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Legal & Policy

Trump Wants Generics Made in America by 2028. The Economics Say They Can’t.

July 23, 2026 by Athithi Verma
rump Wants Generics Made in America by 2028. The Economics Say They Can't.

Trump gave generic drugmakers until August 2028 before a 100% tariff, rising to 200% in 2029. The problem is the margin those drugs actually carry.

Categories Access Read, In Depth, Legal & Policy, Market Access, The Brief Tags Apotex, Drug shortages, Generics, India, Sandoz, Supply Chain, Tariffs, Teva, Viatris

Novo Is Suing Lilly Over a Head-to-Head Trial Lilly Won, Arguing the Result Went Stale

July 23, 2026 by Athithi Verma
Novo Is Suing Lilly Over a Head-to-Head Trial Lilly Won, Arguing the Result Went Stale

Novo Nordisk filed a Lanham Act suit over Lilly’s Zepbound ads, arguing a genuine head-to-head result became misleading once a higher Wegovy dose launched.

Categories Cardio-Metabolic, Legal & Policy, Quick, The Brief Tags Cardiometabolic, Eli Lilly, GLP-1, Lanham Act, Litigation, Mounjaro, Novo Nordisk, Obesity, Ozempic, Wegovy, Zepbound

Sprouts Launches Bold Lawsuit Challenging Insulin Pricing

October 30, 2025 by Athithi Verma
Lawsuit

Sprouts files lawsuit over insulin pricing scheme and PBM collusion.

Categories Legal & Policy, News Tags Lawsuit, PBM, Pharmacy Benefit Managers, Rebate

FDA’s BsUFA III Framework: What It Means for Biosimilar Sponsors

September 10, 2025 by Shajini
Germany Updates Emergency-Care Tiers as IQWiG Questions Daratumumab Benefit in Smoldering Myeloma

FDA defines biosimilar PAS & CBE under BsUFA III

Categories Legal & Policy, News Tags Biosimilars, FDA

Judge Rules ReWalk Device Is Medically Necessary for Medicare

November 3, 2025June 27, 2025 by Shajini
ReWalk

Medicare exoskeleton coverage approved for ReWalk Personal Exoskeleton, sets key precedent.

Categories Legal & Policy, Market Access, News Tags Medicare, Pricing, Reimbursement

J&J Faces $442M Treble Damages Over Catheter Monopoly

June 9, 2025 by Shajini

J&J’s $147M antitrust penalty tripled to $442M for monopolizing cardiac catheter market.

Categories Legal & Policy, News Tags Antitrust Act, MedTech, Monopoly
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24 2025

Synopulse Weekly Pulse – November 24, 2025

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