China's former FDA chief resigned from his current position at the State Administration for Market Regulation, to which the new drug administration belongs, in the wake of a vaccine safety scandal that sparked nationwide uproar. Astellas doubleed down on gene therapy by shelling out $109 million to acquire British firm Quethera. The FDA found problems a year ago at Zhejiang Huahai Pharmaceutical, whose tainted valsartan API recently led to a worldwide recall.
Bi Jingquan, former head of China’s FDA and champion of China’s latest drug reform, was asked by the country’s top rulers to resign from his current position at the all-powerful State Administration for Market Regulation. The crackdown stems from an investigation of Changchun Changsheng Life Sciences, which was found to have faked vaccine production data and sold nearly half a million doses of ineffective vaccine.
Astellas is buying U.K. gene therapy developer Quethera for £85 million ($109 million). The deal gives Astellas a recombinant adeno-associated virus gene therapy platform led by a potential treatment for glaucoma in preclinical development. Astellas has been working with Harvard Medical School investigator Constance Cepko, Ph.D., on a gene therapy for retinitis pigmentosa.
An FDA inspection found quality-control problems a year ago at Zhejiang Huahai Pharmaceutical, which sparked a global recall of valsartan made by its API tainted with a possible carcinogen. In a Form 483, the agency said the plant repeatedly reanalyzed API batches to achieve passing results and never investigated why out-of-specification test results occurred.
South Korean prosecutors are investigating a financial regulator’s complaint about Samsung BioLogics’ deal with Biogen, according to The Korea Herald. Samsung is accused of deliberately withholding information that it gave Biogen rights to buy additional shares of Samsung Bioepis at a predetermined price. The financial watchdog also has a case against Samsung on alleged accounting fraud.
Westminster Pharmaceuticals is recalling all lots of its thyroid drugs levothyroxine and liothyronine in five dose forms because they were made with an API from China’s Sichuan Friendly Pharmaceutical. The FDA banned all products made by Sichuan Friendly after an inspection found big problems. Westminster said it had used the API before the ban.
The FDA issued a warning letter to the Apotex Research Private plant in Bangalore, India, citing it for many of the same issues uncovered in 2014 and 2015. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” said a frustrated FDA in the warning letter.
Chinese authorities have rejected a key patent for Gilead Sciences’ hepatitis C drug Sovaldi. The ruling concerns the base compound patent and followed a rejection in 2015 about the prodrug, which once taken is metabolized into the active ingredient. The Initiative for Medicines, Access & Knowledge, which brought the patent challenge, said the ruling opens the door to generics as early as 2019.