Spotlight On... Abbott India unit, others, get court stay on fixed-dose drug bans; Mitsubishi Tanabe to be sole Simponi distributor in Japan; India mulls joining Pharmaceutical Inspection Cooperation Scheme; and more...

The Delhi High Court granted a stay for the Indian unit of Abbott Laboratories ($ABT) and local firm Macleods Pharmaceuticals to respond to a regulator ban halting sales of products that fall under so-called fixed-dose formulations that combine medicines, the Economic Times said. Last week, India banned more than 300 fixed-dose drugs that combine therapies often without new clinical trials in a widely used method that has formulations running into the thousands, many of which are approved at the state level in India. The court said the companies have until March to reply on why the formulations should be allowed to remain on the market. In the case of Abbott, this covers cough syrup brands Tixylix toddler syrup and Phensedyl, and for Macleods, panderm plus ointment. The Indian unit of Pfizer's ($PFE) cough syrup Corex was also granted a stay on Tuesday. A separate report by the Economic Times said India's Ministry of Health is examining as many as 1,700 more fixed dose products for safety. Report

> Tokyo-based Mitsubishi Tanabe will be Japan's sole distributor of rheumatoid arthritis therapy Simponi (golimumab) under a revised agreement with Janssen Biotech. Release (PDF)

> India may join the Pharmaceutical Inspection Convention Scheme and Pharmaceutical Inspection Cooperation Scheme (PIC/S) in an initial observer status. Report

> An international research effort that includes the National University of Singapore has found genetic variants that make children with acute lymphoblastic leukemia (ALL) suffer excess side effects during routine treatment. Report

> China has moved to increase the number of undergraduates in pediatric studies in the wake of the lifting of the one-child policy in October last year. Report

> Cambridge, U.K.-based Avita Medical inked an exclusive distribution deal for China with Sinopharm. Release

> Sydney-based Viralytics announced positive data from its CANON clinical trial of its lead drug candidate, CAVATAKTM, at the 31st Annual European Association of Urology Congress in Munich. Release

> Japan's Pharmaceuticals and Medical Devices Agency said it aims to finish reviews on 70% of priority product drugs this year, a faster pace than the 60% level achieved in 2015. MHLW website

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