND, leads to the degeneration of nerve cells in the spinal cord and brain, while FTD results from damage to neurons in the frontal and temporal lobes of the brain. Together, these conditions affect over 35,000 people in the UK. Axonal dysfunction, characterized by the degeneration of axons - the structures in the neurons responsible for transmitting signals to other cells - is a key pathology in both ALS and FTD. Early signs of axonal dysfunction include hyperexcitability, abnormal plasticity, and reduced synapse function. These abnormalities significantly contribute to disease progression. The collaborative project, led by Professor Juan Burrone from the Centre for Developmental Neurobiology at KCL and Dr. Ivo Lieberam from the Centre for Gene Therapy and Regenerative Medicine at KCL, aims to systematically investigate these early axonal pathologies. The researchers will develop human neuronal culture models with mutations found in patients with ALS and FTD. These models will be used to characterize altered axon functions and uncover the specific molecular mechanisms behind the dysfunction. "This is an exciting collaborative project that aims to understand the cellular pathologies behind ALS/FTD to identify a new therapeutic angle," said Professor Burrone. The final stage of the project involves restoring normal neuronal activity and communication in the cultured neurons. If successful, this approach could potentially prevent neuronal cell death and halt the progression of these debilitating diseases. This grant follows a recent £2 million funding awarded to Health Data Research UK and Dementias Platforms UK to launch a new initiative aimed at accelerating the discovery of new diagnostics and treatments and improving care for MND patients. These combined efforts highlight the ongoing commitment to understanding and combating neurodegenerative diseases. In summary, this groundbreaking research funded by the MRC and the MND Association aims to pave the way for novel therapeutic strategies targeting early axonal dysfunction in ALS and FTD. Through this work, researchers hope to bring new hope to patients suffering from these currently incurable diseases. Author BioFocus Newsroom Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

In a major development, the FDA has approved Roche’s new drug, Itovebi, which offers a promising option for patients with advanced HER2-positive breast cancer. < Back Roche's New Breast Cancer Drug Itovebi Receives FDA Approval In a major development, the FDA has approved Roche’s new drug, Itovebi, which offers a promising option for patients with advanced HER2-positive breast cancer. Breast cancer treatments have evolved significantly in recent years, offering patients new options that target specific cancer types. Among these are therapies for HER2-positive breast cancer, an aggressive form characterized by the overexpression of the HER2 protein, leading to faster growth and spread. While advances in the field have improved outcomes, treatment for metastatic and advanced cases remains challenging. In a major development, the FDA has approved Roche ’s new drug, Itovebi, which offers a promising option for patients with advanced HER2-positive breast cancer. This approval allows Itovebi to be used in combination with Ibrance and Ibrance and Faslodex, produced by Pfizer and AstraZeneca , respectively. Itovebi joins several other innovative breast cancer treatments developed by Roche that target HER2-positive forms of the disease. Such therapies include: Herceptin (trastuzumab) – a groundbreaking monoclonal antibody that revolutionized HER2-positive breast cancer treatment by targeting the HER2 receptor. Perjeta (pertuzumab) – another HER2-directed monoclonal antibody, often used in combination with Herceptin. Kadcyla (T-DM1) – an antibody-drug conjugate that combines trastuzumab with chemotherapy to deliver targeted treatment. Itovebi, a HER2-directed antibody-drug conjugate, represents an innovative approach, delivering potent chemotherapy directly to cancer cells while limiting damage to healthy tissues. Roche's clinical trials have shown significant improvement in delaying disease progression when using the drug combination compared to existing treatments. This approval solidifies Roche's leadership in breast cancer treatment, while also positioning the company against competitors like Novartis and AstraZeneca, whose drugs, such as Kisqali and Enhertu, also target advanced breast cancer. By adding Itovebi to its portfolio, Roche aims to provide more personalized and effective treatment options for patients with this challenging diagnosis. Author BioFocus Newsroom Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

