Biocon shares jumped 5 per cent to their 52-week high on Friday after the drugmaker announced that the European regulator has accepted for review a breast cancer biosimilar jointly developed with Mylan. Biocon and American-Dutch Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.
Drug firm Natco Pharma has received the Establishment Inspection Report for its chemical division facility in Chennai from the US health regulator after closure of inspection.
Mylan and Biocon anticipate that this may be the first marketing authorisation application (MAA) for a Trastuzumab biosimilar accepted by the EMA for review, it added.
Drug firm Natco Pharma on Thursday said the US Patent and Trademark Office has ruled in favour of its marketing partner Mylan by invalidating two of Israel-based Teva Pharmaceuticals' patents related to multiple sclerosis drug Copaxone 40 mg/mL.
Strides Shasun on Thursday said it has received approval from the US Food and Drug Administration (FDA) for Polyethylene Elycol 3350, used for treating constipation.
Zydus Cadila is recalling over two lakh bottles of anti-depressant Venlafaxine HCL ER capsules in the US in two different strengths for failed dissolution specifications.
Strides Shasun on Wednesday said it has received approval from the US Food and Drug Administration (FDA) for Ranitidine tablets used for treating intestinal and stomach ulcers and gastroesophageal reflux disease.
Meronem is anti-bacterial used for the treatment of serious infections in hospitalised patients.
Drug major Lupin on Wednesday said its subsidiary Gavis Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to market generic Linezolid tablets used for treating bacterial infection in the American market.
Drug firm Aurobindo Pharma on Tuesday reported a 23.81 per cent rise in consolidated net profit to Rs 584.96 crore for the first quarter ended June 30, 2016, mainly on account of robust sales.
Drug firm Lupin has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Acotiamide 100 mg tablets used for treatment of indigestion.
By purchasing Medivation, Pfizer would add to its portfolio the drug Xtandi, a promising treatment against prostate cancer that analysts estimate will generate some $1.33 billion in annual sales by 2020.
Sun Pharma sees the remediation process at erstwhile Ranbaxy facilities as a "time consuming" process even as it aims to bring at least one of the plants to conform to current good manufacturing practice regulations (cGMP) in the current fiscal year.
Drug firm Strides Shasun on Wednesday said it has completed acquisition of a controlling stake in Australia-based Generic Partners Holdings.
Drug major Lupin expects to launch nearly 25 products in the US market in 2016-17 that the company expects to be the key driver for its revenue growth going forward.
Drug maker Aurobindo Pharma will set up a facility to manufacture 50 million dosages of vaccines per annum as it plans to launch its vaccine products commercially in 2018.
Wockhardt Ltd has said it is increasing investments in R&D, looking at expanding markets and launching new products to accelerate growth.
The imports from China stood at Rs 12,757.96 crore in 2014-15 and Rs 12,061.53 crore in 2013-14, he added.
Regulatory scrutiny of the US Food and Drug Administration (FDA) for domestic pharmaceutical facilities is expected to remain intense over the medium term, rating agency Crisil said on Wednesday.