The European Medicines Agency (EMA) said that the suspension has been ordered for all drugs for which the bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.
Global drug major Novartis has invested, expanded its research & development (R&D) capabilities in India. The global leader in biosimilars through its subsidiary Sandoz is assessing Indian market dynamics to launch its portfolio.
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
Nexium (used to treat certain stomach and esophagus problem) & Pulmicort (used to prevent asthma attacks) supply may boost company's export formulation business during the quarter. Hence, export formulation business may grow around 35-40 percent year-on-year.
The warning, issued to Novartis's generic drugs unit Sandoz on Oct. 22, came after FDA officials inspected its Turbhe and Kalwa sites in western India in August 2014.
Kotak has a buy rating on Cipla with a target price of Rs 730 per share. Expecting launch of other two strengths (USD 600 million) in days to follow , the brokerage says Cipla will receive mark-up and profit share.
The multi-layered deal involves UK-based GlaxoSmithKline (GSK) acquiring the Swiss major's vaccine business, while the latter would purchase GSK's cancer drugs portfolio.
Brokerages are worried about the stocks and stress that approval of Sun Pharma-Ranbaxy deal will be key driver. They feel that this negative surprise may benefit Dr Reddy's.
According to Surajit Pal, both Natco Pharma and Dr. Reddy‘s share exclusivity and two-three more companies are also expected to join the same.
CNBC-TV18's Archana Shukla reports that German pharma MNC Sandoz has filed a citizen's petition against Ranbaxy asking it to forfeit its first-to-file (FTF) status for the blockbuster drug Nexium.
Natco Pharma Ltd has lost a patent litigation against Israel's Teva Pharmaceutical Industries Ltd in the US over multiple sclerosis treatment drug, Copaxone.