VYNE Therapeutics has paused its Phase 1b trial of VYN202 for psoriasis after the FDA imposed a clinical hold due to testicular toxicity observed in non-clinical studies. < Back VYNE Therapeutics Faces Clinical Hold on VYN202 Program Following Toxicity Findings VYNE Therapeutics has paused its Phase 1b trial of VYN202 for psoriasis after the FDA imposed a clinical hold due to testicular toxicity observed in non-clinical studies. VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced a temporary halt in its Phase 1b clinical trial of VYN202, a novel treatment for moderate-to-severe plaque psoriasis, following a clinical hold imposed by the U.S. Food and Drug Administration (FDA). The FDA’s decision came after the company observed testicular toxicity in dogs during a non-clinical toxicology study of VYN202. As a result, VYNE has suspended all screening, patient enrollment, and dosing in the ongoing Phase 1b trial. The company, however, emphasized that no serious adverse events have been reported in the patients already enrolled in the study. FDA Clinical Hold: A Step Toward Resolution VYNE has expressed its commitment to working closely with the FDA to resolve the clinical hold swiftly. "While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority,” said David Domzalski, President and CEO of VYNE Therapeutics. "We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with the FDA.” Despite the setback with VYN202, the company emphasized that the clinical hold does not affect its ongoing Phase 2b trial of repibresib gel, an entirely different compound designed for the treatment of nonsegmental vitiligo. VYNE is still on track to release top-line results from the 24-week, double-blind, vehicle-controlled portion of the Phase 2b study in mid-2025. About VYNE Therapeutics VYNE Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing differentiated therapies aimed at treating chronic inflammatory and immune-mediated conditions with significant unmet medical needs. The company's proprietary BET inhibitors, part of its InhiBET™ platform, are designed to overcome limitations seen in early-generation BET inhibitors, offering enhanced selectivity and alternative administration routes. Investors and stakeholders can follow VYNE’s progress and updates through its website and official filings, as the company continues to navigate its clinical trials and regulatory challenges. Author BioFocus Newsroom Previous Next

Learn more about the challenges of transition from laboratory to industrial-scale bioreactors. < Back Mastering Bioreactor Scale-Up Learn more about the challenges of transition from laboratory to industrial-scale bioreactors. Bioreactors are the lifeblood of bioprocessing across diverse industries such as pharmaceuticals, food, and biofuels. However, the transition from laboratory to industrial-scale bioreactors presents multiple challenges. At the heart of bioreactor scale-up lies the need to maintain consistent process conditions while transitioning from small-scale laboratory setups to large-scale industrial operations. This necessitates a profound understanding of factors such as mixing, mass transfer, heat transfer, and the interplay between biological systems and engineering principles. Mixing is a vital aspect of bioreactor operation, ensuring uniform distribution of nutrients and gases crucial for optimal growth conditions. However, as reactors grow in size, achieving efficient mixing becomes increasingly challenging, prompting the need for innovative strategies such as multiple impellers or specialized mixing techniques. Mass transfer, facilitating the movement of substances between phases, is another critical consideration in bioprocess scaling. Achieving sufficient mass transfer becomes more complex with expanding reactor volumes due to increased nutrient diffusion distances. Overcoming this challenge involves optimising agitation rates, aeration strategies, and reactor design to enhance mass transfer efficiency. Heat transfer poses yet another hurdle in bioreactor scale-up, with the generation and dissipation of heat becoming more pronounced in larger reactor volumes. Maintaining precise temperature control is essential for preserving cell viability and ensuring consistent product quality. Moreover, successful bioprocess scale-up requires a comprehensive understanding of the interplay between biological and engineering aspects. Factors such as cell physiology, metabolic pathways, and product formation kinetics must be meticulously evaluated alongside reactor design parameters. In conclusion, bioreactor scale-up is a multifaceted process demanding a holistic approach encompassing biological, engineering, and operational considerations. By grasping the introductory principles outlined in this article, bioprocess engineers can navigate the complexities of scale-up more effectively, facilitating the seamless translation of laboratory innovations to large-scale industrial production. Author BioFocus Newsroom Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

