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AbbVie and Gubra entered into a global license agreement to develop & commercialize GUB014295, a potential long-acting amylin analog for obesity treatment
As per the deal, AbbVie will lead GUB014295's global development & commercialization, whereas Gubra will get $350M upfront, up to $1.875B development, commercial, sales milestones, with tiered royalties; transaction closure is…
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The EC has approved Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.) in 30 EEA states; launch expected in H1’25. MAA under the UK’s MHRA review with decision anticipated in H1’25
Approval was based on 2 P-III studies that met their 1EP of rapid immune response in 1wk. with ~97.8% of participants…
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BBOT will reverse merge with Helix in a SPAC transaction, where combined entity - "BBOT” will be listed on Nasdaq; closing expected in Q3’25
Upon closing, BBOT will have ~$550M cash (pre-transaction) incl. $100M in existing cash, $196M from Helix’s trust & $260M from PIPE financing. At $10.36/share, the combined entity's implied pro…
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The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP
Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…
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The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025)
Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then…
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The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025
Opinion was based on various clinical data, incl. P-I/II (GEM-1)…
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Magnet Biomedicine & Eli Lilly have entered into a collaboration & license agreement to identify, develop & commercialize molecular glue therapeutics in oncology using Magnet's TrueGlue discovery platform
As per the deal, Magnet will get ~$40M in upfront, near-term payments & equity, plus more than $1.25B in milestones across development, regulatory, & commercial…
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Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US
Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…
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The US FDA has approved Odactra tablet to treat house dust mite (HDM) induced allergic rhinitis, with or without conjunctivitis, in children (5-11yrs.). Regulatory review in Canada is ongoing
Approval was based on P-III (MT-12) study assessing Odactra showed significant efficacy & safety in ~1,460 children across North America & EU. Data published…
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The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma
Patients in the trial have previously received 1-3 prior lines of therapy,…

