Category Archives: Drug Industry Daily

The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children.
Source: Drug Industry Daily

The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design them and how to communicate findings.
Source: Drug Industry Daily

Eli Lilly has filed an appeal to the U.S. Court of Appeals for the Seventh Circuit following a May 9 decision that it violated the False Claims Act by underpaying rebates to Medicaid.
Source: Drug Industry Daily

The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month.
Source: Drug Industry Daily

New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling.
Source: Drug Industry Daily

Eisai’s Leqembi and AstraZeneca’s nirsevimab are both poised for a greenlight from the FDA if agency briefing documents prepared for two advisory committee meetings this week are any indication.
Source: Drug Industry Daily

iRhythm Technologies’ mislabeling of a cardiac monitor and its component software as well as failure to report serious adverse events, including two deaths, netted the devicemaker an FDA warning in late May.
Source: Drug Industry Daily

Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness.
Source: Drug Industry Daily

Biotech firm Promosome is the latest company to sue big pharma for infringing on its patent for messenger RNA (mRNA) technology during the rush to develop a COVID-19 vaccine, claiming in separate filings that Moderna and Pfizer reaped enormous profits using Promosome research.
Source: Drug Industry Daily

Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars on subjects ranging from ICH E8 R1 recommendations, pharmaceutical quality risk management and FDA’s sterilization pilot.
Source: Drug Industry Daily