GlaxoSmithKline has its second recall in as many weeks on its hands, this time affecting batches of the antidepressant Paxil that contain an ingredient manufactured at an Irish plant the FDA says isn't up to snuff.
GlaxoSmithKline CEO Andrew Witty set a precedent back in 2009, when his company placed several patents in a public pool to help developing countries find cures for HIV and other diseases--and then challenged other companies to do the same.
Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.
Much has been made as of late of the manufacturing problems found at some of India's biggest drugmakers. But a warning letter sent in March to a GlaxoSmithKline active pharmaceutical ingredient plant in Cork, Ireland, illustrates that Big Pharma is not immune to quality issues.
GlaxoSmithKline said Monday that after reviewing data from a Phase III trial, it has withdrawn its application to the European Medicines Agency seeking to expand approval of Votrient to include women with advanced ovarian cancer.
Lots of drugmakers see Africa as a market that over time can produce some substantial business. But GlaxoSmithKline is not just manufacturing and selling drugs there. It is going one better with a new "open lab" R&D facility to let African researchers work on the drugs needed by Africans for noncommunicable diseases.
The drug giant is pulling its application in Europe after concluding that the data didn't paint a sufficiently positive portrait of overall survival benefits for patients--despite an improvement seen in progress-free survival.
No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.
The combination of genomics and bioinformatics expertise now needed for target validation has led drugmakers to look outside their walls for skills, with Pfizer teaming with the Broad Institute on such a project. Now GlaxoSmithKline has set up its own initiative and called for its Big Pharma peers to get involved.
Indonesia is one of the rapidly growing markets that drugmakers are trying to tap to boost sales, and GlaxoSmithKline is upping its bet. The U.K.-based drugmaker said today it will buy full control of its consumer health unit there.