Janssen Vaccines Corp.

Celltrion and Eli Lilly's U.S. plant transaction, the FDA complete response letter for Lundbeck and Otsuka's PTSD drug application and an ADC deal between Hengrui and Glenmark made our news this week. Celltrion is buying an Eli Lilly drug substance plant in the U.S. for $330 million. The FDA has declined to approve Lundbeck and Otsuka's Rexulti in PTSD. Hengrui Pharma has out-licensed certain rights to its HER2 antibody-drug conjugate to Glenmark. And more.1. Celltrion snaps up Lilly's NJ drug substance plant for $330M in tariff mitigation move, pledges to retain employeesCelltrion is paying 460 billion Korean won (about $330 million) to buy Eli Lilly’s drug substance plant in Branchburg, New Jersey. Once the deal is closed by the end of the year, Celltrion plans to retain all employees and start operations immediately with existing CDMO contracts at the site. The purchase is meant to protect the company from tariffs, the company said.2. FDA turns down Lundbeck, Otsuka's Rexulti in PTSD on lack of efficacy dataThe FDA has declined to approve Lundbeck and Otsuka’s application for Rexulti as part of a combination with Viatris’ Zoloft in post-traumatic stress disorder. The FDA cited a lack of substantial evidence of effectiveness and asked the partners to run additional trials should they wish to pursue an approval again, according to the companies.3. In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to EnhertuHengrui Pharma is licensing certain rights in emerging markets around its HER2 antibody-drug conjugate, trastuzumab rezetecan, to Glenmark. The deal features $18 million in upfront payment and up to $1.09 billion in milestones. The drug was approved in China in May in second-line non-small cell lung cancer with HER2-activating mutations.4. Generics makers to sell Gilead's Yeztugo at $40 a year under deals with Gates Foundation, othersIndia's Dr. Reddy’s Laboratories and Hetero Lab have signed deals with charity organizations to provide generic versions of Gilead Sciences' long-acting HIV PrEP injection Yeztugo at $40 a year in 120 low- and middle-income countries starting in 2027. The deals were enabled by licensing agreements with Gilead.5. FDA hands warning letter to J&J subsidiary over stopper issues, spotty reporting at Korean plantJohnson & Johnson's Janssen Vaccines in South Korea was hit with an FDA warning letter. The regulator criticized the company’s manufacturing site in Incheon, South Korea, for inconsistent quality control procedures and failure to follow up thoroughly on product complaints. The site no longer performs any vaccine development, a spokesperson said.Other News of Note:6. Fujifilm Biotechnologies cuts ribbon on $3.2B antibody facility in N.C.7. Fujifilm, argenx expand partnership to bring Vyvgart production to the US8. Italy's Angelini inks $550M-plus pact for preclinical brain condition asset9. Takeda scientists tackle Mount Fuji to advocate for patients in need of plasma-derived therapies10. Japan biotech inks research pact in effort to develop new RNA meds11. Lantheus hands GE HealthCare the rights to its blockbuster prostate cancer PET tracer in Japan

Pictured: Johnson & Johnson Sign/iStock, JHVEPhoto The issues the regulator found include the failure to comprehensively review complaints and product defects. The FDA has issued a warning letter to Johnson & Johnson’s subsidiary Janssen Vaccines, flagging lapses in quality control and the failure to follow good manufacturing practices at a production plant in South Korea. The letter , dated July 18, was made public on the FDA’s website on Tuesday; it noted that the facility’s quality control department “does not consistently follow your procedures for the submission of regulatory notification” for defective products. In particular, after receiving a couple of complaints about faulty vial stoppers in its products, officers in charge did not escalate the matter to the appropriate authorities, nor did they take “sufficient action” on these complaints. The South Korean plant, located in Incheon, also did not “thoroughly investigate” discrepancies or failures of batches that failed to meet specifications. Between Nov. 13, 2023 and Nov. 8, 2024, the facility received “recurring complaints” regarding its vial stoppers, and while officers reviewed batch records, they failed to conduct a “comprehensive assessment” of how these stopper problems could affect human use and the stability of its products, as per the warning letter. In response to these issues, the FDA is requesting information from J&J, including a “comprehensive assessment” of the plant’s system for investigating complaints and product defects, as well as a retrospective review of all complaints over the last three years, to help identify other reporting lapses. In a statement to Fierce Pharma on Tuesday, a spokesperson for J&J said that the pharma is “committed to meeting the highest standards of quality and safety in the supply of our products.” Nevertheless, the spokesperson insisted that these observations do “not relate to the safety and efficacy of our products,” noting that the South Korean site in the FDA’s report no longer produces vaccines. “We take FDA observations seriously,” the spokesperson said, adding that the pharma is “confident” that it can address the FDA’s concerns “promptly.” The concerns at J&J’s South Korea plant come as the pharma undergoes a massive domestic manufacturing push. In March, in response to the threat of tariffs from President Donald Trump, J&J announced that it would invest $55 billion into production and R&D capabilities in the U.S., which will be disbursed over the next four years. Then, in August, the pharma added $2 billion to the commitment as part of a 10-year agreement with Fujifilm to construct a 160,000-square-foot facility in North Carolina.

