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Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges

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. ...
- Source: drugdu
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- August 11, 2023
Wegovy shown to reduce risk of heart attack, stroke in major cardiovascular trial

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 ...
- Source: drugdu
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- August 11, 2023
BioNTech and Duality Biologics add third ADC candidate to oncology partnership

BioNTech and Duality Biologics have expanded their existing agreement to include a third antibody-drug conjugate (ADC) for solid tumours. The companies announced the first deal covering two ADCs in April this year. Under the terms of the agreement, DualityBio would receive upfront payments totalling $170m and be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said at the time of the first announcement: “Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as ...
- Source: drugdu
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- August 11, 2023
Astellas invests $50m to support advancement of Poseida’s cancer cell therapy

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 ...
- Source: drugdu
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- August 11, 2023
Eco-minded AstraZeneca doubles down on renewable energy push in Sweden

AstraZeneca is often at the forefront when it comes to sustainability efforts among pharma companies. Now, the British drugmaker is doubling down on its clean energy commitments in Sweden. AstraZeneca and Stratkraft—Europe’s largest renewable energy producer—have entered into an agreement on wind power deliveries that will increase the supply of renewable electricity in Sweden based on the commissioning of new wind farms, the companies said Wednesday. Under the deal, AZ will purchase 200 gigawatt-hours per year for 10 years, the partners explained. That amount corresponds to roughly 80% of the company’s total electricity needs at its research facility in Gothenburg and its manufacturing plant in Södertälje. The wind farms for this project will be located in Strömstad and Årjäng, in the same region as AZ’s research and manufacturing facilities. Across its Swedish operations, AstraZeneca is also working to cut back on its electricity consumption. One way it’s meeting this goal ...
- Source: drugdu
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- August 11, 2023
Celmatix and Aché Laboratórios partner to tackle unmet need for PCOS drugs

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 ...
- Source: drugdu
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- August 11, 2023
Guardant, Illumina agree to end litigation, extend commercial partnership

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 ...
- Source: drugdu
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- August 10, 2023
Dendritic cells found to kill CD47-deficient T cells

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 ...
- Source: drugdu
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Novo’s Wegovy Protects Heart Health in Overweight, Obese Adults

By Tristan Manalac Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies. SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT. Novo was trading approximately 11% higher in pre-market Tuesday following the data drop. The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk ...
- Source: drugdu
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- August 10, 2023
Novavax Posts Surprise Q2 Profit, Hinges Hopes on Updated COVID Shot

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 ...
- Source: drugdu
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- August 10, 2023

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