XenoPort slashes half its work force
2010-03-10 04:42:47
Quote: Xenoport and its partner GlaxoSmithKline PLC said they would assess what steps to take next with Horizant and get back to the FDA.XenoPort announced its plans Friday afternoon, and its shares fell 5.7 percent on the day. They rose 52 cents, or 7 percent, to close Monday at $7.94.The company employed 219 workers at the end of 2009. Through its partnership with GlaxoSmithKline, it is developing Horizant as a treatment for moderate to severe restless legs syndrome and for nerve pain. The company sa...
Read articleDrugmakers boost consumer ad spending 2 pct in '09
2010-03-09 03:19:47
Quote: and GlaxoSmithKline PLC ranked third through fifth, respectively, in spending, even though they all reduced their ad spending slightly last year.Meanwhile, the most heavily advertised drug was Lipitor, which has been the world's top-selling prescription medicine for several years.It loses patent protection after November 2011 and its annual sales, now nearly $13 billion, are expected to plunge as much-cheaper generic versions quickly become available. Pfizer is trying to wring every bit of reven...
Read articleXenoPort slashes half its work force
2010-03-09 03:19:45
Quote: Xenoport and its partner GlaxoSmithKline PLC said they would assess what steps to take next with Horizant and get back to the FDA.XenoPort announced its plans Friday afternoon, and its shares fell 5.7 percent on the day. They rose 52 cents, or 7 percent, to close Monday at $7.94.The company employed 219 workers at the end of 2009. Through its partnership with GlaxoSmithKline, it is developing Horizant as a treatment for moderate to severe restless legs syndrome and for nerve pain. The company sa...
Read articleNabi shareholders approve deal with Glaxo
2010-03-05 03:02:01
Quote: (AP) -- Nabi Biopharmaceuticals said Tuesday shareholders approved its option and license agreement for the smoking vaccine candidate NicVAx with GlaxoSmithKline.More than 73 percent of Nabi's outstanding shares were voted in favor of the transaction, and of the shares that were voted, more than 99 percent were in favor of the deal.In November, GlaxoSmithKline and Nabi Biopharmaceuticals said they will develop vaccines to help smokers quit in a deal that could be worth more than $500 million.Nab...
Read articleNabi shareholders OK GSK deal
2010-03-03 08:41:46
Quote: Nabi Biopharmaceuticals stockholders approved a licensing deal with GlaxoSmithKline PLC, giving it the first chance at owning the rights to the Rockville biotech’s last remaining product, a smoking cessation vaccine called NicVax.At its shareholder meeting Tuesday, Nabi said stockholders voted overwhelmingly in favor of the licensing agreement, which could yield the local company more than $500 million in payments and royalties if certain market and clinical conditions are met.Nabi said sh...
Read article[$$] NIH Study Looks At Long-Acting Asthma Drugs For Children
2010-03-03 08:41:45
Quote: BY JENNIFER CORBETT DOOREN A study found that certain long-acting asthma drugs such as GlaxoSmithKline PLC's Advair were more likely to be the best add-on therapy for children whose asthma isn't well controlled by other drugs. The study, funded by a unit of the National Institutes Health, was designed to help determine which type of drug to add for children whose asthma isn't controlled by inhaled corticosteroids, which are the backbone of asthma treatment. The study, presented Tuesday at th...
Read articleCalifornia county sues Glaxo over diabetes drug
2010-03-02 08:11:20
Quote: (AP) -- A Northern California county has filed suit against GlaxoSmithKline accusing the pharmaceutical company of suppressing evidence that its diabetes drug Avandia causes increased risk of heart attacks.The lawsuit filed by Santa Clara County seeks restitution for all Avandia purchasers in California claiming the company violated state false-advertising statutes."GSK's unlawful conduct has cost patients, their insurers, and government payors millions of dollars, and it has caused needless suf...
