Form 483 News Today

Samsung Bioepis suspends development for its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives a Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

Shares of Indian pharmaceutical company, Ipca Laboratories, fell by 3% after the US Food and Drug Administration (USFDA) issued a Form 483 report, citing 11 observations of its API manufacturing facility situated in Ratlam. Form 483 is issued when an inspector has found conditions that could violate FDA regulations. Ipca said it takes quality and compliance issues seriously and will submit a response in the prescribed time. Trendlyne data showed that the stocks day RSI (14) is at 57.8, while the...

Lupin shares plunged 3.18% to Rs 106.50 against the previous close of Rs 110 on BSE. Market cap of the firm fell to Rs 10,970 crore

Takeda is preparing for the patent loss of its third-largest product but called it quits on a rare disease therapy.

Merck's former China head will return to the Big Pharma to lead international human health operations after a short stint at a Chinese company.

Lupin is no stranger to FDA rebukes. After facing accusations of “inadequate” manufacturing operations writ large last summer, the generics juggernaut is apparently yet to clean up its act.

India’s Zydus Lifesciences is in the FDA’s crosshairs once again, this time for a trio of unnamed violations at an injectables facility.

Catalent received an FDA write-up for its syringe filling facility in Belgium, BioProcess International reports, adding that it is "allegedly" the culprit behind supply challenges for Novo Nordisk’s obesity med Wegovy.

Biogen and Eisai have started an FDA rolling submission for another Alzheimer's disease drug. Samsung Biologics' long-term partnership with Roche has grown in value. Otsuka has penned a near-$1 billion deal for four Sunovion neuropsychiatric candidates. And more.