Pravastatin Sodium

Astellas' Eccles plant closure and a new R&D center, plus a Chinese investigation into some AstraZeneca staffers made our news this week. Astellas is closing a gene therapy manufacturing facility in South San Francisco. But, across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained several current or former AstraZeneca employees. And more.1. Astellas Gene Therapies to turn out the lights at South San Francisco production plantAstellas’ gene therapy branch is closing its Eccles manufacturing facility in South San Francisco. All existing programs at the plant will be moved to another site in Sanford, North Carolina. While the fate of the California site’s 100 employees wasn’t immediately clear, at least 17 staffers are being let go, according to two public notices.2. Astellas unveils Massachusetts lab that will be shared with biotechs, academia researchersAstellas has opened a new life sciences collaboration hub in Massachusetts. Besides about 400 Astellas employees who will work there, the center includes the Japanese pharma’s first U.S.-based SakuLab, which will be shared with external partners. The location also houses a small-molecule unit focused on targeted protein degradation research.3. AstraZeneca staffers detained in China over patient data collection, drug imports: BloombergFive current and former employees in AstraZeneca’s oncology division have been detained in China, the company confirmed. Bloomberg, citing people familiar with the matter, reports that the investigation centers around a possible violation of data privacy laws and potential illegal importation of an unapproved liver cancer drug. The latest investigation follows an insurance fraud case involving AZ in the country about three years ago.4. Glenmark joins growing list of drugmakers to settle long-running US price-fixing claimsGlenmark has agreed to pay the U.S. Department of Justice $25 million to resolve allegations that it colluded with other drugmakers to rig the price and market around the cholesterol med pravastatin. The payment is separate from $30 million in criminal penalties that the generics maker paid last year as part of a deferred prosecution agreement.5. DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continueAmid an ongoing shortage, the U.S. Drug Enforcement Administration has increased production limits on Takeda’s ADHD drug Vyvanse and lisdexamfetamine generics by 24%. Not all increases are being allocated for U.S. domestic demand. Takeda reported “low inventory” for Vyvanse in June 2023 thanks to increased demand and a manufacturing delay.6. BIOSECURE Act heads for possible vote in House of Representatives next weekThe U.S. House of Representatives has added the BIOSECURE Act to a list of legislation that it plans to consider during the week of Sept. 9. As for the Senate, the most promising path forward would be for it to be folded into the annual defense policy this year. The House version recently added a grace period for biotech companies to cut ties with Chinese service providers.Other News of Note:7. FDA scrutiny of India’s Zydus results in warning letter8. Dr. Reddy's banned from China's drug procurement program after inspectors turn up manufacturing problems9. Allist pays Jacobio $21M for KRAS drug combo, landing leading role in Chinese cancer race10. Takeda taps longtime FleishmanHillard alum to head up global corporate brand and content11. Daiichi study finds gender inequality in European cardiovascular care12. EpimAb licenses BCMA bispecific to Vignette in $635M biobucks deal (release)

The U.S. subsidiary of India-based drugmaker Glenmark Pharmaceuticals has agreed to pay $25 million to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic cholesterol drug. The allegations relate to Glenmark's generic pravastatin, which is widely used to treat high cholesterol and triglyceride levels. Glenmark got the green light to sell pravastatin sodium oral tablets, a generic version of Bristol Myers Squibb's Pravachol, in 2007 . The U.S. government alleged that, between 2013 and 2015, Glenmark paid and received compensation prohibited by the Anti-Kickback Statute through arrangements on price, supply and allocation of customers withTeva Pharmaceuticals, Apotex Corp. and others. Glenmark previously entered into a deferred prosecution agreement with the Justice Department’s Antitrust Division to resolve related criminal charges, paying a criminal penalty of $30 million and admitting to conspiring with two other generic drug companies to fix prices on pravastatin. Teva got hit hardests in the criminal case, agreeing to make a $50 million drug donation to humanitarian organizations and pay a $225 million criminal penalty. The recent civil settlement payment is in addition to this criminal penalty. According to the settlement, the agreement "is neither an admission of liability by Glenmark nor a concession by the United States that its claims are not well founded."