Pharmaceuticals

SHERIDAN, WYOMING - December 8, 2025 - Praxis Precision Medicines has doubled down on its neurology strategy with back-to-back updates: a Phase II win for its sodium current blocker relutrigine in rare developmental and epileptic encephalopathies (DEE) and a "successful" pre-NDA meeting for its essential tremor candidate ulixacaltamide, positioning the Boston biotech as a potential new commercial player in both ultra-rare epilepsy and movement disorders.

Relutrigine Study Stopped Early for Efficacy in DEE

Praxis has halted its mid-stage EMBOLD trial of relutrigine early, after an independent data monitoring board recommended the study "stop the study early for efficacy." The Phase II EMBOLD study is evaluating relutrigine in patients with DEE linked to SCN8A and SCN2A mutations, a small but highly underserved genetic epilepsy population with limited therapeutic options and high unmet medical need.

SHERIDAN, WYOMING - December 8, 2025 - Days after Johnson & Johnson reported a mid-stage failure for its anti-tau antibody posdinemab, Eisai is using the Clinical Trials on Alzheimer's Disease (CTAD) 2025 conference to argue that tau is still a viable target-if drug designers hit the right part of the protein-while investors and scientists pivot their attention to inflammation and vascular pathways.

Anti-tau Setbacks Raise the Bar for New Entrants

Tau-directed drugs have been among the most high-profile disappointments in Alzheimer's disease (AD) R&D. J&J's recent miss with posdinemab follows last year's Phase II failure of UCB's bepranemab and Eli Lilly's inability to replicate its amyloid success with the anti-tau candidate LY3372689. Collectively, these readouts have fed a narrative that tau may be an intractable or poorly understood target for disease modification.

SHERIDAN, WYOMING - December 2, 2025 - Roche has reported landmark Phase III results for its oral selective estrogen receptor degrader (SERD) giredestrant, positioning the candidate as a potential new standard of care in early-stage ER-positive, HER2-negative breast cancer after a pivotal trial showed superior invasive disease-free survival versus standard endocrine therapy.

First oral SERD to show superior invasive disease-free survival

The Phase III lidERA Breast Cancer study evaluated adjuvant giredestrant against standard-of-care endocrine monotherapy in more than 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative early breast cancer. At a pre-planned interim analysis, the trial met its primary endpoint: giredestrant delivered a statistically significant and clinically meaningful improvement in invasive disease-free survival compared with standard endocrine therapy.

SHERIDAN, WYOMING - November 13, 2025 - Pfizer has completed its $7 billion acquisition of Metsera, securing a set of differentiated obesity and cardiometabolic candidates as regulatory momentum accelerates around metabolic disease innovation in the United States. The deal positions Pfizer at the center of one of the most politically scrutinized and fastest-growing therapeutic markets, as federal leaders push for expanded access and a stronger domestic pipeline in obesity care.

SHERIDAN, WYOMING - November 13, 2025 - As the TrumpRx platform approaches launch in early 2026, U.S. drugmakers are rolling out targeted direct-to-consumer pricing for a carefully chosen mix of dermatology, respiratory, cardiovascular, immunology, and metabolic products. While the discounts generate attention, analysts say their commercial impact varies sharply by drug class, revenue cycle, and therapeutic demand-revealing a strategic pattern rather than a broad affordability shift.

Discounting Patterns Reveal Manufacturers' Portfolio Priorities
Pfizer, AstraZeneca, Amgen, Bristol Myers Squibb, Novo Nordisk, and Lilly have each chosen different subsets of products for deep DTC price cuts. Across these offerings, a clear pattern emerges: brands with declining growth, approaching patent expirations, or limited payer friction are overrepresented.

SHERIDAN, WYOMING - November 13, 2025 - Major pharmaceutical companies are rapidly rolling out direct-to-consumer (DTC) pricing programs ahead of the federal TrumpRx platform's debut in early 2026, signaling a shift in commercial strategy as manufacturers seek to bypass traditional intermediaries and regain control of how patients access branded therapies. Yet analysts warn that these channels-despite deep headline discounts-may offer only marginal financial relief to most patients and are unlikely to dent overall U.S. drug spending.

SHERIDAN, WYOMING - November 13, 2025 - As the federal government prepares to launch its TrumpRx direct-to-consumer platform in early 2026, U.S. drugmakers are accelerating their own discount initiatives in anticipation of sweeping pricing reforms tied to the Most Favored Nation (MFN) framework. Yet analysts and health economists warn that these programs-ranging from discounted dermatology creams to multi-billion-dollar GLP-1 therapies-may have limited influence on overall spending, with most insured patients unlikely to shift away from existing payer pathways.

SHERIDAN, WYOMING - November 13, 2025 - In a sweeping regulatory shift with major implications for women's health providers, pharmaceutical manufacturers, and payers, the FDA has removed the black box warning from all hormone replacement therapy (HRT) products. The reversal ends a 22-year stance shaped by the early 2000s Women's Health Initiative (WHI) trial and opens the door to renewed clinical adoption and investment across the growing HRT market.

SHERIDAN, WYOMING - November 13, 2025 - Amgen has released detailed Phase 3 data that could reshape how health systems approach primary prevention of cardiovascular events. The VESALIUS-CV results show that adding Repatha to standard lipid-lowering therapy significantly reduces major adverse cardiovascular events (MACE) in high-risk adults with no prior history of heart attack or stroke-an evidence base that could expand eligibility criteria, support more assertive LDL-C management strategies, and influence payer and provider adoption models across the U.S. and abroad.

SHERIDAN, WYOMING - November 13, 2025 - Amgen has introduced a new U.S. direct-to-patient model that aims to make Repatha more affordable and accessible to adults at elevated cardiovascular risk. The initiative, called AmgenNow, offers a nearly 60% price reduction and removes common payer-driven barriers-an unusual move in the cardiometabolic market and one that could ripple across manufacturers, payers, and care-delivery partners seeking more predictable access pathways.