FiercePharmaAsia—Mylan plant’s data issue, Takeda’s deal spree, China’s hardened trial data policy

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FDA slaps another Mylan plant in India with a warning letter.

Welcome to this week’s FiercePharmaAsia report, which includes stories about an FDA warning letter for another Mylan plant in India, Takeda's second microbiome gastrointestinal deal in a week, China's regulatory and criminal law measures against forging clinical trial data and more.

1. FDA jumps on another Mylan plant in India, slapping it with a warning letter

Less than two years ago, the FDA warned Mylan of problems at three Indian plants it got in the $1.75 billion buyout of sterile injectables specialist Agila Specialties. Now the agency has, in a warning letter, cited a finished pharmaceutical plant of Mylan’s in India for data integrity issues, saying that about 72% initial testing results were invalidated without investigation.

2. NuBiyota pact continues Takeda’s GI, microbiome deal blitz

After reaching a deal just last week with Finch Therapeutics to jointly work on a microbial drug for inflammatory bowel disease, Takeda has inked another microbiome gastrointestinal deal, this time with low-profile biotech NuBiyota. The Japanese pharma is offering an undisclosed amount of upfront fee and milestone commitments for the latter’s microbiome platform.

3. China to tighten rules against faking clinical trial data, criminal charges possible

China is proposing new actions against forging clinical trial data. The CFDA specifies in a revised proposal details about bans, certificate retraction and black list for new drug registration applicants, hospitals that conduct trials and CROs that forge trial data. The Supreme Court made it clear for the first time that certain criminal laws are applicable in such cases.

4. Teva's China API plant smacked by FDA warning letter, adding to drugmaker's burdens

The FDA has nailed an API facility operated by Teva in China with a warning letter, which noted issues in manufacturing control and sampling processes. This followed another letter for the Israeli drugmaker in half a year—the previous one was for a sterile injectables plant in Hungary, adding on to the company’s burdens of a CEO shift and possible large-scale job cuts on the horizon.

5. Samsung BioLogics nears finish line with massive biologics manufacturing project

Samsung BioLogics will complete its third manufacturing plant in the fourth quarter this year. The Incheon-based 118,168-square-meter plant costs about $750 million to build and includes a dozen, 15,000-liter bioreactors. When complete, the South Korean company will become the largest contract manufacturer in the world focused solely on biologics.

6. Takeda lays out financial details of JV with PRA Health Sciences

An already announced joint venture between Takeda and PRA Health Sciences is now slated to be finalized on June 1. Takeda will increase the capital in a subsidiary to about $4.1 million before sharing half of the shares in that unit with the CRO. The JV will provide clinical development and pharmacovigilance services for Takeda’s products in Japan.

7. Malaysia calls for phase 4 Dengvaxia study before considering full approval

Sales of Sanofi Pasteur’s Dengvaxia have already fallen far short from the company’s original expectation, and now the dengue vaccine will have to undergo phase 4 testing in Malyasia before regulators agree to a full rollout. The country’s National Pharmaceutical Regulatory Agency warned that if the shot fails to prove its clinical benefit, it will withdraw its conditional registration.

8. FDA ban of Chinese company leaves WHO scrambling for contraceptive

The FDA recently added Qinghuangdao Zizhu to its import alert list after data integrity issues arose, and the company is recalling all of its APIs from the U.S. market. That caught the World Health Organization off guard, as the Chinese API maker was the only WHO-prequalified supplier of the API levonorgestrel for the two birth control tablets the WHO has greenlighted.

9. FDA issues warning for sterile drugmaker after 1,500 customer complaints

India’s Indoco Remedies, over a four-year plus period, had received 1,500 complaints about cracked, broken, leaking and underfilled vials. As a Form 483 didn’t seem to have worked, the FDA has served the company’s sterile injectables plant with a warning letter, saying that it’s still unclear how Indoco is planning to solve the problems.