AstraZeneca (AZ) and Absci have entered into a collaboration agreement worth up to $247m to develop an artificial intelligence (AI)-designed antibody drug for a specified oncology target. The partnership will combine AZ’s capabilities in oncology research and development with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. The agreement includes an upfront commitment from AZ as well as research and development funding, milestone payments and royalties on product sales. Puja Sapra, senior vice president of biologics engineering and oncology targeted delivery at AZ, said: “This collaboration is an exciting opportunity to utilise Absci’s de novo AI antibody creation platform to design a potential new antibody therapy in oncology.” Absci outlines that its approach “overcomes the limits of traditional drug discovery”. ...
Direct-to-consumer telemedicine platform Hims & Hers launched a new weight loss program Monday that offers weight loss medications, educational content and digital tracking tools. San Francisco-based Hims & Hers is a health and wellness platform that provides support for sexual health, hair, skin, primary care, mental health and other areas. The launch of the new weight loss offering comes at a time when more people are battling obesity. About 42% of U.S. adults struggle with obesity, according to the Centers for Disease Control and Prevention. Compare that to more than 20 years ago when a little over 30% struggled with obesity. The company’s new program starts with a consultation with a licensed healthcare provider from Hims & Hers. If considered appropriate, the patient will then receive a personalized treatment plan that is based on several factors, including the person’s body, health history and goals. The treatment plans have three elements. ...
Dive Brief Intuitive Surgical’s venture capital arm has launched a second investment fund with $150 million in new capital. The Intuitive Ventures fund will support startups focused on improving healthcare access and coordination, developing precision diagnostics and interventions, and integrating digital technology, the firm said Monday. The new fund follows the launch of Intuitive’s first venture capital fund three years ago and brings the firm’s total assets under management to $250 million. Dive Insight The robotic surgery leader is among a number of large medtech companies to establish a venture capital operation dedicated to supporting a portfolio of early-stage companies. GE HealthCare, Johnson & Johnson and Boston Scientific have also launched venture funds. The venture has since invested in more than 10 startups, supported by Intuitive Surgical’s network and corporate oversight. Those companies include Capstan Medical, Endogenex, Flywheel, KelaHealth, MedCrypt, Neocis Optellum and Surge Therapeutics. “Fund II deepens Intuitive’s commitment ...
BY CHRIS NEWMARKER ExactechGPS Ankle [Image courtesy of Exactech]Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle. The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan. Designed to improve surgical precision, the ExactechGPS Ankle combines propriety active tracker technology with a touchscreen tablet, providing dynamic feedback to surgeons during procedures. “I am already a fan of Exactech’s patient-specific instrumentation solution and am thrilled how GPS Ankle provides intraoperative flexibility at my fingertips. The ability to quantify soft tissue laxity will be a game changer for me and my patients,” said design team surgeon Dr. Edward Haupt of the Mayo Clinic in Florida. GPS Ankle has compatibility with Exactech’s flagship Vantage Total Ankle System. It will be available to hospitals ...
Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024. Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024. Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens. The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval. ImmunoGen reported $105.2m in ...
As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
The European Commission (EC) has approved UCB’s Zilbrysq (zilucoplan) as an add-on therapy for certain patients with generalised myasthenia gravis (gMG), a rare autoimmune disease with a global prevalence of 100 to 350 cases per one million people. The marketing authorisation, which specifically applies to adults who are anti-acetylcholine receptor (AChR) antibody-positive, makes Zilbrysq the first once-daily subcutaneous, targeted component 5 (C5) complement inhibitor for gMG. Patients with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty swallowing, chewing and talking, and life-threatening weakness of the muscles of respiration. UCB’s Zilbrysq inhibits complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action, the company said, adding that the therapy can be used simultaneously with intravenous immunoglobulin and plasma exchange without the need for supplemental dosing. The EC’s decision was supported by positive results from the late-stage ...
At the 2023 Reaching the Last Mile (RLM) Forum during the United Nations Climate Change Conference (COP28), global donors pledged $777.2m to help control, eliminate and eradicate neglected tropical diseases (NTDs). The funding will accelerate progress towards achieving the goals outlined in the World Health Organization’s (WHO) 2030 roadmap on NTDs. The forum, hosted by RLM in partnership with the Bill & Melinda Gates Foundation, comprised over 450 government ministers, global health leaders and development experts, philanthropists and civil society leaders to mitigate the effects of the climate crisis on human health. Established in 2020, WHO’s roadmap for NTDs includes eliminating at least one NTD in 100 countries by 2030 and reducing the number of people requiring NTD treatment by 90%. Despite progress, climate change has slowed the reach and prevalence of infectious diseases. NTDs are a diverse group of several parasitic viral, bacterial, fungal and non-communicable diseases that can ...
By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
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