Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…

ByRidhi RastogiMay 22, 2025

NEWS

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

Shots: CRISPR & Sirius have partnered to co-develop & co-market SRSD107, with CRISPR having the option to nominate ~2 siRNA targets, fund related research, & retain opt-in rights for clinical development & marketing As per the deal, Sirius will receive $25M cash & $70M in equity upfront, with both companies jointly developing SRSD107 under a…

ByRidhi RastogiMay 20, 2025

NEWS

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Shots: The US FDA has granted 510(k) clearance to the OptaBlate BVN system for minimally invasive procedure designed to deliver long-lasting relief from vertebrogenic pain OptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precision OptaBlate BVN combines…

ByRidhi RastogiMay 20, 2025

NEWS

Regeneron to Acquire 23andMe Assets for $256M

Shots: Regeneron has entered into an asset purchase agreement with 23andMe for $256M, strengthening Regeneron’s genetics-guided research & drug development activities Regeneron to acquire key assets of 23andMe, incl. Personal Genome Service, Total Health & Research Services business lines, plus its Biobank & associated assets, with services continuing uninterrupted; closing is expected in Q3’25 23andMe…

ByRidhi RastogiMay 20, 2025

NEWS

Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…

ByRidhi RastogiMay 20, 2025

NEWS

Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

Shots: FDA has approved the BLA for Nuvaxovid against COVID-19 in adults (≥65yrs.) & individuals (12-64yrs.) with at least one underlying condition increasing risk of sev. COVID-19 based on a P-III trial, showing favorable safety & efficacy; commercially available in US this fall pending strain selection at FDA VRBPAC meeting on May 22, 2025 FDA…

ByRidhi RastogiMay 20, 2025

NEWS

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Shots: 3SBio & its subsidiaries will grant Pfizer exclusive license to develop, manufacture & market SSGJ-707 worldwide, excl. China, with an option to obtain marketing rights in China As per the deal, 3SBio will receive $1.25B upfront & ~$4.8B in development, regulatory & commercial milestones, plus double-digit tiered royalties on SSGJ-707 sales; closing is expected…

ByRidhi RastogiMay 20, 2025

NEWS

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Shots: Ionis has reported topline P-III (ESSENCE) trial data assessing olezarsen (50mg: 276 pts or 80mg: 832 pts, SC, Q4W for 12mos.) vs PBO (n= 369) in 1,478 adults with mod. hypertriglyceridemia (fasting TG ≥150mg/dL to <500mg/dL) with or at risk of ASCVD Trial met its 1EP with significant PBO-adjusted TG reductions of 61% (80mg)…

ByRidhi RastogiMay 19, 2025

NEWS

Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapy Trial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory…

ByRidhi RastogiMay 19, 2025

NEWS

Skye Bioscience Enters a Formulation Development Agreement with Arecor Therapeutics for Nimacimab

Shots: Skye Bioscience has partnered with Arecor Therapeutics to develop a higher concentration formulation of Skye’s nimacimab, leveraging Arecor’s Arestat formulation platform As per the deal, Skye will fund Arecor's development efforts, with the option to license rights of the new proprietary formulation & its intellectual property for further development & commercialization Nimacimab (CB1 inhibitor,…

ByRidhi RastogiMay 19, 2025

Ridhi Rastogi

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Regeneron to Acquire 23andMe Assets for $256M

Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Skye Bioscience Enters a Formulation Development Agreement with Arecor Therapeutics for Nimacimab

Contact US

FOLLOW US