NEWS

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…

February 12, 2025

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

Shots: The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in…

February 12, 2025

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

NEWS

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

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

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