The possibility of a government investigation looms ever larger for Sun Pharma, as Indian regulators said they're indeed reviewing whistleblower allegations against the company. In a newly posted warning letter, the FDA lambasted Zhejiang Huahai for failing to uncover a possible carcinogen in its active pharmaceutical ingredients for valsartan. Eisai and University College London's neurological disorders partnership could soon see its first clinical candidate. And more.
India’s securities regulators are indeed examining whistleblower allegations against Sun Pharma, local media reported. The Securities and Exchange Board of India could reopen a probe on alleged insider trading in the company’s acquisition of Ranbaxy and irregularities in raising money overseas, among other damaging accusations.
Zhejiang Huahai Pharmaceutical, the Chinese API maker at the heart of a global recall of blood pressure medicines, has been cited in an FDA warning letter. The agency criticized the company for failing to adequately assess the risks of changing its manufacturing process in 2011. What's more, the FDA said, if Huahai had taken a customer complaint seriously, it might have uncovered carcinogens sooner.
Eisai and University College London teamed up in 2012 to discover new therapies for neurological diseases. The partnership survived a R&D cull at Eisai in 2013, when the Japanese pharma cut medicinal chemistry at its U.K. site. Now, the partners are moving their first candidate, an anti-tau drug dubbed E2814, into the clinic.
The Korea Exchange decided to resume trading of Samsung BioLogics after the country’s securities regulators put the stock on temporary hold over an alleged accounting breach. But Samsung is not out of the woods yet. The company’s head office was raided by South Korean prosecutors as part of a criminal probe, according to Reuters.
Junshi Biosciences, whose JS001 is on track to become the first domestically developed anti-PD-1 approved in China, is looking to raise around $400 million in a Hong Kong IPO. The new Hong Kong exchange rule that welcomes pre-revenue biotechs has also attracted such local firms as Ascletis and Innovent Biologics.
Lonza is buying a GE Healthcare off-the-shelf biologics factory in China. Expected to be up and running by 2020, the 17,000-square-meter site in Guangzhou will be the Swiss CDMO’s first outpost in the country. It will include a 1,000-liter bioreactor and a 2,000-liter bioreactor and will hire 160 workers.
Looking to spur drug development in China’s booming biotech industry, Parexel is partnering with Eli Lilly to build a clinical trial learning and development program in the country. While registered clinical trials in China increased by 63% in 2017, the number of GCP-qualified trial sites didn’t grow much.