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Glaukos Receives FDA Approval for Epioxa
Shots: Glaukos reported the US FDA approval of Epioxa HD/Epioxa, an incision-free, topical drug therapy for keratoconus, offering a non-surgical alternative to traditional corneal cross-linking The approval was based on two P-III pivotal studies (>400 pts) that met its pre-specified 1EPs strong efficacy and safety; Epioxa uses a UV-activated, oxygen-enriched formulation that preserves the corneal…
Boston Scientific to Acquire Nalu Medical for ~$533M
Shots: Boston Scientific has entered into a definitive agreement to acquire Nalu Medical, expanding its neuromodulation portfolio for chronic pain with the Nalu Neurostimulation System As per the deal, Boston Scientific will acquire the remaining equity of Nalu Medical for ~$533M in cash, in which it has been a strategic investor since 2017; closing expected…
Blackstone and TPG Acquire Hologic for ~ $18.3B
Shots: Hologic has agreed to be acquired by Blackstone and TPG for up to $79 per share, valuing the deal at up to $18.3B. The deal is expected to close in H1'26 As per the deal, Blackstone and TPG will acquire all Hologic shares for $76 per share in cash plus a non-tradable CVR worth…
Teva and Prestige Biopharma Sign a Licensing Agreement to Commercialize Tuznue (Biosimilar, Herceptin) Across EU
Shots: Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities Tuznue, biosimilar of Herceptin, with…
Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Shots: Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III study Across all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
Celltrion
FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients
Shots: The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.) Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…