Fierce Pharma Asia—Eisai's subcutaneous Leqembi study; Astellas' IRA lawsuit; and GSK's Taiwan recall
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Source: FiercePharma
After a recent study of Eisai's subcutaneous Leqembi formulation, the company is touting its "promising" results. Plus, Astellas joined the list of drugmakers taking legal swings at the Inflation Reduction Act, with Johnson & Johnson quickly following. And GSK pulled two batches of its severe asthma injection Nucala in Taiwan after a hospital reported glass particles in one vial.
Eisai shared an exposure/bioavailability and modeling study of Leqembi, showing "promising" results for a subcutaneous version of the Alzheimer’s disease med. Models have shown that a common side effect of the drug, amyloid-related imaging abnormalities with edema/effusion, is tied to higher concentrations of the med in the blood, meaning the subcutaneous version could offer lower incidence of the condition.
2. Johnson & Johnson becomes 4th drugmaker to file suit against IRA's drug price negotiations
Astellas’ recent legal action levied at the Inflation Reduction Act was closely followed by Johnson & Johnson’s suit, making them the third and fourth drugmakers to take swings at the law. The Tokyo-based company called the negotiations “price setting” that violates that “Takings Clause, the Due Process Clause and the First Amendment,” Astellas wrote in its release. Astellas says its “constitutional rights will be violated” come Oct. 1, when it has to sign on to the program, the company said in its complaint.
Taiwan’s Food and Drug Administration recalled two batches of GSK’s severe asthma injection Nucala after glass particles were found in a vial of the drug. The recall should be complete by Aug. 7, according to local news outlet Focus Taiwan. A GSK spokesperson told Fierce Pharma in an emailed statement that none of the suspect vials were administered to patients.
4. FDA accepts Elevar, Jiangsu Hengrui Pharmaceuticals’ liver cancer combo therapy: Fierce Pharma regulatory tracker
Elevar Therapeutics’ FDA application for investigational VEGFR rivoceranib, in combination with Jiangsu Hengrui Pharmaceuticals' PD-1 inhibitorPD-1 inhibitor camrelizumab, has been accepted for review in unresectable liver cancer and given a decision date of May 16, 2024. The combo was approved for first-line use in China in February and would compete with Roche’s PD-L1/VEGF combo of Tecentriq and Avastin on the U.S. market if cleared.
5. GSK, Yuhan, GC, SK discovery among 32 firms fined for fixing vaccine prices (Korea Biomedical Review)
Korea’s Fair Trade Commission slapped 32 companies with a fine worth a total of 40.9 billion South Korean won ($32.2 million) for colluding in 170 vaccine tenders ordered by the country’s Public Procurement Services for more than six years, Korea Biomedical Review reports. Vaccine maker GSK was targeted, along with six distributors and 25 wholesalers.
6. Sosei Heptares acquires Idorsia’s pharma business in Japan and beyond (Labiotech)
Sosei will take over all shares of Idorsia Pharmaceuticals Japan and Idorsia Pharmaceuticals Korea in a deal worth approximately 65 billion Japanese yen ($470 million). The agreement also includes the Japan and Asia-Pacific (excluding China) rights to Idorsia’s pipeline, including lead product Pivlaz, which was approved in Japan in April.
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