< Back BD Hit With Antitrust Lawsuit Over Hernia Mesh Market Power Rival Tela Bio claims pricing and contracting tactics shut out lower-cost alternatives, raising costs in a $12B surgical market. Becton Dickinson (BD) is facing a new legal challenge, this time from a competitor rather than patients. Tela Bio has filed an antitrust lawsuit in federal court in Philadelphia alleging that BD used its dominance in the U.S. hernia mesh market to stifle competition and block adoption of Tela’s OviTex reinforced biologic mesh. According to the complaint, BD leveraged conditional pricing, long-term bundling contracts and purchasing agreements with group purchasing organisations, integrated delivery networks and hospitals to penalise providers that stocked Tela’s products. Tela argues these tactics effectively excluded OviTex from the market despite its lower price point, about $3,000 per unit compared with roughly $4,500 for BD’s Phasix mesh, and limited its U.S. resorbable mesh share to under 8% in 2024. OviTex, cleared by the FDA in 2016, combines a sheep-derived extracellular matrix with synthetic fibres and is designed for open, robotic and laparoscopic hernia repairs. Tela claims its performance has been stronger in markets such as the UK, where BD does not hold similar contracting arrangements. BD’s mesh portfolio accounts for an estimated 65% of spending on permanent hernia mesh and 77% of the resorbable segment, according to the lawsuit. Tela says the alleged conduct has not only harmed its business but also driven up costs for hospitals and patients in a market that sees roughly 1.5 million procedures annually, representing about $12 billion in U.S. healthcare spending. “BD operates fairly in a complex, highly competitive industry, complying with all laws and regulations governing our commercial activities,” the company said in a statement to Fierce Medtech through a company spokesperson. “The allegations in this matter are without merit and BD will vigorously defend against these claims.” The case comes against the backdrop of extensive prior litigation over BD’s hernia mesh products. Last year, the company agreed to settle about 38,000 personal injury lawsuits, with Reuters reporting the deal covered a “large majority” of the $1.7 billion BD had set aside for mesh-related liability, without admitting wrongdoing. Author BioFocus Newsroom Previous Next

In a strategic move to strengthen its portfolio in the neurotechnology space, Stryker has acquired NICO Corporation, a specialist in minimally invasive brain surgery devices. < Back Stryker Acquires NICO Corporation In a strategic move to strengthen its portfolio in the neurotechnology space, Stryker has acquired NICO Corporation, a specialist in minimally invasive brain surgery devices. In a strategic move to strengthen its portfolio in the neurotechnology space, Stryker has acquired NICO Corporation, a specialist in minimally invasive brain surgery devices. This acquisition is part of Stryker’s ongoing expansion in the neurosurgical market, adding NICO’s advanced technologies to their already robust offering. With this deal, Stryker aims to enhance its capabilities in brain surgery, improving patient outcomes and driving innovation in the treatment of complex neurological conditions. Stryker Corporation is a global leader in medical technology, providing a wide range of products and services across orthopedics, medical and surgical devices, neurotechnology, and spine. Headquartered in Michigan, Stryker specializes in developing innovative solutions to improve patient care and surgical efficiency. Their portfolio includes advanced surgical equipment, robotic systems, implants, and technologies designed to treat a variety of medical conditions. Stryker operates in over 100 countries, working with healthcare professionals to enhance patient outcomes through cutting-edge medical innovations. NICO Corporation specializes in developing minimally invasive technologies for brain surgery, focusing on improving outcomes in tumor and stroke treatment. NICO’s devices enable neurosurgeons to access and remove brain tissue through small, precise openings, minimizing trauma to surrounding areas. Their innovative solutions, such as the BrainPath and Myriad systems, are used for tumor resection, hemorrhage evacuation, and other delicate brain procedures, making neurosurgical treatments safer and more effective for patients. Author BioFocus Newsroom Previous Next

