An Indian CRO that counts Johnson & Johnson, Novartis and Sanofi among its clients is under fire from the FDA for repeated quality control issues, the latest ding to the country's reputation as a go-to destination for outsourced drug development.
Industry watchers have pointed to a slowdown in pharma's emerging markets growth as a worrying sign for companies that have been heavily targeting developing nations while the U.S. and European markets stagnate. But just how slow has the growth become?
Sisu Global Health, which specializes in developing medical devices tailored to meet a specific need in a community, will launch a clinical study later this year for a device that can recycle a patient's blood lost through traumatic internal bleeding.
Not so long ago, China was such a promising pharma market that drugmakers recruited hundreds of new sales reps to race after a share. But growth is slowing there now, and drug companies are feeling it.
The FDA has issued warning letters blasting any number of Indian API and drugmakers for not carefully testing drugs or sometimes fabricating test results of batches of their products that they shipped to the U.S. Now the agency has sent a warning letter to an Indian contractor some companies rely on for product testing and analysis, noting repeat violations of GMP standards.
GlaxoSmithKline is still dealing with the aftermath of its China bribery scandal. As the dust settles, the company is rehiring a former senior Chinese employee once suspected of blowing the whistle on GSK in the country.
GlaxoSmithKline's malaria jab got the green light from the EMA on Friday and the British pharma is making plans for a gradual rollout of the vaccine.
According to reports posted on the EudraGMDP site, regulators from Italy recommended bans on specific products made by Jinan Jinda Pharmaceutical in Shandong Province in China and Wuxi Jida Pharmaceutical in Jiangsu City, China, as well as Parabolic Drugs in Haryana, India.
GE Healthcare is betting that a more than $1 billion investment over 5 years to train more than 2 million global healthcare providers will pay off. In developed economies, it's looking to ingratiate itself by offering options for improving efficiency as the demand for value-based healthcare looms, while in emerging economies it hopes to establish itself firmly as more people are able to receive basic healthcare.
Despite strong contributions from fingerstick-free blood glucose monitor Freestyle Libre and mitral valve repair device MitraClip--medical devices remained the worst performing business for Abbott Laboratories last quarter as sales climbed 3.1% on an operational basis to $1.3 billion.