Rufinamide

According to the letter from House Republicans, the FDA ended its surprise foreign inspection program in a bid to engender deeper collaboration with India. Once again, U.S. lawmakers are pressing the Food and Drug Administration for clarity around the agency’s tracking of scarce medicines and foreign inspection priorities. After contacting the FDA back in July, Republicans on the House Committee on Energy and Commerce are digging into a Bloomberg report stating that the agency has put the kibosh on its unannounced foreign inspection program.  Drug shortages have become increasingly common and drawn-out affairs in the U.S. in recent years, with medications such as amoxicillin, penicillin, Adderall and certain chemotherapies being some of the most recent and high-profile products to run scarce. Throughout 2023, the issue has garnered concern from U.S. officials and lawmakers on both sides of the aisle. Those shortages can be blamed, at least in part, on the FDA’s wind-down of inspectional activities overseas, a trio of Energy and Commerce Committee Republicans alleged in a letter this week. “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions,” the Republican lawmakers wrote to FDA Commissioner Robert Califf, M.D. In their letter, the lawmakers cited a 2022 study that showed FDA foreign inspections were down 79% last year compared to 2019, while the number of citations from the regulator “’rose dramatically.’” The letter also singled out a slew of recalls by Indian drugmakers in recent months, as well as a number of plant closures in the U.S., both of which could further plunge the pharmaceutical supply chain into further uncertainty. Back in August, for instance, Alembic recalled more than 80,000 bottles of the bacterial eye infection treatment tobramycin, while the U.S. unit of India’s Aurobindo pulled 96 bottles of rufinamide tablets for treating seizure disorders. In both cases, the recalls were initiated due to the products being distributed throughout the U.S. without being approved. Elsewhere, Pfizer spent much of the second half of the year working with the FDA to right the ship at its Rocky Mount, North Carolina facility, which was damaged by a tornado this past summer. The House Committee has been investigating FDA’s foreign drug inspection program for some time. The committee says it sent a letter requesting information and documents in July, but as of mid-December, hasn’t received any response. Now, three committee members—Cathy Rodgers (R-WA), H. Morgan Griffith (R-VA) and Brett Guthrie (R-KY)—are seeking answers to nearly two-dozen questions around the FDA’s inspectional oversight, specifically concerning the agency’s operations in both China and India. They’re giving the FDA three weeks to respond. This isn’t the first time U.S. lawmakers have targeted the nation’s regulatory authority. Earlier this year, Republican leaders from the Energy and Commerce Committee separately pressed FDA Commissioner Califf to respond to questions on the FDA’s tracking of scarce medicines, its inspection priorities and what the agency has done to parse and prevent shortages for than half a dozen drugs. And in July, the ranking member of the Committee, Frank Pallone Jr. (D-NJ), urged House Republicans to take up legislation that would include FDA-related oversight in the reauthorization of the Pandemic and All-Hazards Prevention Act (PAHPA). Just last month, meanwhile, the chairman of the House Committee on Oversight and Accountability, James Comer (R-KY), and Lisa McClain (R-MI), chairwoman of the Subcommittee on Health Care and Financial Services, requested documents and a staff-level briefing from the FDA to parse through the agency’s shortage mitigation strategies.

Moderna and CARsgen's cancer deal, GSK's shingles trial in China and Glenmark's settlement with the U.S. Justice Department made our news this week. Moderna is considering pairing one of its mRNA cancer vaccine candidates with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a postmarketing trial in China. Glenmark and Teva have reached a settlement with U.S. prosecutors over price-fixing charges. 1. Moderna reveals Claudin18.2 ambitions via cancer vaccine, solid tumor CAR-T combo plans Chinese company CARsgen Therapeutics has reached a deal with Moderna for the two companies to “contemplate conducting preclinical studies and a phase 1 clinical trial” for a combination of Moderna’s Claudin18.2 mRNA cancer vaccine and CARsgen’s CAR-T therapy directed at the same target. Astellas, AstraZeneca, BioNTech and Legend Biotech are also working on Claudin18.2 therapies. 2. In GSK's trial of shingles vaccine in China, Shingrix keeps it 100 In a postmarketing study of GSK’s Shingrix in China, the shingles vaccine demonstrated 100% efficacy in nearly 6,000 people ages 50 and up. No Shingrix recipients got shingles, compared with 31 cases in the placebo group. GSK has attributed much of Shingrix’s recent sales growth to the shot's expansion in China. 3. Teva, Glenmark ⁠reach $255M price-fixing settlement with DOJ, agree to offload certain meds Teva and Glenmark have reached a settlement with the U.S. Department of Justice to resolve a price-fixing case. In the deferred prosecution agreement, Glenmark agreed to pay a fine of $30 million. Glenmark also admitted to participating in a conspiracy over the price of pravastatin. Teva will pay $225 million in the deal. 4. Hutchmed eyes Chinese approval for autoimmune disorder drug after phase 3 success Hutchmed said a phase 3 trial in China testing its Syk inhibitor sovleplenib as a primary immune thrombocytopenia treatment has met its goals. Compared with placebo, sovleplenib showed a significant increase in durable response rate compared with placebo in previously treated patients. The company plans to file for approval in China by the end of the year. 5. Alembic and Aurobindo issue US drug recalls, citing quality and production issues Two Indian companies, Alembic and Aurobindo, issued voluntary recalls in the U.S. Alembic pulled bottles of the antibiotic tobramycin because of quality issues. Aurobindo recalled some rufinamide tablets for treating seizure disorders because the products were distributed without being approved. 6. With health panel backing, Eisai one step away from Leqembi approval in Japan (Fierce Pharma regulatory tracker) A Japanese drug review panel has recommended approval of Eisai’s Alzheimer’s disease drug Leqembi. The decision sets up an official go-ahead from the local health ministry. A Jefferies analyst said he expected the Japanese government will reimburse the drug at around $13,700 per year, according to Bloomberg. Other News of Note: 7. Chinese CRO Tigermed debuts new HQ den in Hong Kong 8. Crown Bioscience, HanX pact shows promise of lymphoma drug