January 2016

The use of oral contraceptive just before pregnancy is not associated with an increased risk of major birth defects, says a study.

Persons residing at higher latitudes, with lower sunlight exposure and greater prevalence of vitamin D deficiency, are at greater risk of developing cancer, including leukemia, a type of blood cancer, new research reveals.

Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.

BioQ Pharma and Cipla the signed of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's  Ropivacaine infusion  pharmaceutical in India.

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF)

Pharma Major Lupin Limited (Lupin) announced that its US subsidiary Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of Janssen Pharmaceuticals Inc. (Janssen) Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg).