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Regulatory

Latest Headlines

Latest Headlines

FDA tweaks openFDA to allow downloading of databases

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 files for bankruptcy in the shadow of Shkreli's arrest

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.

Indian pharma alliance head wary on TPP

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.

South Korea approves SK's quadrivalent flu vaccine

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.

Indian government may loosen clinical trial rules

The government of India may do about about-face on clinical trial rules put into place in 2013 and loosen restrictions for drug makers.

Sun Pharma smacked by FDA warning letter for leaky ceiling, contamination risks

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 takes an FDA shortcut with its diabetes combo, racing with Novo

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 bags FDA OK on gout drug lesinurad as safety doubts linger

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.

Japanese government to cut treatment fees in 2016

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.

U.S. FDA warns on potential contamination from Tianjin, China

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.
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