Fierce Pharma Asia—Moderna's cancer combo plan; GSK's trial win; Glenmark's DOJ deal

2023-08-25

疫苗上市批准临床3期临床1期信使RNA

Fierce Pharma Asia—Moderna's cancer combo plan; GSK's trial win; Glenmark's DOJ deal

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来源: FiercePharma

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 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

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