The FDA has acted on requests from users to allow data it makes available through openFDA to be downloaded. The U.S. regulator revised the system late last year to enable users to download the data for use offline.
KaloBios was days away from shutting its doors for good when controversial entrepreneur Martin Shkreli swooped in to keep the company afloat last month. Now, with its purported savior facing up to 20 years in prison on charges of fraud, the tiny biotech is roughly back where it started, filing for bankruptcy to settle its debts.
In a recent opinion essay written for The Hindu newspaper, the head of the Indian Pharmaceutical Alliance, Archana Jatkar, said the recently agreed-upon Trans-Pacific Partnership (TPP)--of which India is not a signatory--would nonetheless have wide-ranging impacts on the country's $15 billion pharmaceutical sector because of new rules on intellectual property.
Christmas was kind to South Korea's SK Chemicals after government officials on Christmas Eve approved the company's quadrivalent influenza vaccine, which can act against four types of flu with one inoculation. The approval was notable because the approved vaccine was made using the cell-culture method for the first time, according to the country's Ministry of Food and Drug Safety.
The government of India may do about about-face on clinical trial rules put into place in 2013 and loosen restrictions for drug makers.
The FDA indicated in a warning letter this week that Sun Pharmaceutical has some gaps in its manufacturing processes at its Halol plant, as well as leaks in the ceiling, that put its drugs at risk for contamination.
Sanofi is using its $245 million coupon for a quick FDA review to speed up the approval process for a combination of its top-selling insulin and a new diabetes drug, angling to beat rival Novo Nordisk to the market.
AstraZeneca has scored another drug approval. Just weeks after the FDA flagged through its landmark cancer drug Tagrisso, the agency has delivered an OK on lesinurad, a new gout drug that will be marketed as Zurampic.
The government of Japan said this week it plans to cut medical treatment fees by 0.84% in its fiscal 2016 budget as the country tries to trim social spending, which has become a huge problem as Japan's population continues to age and incur high healthcare costs.
The U.S. Food and Drug Administration has issued an alert to drug compounders and drugmakers that ingredients produced in China's Tianjin city may be contaminated by chemicals, the result of massive explosions that occurred there in August this year.