Shots:
The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states
Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation…
NEWS
Shots:
Otsuka, via its subsidiary Otsuka America, has entered into an agreement to fully acquire Transcend, with an aim to expand its portfolio in psychiatric & neurological indications
As per the deal, Otsuka will acquire Transcend for $700M upfront, & ~$525M in sales milestones, representing the total deal value of ~$1.225B; closing is expected in…
Shots:
Insilico has entered into a drug discovery collaboration with Eli Lilly to accelerate the discovery & development of novel therapeutics across multiple therapeutic areas using Insilico’s Pharma.AI
As per the deal, Lilly will gain exclusive global rights to develop, manufacture & commercialize Insilico’s preclinical oral candidates for select indications. Also, both will collaborate on…
Shots:
The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB)
MAA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries
Both trials met…
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Novartis has entered into an agreement to acquire Excellergy, incl. its asset Exl-111, strengthening Novartis immunology strategy in food allergy & other IgE-driven diseases
As per the deal, Novartis will acquire Excellergy for ~$2B, incl. upfront & milestone payments, with closing expected in H2’26
EXL-111 is engineered to dissociate receptor-bound IgE, enabling faster &…
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AstraZeneca reported data from replicate P-III (OBERON & TITANIA) trials assessing tozorakimab (300mg, Q4W) vs PBO over 52wks. on top of inhaled therapy in 2,306 adults with symptomatic COPD & prior exacerbations
The trial met its 1EP, reducing annualised rates of mod. to sev. COPD exacerbations in former smokers & the overall population, incl.…
Shots:
Insilico Medicine and Tenacia Biotechnology have expanded their AI-driven R&D collaboration to develop an additional CNS candidate with defined properties, advancing it to the preclinical candidate stage for neurological disorders
The initial collaboration, launched in Mar 2025, combined Insilico’s Pharma.AI platform with Tenacia’s CNS expertise to develop BBB-permeable small-molecule inhibitors, with the program progressing…
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The EC has approved Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg) across EEA markets
Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women
Preclinical and clinical data show that estetrol (E4) has…
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Abcuro has reported the P-II/III (MUSCLE) trial data assessing ulviprubart (ABC008; Q8W) in 272 IBM pts randomized to either 0.5mg/kg (n=94, Low Dose), 2mg/kg (n=92, High Dose), or PBO (n=86)
Across all pts, the 1EP showed a trend toward slower IBMFRS decline at Wk. 76, with a 1.7-point decrease in the low-dose group vs…
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The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26
Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in…

