BioWeek

Policy

Biotech Groups Sue Again to Stop Medicare's GLOBE Drug-Pricing Model

Three biotech trade groups filed suit in San Francisco to block CMS's GLOBE Medicare Part B pricing model before its first rebates arrive. The fight is over agency authority, but the model they sued has shrunk to a fraction of what they first opposed.

8 Nov 2026 · 3 min read

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Zolgensma's Theoretical Cancer Risk Now Has Molecular Proof

8 Nov 2026

The Race to Delete a Protein and Treat Rheumatoid Arthritis

6 Nov 2026

FDA Pushes Mitapivat's Sickle Cell Decision to February Over Liver Safety

5 Nov 2026

Lonza Is Buying the Plants Where the Hardest Drugs Get Made

4 Nov 2026

Huntington's First Disease-Modifying Drug Is Now One FDA Decision Away

3 Nov 2026

Lynch interception is the harder vaccine trial, and Nouscom just funded it

An oversubscribed EUR 120M Series D sends an off-the-shelf cancer vaccine toward a prevention trial measured in colonoscopy results from dozens, not thousands, of patients.

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Pipeline

Genmab's Antibody Halves Death Risk in Head and Neck Cancer

30 Oct 2026 · 3 min read

Pipeline

Merck and Moderna's Cancer Vaccine Beat Keytruda. The Harder Test Is Manufacturing.

27 Oct 2026 · 3 min read

Markets

Bolt's Original Stockholders Own 6.9% After the Prana Reverse Merger

26 Oct 2026 · 3 min read

Markets

Gilead Is Buying Oral IL-23 Before Its Peptide Has Shown It Works

25 Oct 2026 · 3 min read

Pipeline

Ultomiris Is the Latest IgA Nephropathy Drug to Win on Proteinuria, Not Proof It Saves Kidneys

23 Oct 2026 · 3 min read

Pipeline

The First Functional Cure for Hepatitis B Clears One Patient in Five

22 Oct 2026 · 3 min read

Pipeline

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Pipeline 14 Oct 2026

BioNTech's Cancer Vaccine Missed the Endpoint Pembrolizumab Itself Never Won

AHEAD-MERIT missed its progression-free survival endpoint. In this disease, pembrolizumab itself never won PFS either. The trial now turns to overall survival, the endpoint where this cancer actually rewards immunotherapy.

The First Keytruda Biosimilar Filing Reaches FDA Without a Phase 3 Trial. Can Analytics Carry a $31.7 Billion Molecule?

13 Oct 2026

Rasonque's Broad Label Is Built on Survival, Not Response

11 Oct 2026

ArriVent Beat the Chemotherapy Arm It Designed and Lost to the Referee It Chose

7 Oct 2026

Markets

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Markets 12 Oct 2026

Viatris Just Bought Four More Years of EXPAREL Before Its Generic Cliff Arrives

Viatris is paying $1.65 billion for Pacira, roughly 2.2 times trailing revenue. The price only makes sense if you count EXPAREL's early 2030 licensed generic cliff and the four years of runway before it.

Is Claudin-1 Worth $355 Million Upfront? CSL Just Placed Its Bet

5 Oct 2026

Celcuity Ships Its First Drug Into the Corner of Breast Cancer No PI3K Label Covered

1 Oct 2026

BigHat Closes $75 Million Series C as Its AI-Designed ADC Enters the Clinic

25 Sep 2026

Policy

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Policy 8 Oct 2026

PhRMA Sued Over a Rule That Barely Covers Anyone. The Target Is Bigger Than Drug Pricing.

PhRMA sued CMS on October 7 over the GLOBE most-favored-nation rule for Medicare Part B. The final rule covers as few as four manufacturers and $440 million in projected savings. The suit's real target is the CMMI test authority beneath it.

Why the FDA Overrode Its Advisers on Camizestrant

7 Sep 2026

Why uniQure's Huntington Filing Rests on Twelve Patients and Two FDA Reversals

3 Sep 2026

European Joint Clinical Assessments Squeeze Biopharma Market Access Timelines

22 Aug 2026

Science

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Science 9 Oct 2026

Biotech Groups Sue Again to Stop Medicare's GLOBE Drug-Pricing Model

Zolgensma's Theoretical Cancer Risk Now Has Molecular Proof

The Race to Delete a Protein and Treat Rheumatoid Arthritis

FDA Pushes Mitapivat's Sickle Cell Decision to February Over Liver Safety

Lonza Is Buying the Plants Where the Hardest Drugs Get Made

Huntington's First Disease-Modifying Drug Is Now One FDA Decision Away

More stories

Gilead’s Latest Deal Shows Big Pharma’s Appetite for Oral Peptides. Which Stocks Are Worth Watching?

Inovio's First DNA Drug Won Approval on 7 of 26 Patients Avoiding Surgery

Lilly's Retatrutide More Than Doubled Ozempic's Weight Loss

Lynch interception is the harder vaccine trial, and Nouscom just funded it

Latest

Genmab's Antibody Halves Death Risk in Head and Neck Cancer

Merck and Moderna's Cancer Vaccine Beat Keytruda. The Harder Test Is Manufacturing.

Bolt's Original Stockholders Own 6.9% After the Prana Reverse Merger

Gilead Is Buying Oral IL-23 Before Its Peptide Has Shown It Works

Ultomiris Is the Latest IgA Nephropathy Drug to Win on Proteinuria, Not Proof It Saves Kidneys

The First Functional Cure for Hepatitis B Clears One Patient in Five

Pipeline

BioNTech's Cancer Vaccine Missed the Endpoint Pembrolizumab Itself Never Won

The First Keytruda Biosimilar Filing Reaches FDA Without a Phase 3 Trial. Can Analytics Carry a $31.7 Billion Molecule?

Rasonque's Broad Label Is Built on Survival, Not Response

ArriVent Beat the Chemotherapy Arm It Designed and Lost to the Referee It Chose

Markets

Viatris Just Bought Four More Years of EXPAREL Before Its Generic Cliff Arrives

Is Claudin-1 Worth $355 Million Upfront? CSL Just Placed Its Bet

Celcuity Ships Its First Drug Into the Corner of Breast Cancer No PI3K Label Covered

BigHat Closes $75 Million Series C as Its AI-Designed ADC Enters the Clinic

Policy

PhRMA Sued Over a Rule That Barely Covers Anyone. The Target Is Bigger Than Drug Pricing.

Why the FDA Overrode Its Advisers on Camizestrant

Why uniQure's Huntington Filing Rests on Twelve Patients and Two FDA Reversals

European Joint Clinical Assessments Squeeze Biopharma Market Access Timelines

Science

One Transfer RNA Molecule Controls Whether Prostate Cancer Stays Treatable

Brain Shuttle Platforms Tackle the Blood-Brain Barrier for Genetic Medicines

What tumour-neuron synapses mean for glioblastoma - and why a local siRNA gel is the proposed answer

What blocking Activin A means for FOP - Regeneron’s Pasatru and a disease that turns muscle into bone