CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Source: Drug Industry Daily

The FDA released a proposed rule to codify the use of master files for biologics applications. Source: Drug Industry Daily

Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA…

Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed multiple serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Source: Drug Industry Daily

Drugmakers in Australia will soon be subject to higher GMP clearance fees, the Therapeutic Goods Administration (TGA) announced Wednesday. Source: Drug Industry Daily

A key committee is urging European regulators to turn down a sickle cell treatment—two years after their American counterparts approved the drug. Source: Drug Industry Daily

The price tag for Novartis’ newly approved and seemingly miraculous gene therapy for a rare childhood disease presents a whole new challenge of its own. Source: Drug Industry Daily

The FDA cited Sovereign Pharmaceuticals for quality and other failures observed during a Dec. 11-19 inspection of its facility in Fort Worth, Texas—including its failure to ensure the quality of…

The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility. Source: Drug Industry Daily

The EMA’s Committee for Medicinal Products for Human Use (CHMP) flagged 13 medicines for approval at its April meeting, including two orphan medications and a biosimilar. Source: Drug Industry Daily