{"id":10645,"date":"2025-04-22T16:08:55","date_gmt":"2025-04-22T20:08:55","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=10645"},"modified":"2025-04-22T16:08:55","modified_gmt":"2025-04-22T20:08:55","slug":"life-sciences-voice-top-five-newsletter-38","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/life-sciences-voice-top-five-newsletter-38\/","title":{"rendered":"Life Sciences Voice Top Five Newsletter"},"content":{"rendered":"

Welcome to this week\u2019s edition of the <\/span>Life Sciences Voice Top Five Newsletter<\/span><\/i>, your go-to source for the latest breakthroughs in the life sciences industry! This time, we\u2019re taking a look at how liver safety concerns have halted the development of Pfizer\u2019s lead obesity asset, Merck\u2019s deal with Cyprumed to leverage its oral peptide platform, the success of Lilly\u2019s oral GLP-1 receptor in a phase 3 trial, and other top news! Stay informed and inspired by the innovations driving life sciences forward!<\/span><\/p>\n

Pfizer Ends Development of Danuglipron Following Liver Safety Concerns<\/b><\/a><\/p>\n

Pfizer has ceased development of its oral GLP-1 drug danuglipron due to a potential case of drug-induced liver injury observed during dose-optimization trials. The affected patient showed no symptoms, and the condition resolved after discontinuation. Despite liver enzyme levels being comparable to similar drugs, Pfizer opted to stop development after regulatory discussions. Danuglipron had shown high adverse event rates, including nausea (73%), vomiting (47%), and over 50% discontinuation across doses. Following a prior formulation setback, the drug was reintroduced as a once-daily pill but was now abandoned. Pfizer\u2019s remaining obesity candidate is PF-07976016, currently in Phase II trials.<\/span><\/p>\n

Merck Licenses Cyprumed\u2019s Oral Peptide Delivery Platform in $493 Million Deal<\/b><\/a><\/p>\n

Merck & Co. has entered a licensing agreement with Austria-based Cyprumed, potentially worth up to $493 million, to access Cyprumed\u2019s oral peptide delivery platform for an undisclosed number of drug targets. The nonexclusive deal includes upfront and milestone-based payments tied to development, regulatory, and commercial progress. Merck may secure exclusive rights to specific targets later. The company will oversee all R&D and commercialization efforts. Cyprumed\u2019s technology enhances peptide oral bioavailability using approved excipients. This agreement follows Merck\u2019s earlier peptide-related deals, including with Unnatural Products and ongoing development of MK-0616 and efinopegdutide in its peptide pipeline.<\/span><\/p>\n

Eli Lilly\u2019s Orforglipron Shows Comparable Results to Semaglutide in Phase 3 Trial<\/b><\/a><\/p>\n

Eli Lilly\u2019s oral GLP-1 receptor agonist orforglipron met its primary efficacy endpoint in a Phase 3 trial, showing A1C reductions of 1.3% to 1.6% over 40 weeks in people with Type 2 diabetes, compared to 0.1% with placebo. Weight loss ranged from 4.7% to 7.9%, with the highest dose group averaging a 7.3 kg reduction. Reported adverse events included diarrhea (up to 26%), nausea (18%), and indigestion (20%). The results are part of a larger clinical program, with additional Type 2 diabetes and obesity trials ongoing. Lilly plans to seek approval for obesity in 2025 and Type 2 diabetes approval in 2026.<\/span><\/p>\n

Vanda Sues FDA Over Restrictions on Off-Label Drug Promotion<\/b><\/a><\/p>\n

Vanda Pharmaceuticals has filed a lawsuit against the U.S. FDA, alleging that the agency\u2019s restrictions on off-label drug communication violate First Amendment rights. Filed on April 9 in the Southern District of Texas, the lawsuit centers on Vanda\u2019s desire to share clinical data supporting the use of Hetlioz, approved for non-24-hour sleep-wake disorder and Smith-Magenis syndrome, for jet lag, an unapproved indication. Vanda argues that FDA policies deter the dissemination of accurate, non-promotional information. This legal action follows prior disputes, including the FDA\u2019s rejections of Hetlioz for jet lag in 2019 and tradipitant for gastroparesis in 2024.<\/span><\/p>\n

Johnson & Johnson MedTech Begins First Human Trial of Ottava Surgical Robot<\/b><\/a><\/p>\n

Johnson & Johnson MedTech has completed the first clinical use of its Ottava surgical robot during a minimally invasive Roux-en-Y gastric bypass procedure at Memorial Hermann-Texas Medical Center. The system, which received FDA approval in fall 2023 to begin human trials, is intended for laparoscopic, open, and hybrid soft tissue surgeries. Initially slated for a 2022 debut, development was delayed by pandemic-related disruptions. Successful trial completion may lead to FDA de novo clearance for multiple upper abdominal procedures. Ottava integrates robotic arms with a movable patient table and is compatible only with instruments from J&J\u2019s Ethicon division.<\/span><\/p>\n

Exclusive Sponsor: <\/span>Axtria<\/span><\/a> – the leading global provider of cloud software and data analytics solutions to the life sciences industry.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Welcome to this week\u2019s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we\u2019re taking a look at how liver safety concerns have halted the development of Pfizer\u2019s lead obesity asset, Merck\u2019s deal with Cyprumed to leverage its oral peptide platform, […]<\/p>\n","protected":false},"author":1,"featured_media":10646,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[631],"tags":[],"class_list":{"0":"post-10645","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-newsletter"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10645","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=10645"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10645\/revisions"}],"predecessor-version":[{"id":10647,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10645\/revisions\/10647"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/10646"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=10645"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=10645"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=10645"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}