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January 30, 2013
11:56 EDTGSKGlaxoSmithKline says Guardian wrong to suggest Avandia safety data concealed
GlaxoSmithKline, in response to a news article published this morning in The Guardian on U.K. legal proceedings related to the type 2 diabetes medicine Avandia, said: "We have every sympathy for people with health complications associated with diabetes and those who care for them. However, respecting the UK court process, we are unable to comment on ongoing legal cases. We continue to believe that the company acted appropriately and responsibly in its management of Avandia. Specifically, it is wrong to suggest that we hid or concealed safety data relating to Avandia. We made Avandia clinical trial results available on our website and shared these with regulators. With respect to Avandia, the settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain Food and Drug Administration regulatory reports of information regarding the initiation and status of certain studies. The Department of Justice has expressly acknowledged that the information had been provided by GSK to the FDA in other forms. The FDA has also stated that the omissions did not impact the agency’s evaluation of the safety data related to Avandia. We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type 2 diabetes when used appropriately. Nevertheless, we fully accept regulators’ decisions to restrict its use and have worked to make sure health professionals and patients understand this latest advice and guidance." In its report, The Guardian said "GlaxoSmithKline has admitted concealing data about the damaging side-effects of the drug...But, despite this, GSK is not prepared to settle claims in the UK without a court fight." The Guardian's health editor, Sarah Boseley, also stated the history of U.K. drug litigation suggests that "families might not easily get compensation." Shares of GlaxoSmithKline trading in New York were up 0.24% to $45.68 near noon.
News For GSK From The Last 14 Days
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October 1, 2015
08:04 EDTGSKPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
September 30, 2015
12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
September 28, 2015
07:52 EDTGSKIIR Holdings to hold a conference
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September 27, 2015
16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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September 23, 2015
13:09 EDTGSKEU could green light GlaxoSmithKline's new asthma drug this week, Reuters says
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05:32 EDTGSKViiV Healthcare announces Triumeq Phase IIIb study met primary endpoint
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September 22, 2015
07:43 EDTGSKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTGSKClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:28 EDTGSKTuring CEO says will not change Daraprim price despite criticism
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11:24 EDTGSKHillary Clinton vows to take on 'outrageous' specialty drug pricing
Hillary Clinton, on the heels of a Wall Street Journal report detailing Turing Pharmaceuticals' price hike to $750 from $13.50 per pill of a drug called Daraprim which treats a life-threatening parasitic infection, vowed to lay out a plan tomorrow to take on what she calls "price gouging" of specialty drugs. The presidential nominee stated in a tweet, "Price gouging like this in the specialty drug market is outrageous. Tomorrow I'll lay out a plan to take it on." The iShares Nasdaq Biotechnology Index (IBB) moved lower following Clinton's tweet.

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