As the company's current scandal in China shows, Witty was caught somewhat flat-footed by problems there, and some investors wonder whether Witty's reforms have been rigorous enough.
GSK will begin adding 2-D barcodes to its Fluarix Quadrivalent 4-in-1 influenza vaccine, which the FDA cleared for shipping on Monday. Over the next 6 months GSK will add the barcode technology to the packaging of more vaccines.
The FDA asked for a few more months to review GSK's app on albiglutide, which would compete with Novo Nordisk's Victoza and Bristol-Myers Squibb and AstraZeneca's Byetta and Bydureon, among others.
Glaxo says that the FDA asked for more time to review the information the big pharma company had submitted in response to the agency's queries and pushed back the deadline to April 15, 2014.
Big Pharma companies are fighting to stay out of the spotlight as authorities show up to visit them.
India's Intellectual Property Appellate Board (IPAB) has pulled the patent that GlaxoSmithKline had for its breast cancer drug Tykerb, a salt form of lapatinib, while upholding the patent on the original API.
Last year GlaxoSmithKline ($GSK) made an unprecedented commitment to share patient-level clinical trial data with independent researchers. Ten months later, the first portion of the data is live, and vaccines are well represented.
The early success of a Unicef program to bring pneumococcal vaccines to poor countries has created a problem for the agency--demand is outstripping supply. To fix the problem, Unicef has negotiated new deals with GlaxoSmithKline and Pfizer, securing more vaccines at lower costs.
As if GlaxoSmithKline didn't have enough trouble on its hands, Moody's Investors Service has cast some dark clouds over its credit outlook. The agency cut the outlook on Glaxo's long-term A1 rating to "negative" from "stable," citing worries about debt, share buybacks, and massive legal settlements.
In Asia Pacific viral hepatitis kills one person every 30 seconds. This creates a huge opportunity for vaccines from GlaxoSmithKline, Merck and others to improve public health, yet a lack of national action plans is restricting the impact of these preventative measures.