NEWS

Neurizon Therapeutics Licenses Monepantel from Elanco Animal Health to Accelerate NUZ-001 Commercialization

Shots: Elanco has granted Neurizon exclusive global rights to monepantel’s data package & related IP to develop & commercialize NUZ-001 & related compounds for the treatment, prevention, or palliation of ALS & other neurodegenerative diseases in humans As per the deal, Elanco will receive an upfront payment, development milestone payments of $9.75M for the initial…

July 3, 2025

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…

July 3, 2025

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Shots: The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing In…

July 3, 2025

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Shots: The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…

July 2, 2025

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots: The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026 Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…

July 2, 2025

BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate

Shots: BioVersys & Shionogi have entered into a global research & exclusive license option agreement to co-develop novel ansamycin compounds from BioVersys’ BV500 program into clinical candidates for treating NTM infections Shionogi will gain access to BioVersys’ ansamycin chemistry platform & BV500 program, with an exclusive option to license selected molecules for clinical development &…

July 2, 2025

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)

Shots: Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab) Ref: PRNewsWire | Image:…

July 2, 2025

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

Shots: Alvotech has entered into a supply & commercialization agreement with Advanz Pharma for AVT10, a biosimilar version of Cimzia (certolizumab pegol) Alvotech & Advanz Pharma have previously partnered on biosimilars for over 10 reference biologics, with a plan to launch their first biosimilars in the EU by Q4’25 Cimzia binds with both soluble &…

July 2, 2025

Unnatural Products Collaborates with argenx to Develop Oral Macrocyclic Peptides Across Multiple Indications

Shots: Unnatural Products (UNP) & argenx have entered into a strategic multi-target research collaboration to identify & develop oral macrocyclic peptide drugs for hard-to-target diseases leveraging UNP’s drug discovery platform As per the deal, UNP will receive upfront payment, equity investment, near-term, & R&D payments, plus ~$1.5B in research, development, regulatory, & commercial milestones as well as…

July 2, 2025

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots: The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…

July 2, 2025

NEWS

Neurizon Therapeutics Licenses Monepantel from Elanco Animal Health to Accelerate NUZ-001 Commercialization

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

Unnatural Products Collaborates with argenx to Develop Oral Macrocyclic Peptides Across Multiple Indications

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Contact US

FOLLOW US