NEWS

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Shots: Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…

April 29, 2025

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Shots: The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025) In the trial, 117 pts on 200mg had a 71% ORR, with…

April 29, 2025

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC's decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyond Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…

April 29, 2025

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Shots: Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…

April 29, 2025

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25 Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…

April 29, 2025

Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Shots: The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab) Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the reference Denosumab is a mAb that works by targeting…

April 29, 2025

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Shots: The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025) At 38.3 mos. mFU,…

April 28, 2025

Prilenia Therapeutics Collaborates with Ferrer to Co-Develop and Commercialize Pridopidine for Indications Beyond Huntington’s Disease (HD)

Shots: Prilenia & Ferrer have entered into a collaboration & license agreement to co-develop & commercialize pridopidine for indications beyond HD in Europe & select markets, with Prilenia retaining rights in major markets incl. North America, Japan, & APAC As per the deal, Prilenia will receive ~$90.8M upfront, ~$51.1M in near-term development, regulatory, & commercial…

April 28, 2025

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

Shots: Merck KGaA has entered into a definitive agreement to acquire SpringWorks Therapeutics to strengthen its rare disease portfolio & expand SpringWorks’ reach to markets beyond the US As per the agreement, Merck KGaA will acquire SpringWorks for $47/share (~26% premium), with an equity value of ~$3.9B or an enterprise value of ~$3.4B, funded by…

April 28, 2025

Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF)

Shots: Kardium has reported 1yr. global PULSAR IDE trial data assessing Globe PF System in 183 symptomatic PAF pts across 12 centers in the US, EU, & Canada; Globe PF under the PMA review with the US FDA Trial showed 0% device-related safety events, 78% 12mos. effectiveness, 100% acute procedural success, 25min. average time to isolate…

April 28, 2025

NEWS

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Prilenia Therapeutics Collaborates with Ferrer to Co-Develop and Commercialize Pridopidine for Indications Beyond Huntington’s Disease (HD)

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF)

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