Shots:
Memo has entered into a strategic collaboration & exclusive option-to-license agreement with CSL for Memo’s recombinant polyclonal IgG technology
As per the deal, Memo will use its Dropzylla platform for cloning human antibody repertoires & polyclonal antibody expression to develop recombinant polyclonal IgG products, while CSL will obtain an option to exclusively license those…
Shots:
The Chinese NMPA has approved neffy 2mg for the emergency treatment of type I allergic reactions (anaphylaxis) in adults & children (≥30kg), with availability anticipated in the spring of 2026. Filing for neffy 1mg for children (15 to <30kg) to the NMPA is expected in the coming mos.
In 2021, ARS Pharma licensed neffy…
Shots:
VarmX has collaborated with CSL to advance its lead asset, VMX-C001 (commercial launch expected in 2029), & granted CSL an exclusive option agreement with its shareholders to acquire all issued & outstanding shares of the company
As per the collaboration, CSL will fully fund the global P-III (EquilibriX-S) trial of VMX-C001 in FXa DOAC…
Shots:
Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs)
Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean; data was published in The Lancet
Interim analysis of the ongoing OLE…
Shots:
The UK’s MHRA has approved EURneffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in children (>30kg); commercially available in the UK by late Q3’25
In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU (as EURneffy), Canada, & select markets in exchange for $145M upfront, ~$320M…
Shots:
The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end
Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…
Shots:
Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones
With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
Shots:
The EC has approved Kostaive (ARCT-154) for active immunization to prevent COVID-19 in subjects of age ≥18yrs in the EU & EEA states following CHMP positive opinion in Dec 2024
Approval was based on Kostaive's clinical data incl. P-I/II/III showing its efficacy & tolerability, plus P-III COVID-19 booster trial depicting superior immunogenicity vs…
Shots:
EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada
Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet)Â assessing Andembry vs PBO & OLE…
Shots:
The CHMP has granted positive opinion to CSL (exclusive commercialization rights holder in the EU, Australia & New Zealand) & Travere’s sparsentan for its conditional approval to treat primary IgAN with a urine protein excretion >1.0 g/day. EC’s decision is anticipated in Q2’24Â
The opinion was supported by the P-III (PROTECT) trial investigating the…

