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The FDA warned Cadila Pharmaceuticals for cGMP violations that include quality controls, complaint handling and data integrity at its Gujarat, India, active pharmaceutical ingredients manufacturing plant. Read More
Takeda’s monoclonal antibody Entyvio got a tentative green light from the UK’s health cost watchdog as a treatment for severe colitis, paving the way for a final consultation and adoption by the National Health Service. Read More
Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483. Read More
Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form. Read More
The FDA approved an under-the-tongue formulation of Actavis’ atypical antipsychotic Saphris for 10- to 17-year-old children with bipolar 1 disorder. The company plans to begin marketing the new formulation in the second quarter. Read More
India’s patent office sided with a challenge from generics maker Cipla and struck down a patent protecting Boehringer Ingleheim’s blockbuster COPD drug Spiriva. Read More
A federal appeals court has extended an injunction barring four companies from marketing generic versions of AstraZeneca’s blockbuster inhaled asthma drug Pulmicort Respules while it hears an appeal of a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
Bristol-Myers Squibb has submitted a new NDA for its hepatitis C drug Daklinza, this time in combination with Gilead Sciences’ Sovaldi for patients with genotype 3 disease. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More