Pharmaceutical Industry Roundup: Enhertu's Success, Takeda's Strategy, and Trump's Manufacturing Push

In a week of significant developments for the pharmaceutical industry, AstraZeneca and Daiichi Sankyo's Enhertu showed promising results in early-stage breast cancer, Takeda outlined its strategic focus, and President Trump signed an executive order aimed at boosting domestic drug manufacturing.

Enhertu Delivers Positive Results in Neoadjuvant Breast Cancer Trial

AstraZeneca and Daiichi Sankyo have reported a successful phase 3 trial for Enhertu as a neoadjuvant therapy in early-stage breast cancer. The antibody-drug conjugate demonstrated a statistically and clinically meaningful improvement in pathologic complete response (pCR) when added to the standard THP regimen (paclitaxel, Herceptin, and Perjeta) before surgery, compared to THP alone.

While the secondary endpoint of event-free survival is not yet mature, pCR is considered an approvable endpoint for neoadjuvant breast cancer treatment by the FDA. This positive outcome could potentially expand Enhertu's indications and strengthen its position in the breast cancer treatment landscape.

Takeda Focuses on Key Pipeline Assets Amid Generic Challenges

Takeda Pharmaceutical is looking towards what CFO Milano Furuta described as a potential "inflection point" for the company, as it faces the loss of exclusivity for key products Vyvanse and Entyvio. The Japanese drugmaker is pinning its hopes on three late-stage pipeline candidates:

1. Rusfertide for blood disorders
2. Oveporexton for narcolepsy
3. Zasocitinib, a TYK2 inhibitor, for psoriasis

As part of its pipeline optimization, Takeda has also terminated two T-cell engagers targeting EGFR and B7-H3, acquired from Maverick Therapeutics, and axed the STING agonist dazostinag in solid tumors. These cuts have reduced Takeda's phase 1 and 2 oncology pipeline by half, reflecting a strategic refocus on assets with the highest potential for success.

Trump Administration Targets Foreign Drug Manufacturing

President Donald Trump has signed an executive order aimed at boosting domestic pharmaceutical manufacturing while increasing scrutiny on foreign facilities. The order directs the FDA to:

1. Reduce regulatory hurdles for domestic drug manufacturers
2. Increase inspection fees for foreign manufacturing plants
3. Switch from announced to surprise visits for overseas drug facility inspections

FDA Commissioner Marty Makary, M.D., confirmed the agency's commitment to implementing these changes, which could significantly impact the global pharmaceutical supply chain and potentially reshape drug manufacturing dynamics in the coming years.