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Regulatory

Latest Headlines

Latest Headlines

Lilly and Incyte shoot for FDA approval with an oral RA drug

Partners Eli Lilly and Incyte filed an oral rheumatoid arthritis treatment for FDA approval, hoping to launch an agent that can steal market share from blockbuster injectables.

GAO report hammers FDA for lax oversight on speedily approved drugs

These days, the FDA is approving more and more drugs under its expedited programs, meaning new treatments are getting to patients faster. The problem? The agency isn't doing such a good job of monitoring those meds after they hit the marketplace, according to a government report.

Shkreli, Valeant CEO set for a grilling at congressional price-hike hearing

Vocal pricing critic Rep. Elijah Cummings (D-MD) has his chance to put some pharma execs in the hot seat. Former Turing Pharmaceuticals CEO Martin Shkreli, who kicked off the latest brouhaha with an unapologetic 5,000% price increase, and Valeant Pharmaceuticals interim CEO Howard Schiller are expected next week at a congressional hearing on drug prices.

French drug trial disaster leaves patient dead amid a slew of unanswered questions

The patient left brain-dead in last week's botched drug trial has died, French authorities said, spurring more questions about how a routine Phase I study went awry and sent 6 volunteers to the hospital.

Indian drug firms may finally put quality at top of management agenda

India faces the coming year still mired in a long list of U.S. FDA manufacturing compliance failures that have snared the top generics makers and overshadowed domestic reform efforts--but that might change drastically.

Samsung and Biogen win first EU approval for an Enbrel copycat

A joint venture between Biogen and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen and Pfizer's blockbuster Enbrel, planning to launch its injection in the coming weeks.

Wockhardt's new sterile injectable plant issued a Form 483 by the FDA

India's Wockhardt, already trying to get out from under an FDA warning letter for two key plants, has come up short in its effort to get the agency to approve a new sterile injectables facility.

South Korea's Samsung Bioepis gets EU nod for Enbrel biosimilar

South Korea's Samsung Bioepis won European Commission approval for commercial sales of a biosimilar of Amgen's Enbrel, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as Norway, Iceland and Liechtenstein.

Indian Council of Medical Research hopes to spur clinical trial upswing

The Indian Council of Medical Research wants a greater push on clinical trials of existing medicines used to treat tuberculosis, malaria and cancer among other prevalent diseases in the country to stem a noticeable decline in overall clinical work in those areas in the past three years.

Sanofi may get waiver from large-scale dengue vaccine trials in India

A waiver of large-scale clinical trials for Sanofi's dengue vaccine, Dengvaxia, was recommended by a special committee that advises the Drug Controller General of India, the Economic Times reports.