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Obesity drug development—dual-acting GLP-1/glucagon
Boehringer Ingelheim reported Phase 3 results for survodutide, a dual-acting obesity injection, showing substantially greater weight loss than placebo in its Synchronize-1 study. In participants...
Regulatory action—FDA alleges data manipulation and targets Tavneos
The FDA escalated its action against Amgen’s Tavneos (immunosuppressant for a rare disease), alleging that trial data supporting the drug’s approval were manipulated. The agency moved to withdraw...
CRISPR in vivo—Phase 3 win and FDA filing path
Intellia Therapeutics reported Phase 3 success for lonvo-z, an in vivo CRISPR-based therapy for hereditary angioedema, hitting the study’s primary endpoint and cutting attack rates by 87% versus...
Big pharma dealmaking—Lilly buys Ajax for next-gen JAK
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion, adding a next-generation JAK2 inhibitor program for myeloproliferative neoplasms to its hematology pipeline. The deal brings...
Dermatology pipeline—Oruka’s IL-23 leads to high PASI responses
Oruka Therapeutics reported strong Phase 2 psoriasis results for ORKA-001, including total skin clearance in 40 of 63 patients (63.5%) at 16 weeks. The company said 83% of patients achieved PASI...
Diagnostics—FDA Breakthrough Device for mRNA blood test in psychiatry
Laguna Diagnostics said its mRNA Gene Biomarker blood test for differentiating schizophrenia from bipolar I disorder received FDA Breakthrough Device Designation. The assay is intended to generate...
Acquisition—Sun Pharma to buy Organon for $11.75B
Sun Pharmaceuticals agreed to acquire Organon & Co. in an all-cash deal valued at $11.75 billion, aiming to expand its women’s health portfolio and strengthen its biosimilar business. Organon’s...
Immuno-oncology platform deal—Kahimmune and Gustave Roussy
Kahimmune Therapeutics partnered with Gustave Roussy to use patient samples from treated individuals to generate neoantigen data for Kahimmune’s first mRNA therapeutic candidate. The collaboration...
Clinical development—Faron hires Parexel for bexmarilimab Phase 2 in HR-MDS
Faron selected Parexel to run its Phase 2 program for bexmarilimab in higher-risk myelodysplastic syndromes, covering sites in the US, UK, and Europe. The study, described as BEXERA Phase 2b, is...
Funding—AI protein design startup Fathom raises $47M Series A
Fathom Therapeutics, formerly Atommap, raised a $47 million oversubscribed Series A to advance its Microcosmos drug design engine. The platform uses physics-based simulations and AI to model...
Regulatory action and enforcement moves
The FDA escalated its effort to remove Tavneos (amgen) from the market, alleging trial manipulation that tainted the data supporting approval. The agency’s action adds a new layer of regulatory...
AI-enabled molecular medicine deals
Eli Lilly struck a collaboration with AI-focused biotech Profluent to develop next-generation gene editors that could enable insertion of entire genes. The companies did not detail the number of...
Big pharma dealmaking for blood cancer pipeline
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion in cash, securing a clinical-stage JAK2 inhibitor for myeloproliferative neoplasms. Ajax’s lead asset, AJ1-11095, is a Type II...
Regenerative diagnostics and platform commercialization
Nautilus Biotechnology reported narrower Q1 losses and began rolling out early access for its Voyager protein analysis platform. The Seattle-based company said it reduced its net loss to $14.7...
Precision diagnostics platform FDA progress in psychiatry
Laguna Diagnostics’ blood-based mRNA Gene Biomarker test for differentiating schizophrenia from bipolar I received FDA Breakthrough Device designation. The test, intended for use alongside...
Oncology: in vivo CRISPR nears FDA filing after Phase 3 win
Intellia reported Phase 3 success for its in vivo CRISPR therapy lonvo-z in hereditary angioedema, setting up regulatory steps toward potential FDA approval. The biotech said the therapy met its...
Company earnings and guidance: diagnostics demand headwinds
Qiagen lowered its full-year 2026 guidance after reporting preliminary Q1 net sales growth that missed expectations and remained pressured by external demand shifts. The company reported...
Autoimmune pipeline asset: Oruka’s psoriasis data
Oruka Therapeutics posted Phase 2 results for ORKA-001 in plaque psoriasis, reporting that 63% of patients achieved complete skin clearance at 16 weeks and that updated exposure data supports...
Procurement and reimbursement friction: prior authorization remains a bottleneck
Healthcare organizations are finding that digitizing medical policy and implementing FHIR APIs does not automatically solve prior authorization delays at scale. The issue is that medical-necessity...
Oncology: pancreatic and lung RAS inhibitor early clinical signals
Erasca released preliminary clinical data for ERAS-0015, reporting tumor shrinkage in subsets of patients with advanced pancreatic cancer and advanced non-small cell lung cancer. The company said...