Fierce Pharma Asia—Takeda's GammaDelta buy, FDA warning letter removal; Fujifilm's massive North Carolina plant

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Takeda's T-cell therapy-focused GammaDelta buyout and Fujifilm's massive biologics plant in North Carolina made our news this week. (Google)

Takeda has exercised an option first penned in 2017 to acquire U.K. T-cell therapy expert GammaDelta Therapeutics. The Japanese pharma has also resolved an FDA warning letter regarding its Hikari, Japan, plant, which will make Novavax's COVID-19 vaccine for the country. Fujifilm Diosynth has started construction of a massive biologics plant in North Carolina, with a goal for completion in 2025. And more.

1. Takeda buys out collaborator GammaDelta Therapeutics for solid tumor pipeline

Back in 2017, Takeda and investment shop Abingworth committed up to $100 million to accelerate R&D at GammaDelta Therapeutics, with an option to buy out the U.K. biotech. The Japanese pharma has now followed through on that deal to get its hands on a pipeline of gamma-delta T-cell therapies for various cancers.

2. Takeda's Japan plant reemerges from FDA warning letter as pharma works through pipeline setbacks

Meanwhile, Takeda has resolved an FDA warning letter issued for its Hikari plant in Japan. Problems with the site triggered a shortage of hormone therapy Lupron and a legal battle with the drug’s U.S. distributor AbbVie. Still, Takeda has several setbacks to work through, including Natpara’s impurity issue, a delayed FDA decision on eosinophilic esophagitis candidate Eohilia, as well as questions about the prospects for its orexin franchise after a safety signal.

3. Fujifilm starts build-out for massive NC plant, the latest piece of its multibillion-dollar CDMO expansion effort

Fujifilm has started building a flagship plant in Holly Springs, North Carolina. Once completed in 2025, the $2 billion complex will be the largest for biologics production in the world, with eight 20,000-liter bioreactors and the capacity to add 24 more. “One of the things that we did learn from the pandemic is that there is probably a little more demand out there,” Fujifilm Diosynth CEO Martin Meeson said.

4. Juventas Cell Therapy closes a $63M funding round as it eyes a big push for blood cancer hopeful

China’s Juventas Cell Therapy raised $63 million in a series C to help move forward a CD19-targeted CAR-T program, dubbed CNCT19. The company is planning a new drug application and launch in China as well as an international development plan. The latest financing was led by CICC Capital.

5. Strides Pharma to pump $42M into former Endo manufacturing plant in New York

India’s Strides Pharma is pumping $42 million into upgrades at a New York manufacturing facility that it recently acquired from Endo. New York state is giving Strides $10 million in tax credits, and the company will retain 215 employees and create 40 more positions.

6. Science 37 partners with two CROs in Japan as part of decentralized trials push

Fresh off a $235 million Nasdaq IPO, Science 37 has teamed with Japan’s CRO giant CMIC and 3H Medi Solution. While details of the pacts were not shared, the two Japanese partners will use Science 37’s clinical trial operating system and tech platform for decentralized, or virtual, trials.