The issues detailed in the warning letter came to light during an inspection of Janssen Vaccines' manufacturing site in Incheon, South Korea, between Nov. 11 and Nov. 19 of last year. A Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a warning letter dated July 18 and posted on the FDA’s website this week, the regulator chastised Janssen Vaccines for inconsistent quality control procedures and failure to follow up thoroughly on product complaints—issues that came to light during an inspection of the J&J subsidiary’s manufacturing site in Incheon, South Korea, between Nov. 11 and Nov. 19 of last year.The inspection resulted in Janssen Vaccines initially receiving a Form 483, which is a less severe reprimand for production shortfalls. The FDA may follow up with a warning letter if a company does not rectify the issues identified.“We are committed to meeting the highest standards of quality and safety in the supply of our products. We take FDA observations seriously,” a J&J spokesperson said in an emailed statement. “We will work closely with the FDA and are confident that we will promptly address the findings. This does not relate to the safety and efficacy of our products, and we do not expect any interruption to manufacturing or supply.”The spokesperson also said that despite still carrying the Janssen Vaccines name, the site in the FDA's letter no longer supports any vaccine development. The warning letter’s first citation involved Janssen’s failure to properly investigate numerous complaints about a partially redacted issue pertaining to vial stoppers.“Your investigations, which included review of batch records, did not identify any ‘… relevant issue recorded which might have impacted the product quality and could lead to the investigated defect …,’ and you add that ‘The manufacturing process is in a validated state of control and is capable to consistently meet specifications,’” the FDA said. The FDA’s public-facing letter did not disclose the details of Janssen’s stopper issue. The agency has dinged drugmakers in the past when particulates have stuck to vial stoppers or stoppers themselves were shedding particulates into vials and drug product.The FDA went on to suggest that Janssen’s internal probe lacked a “comprehensive assessment of human use, manufacturing and stability factors” that could have contributed to the stopper problem.“In addition, you did not always sufficiently pursue collection of relevant samples of vials from complainants,” the regulator continued. The second and final observation in the warning letter related to the same stopper issue but focused its scrutiny on the Incheon facility’s quality unit, which “does not consistently follow your procedures for the submission of regulatory notification of product quality defects,” according to the FDA.In essence, the quality unit failed to escalate those stopper complaints to the appropriate channels, circumventing the process through which regulators would have been made aware of a potential issue.“Timely submission of [Biologic Product Deviation Reports] to regulatory authorities facilitates awareness and evaluation of potentially hazardous product defects,” the FDA explained.The FDA caveated that the company did eventually submit one of those product deviation reports on Dec. 10 and pledged to update its procedures around them moving forward.But the federal agency argued that Janssen’s response didn’t go far enough, pointing out that the company failed to propose a retrospective review of complaints around marketed products, which would be necessary to pinpoint other instances where a product deviation report should have been submitted.In turn, the FDA is calling on the company to conduct a “retrospective review of product quality complaints received within the last three years for all Janssen products to identify any circumstances” in which the unit may have failed to properly report deviations at the Incheon site. The regulator also called on Janssen to work out a remediation plan that ensures its Incheon quality unit is “given the authority and resources to effectively function.”Janssen is also on the hook to further review its overall system for investigating manufacturing issues at the facility, as well as the undisclosed stopper issue, with the FDA specifically calling on the company to examine whether its stopper sterilization process, container closure system assembly process or human use factors could be contributing to the problem. Stopper problems recently surfaced at a former Catalent plant in Bloomington, Indiana, which Novo Nordisk has taken over following its parent company’s acquisition of the CDMO in late 2024.In a Form 483 directed at the Bloomington facility, the FDA chided Novo earlier this year for failing to properly follow up on “an ongoing trend” of hair turning up on vial stoppers. Editor's note: This story was updated at 4 p.m. ET on Sept. 23 to include a statement and further information from Janssen.