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Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France
Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland
Ranibizumab is a recombinant humanized…
NEWS
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Samsung Bioepis and Phrontline Biopharma have entered a global agreement to develop, manufacture, and commercialize two ADC assets, including TJ108
Under the deal, Phrontline will receive an upfront payment and potential milestone payments. Phrontline will develop bispecific, dual-payload ADCs using its proprietary platforms. As part of the agreement, Samsung Bioepis received exclusive rights to…
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The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…
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The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor
Trial met its 1EP of improved PFS by 38% (mPFS:…
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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…
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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…
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The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.
Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…
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The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts
Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…
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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…
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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…

