New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
November 25, 2013
14:19 EDTGSKFDA requires removal of certain restrictions on diabetes drug Avandia
The U.S. Food and Drug Administration announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia to reflect new information regarding the cardiovascular risk of the medicine. The FDAs actions include requiring modifications to labeling about cardiovascular safety, requiring changes to the Risk Evaluation and Mitigation Strategy program, and releasing a postmarket study requirement. Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, or RECORD, clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007. The FDA is also releasing GlaxoSmithKline from the postmarket requirement to conduct a clinical trial, known as Thiazolidinedione Intervention with Vitamin D Evaluation, comparing Avandia to Actos (pioglitazone), the only other approved drug in the thiazolidinedione class, and to standard diabetes drugs. The FDA has concluded that this trial is no longer necessary or feasible.
News For GSK From The Last 14 Days
Check below for free stories on GSK the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
April 15, 2014
14:29 EDTGSKGlaxoSmithKline confirms FDA approval for Tanzeum
Subscribe for More Information
10:14 EDTGSKFDA approves Tanzeum to treat type 2 diabetes
The Food and Drug Administration approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. Tanzeum is manufactured by GlaxoSmithKline.
08:23 EDTGSKLeerink's pharma and biotech analysts hold an analyst/industry conference call
Subscribe for More Information
08:06 EDTGSKProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
Subscribe for More Information
06:32 EDTGSKPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
06:40 EDTGSKGlaxoSmithKline paid bribes to Polish doctors to promote Seretide, BBC says
Subscribe for More Information
April 10, 2014
11:42 EDTGSKReport claims Tamiflu, Relenza do little to prevent the spread of flu
Subscribe for More Information
April 8, 2014
11:03 EDTGSKPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
08:46 EDTGSKTeva announces first approval, launch of generic Lovaza capsules in the U.S.
Teva (TEVA) announces the approval of the generic equivalent to Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza Capsules, marketed by GlaxoSmithKline (GSK), had annual sales of approximately $1.1B in the United States, according to IMS data as of December 2013.
07:22 EDTGSKCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 7, 2014
14:18 EDTGSKGlaxoSmithKline reports 14.1% stake in Applied Genetic Technologies
Subscribe for More Information
April 6, 2014
16:23 EDTGSKGlaxoSmithKline investigates bribery allegations in Iraq, WSJ says
GlaxoSmithKline is investigating allegations of bribery by employees in Iraq, says the Wall Street Journal, citing emails reviewed by the publication. Reference Link
April 4, 2014
06:29 EDTGSKGlaxoSmithKline cuts China employees amid probe, WSJ reports
According to a source, as it deals with a bribery probe in Beijing, GlaxoSmithKline is cutting employees in China, the Wall Street Journal reports. It is unclear how many of Glaxo's 7,000 employees in China have been let go. Reference Link
April 3, 2014
09:37 EDTGSKAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use