Three new diabetes drugs come under the scanner of US drug regulator Three new type-2 diabetes medicines, two of which were recently launched in India, have come under the scanner of the US drug regulator for potential risk of causing acidosis that could require hospitalization. The US Food and Drug Administration (FDA) has warned medical professionals and patients that type-2 ... Read More »
Pharma News
US lawsuit puts generic drug imports from India under scanner
US lawsuit puts generic drug imports from India under scanner WASHINGTON: A US class action lawsuit accusing India’s Ranbaxy of large-scale deception on its generic drug applications puts a question mark on drug imports from India, the largest supplier of generic drugs to the US. The problem of lack of compliance with US Food and Drug Administration (FDA) guidance and ... Read More »
US pharma sector welcomes India’s intellectual property policy
US pharma sector welcomes India’s intellectual property policy The US pharma sector has welcomed India’s recent moves on intellectual property, including bringing out a draft policy and sustained engagement, while regretting the consistent barriers posed by the country’s pharma sector to US companies. Acknowledging the “measured and cautious approach” of India in responding to recent requests for compulsory licenses and ... Read More »
Glenmark Pharma receives US FDA approval for calcipotriene cream
Glenmark Pharma receives US FDA approval for calcipotriene cream Glenmark Pharmaceuticals Inc., USA (Glenmark), a subsidiary of Glenmark Pharmaceuticals, Mumbai, has received tentative approval from United States Food & Drug Administration (FDA) for calcipotriene cream, 0.005 per cent, the therapeutic equivalent of Dovonex topical cream, 0.005 per cent of Leo Pharma A/S. Glenmark will market this product upon receiving final ... Read More »
FDA grants Priority Review for potential new indication for Brilinta
FDA grants Priority Review for potential new indication for Brilinta AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for BRILINTA® (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes ... Read More »
Invest in pharma sector: Dipan Mehta
Invest in pharma sector: Dipan Mehta Dipan Mehta, Member at BSE & NSE is overweight in pharma sector and feels that it is good to invest in the space. Dipan Mehta, Member at BSE & NSE told CNBC-TV18, “Typically when pharma companies come out with earnings, there is a fair degree of volatility and there are surprises negative as well ... Read More »
Rs 2,277 drug can treat hepatitis B patients
Rs 2,277 drug can treat hepatitis B patients An effective drug for treating hepatitis B virus (HBV) could be mass-produced for as little as USD 36 per person per year against the current US price of over USD 15,000, scientists say. The advance could lead to huge reductions in the number of people being infected with Hepatitis B which causes ... Read More »
Sun Pharma plunges 11% as Daiichi Sankyo sells 8.9% stake
Sun Pharma plunges 11% as Daiichi Sankyo sells 8.9% stake Shares of Sun Pharma plunged 11 percent intraday on Tuesday after Daiichi Sankyo decided to offload its stake. Daiichi Sankyo has sold its its entire 8.9 percent stake via multiple blocks at between Rs 930-968 per share (lower end of the band). Daiichi has raised USD 3 billion via stake sale in Sun Pharma. Daiichi ... Read More »
Bar-coding of drugs becomes mandatory to trace their origins
Bar-coding of drugs becomes mandatory to trace their origins The government has mandated bar-coding of mono cartons of drugs shipped out of the country from July as an additional measure to ensure that its reputation isn’t tarnished by medicines manufactured illicitly in other countries and passed off as made in India. Bar-coding of mono cartons, which hold primary packs ... Read More »
UTMB researchers develop Ebola vaccine effective in a single dose
UTMB researchers develop Ebola vaccine effective in a single dose An interdisciplinary team from The University of Texas Medical Branch at Galveston and Profectus BioSciences, Inc. has developed a quick-acting vaccine that is both safe and effective with a single dose against the Ebola strain that killed thousands of people in West Africa last year. These findings are detailed in ... Read More »
VIVAN Life Sciences Blog