NEWS Archives

NEWS

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…

1 day ago

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Shots: Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…

1 day ago

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…

1 day ago

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

1 day ago

Merck Animal Health’s Exzolt Cattle-CA1 Receives the US FDA Conditional Approval Against New World Screwworm and Cattle Fever Tick

Shots: The US FDA has granted conditional approval to Exzolt Cattle-CA1 to prevent & treat New World screwworm (Cochliomyia hominivorax) larvae (myiasis) & cattle fever tick (Rhipicephalus microplus) Exzolt Cattle-CA1, a systemic fluralaner pour-on available in 1L & 5L presentations, is approved for use in beef cattle (≥2mos.) & replacement dairy heifers (<20mos.), with US availability…

1 day ago

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Shots: Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China) Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…

1 day ago

Lupin and Valorum Biologics Join Forces to Commercialize Armlupeg (Biosimilar, Neulasta) in the US

Shots: Lupin has entered into an exclusive licensing agreement with Valorum Biologics for Armlupeg, a biosimilar version of Neulasta (pegfilgrastim) As per the deal, Valorum will be responsible for the commercialization and distribution of Armlupeg in the US, while Lupin will handle manufacturing & supply of the product In return, Lupin will receive an upfront…

2 days ago

Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Shots: The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…

2 days ago

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…

2 days ago

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

2 days ago

NEWS

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Merck Animal Health’s Exzolt Cattle-CA1 Receives the US FDA Conditional Approval Against New World Screwworm and Cattle Fever Tick

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Lupin and Valorum Biologics Join Forces to Commercialize Armlupeg (Biosimilar, Neulasta) in the US

Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

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