Skip to content Skip to footer
Subscribe Now
Novo Nordisk
NEWS
Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors
Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…
1 day ago0Comments
Merck new
NEWS
Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025
Shots: The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progression Trial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…
1 day ago0Comments
Novocure
NEWS
Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC
Shots: The P-III (METIS) trial assessed TTFields therapy + best supportive care (BSC) (n=149) vs BSC (n=149) in 298 adults with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery; median TTFields use was 67% over 16wks. Trial met its 1EP, with a 28% lower risk of intracranial progression, extending median time to 15…
2 days ago0Comments
NEWS
Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
Shots: FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label Plaque PsO approval was based…
2 days ago0Comments
VIEWPOINTS
Expanding Solid Tumor Care: Shaun Bagai from RenovoRx in a Stimulating Conversation with PharmaShots 
Shots:  RenovoRx, a clinical-stage life sciences company, is developing targeted oncology therapies and has created RenovoCath, an FDA-cleared novel drug delivery device.  Its proprietary TAMP therapy platform enables precise delivery of therapeutics across the arterial wall near the tumor site, directly targeting the tumor while potentially reducing the toxicities linked to systemic IV chemotherapy.  In…
2 days ago0Comments