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UK’s MHRA has approved Tepezza (teprotumumab) for the treatment of adult pts with mod. to sev. thyroid eye disease (TED)
Approval was based on extensive clinical data incl. P-III (OPTIC) trial (n=83), P-II (TED01RV) trial (n=88), P-IV (HZNP-TEP-403) trial (n=62) & P-III (OPTIC-J) trial in Japan (n=54)
OPTIC trial showed that 83% (34/41) of…
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China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levels
Approval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos.…
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The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions
Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
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ViVerita Therapeutics & BI have entered into a strategic research collaboration to accelerate discovery & validation of novel cancer targets. Although financial terms of the deal were not disclosed
As per the deal, ViVerita will utilize its in vivo CRISPR discovery platform to study selected potential targets from BI, evaluating their functions in physiologically relevant…
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Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based…
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Gilead has reported final P-III (MYR301) trial data assessing bulevirtide (QD) for 144wks. in 150 pts living with HDV, who were randomized to either bulevirtide (2mg, n=49 or 10mg, n=50) or no antiviral therapy arm (n=51); pts in no therapy arm were switched to 10mg after 48wks.
In the trial, 36% adults (23/64) with…
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Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927)
Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…
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The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25
The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…
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PBI-Gordon Companies has acquired TriviumVet, incl. its product Felycin-CA1 (Sirolimus Delayed-Release Tablets), adding it to the PRN Pharmacal portfolio (PBI-Gordon’s Brand) to expand its animal healthcare product portfolio
Felycin-CA1 will be available for veterinary orders by Aug 2025, with PRN Pharmacal expanding its team by hiring over 50 additional employees
Felycin-CA1 has been conditionally…
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Elanco has sold certain future royalties & milestones linked to Xdemvy (0.25% lotilaner ophthalmic solution) for human use, to Blackstone Life Sciences & Blackstone Credit & Insurance to reduce its debt & strengthen its financial position
As per the deal, Elanco will receive $295M in cash to repay portions of its loans on a…

