Enhertu delivered a phase 3 trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more.
1. AstraZeneca, Daiichi Sankyo's Enhertu rings up success in another breast cancer trial
AstraZeneca and Daiichi Sankyo reported a positive readout for Enhertu as a neoadjuvant therapy in early-stage breast cancer. When added to the THP regimen of paclitaxel, Herceptin and Perjeta before surgery, the antibody-drug conjugate mounted a statistically and clinically meaningful improvement in pathologic complete response (pCR) versus THP alone. Although the secondary endpoint of event-free survival is not mature yet, pCR is an approvable endpoint for neoadjuvant breast cancer treatment at the FDA.
2. Takeda looks toward 'inflection point' as it eyes new launches to shake off Vyvanse generic impacts
Takeda is looking to phase 3 readouts from three key drugs that Chief Financial Officer Milano Furuta called could form an “inflection point” for the company as it tackles the loss-of-exclusivity impact from Vyvanse and Entyvio. These are blood disorder candidate rusfertide, narcolepsy drug oveporexton and TYK2 inhibitor zasocitinib in psoriasis.
3. Takeda shoots down bispecifics bagged in Maverick buyout amid pipeline clearout
Takeda has terminated two T-cell engagers separately targeting EGFR and B7-H3, which the company got from its acquisition of Maverick Therapeutics. Separately, the company has axed the STING agonist dazostinag in solid tumors. The three removals halved the size of Takeda’s phase 1 and 2 oncology pipeline.
4. Trump signs executive order to boost US drug manufacturing amid threat of tariffs
President Donald Trump has signed an executive order asking the FDA to reduce regulatory hurdles for domestic drug manufacturers but to “increase fees for an inspections of foreign manufacturing plants.” FDA Commissioner Marty Makary, M.D., also said that the agency will switch from announced to surprise visits for overseas drug facility inspections.
5. Vivo Capital secures $740M to invest in preclinical- and clinical-stage biotechs
California-headquartered investment firm Vivo Capital, which has a major presence in Asia, has secured $740 million in commitments to fund preclinical- and clinical-stage life science companies. The so-called Vivo Opportunity Fund is now in its third three-year investment cycle. Some of the biotechs Vivo has backed include Chinook Therapeutics, Gracell Therapeutics and RayzeBio.