Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…

ByRidhi Rastogi1 day ago

NEWS

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Shots: The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3) Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS Venglustat received US…

ByRidhi Rastogi2 days ago

TOP 20

PharmaShots Women’s Day Special: 20 Leaders Redefining Healthcare

Shots: Women leaders are reshaping the healthcare industry, bringing visionary leadership, scientific expertise, and strategic insight to traditionally male-dominated spaces From biotech innovation to global pharmaceutical enterprises, these trailblazers are driving transformative solutions, advancing patient care, and championing inclusive workplace cultures PharmaShots spotlights 20 extraordinary women leaders in healthcare, celebrating their achievements, impact, and inspiring journeys that…

ByPrince GiriMarch 8, 2026

NEWS

Sino Biopharmaceutical and Sanofi Partner to Advance Rovadicitinib in a ~$1.53B Deal

Shots: Sino Biopharm via its subsidiary Chia Tai Tianqing has entered into an exclusive license agreement with a fully owned subsidiary of Sanofi for rovadicitinib As per the deal, Sanofi will obtain exclusive global license to develop, manufacture & commercialize rovadicitinib in exchange for $135M upfront & ~$1.395B in development, regulatory & sales milestones, as…

ByRidhi RastogiMarch 5, 2026

NEWS

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

Shots: FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…

ByRidhi RastogiFebruary 25, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2026

Shots: The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka. The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock. Decisions were backed by strong Phase II/III data…

ByDipanshu DixitFebruary 17, 2026

NEWS

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Shots: Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…

ByRidhi RastogiFebruary 17, 2026

NEWS

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Shots: Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3 Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…

ByRidhi RastogiFebruary 3, 2026

NEWS

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks. Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…

ByRidhi RastogiFebruary 2, 2026

TOP 20

Top 20 M&A of 2025 by Total Deal Value

Shots: 2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchises The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…

ByPrince GiriJanuary 30, 2026

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

PharmaShots Women’s Day Special: 20 Leaders Redefining Healthcare

Sino Biopharmaceutical and Sanofi Partner to Advance Rovadicitinib in a ~$1.53B Deal

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

EMA Marketing Authorization of New Drugs in January 2026

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Top 20 M&A of 2025 by Total Deal Value

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