NEWS

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Shots:Pfizer & Astellas have reported follow-up data from P-III (KEYNOTE-A39/EV-302) trial assessing Padcev + Keytruda vs Pt-based CT in previously untreated la/mUCpts (n=886)The 12mos. follow up study (mFU: 29.1mos.) showed reduced risk of death by 49% & decrease in PFS by 52% (mPFS: 12.5 vs 6.3mos.) with improved mOS (33.8 vs 15.9mos.), where OS…

February 12, 2025

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

Shots:The US FDA has granted 510(k) clearance to Ibex Prostate Detect, which generates heatmaps using AI to detect small & rare missed prostatic cancers In studies, the device showed 99.6% PPV for cancer heatmap accuracy & detected 13% rate of missed cancer in pts initially diagnosed as benign, where these false negatives were later confirmed…

February 11, 2025

Novartis to Acquire Anthos Therapeutics for ~$3.1B

Shots:Novartis to acquire Anthos (launched by Blackstone Life Sciences & Novartis in 2019) for ~$3.1B to boosts its cardiovascular portfolio with Anthos’ abelacimab; closing expected in H1’25 As per the deal, Anthos will receive $925M upfront & is eligible to receive ~$2.15B in regulatory & commercial milestones Abelacimab (licensed from Novartis) showed…

February 11, 2025

Eli Lilly Acquires OLX75016 from OliX Pharmaceuticals for Metabolic-Associated Steatohepatitis

Shots:OliX & Eli Lilly have entered into a global license agreement to develop & commercialize OliX’s OLX75016 for metabolic-associated steatohepatitis (MASH) as well as other cardiometabolic indications As per the agreement, Eli Lilly will make an initial payment of ~$630M to OliX for completing the ongoing P-I trial of OLX75016 in Australia, after…

February 11, 2025

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Shots:The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25 Application was backed by the development program of…

February 11, 2025

Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)

Shots:BI reported topline data from P-III (FIBRONEER-ILD) study assessing nerandomilast (BI 1015550; 9/18mg, BID) vs PBO in PPF pts (n=1178) for ~52wks. with regulatory filings in the US & other regions underway Study met its 1EP of absolute change from baseline in forced vital capacity (FVC; mL) with favorable safety consistent with P-II; full…

February 11, 2025

BMS Reports Topline Data from P-II (TRANSCEND FL) trial of Breyanzi for R/R Indolent B-cell non-Hodgkin lymphoma

Shots:BMS reported topline data from P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & marginal zone lymphoma (MZL) Study met its 1EP of significant ORR in the MZL cohort as well as its 2EP of CRR with durable responses & favorable safety Breyanzi…

February 11, 2025

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

Shots:Dr. Reddy’s & Henlius have entered into a license agreement to develop & market HLX15, biosimilar version of Darzalex & Darzalex Faspro (daratumumab) As per the agreement, Dr. Reddy’s will get exclusive rights to market HLX15 (SC & IV) in the US & EU in exchange for ~$131.6M ($33M upfront + milestones), plus…

February 10, 2025

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots:The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

February 10, 2025

Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration

Shots:Regeneron reported 3yr. data from an extension study of P-III (PULSAR) trial of Eylea for wAMD pts, randomized to Eylea HD (8mg; Q3M or Q4M) or Eylea (2mg; Q2M) After 2yrs., 88% of Eylea HD patients maintained a dosing interval of ≥3 months, while in 60wk. extension, 77%, 58%, 40% & 24% (out…

February 10, 2025

NEWS

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Ibex Medical Analytics Receives the US FDA’s 510(k) Clearance for Ibex Prostate Detect

Novartis to Acquire Anthos Therapeutics for ~$3.1B

Eli Lilly Acquires OLX75016 from OliX Pharmaceuticals for Metabolic-Associated Steatohepatitis

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)

BMS Reports Topline Data from P-II (TRANSCEND FL) trial of Breyanzi for R/R Indolent B-cell non-Hodgkin lymphoma

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

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