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…

ByRidhi RastogiFebruary 11, 2025

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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…

ByRidhi RastogiFebruary 11, 2025

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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…

ByRidhi RastogiFebruary 11, 2025

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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…

ByRidhi RastogiFebruary 11, 2025

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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…

ByRidhi RastogiFebruary 11, 2025

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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…

ByRidhi RastogiFebruary 10, 2025

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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…

ByRidhi RastogiFebruary 10, 2025

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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…

ByRidhi RastogiFebruary 10, 2025

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Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Shots: Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar…

ByRidhi RastogiFebruary 10, 2025

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Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

Shots: Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha,…

ByRidhi RastogiFebruary 10, 2025

Ridhi Rastogi

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

Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US

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