Posts tagged ‘Generic drug’

03/04/2015

A New Cancer Drug, Made in China – China Real Time Report – WSJ

Xian-Ping Lu left his job as director of research at drug maker Galderma R&D in Princeton, N.J., to co-found a biotech company to develop new medicines in his native China. As the WSJ’s Shirley S. Wang reports:

It took more than 14 years but the bet could be paying off. In February, Shenzhen Chipscreen Biosciences’ first therapy, a medication for a rare type of lymph-node cancer, hit the market in China.

The willingness of veterans like Dr. Lu and others to leave multinational drug companies for Chinese startups reflects a growing optimism in the industry here. The goal, encouraged by the government, is to move the Chinese drug industry beyond generic medicines and drugs based on ones developed in the West.

Chipscreen’s drug, called chidamide, or Epidaza, was developed from start to finish in China. The medicine is the first of its kind approved for sale in China, and just the fourth in a new class globally. Dr. Lu estimates the research cost of chidamide was about $70 million, or about one-tenth what it would have cost to develop in the U.S.

“They are a good example of the potential for innovation in China,” said Angus Cole, director at Monitor Deloitte and pharmaceuticals and biotechnology lead in China.

China’s spending on pharmaceuticals is expected to top $107 billion in 2015, up from $26 billion in 2007, according to Deloitte China. It will become the world’s second-largest drug market, after the U.S., by 2020, according to an analysis published last year in the Journal of Pharmaceutical Policy and Practice.

via A New Cancer Drug, Made in China – China Real Time Report – WSJ.

07/12/2014

EU States Suspend Marketing of Drugs Tested at Lab in India – Businessweek

A European Union review of a contract lab in India hired by drugmakers to perform clinical trials pivotal to approval of certain generic medicines has led some member states to suspend marketing of those drugs.

The European Medicines Agency is reviewing findings GVK Biosciences, based in Hyderabad, India, didn’t comply with clinical practice standards, and the suspensions are a precaution until the review is finished, according to a statement yesterday from the agency. The EMA didn’t name the countries or the drugs being suspended, and its press representatives didn’t respond to a call and an e-mail after business hours.

The review is based on an inspection by the French medicine agency that raised concerns about the reliability of studies done at GVK Bio since 2008. The French agency inspected GVK Bio from May 19 to 23 and found falsification by at least 10 people between 2008 and 2013 of electrocardiograms in all of the nine trials they examined.

via EU States Suspend Marketing of Drugs Tested at Lab in India – Businessweek.

Law of Unintended Consequences

continuously updated blog about China & India

ChiaHou's Book Reviews

continuously updated blog about China & India

What's wrong with the world; and its economy

continuously updated blog about China & India