As global leaders and industry power players gather in Davos to address the world’s most pressing problems, the World Economic Forum’s (WEF) AI Governance Alliance (AIGA) has called for stronger collaboration to create a framework for advanced AI. In a series of three new reports, AIGA has focused on unlocking the value and creating a framework for generative AI (GenAI) usage. AIGA said a global effort is needed to create equitable access to AI. According to Cathy Li, head of AI, data and metaverse at the WEF: “The AI Governance Alliance is uniquely positioned to play a crucial role in furthering greater access to AI-related resources, thereby contributing to a more equitable and responsible AI ecosystem globally.” “We must collaborate among governments, the private sector and local communities to ensure the future of AI benefits all,” she added. AIGA has called for experts in various sectors to address key areas ...
After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
Lundbeck wants migraine suffers to say “nope” to doing more and “yep” to doing less with their condition as the core message of its new campaign for Vyepti. The “Say Yep” initiative plays on the yep in Vyepti, the pharma’s intravenous migraine prevention therapy that was approved by the FDA exactly four years ago next month. The therapy brought in DKK 1 billion ($145.9 million) in 2022, double what it made in 2021 and driven by what Lundbeck said was “strong demand.” The multi-channel media campaign is trying to reach the 40 million Americans who suffer from the often-debilitating condition. The message is to slow down and not push through the pain of a migraine. The campaign “brings to life the brand’s empathetic understanding that people are doing a lot to manage migraine and deserve to do a little less, if possible,” a spokesperson from Lundbeck said. “Say Yep subtly ...
Considering trial setbacks and cash concerns, Satsuma Pharmaceuticals faced an uphill climb to even file for approval of its migraine spray treatment at the FDA. Now, the agency has thrown another wrench in the company’s commercial hopes by issuing a manufacturing-related complete response letter. In rejecting the application, the agency cited chemistry, manufacturing and controls concerns, Satsuma’s parent company, Shin Nippon Biomedical Laboratories, said in a press release. The agency did not flag issues with the clinical data package or request new trials. “We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible,” Satsuma’s CEO Ryoichi Nagata, M.D., Ph.D., said in the release. The company will detail potential timing for a resubmission after consulting with the FDA. The update is just the latest in a series of setbacks for Satsuma and its migraine asset, dubbed STS101. After coming up short two ...
CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
Pharmaceutical Executive Editorial Staff Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease. The FDA has granted another approval to Vertex Pharmaceuticals’ and CRISPR Therapeutics’ gene-editing therapy Casgevy (exagamglogene autotemcel [exa-cel]) as a one-time treatment for transfusion-dependent beta thalassemia (TDT) in patients 12 years of age and older.1 Last month, Casgevy became the first FDA-approved novel genome editing technology for sickle cell disease (SCD), which was a significant advancement in gene therapy. The latest approval was months ahead of the FDA’s assigned Prescription Drug User Fee Act (PDUFA) date. “We are pleased with the approval of Casgevy in TDT well ahead of the PDUFA date,” said Samarth Kulkarni, PhD, chairman and chief executive officer of CRISPR Therapeutics.2 “The approval is a reflection of the power and versatility of the CRISPR ...
Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark Office (U.S. PTO) has handed Daiichi the latest win in the saga. For years, the companies have clashed over Seagen’s so-called “‘039 patent,” which covers certain peptides conjugated to an antibody through various linkers. After a 2008 antibody-drug conjugate (ADC) partnership between the drugmakers ended in 2015, Daiichi Sankyo entered into a lucrative agreement with AstraZeneca to work on what became the cancer blockbuster Enhertu. Seagen staked a claim on the AZ contract in a 2020 lawsuit, arguing that the technology used for the med was created under its previous Daiichi ADC partnership. In 2022, a Texas jury found that Daiichi Sankyo stepped on Seagen’s patent willfully, awarding the latter company $41.8 million in royalties. The now Pfizer-owned company took its case a step further by asking for royalties from future U.S. ...
Encased within a complex network of specialized blood vessels, the brain remains the body’s most protected organ. This intricate structure, while protective against external threats, poses significant challenges for researchers seeking to understand gene expression dynamics and their link to diseases. Addressing this challenge, scientists have now introduced a noninvasive method to track gene expression in the brain, potentially transforming research in brain development, cognitive function, and neurological disorders. The team of scientists at Rice University (Houston, TX, USA) has developed a groundbreaking class of molecules named released markers of activity (RMAs). These RMAs offer a noninvasive solution to measure gene expression in the brain via a simple blood test. Traditionally, assessing gene expression in the brain has been limited to post-mortem analysis or less sensitive and specific modern neuroimaging techniques. The RMA platform, however, introduces a synthetic gene expression reporter into the brain, which synthesizes a protein capable of ...
Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation. By FRANK VINLUAN The lead therapeutic candidate of Allakos has failed in two mid-stage clinical trials for inflammatory skin disorders, leading the biotech to halt work on the drug. Allakos is shifting its focus to an earlier-stage program in its pipeline but will do so with fewer staff. A corporate shakeup is shaving about half of the company’s workforce. San Carlos, California-based Allakos aims to treat allergic, inflammatory, and proliferative diseases with antibodies that target receptors on cells that create immune responses in the body. By activating inhibitory receptors, these drugs are intended to stop inflammation. Its most advanced drug candidate was lirentelimab, which was designed to target an inhibitory receptor on mast cells ...
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