FiercePharmaAsia—Daiichi, Glenmark FDA refusals; Takeda U.S. HQ move; JLABS Shanghai opening

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Daiichi Sankyo, Glenmark, Takeda and JLABS made our news this week. (Google)

The FDA rejected Daiichi Sankyo's blood cancer drug quizartinib after questioning its phase 3 data. The agency also turned down Glenmark's rhinitis nasal spray Ryaltris on manufacturing concerns. Takeda plans to move its U.S. headquarters from Chicago to Boston by year's end. Johnson & Johnson launched JLABS Shanghai, now the world's largest site for the biopharma incubator. 

1. FDA nixes Daiichi's blood cancer drug quizartinib after Japanese regulators wave it through

Right after Japanese regulators cleared Daiichi Sankyo’s blood cancer drug quizartinib, the FDA followed an expert panel’s advice and decided against a green light. Agency officials previously questioned the reliability of quizartinib's phase 3 data. The rejection gives Astellas’ rival drug Xospata some additional breathing room in second-line FLT3-mutated acute myeloid leukemia.

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2. Glenmark has wind knocked out of NDA for respiratory drug by FDA

Glenmark, in the process of spinning off its innovative drug franchise, hit a setback in its development efforts. The Indian company said the FDA rejected Ryaltris, its lead respiratory candidate designed to treat seasonal allergic rhinitis. The FDA wasn’t concerned about the clinical data but rather about its manufacturing, Glenmark said. It now expects to solve the problems in six to nine months.

3. Goodbye, Chicago: Takeda sets December deadline for U.S. employees' Boston move

Takeda has decided to pull up stakes in Deerfield, Illinois, by Dec. 31 as part of its plan to relocate U.S. operations to the Boston area, close to Shire’s legacy business. The Deerfield facility will be put up for sale by March of next year. The move affects about 1,000 employees, and Takeda said it expects to part ways with some of them.

4. J&J launches JLABS Shanghai, with room to host 50-plus biotech startups (release)

Johnson & Johnson has opened JLABS Shanghai, the world’s largest JLABS and the first in the Asia-Pacific region. The 4,400-square-meter facility now hosts 31 resident firms and boasts the capacity to house more than 50 startups in biopharma, the company said.

5. Progress at Sun's Halol, India, plant tarnished by new FDA findings

Sun Pharma has continued to struggle with its key launch plant in Halol, India. It took the plant seven years to gain approval for a design plan change, but in a new Form 483, the FDA faulted Sun for failing to keep track of the project's history. The four-observation letter also cited the fact that employees introduced unapproved processes to a filling line.

6. Genfit partners with Terns in $228M China deal for NASH drug elafibranor (release)

After taking in all three of Eli Lilly’s nonalcoholic steatohepatitis programs at launch in 2017, Terns Pharmaceuticals has gained Greater China rights to GenFit’s lead candidate elafibranor for NASH and primary biliary cholangitis. The company is paying just-IPOed GenFit $35 million upfront and up to $193 million in milestone payments if the candidate hits certain goals.

7. India’s Piramal adds capacity to U.S. high-potency API site

CDMO Piramal Pharma Solutions completed a $10 million expansion at its site in Riverview, Michigan, where it makes high-potency active pharmaceutical ingredients. It also added nearly 50 jobs.

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