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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 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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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 company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy
FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization
FP008 is an anti-PD-1×IL-10M fusion protein with a…
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The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25
Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper…
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Teleflex to acquire BIOTRONIK's vascular intervention business for ~$797.7M (€760M) in cash, subject to adjustments. Closing expecting in Q3’25
Acquisition will expand Teleflex’s interventional portfolio with coronary products like Pantera Lux Catheter, PK Papyrus Covered Stent & Orsiro Stent, plus peripheral product like Passeo-18 Lux Catheter, Dynetic-35 Stent, & Pulsar-18 T3 4F Stent,…
Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
Shots:
The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health
Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19)
Under the…

