By Kate Goodwin Pictured: Novartis Building/iStock, JHVE Photo With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year. In two late-stage studies, remibrutinib met the primary endpoint of change from baseline in a weekly urticaria activity score at week 12. While studies will continue for a full year, the BTK inhibitor demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks. Patients with chronic spontaneous urticaria (CSU) deal with chronic hives that can last for six weeks or longer. The trigger is internal, as opposed to allergen exposure. While antihistamines are the first line of treatment, around 60% of patients’ symptoms are inadequately controlled with antihistamines alone. ...
By Meg Tirrell, CNN The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart-related death by 20% in what’s being called a landmark clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects. Novo Nordisk studied Wegovy against placebo in addition to standard of care for prevention of major adverse cardiac events in 17,604 adults with heart disease and obesity or who were overweight, but who didn’t have diabetes. It called the five-year trial “Select.” The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes. “Historically, trials ...
Astellas Pharma and Poseida Therapeutics have announced a strategic investment to support Poseida’s commitment to redefining cancer cell therapy. Under the terms of the agreement, Astellas will invest a total of $50m, including $25m to acquire 8,333,333 in shares of the common stock of Poseida, as well as a one-time $25m payment for a right of exclusive negotiation and the first refusal to licence one of Poseida’s clinical stage programmes. In oncology, Poseida’s research and development of cell and gene therapies for cancer and rare genetic diseases provides a broad pipeline of allogeneic CAR-T cell therapy product candidates for solid and liquid tumours. This includes P-MUC1C-ALL01, an allogeneic CAR-T cell therapy that is currently in phase 1 development for multiple solid tumour indications. The company has provided Astellas with a board observer seat to allow it to attend scientific advisory board meetings, as well as certain notice rights related to ...
Celmatix and Aché Laboratórios have announced a partnership and license option agreement to research novel peripherally preferred melatonin receptor agonists. The partnership aims to address unmet needs in women’s health by developing first-line therapies for different indications, beginning with polycystic ovary syndrome (PCOS). This news follows Celmatix’s April press release where it announced its melatonin receptor agonist program. The New York, USA- based Celmatix is a preclinical-stage biotech focusing specifically on ovarian biology. Its drug program uses artificial intelligence and computational methods for drug design. The biotech’s melatonin receptor agonists target melatonin receptor type 1A (MTNR1A) and melatonin receptor type 1B (MTNR1B) to improve endocrine, metabolic and reproductive traits in PCOS. In the collaboration, the two companies will work together to investigate the potential of the drug candidate for PCOS. Following the successful completion of these studies, the biotechs plan to enter a separate license and development agreement. PCOS is ...
Dive Brief Guardant Health and Illumina have reached an agreement to settle litigation and extend a long-standing commercial partnership to advance cancer research, Guardant announced last week. The three-year agreement includes a joint request to dismiss with prejudice the pending litigation between the companies, including allegations of intellectual property theft. In addition, the companies will collaborate by sharing specimen samples and entering into a new long-term purchase and supply commitment, the Palo Alto, California-based cancer test maker said. Dive Insight DNA sequencing company Illumina last year sued Guardant co-CEOs and founders Helmy Eltoukhy and AmirAli Talasaz for breach of contract and alleged misappropriation of trade secrets. The lawsuit accused Eltoukhy and Talasaz of working on technology for Guardant while still employed by Illumina. Guardant at the time called the lawsuit an attempt to stifle competition and retaliate against the company for registering concerns about the antitrust implications of Illumina’s acquisition ...
Researchers at Kobe University discovered an entirely new and unexpected mechanism by which the immune system can get rid of cells lacking molecules that identify them as part of the self in mice. The finding, published in PNAS, has possible implications for cancer treatment. The immune system comprises many types of cells that work together to fight off diseases. Two important types are dendritic cells and T cells. Dendritic cells are located in strategic positions throughout the body including the gut and skin, as well as in the lymph nodes, sample their environment and present small components derived from these samples on their surface. T cells check these samples and if they recognize them as foreign (or “non-self”), they will initiate an immune response, otherwise they will move on. The ability to distinguish self from non-self is therefore a key characteristic of the immune system and T cells undergo very ...
By Connor Lynch Pictured: Gloved hand holding syringe in front of Novavax sign, Courtesy of rafapress/Getty Images Embattled vaccine maker Novavax is back in the black—at least, for now. In its second-quarter financial update Tuesday, the Maryland-based biotech posted a surprise $58 million in net income compared to a net loss of $510 million in the same period last year. Novavax reported second-quarter sales of $424.4 million, a significant increase from the expected $239.2 million in the quarter and $185.9 million during the same period in 2022. The latest update saw the biotech trim its full-year revenue forecast, but it is still anticipating between $1.3 and $1.5 billion in sales and grants, down from the $1.4 billion to $1.6 billion guidance provided in May. The company also entered into a stock purchase agreement with SK Bioscience, with Novavax issuing 6.5 million shares at $13 each to the South Korean company ...
Novo Nordisk has been riding the momentum of weight loss drug Wegovy ever since it stormed onto the market in 2021, creating widespread hype and even some supply shortfalls. But, now, a cardio outcomes trial could seriously change the game for the burgeoning medicine. In a large phase 3 trial, the drug cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy’s 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke. The trial enrolled 17,604 people and tested the drug for up to five years in people 45 and older who were overweight or obese and who had established cardiovascular disease. To be eligible for the trial, patients had to have had no history of diabetes. Based on the trial win, Novo Nordisk said it expects to seek ...
Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
Merck & Co – known as MSD outside the US and Canada – and Ginkgo Bioworks have announced a new biologic manufacturing collaboration worth up to $490m. The partnership will utilise Ginkgo’s capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterisation and process optimisation to improve production efficiency and increase yields. In exchange, Ginkgo could receive up to $490m in upfront research fees, research milestone fees, option licence payments and commercial milestone payments. Jason Kelly, chief executive officer and co-founder of Ginkgo, said: “We’re thrilled to leverage our platform to improve the production of biologics in collaboration with Merck. “In particular, we will utilise some of our unique capabilities, such as automated protocols to do predictive ultra high-throughput multiplexed screening, product characterisation and process optimisation.” Also commenting on the collaboration, Dr Michael Kress, senior vice president, development sciences and clinical supply at Merck Research Laboratories, said: “At Merck we ...
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