The Pharmaceutical Research and Manufacturers of America (PhRMA) has released a new report detailing twenty-five years of Hepatitis C research, advances, and current areas of unmet need.
The FDA has issued a proposed rule which will require drug makers to electronically submit and monitor all labeling information for marketed drugs.
Amid ongoing backlash from the pharma industry, the National Pharmaceutical Pricing Authority (NPPA) has announced price caps for 52 more medicines deemed to be essential for public health in an ongoing effort to improve healthcare affordability.
The Generic Pharmaceutical Association has offered a compromise to existing legislation being lobbied by biotech companies on behalf of their biologic drugs whose patents are about to expire — an event that will lead to a flood of biosimilars in the U.S. pharmaceutical market.
The Indian Drug Manufacturers’ Association (IDMA) wrote to the ministry of health and family welfare to voice their concern over the health minister’s proposed ban of plastic containers as drug packaging in India, the Financial Express reports.
GlaxoSmithKline (GSK) has received concerns from health professionals that the color of their Revlar Ellipta inhaler might be misleading to patients and announced today that in in future, they would be manufacturing the inhaler as yellow rather than blue and providing additional information in the labeling, The Pharmaceutical Journal (TPJ) reports.
Changes in China’s regulatory procedure may mean delays of up to two years for many foreign pharmaceutical companies hoping to introduce new medicines to the Chinese market. The changes will affect over 33 new applications, Bloomberg reports.
In the past year, the rate of return on research and development investment has increased from 5.1 percent to 5.5 percent, says a new survey from Deloitte consulting firm. This is the first increase the industry has seen since 2010 and represents a replenishing pipeline, reports Reuters.
CSL, Hospira, and GlaxoSmithKline will collaborate on a new manufacturing project, which hopes to generate solutions to productivity issues at a select number of Australian manufacturing sites.
Regeneron and Sanofi have developed a new cholesterol-lowering biologic, Alirocumab which has been found effective in high-risk patients with statin intolerance. The drug recently completed six phase 3 drug trials in which it met all of its primary endpoints and showed greater efficacy than competitive drugs, Reuters reports.