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

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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

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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

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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

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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

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BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

Shots: BioMarin has entered into a definitive agreement to acquire Inozyme, strengthening its enzyme therapies portfolio with the addition of INZ-701, an enzyme replacement therapy As per the deal, Inozyme’s shareholders will receive $4.00 per share in an all-cash transaction for a total consideration of ~$270M; closing is expected in Q3’25 INZ-701 (SC) is being evaluated…

ByRidhi RastogiMay 19, 2025

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GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 19, 2025

NEWS

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots: The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

Ridhi Rastogi

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

BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

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