Antibodies.com has moved to a new, five-times-larger headquarters at Cambridge Technopark to support rapid growth and better serve life science researchers worldwide. < Back Antibodies.com Supercharges UK Operations with Move to Larger Cambridge HQ Antibodies.com has moved to a new, five-times-larger headquarters at Cambridge Technopark to support rapid growth and better serve life science researchers worldwide. Antibodies.com , a leading provider of high-quality reagents for life science research, has today announced the opening of its new UK headquarters at Cambridge Technopark, a significant expansion that marks a new chapter in the company’s rapid global growth. The new 5,000 sq. ft facility, five times larger than its previous site, is designed to boost the company’s logistics, research and development (R&D), and operational capabilities, as it continues to scale with rising international demand. The move reinforces Antibodies.com ’s position within the UK’s thriving biotech cluster and enhances its ability to deliver faster, more customizable solutions to scientists worldwide. “This relocation isn’t just about more space, it’s about unlocking greater potential for innovation and service,” said Dr Stewart Newlove, Chief Technology Officer and Co-Founder of Antibodies.com . “Our new headquarters in the heart of Cambridge’s life sciences community allows us to scale more effectively, improve turnaround times, and continue supporting researchers at the forefront of antibody therapeutics.” Founded to meet the growing demand for affordable, high-performance biological reagents, Antibodies.com has tripled its global customer base in the last five years and now supports over 5,000 research institutions in more than 100 countries. Its extensive product catalogue, featuring over 100,000 items including antibodies, proteins, and ELISA kits, has become a go-to resource for scientists conducting cutting-edge biomedical research. The newly designed headquarters features expanded laboratory and logistics spaces, upgraded infrastructure to improve inventory and fulfilment systems, and state-of-the-art R&D facilities. Designed with sustainability and collaboration in mind, the space also includes shared meeting areas, breakout zones, and secure cycle storage, all aimed at fostering a dynamic and environmentally conscious workplace. With additional offices in Stockholm, Sweden, and St. Louis, USA, this expansion solidifies Antibodies.com ’s international footprint while reaffirming its commitment to customer-centric innovation and operational excellence. Author BioFocus Newsroom Previous Next

Despite the UK securing an initial trade agreement with the US, the pharmaceutical sector remains uncertain, as the deal notably omits specific provisions for medicines, leaving the industry awaiting clearer terms regarding potential tariffs and preferential treatment. < Back UK-US Trade Deal: What's in it for Pharma? Despite the UK securing an initial trade agreement with the US, the pharmaceutical sector remains uncertain, as the deal notably omits specific provisions for medicines, leaving the industry awaiting clearer terms regarding potential tariffs and preferential treatment. Hopes were high that the new UK-US trade deal would clear things up for one of Britain’s biggest exports—pharmaceuticals. Alas. Sure, the UK scored the first deal with the US since Donald Trump slapped on new tariffs back in April. But despite the hype about it being "full and comprehensive," pharma didn’t so much as get a mention when Trump and UK Prime Minister Keir Starmer announced their ‘agreement in principle.’ Instead, the focus was on cars, where US tariffs fell from 27.5% to 10%, and steel/aluminium, now tariff-free. Trump hasn’t hit medicines with tariffs (yet), so maybe it was wishful thinking to expect them to be part of this deal. The UK government did say talks will keep going on other sectors—including pharma—but for now, the industry is left waiting. Downing Street claims the UK will get "preferential treatment" if the US imposes tariffs on pharma imports—something that could happen very soon as part of a Section 232 investigation, which is the first step before tariffs are dropped. But here’s the problem: the UK exports £8.8 billion worth of medicinal and pharmaceutical products to the US every year—all currently tariff-free. If Trump goes ahead with new taxes, what does "preferential" even mean? Less painful? Slightly less painful? Politically, this deal is a big win for Starmer, especially as the UK becomes the first country to strike a deal in Trump’s new trade war era. The PM called it a victory for British jobs in cars and steel. But, for pharma, the question remains to be answered. This follows the UK’s trade deal with India , which the pharma industry called a missed opportunity—it didn’t fix issues like weak intellectual property protections for UK drugmakers. Bottom Line The UK-US deal is a start, but for pharma—one of Britain’s most valuable industries—it’s still a waiting game. Will the next round bring better news? Or just more tariffs? Author BioFocus Newsroom Previous Next