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OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Shots: OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD) The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…

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Insilico Medicine and CMS Enter Multiple Collaborations to Advance Therapeutics in CNS and Autoimmune Indications

Shots: Insilico Medicine has entered into multiple AI-powered drug discovery collaborations with CMS, focusing on advancing therapeutic programs across CNS & autoimmune disease indications As per the deal, Insilico will leverage its Pharma.AI platform for target discovery & small-molecule design & optimization, while CMS will lead clinical development, regulatory strategy, trials, & commercialization Under the…

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Takeda

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Shots: The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26 NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…

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NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…

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Iambic Therapeutics Partners with Takeda to Advance AI-Driven Drug Discovery in Oncology and GI/Inflammation

Shots: Iambic has partnered with Takeda in a multi-year tech & discovery collaboration to utilize Iambic’s AI drug discovery models toward advancing select high-priority small molecule programs in Takeda’s Oncology, & GI & Inflammation therapeutic areas The collaboration will leverage Iambic’s AI drug discovery suite & wet lab capabilities, with Takeda also gaining access to…

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Eli Lilly to Acquire Orna Therapeutics for ~$2.4B

Shots: Eli Lilly has entered into a definitive agreement to acquire Orna Therapeutics, gaining a broad platform to drive long-term innovation in genetic medicine & in vivo cell engineering As per the deal, Lilly will acquire Orna, with Orna’s shareholders receiving up to $2.4B in cash, incl. an upfront & subsequent clinical development milestones payment Acquisition…

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MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Shots: MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion…

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