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Everest Medicines
News

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Shots: 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.…
May 8, 20250Comments

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Astrazeneca
News

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots: 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%,…
May 8, 20250Comments

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Viverita and Boehringer Ingelheim
News

ViVerita Therapeutics Collaborates with Boehringer Ingelheim to Accelerate Discovery of Novel Therapeutic Targets in Oncology

Shots: 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…
May 8, 20250Comments

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Daiichi-Sankyo-Astrazeneca
News

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: 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…
May 7, 20250Comments

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Omeros
News

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots: 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…
May 7, 20250Comments

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TriviumVet
News

PBI-Gordon Companies Acquires TriviumVet, Expanding its Animal Healthcare Product Portfolio

Shots: 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…
May 7, 20250Comments

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