2 Minute Medicine: Pharma Roundup: Price Hikes, Breakthrough Approvals, Legal Showdowns, Biotech Expansion, and Europe’s Pricing Debate [May 12nd, 2025]

Drugmakers Increase Prices on Over 250 Medications
Pharmaceutical companies have raised prices on over 250 branded medications in the U.S., including well-known treatments like Pfizer’s Paxlovid, Bristol Myers Squibb’s CAR-T therapies, and a range of vaccines from Sanofi. The median price hike is about 4.5 percent, with most increases falling below 10 percent. That’s a noticeable uptick compared to the 140 price hikes recorded at the end of the previous year. These increases apply to list prices and don’t reflect rebates or discounts, which are often privately negotiated with pharmacy benefit managers. Experts suggest that with expanded penalties on year-over-year price jumps, drugmakers are shifting their strategy by opting for steeper launch prices from the outset. The move has reignited debates around access, affordability, and the ethics of pharmaceutical pricing in the U.S. Pfizer and others argue the hikes are essential for funding future innovation, but that hasn’t stopped criticism from lawmakers and advocacy groups. At a time when healthcare costs are under the microscope, these pricing decisions are facing more public pressure than ever.
Further Reading: Pfizer, BMS and more ring in 2025 with fresh round of drug price hikes

FDA Approves Dupilumab for Chronic Spontaneous Urticaria
The FDA has granted approval for dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older who don’t respond well to antihistamines. The green light follows strong results from the phase 3 LIBERTY-CUPID trial, where patients experienced meaningful reductions in hives, itch, and flare-ups. CSU is a frustrating chronic condition that can impact sleep, confidence, and overall well-being, often with no clear trigger. Dupilumab targets type 2 inflammation by blocking IL-4 and IL-13 signaling, offering a more precise approach than traditional therapies. It’s already proven itself in conditions like eczema and asthma and now it’s adding CSU to its résumé. Side effects are generally manageable, most commonly including injection site reactions and some eye irritation. This approval gives physicians and patients another long-needed tool in the treatment toolbox. It also reflects a broader shift toward biologics for conditions once considered poorly understood or tough to treat.
Further Reading: FDA Greenlights Dupilumab for Chronic Spontaneous Urticaria

Eli Lilly Takes Legal Action Against Telehealth Startups
Eli Lilly has filed lawsuits against four telehealth startups for selling unauthorized compounded versions of its blockbuster GLP-1 drugs Mounjaro and Zepbound. Together these medications brought in over $16.4 billion in revenue last year and that kind of success tends to draw attention both legal and otherwise. The companies named in the suits are accused of mixing in unapproved ingredients like vitamins and amino acids under the guise of customization. According to Lilly these compounded versions are mass-produced and lack the safety data required for regulatory approval. The FDA had previously announced that shortages of these drugs had ended which removes one of the key justifications for compounding. This legal fight highlights a growing gray area between telehealth innovation and the need for tighter regulatory oversight. With the GLP-1 market continuing to surge this case could set important precedents for both drugmakers and digital health platforms.
Further Reading: GLP-1 Drug Compounding Sparks FDA Scrutiny and Lawsuits

Samsung Biologics Expands Manufacturing Capacity
Samsung Biologics is rapidly scaling up its production footprint by fast-tracking construction of its fifth plant which will increase capacity by a substantial 180,000 liters. Once operational this facility will bring the company’s total to 784,000 liters the highest biomanufacturing capacity at a single site anywhere in the world. The plant will feature cutting-edge automation digital integration and energy-efficient systems tailored for biologic drug production. It’s part of Samsung’s strategic push to meet growing global demand for monoclonal antibodies vaccines and other complex biologics. The company is also eyeing a sixth plant signaling its long-term commitment to expand further. A recent $1.4 billion deal with a major European pharmaceutical partner further underscores its global momentum. It’s not just about scale this expansion is designed to improve speed reliability and sustainability across the supply chain.
Further Reading: Samsung Biologics Accelerates Timeline of New Fifth Plant

Novartis and Sanofi Urge EU to Raise Drug Prices
Top executives from Novartis and Sanofi are calling on the European Union to raise drug prices to levels more in line with the U.S. arguing that current policies are stifling innovation. They say tight price controls and post-COVID austerity measures have made Europe less attractive for pharma investment pushing companies to funnel funds into American operations instead. With tariffs and trade barriers on the rise many big names including Roche Eli Lilly and Johnson & Johnson are making similar moves. The CEOs are asking EU leaders to adopt a pan-European pricing framework that rewards innovation while still ensuring access. They warn that without reform Europe may fall behind in drug development and manufacturing leadership. Critics say proposed reforms are too slow and lack teeth. Whether the EU listens remains to be seen but the industry’s warning shot is loud and clear.
Further Reading: Novartis, Sanofi CEOs Say EU Should Raise Drug Prices to Face Tariffs

Image: PD

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