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Roche Kidney Breakthrough • Sanofi's $2.4B Ocular Gamble • Medtronic Earnings

Feb 17, 2026

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7 min read

Roche Kidney Breakthrough • Sanofi's $2.4B Ocular Gamble • Medtronic Earnings

Gazyva first-ever PMN win • OCUL faces make-or-break readout today • India's $240M reshoring play.

BioMed Nexus
BioMed Nexus

THE LATEST


Feb 16, 2026

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8 min read

Weekly Recap: FDA Rejects Moderna & Disc • BridgeBio Phase 3 Win • HRT Label Shift

Surrogate scrutiny intensifies • Oral achondroplasia data raises switching pressure • Lilly builds $1.5B ahead of PDUFA.

Feb 13, 2026

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7 min read

BridgeBio Phase 3 Win • FDA HRT Label Shift • Universal Flu Trial

Oral dwarfism pill outpaces prior injectable data • Hormone boxed warnings removed • Seres & Ultragenyx cut staff

Feb 12, 2026

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10 min read

Merck Keytruda Win, Madrigal $4.4B Deal, Jobs Report Surprise

First immunotherapy for platinum-resistant ovarian cancer, Viking confirms Phase 3 timeline, Healthcare adds 82k jobs.

TRENDING


Moderna Flu RTF • REGENXBIO CRL • FDA BHA Review

Moderna Flu RTF • REGENXBIO CRL • FDA BHA Review

FDA cites comparator design in flu filing • Hunter syndrome application declined • CSL leadership transition

Lilly–Innovent Partnership, Takeda’s AI Strategy, J&J Recall

Lilly–Innovent Partnership, Takeda’s AI Strategy, J&J Recall

China-sourced drug development, AI-enabled discovery, FDA telehealth extension, and Krystal Biotech RMAT.

Priovant Phase 2 Breakthrough, REGENXBIO PDUFA Watch, Eikon IPO Down 19%

Priovant Phase 2 Breakthrough, REGENXBIO PDUFA Watch, Eikon IPO Down 19%

Roivant subsidiary posts rare autoimmune win, Gene therapy decision under FDA review, IPO volatility tests 2026 window

FDA “Clean Label” Enforcement Shift, TrumpRx Platform Launch

FDA “Clean Label” Enforcement Shift, TrumpRx Platform Launch

FDA grants enforcement discretion for natural colors. Plus: manufacturers join federal DTC pricing framework; Cardinal Health updates FY26 outlook.

The IPO Window Reopens: Eikon's $381M Debut | Oncology Pipeline Updates

The IPO Window Reopens: Eikon's $381M Debut | Oncology Pipeline Updates

Rare disease incentives restored, Medtronic acquires CathWorks, Eikon prices at $18.

HHS Pivots $100M to Antivirals • Pfizer Obesity Miss (-4%)

HHS Pivots $100M to Antivirals • Pfizer Obesity Miss (-4%)

Federal strategy shifts from mRNA to oral antivirals • Monthly GLP-1 hits 10–12% vs. 15%+ bar • Quest MRD disrupts bone marrow biopsies

FDA PreCheck Pilot Opens, Sanofi Split in Gaucher and Fabry

FDA PreCheck Pilot Opens, Sanofi Split in Gaucher and Fabry

PreCheck applications now open. Venglustat wins Gaucher, misses Fabry.

Telehealth Reverts, AstraZeneca’s $18.5B Metabolic Alliance

Telehealth Reverts, AstraZeneca’s $18.5B Metabolic Alliance

Originating site restrictions return. AZ pays $1.2B upfront for monthly obesity dosing platform.

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