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What’s in Today’s Brief? (January 27th Preview)
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FDA lifts partial hold on Intellia CRISPR trials — one study cleared
The U.S. Food and Drug Administration has removed a clinical hold on one of two Phase 3 trials testing Intellia Therapeutics’ CRISPR-based therapy for transthyretin amyloidosis (ATTR). The action follows a grade 4 liver event and a fatality reported in the sister study; the agency allowed a non-cardiac ATTR study to resume while the cardiac ATTR trial remains paused. Intellia and regulators will need to reconcile safety signals from the halted study with data collection plans for the resumed program. The FDA’s selective clearance preserves a pivotal pathway for Intellia’s lead asset but maintains heightened oversight of dosing and hepatic risk assessments. Clinical sites and investigators will now restart enrollment under revised monitoring protocols.
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Insilico and Qilu ink $120M pact — AI fuels cardiometabolic push
Insilico Medicine and Qilu Pharmaceutical signed a collaboration worth up to $120 million to co-develop AI-enabled small molecules targeting cardiometabolic disease. The deal pairs Insilico’s generative and screening platforms with Qilu’s development and regional commercialization capabilities, creating a joint path for discovery through early development. Qilu’s commitment positions the Shanghai-based pharma to accelerate its cardiometabolic pipeline while giving Insilico a sizable near-term commercial partner for AI-designed candidates. Financial terms include upfront payments and milestone structures; the alliance follows a string of similar AI-driven drug discovery partnerships announced by Insilico in recent months.
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Boehringer inks billion-euro IBD bet with Simcere — bispecific licensed
Boehringer Ingelheim struck a license and collaboration deal with China’s Simcere to develop SIM-0709, a preclinical TL1A×IL‑23p19 bispecific for inflammatory bowel disease. The agreement includes approximately €42 million upfront and potential payments that could top €1.05 billion, reflecting the market value placed on novel IBD modalities. Under the pact, Boehringer will lead clinical development and global commercialization while accessing Simcere’s preclinical program. The transaction demonstrates continued big‑pharma appetite for multispecific biologics in immunology and provides Simcere with a substantial non-dilutive financing avenue.
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Roche advances obesity program — dual agonists head to Phase 3
Roche reported strong mid-stage weight‑loss data for a dual GLP‑1/GIP receptor agonist and is preparing Phase 3 studies after patients in a near‑year trial achieved clinically meaningful weight reductions. Separately, Roche said a GLP‑1/GIP candidate from Carmot produced 22.5% placebo‑adjusted weight loss at 48 weeks, underpinning Roche’s decision to escalate its obesity portfolio. The readouts validate Roche’s late‑stage investment in incretin biology and add competitive pressure to existing GLP‑1 incumbents. Roche’s progression to Phase 3 will expand the field of dual-agonists and intensify competition in regulatory filings and payer negotiations.
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GLP‑1 patent surge — Novo Nordisk and Chinese groups file new agonists
Intellectual property activity in incretin therapeutics accelerated this week as Novo Nordisk disclosed new GLP‑1 receptor agonist polypeptide analogues and Chinese research groups and companies published patent filings for GLP‑1R agonists. The filings span claims on modified peptides and delivery-relevant sequences intended for obesity and diabetes treatment. The wave of patents reflects continued R&D investment following commercial success for GLP‑1 drugs and a push to secure next‑generation sequences and formulations. Expect heightened freedom‑to‑operate negotiations and licensing activity as companies seek to protect or access optimized incretin scaffolds.
...and 5 more selected Biotech stories in today’s full edition.
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