Shots:
The CVMP has recommended Vaxxitek HVT+IBD+H5 & Vaxxinact H5 for active immunization of birds against H5 avian influenza virus
Vaxxitek HVT+IBD+H5 is a trivalent vaccine providing single-dose protection against Marek’s disease, Infectious Bursal Disease, & H5 avian influenza in chickens & turkeys, while Vaxxinact H5 is an inactivated vaccine that protects chickens, turkeys, & ducks…
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The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations
Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC
Oncomine Dx Target Test, first…
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GE HealthCare has entered into an agreement to acquire Intelerad, expanding its cloud-enabled & AI-powered solutions portfolio
As per the deal, GE HealthCare will acquire Intelerad for a purchase price of $2.3B in cash; closing is expected in H1’26
Acquisition will add Intelerad’s cloud-enabled radiology & cardiology imaging platforms & outpatient enterprise workflow solutions…
Shots:
Valo Health has entered into a strategic collaboration with Merck KGaA to accelerate therapeutic discovery for Parkinson’s disease & related neurodegenerative disorders
As per the deal, Valo Health will receive an upfront & milestone payment totaling over $3B, with royalties & R&D funding
Collaboration will use Valo’s AI-enabled human causal biology platform to discover &…
Shots:
Abbott has entered into a definitive agreement to acquire Exact Sciences, making Exact a subsidiary of Abbott upon deal completion
As per the deal, Abbott will acquire Exact Sciences for $105 per share, representing a total equity value of ~$21B & an estimated enterprise value of $23B, with financing that includes absorbing Exact’s ~$1.8B in…
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The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review
Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in…
Shots:
The US FDA has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)
Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries, incl. North America, South America, Europe, Asia…
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The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states
Approval was based on extensive data, incl.…
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The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537)
Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
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The P-III (GLORY-2) trial assessed mazdutide (9mg) plus lifestyle intervention vs PBO in 462 Chinese adults with obesity (BMI ≥30kg/m²), incl. 16% with T2D, with an NDA submission to the NMPA planned in the near term
Trial met its 1EP, showing continuous weight loss with no plateau through Wk. 60, with pts achieving a…

