Despite assembling the largest body of data the FDA said it may ever see for a drug intended to treat anemia due to chronic kidney disease, Fibrogen Inc. will have to get even more trial data to push roxadustat over the finish line in the U.S. – if the FDA follows the advice of its Cardiovascular and Renal Drugs Advisory Committee.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
The FDA took Amgen Inc. to task for promotions claiming Neulasta (pegfilgrastim) Onpro on-body injector is more effective than pegfilgrastim delivered via a prefilled syringe.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkeus, Antengene, Immunitybio, Kintor, Qualigen, Ryvu, Sesen.
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
It’s more than 20 years since the tobacco firm Philip Morris International Inc. commissioned a controversial research paper, “Public Finance Balance of Smoking in the Czech Republic,” which infamously argued that smokers cut state health care expenditure by dying early. The paper was considered an outrage and led to a high-profile apology from the company, after being widely derided by politicians and commentators internationally. The company’s July 9 proposal to buy the respiratory diseases firm Vectura Group plc for $1.2 billion is already looking just as provocative according to U.K. politicians and anti-smoking groups, who are calling for the government to intervene to stop it going ahead.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Arca, Artax, AVM, Evgen, Innovent, Moleculin, Oryzon, Targovax, Valo.
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Bayer, Chemocentryx, Coya, Diurnal, Enochian, Gensight, Inotrem, Iveric, Janssen, Kintor, Prilenia, Provention, Seagen, Sigilon, Sirnaomics, Soleno, Tetra, Tevogen, Valneva.
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