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

2023-08-25

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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 cCARsgeningcancerng one GSKits mRNA cancer vaccine candidaGlenmark 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.

Modernarna reveals Claudin18.2 ambitions via cacanceraccine, solid tumor CAR-T combo plansGSK Shingrix Glenmark Teva

Chinese company CARClaudin18.2eutics has reaccancerdeal with solid tumor 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 triaCARsgen Therapeuticse in China, Shingrix keepModerna0Moderna Claudin18.2 cancer CARsgen Astellas AstraZeneca BioNTech Legend Biotech Claudin18.2

In a pGSKmarketing stshingles vaccinengrix 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 $25GSKpriShingrixg settlement wishingles vaccine offload certain medsShingrix GSK

TevTevad 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.

TevautchmGlenmarkChinese approval for autoimmune disorder drug after phase 3 successGlenmark Glenmark pravastatin Teva

Hutchmed said a phase 3 trial in Chinaautoimmune disorderhibitor 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.

Hutchmedic and Aurobindo issue US drug recalls, citSyk inhibitor Syk quality ansovleplenibn issuprimary immune thrombocytopenia sovleplenib

TwoAlembic compAurobindoembic 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 bAlembic EisaAurobindop away from Leqembi approval in Japan (AlembicPharma regulatory tracker)tobramycin Aurobindo rufinamide seizure disorders

A Japanese drug review panel hEisaicommended approval oLeqembi’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.