Read articleRegulus and Glaxo will work on hepatitis C drugs
2010-02-26 06:33:23
Quote: NEW YORK (AP) -- Drugmaker Regulus Therapeutics LLC said Thursday it is expanding a partnership with GlaxoSmithKline, and will begin researching new treatments for hepatitis C.Regulus said it will identify a potential drug candidate in late 2010, and file an application with the Food and Drug Administration in 2011. Regulus said it could get more than $150 million from the new collaboration, along with royalty payments of up to 10 percent on sales of any drugs developed under the agreement.Regul...
Read articleGlaxo defends handling of Avandia heart risks
2010-02-26 06:33:23
Quote: WASHINGTON (AP) -- GlaxoSmithKline said Wednesday a Senate report criticizing its handling of heart risks with its diabetes drug Avandia "mischaracterizes and distorts" the company's record.In a memo posted online, the British drugmaker takes aim at the highly critical Senate Finance Committee report that has reignited debate around its troubled diabetes treatment.The Food and Drug Administration added a warning about potential heart attacks to Avandia in 2007, but the scope of that risk is stil...
Read articleGlaxoSmithKline Responds to US Senate Committee on Finance Report on Avandia
2010-02-25 06:37:48
Quote: TIDE also has been approved by an independent review board and appropriate safety boards that are responsible for monitoring and assessing the safety of the trial in Type 2 diabetes patients.GSK is committed to transparency and has been diligent in reporting the results of clinical trials, observational studies and meta-analyses on the company's website, as well as reporting them to regulatory agencies in a timely fashion.GlaxoSmithKlineus.gsk.com Cautionary statement regarding forward-looking s...
Read articleGlaxoSmithKline: U.S. report on Avandia inaccurate
2010-02-25 06:37:47
Keywords: , GSK, GlaxoSmithKline PLC
Quote: SAN FRANCISCO (MarketWatch) -- GlaxoSmithKline/quotes/comstock/13*!gsk/quotes/nls/gsk(GSK37.33,-0.09,-0.24%) on Wednesday criticized a recent report issued by the Senate committee on finance as being erroneous and inaccurate. "The company rejects any allegations of concealing safety information or acting inappropriately on behalf of patients. GSK respectfully disagrees with the Committee's decision to publish a Staff Report with the errors of fact, omission, and inference detailed in this white ...
Read articleGlaxo defends handling of Avandia heart risks
2010-02-25 06:37:46
Quote: WASHINGTON (AP) -- GlaxoSmithKline said Wednesday a Senate report criticizing its handling of heart risks with its diabetes drug Avandia "mischaracterizes and distorts" the company's record.In a memo posted online, the British drugmaker takes aim at the highly critical Senate Finance Committee report that has reignited debate around its troubled diabetes treatment.The Food and Drug Administration added a warning about potential heart attacks to Avandia in 2007, but the scope of that risk is stil...
Read articleGlaxoSmithKline slams Senate report, defends Avandia
2010-02-25 06:37:45
Quote: GlaxoSmithKline, the British pharmaceutical giant with North American headquarters in Research Triangle Park, on Wednesday issued a 30-page statement that slams a Senate committee staff report accusing GSK of concealing safety problems with its diabetes drug Avandia.The drug maker said it “rejects any allegations of concealing safety information or acting inappropriately on behalf of patients.”GSK (NYSE: GSK) also says that the Senate staff report “fails to present an accurate,...
Read articleDrug Companies Disappoint Me Again
2010-02-25 06:37:44
Quote: del.icio.usDigg It!yahooFacebookTwitterRedditrssOver the years GlaxoSmithKline(GSK -news-people) has repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia. But this weekend the Senate Finance Committee released a report revealing that inside the company Glaxo's own experts and advisors were raising concerns about whether the drug could cause heart problems all along.The report, based on more than 250,000 internal documents, provides a rare and unsettling glimp...
Read articleDiabetes Rivals Lick Chops Over Avandia Setback
2010-02-24 01:37:55
Keywords: Diabetes, Insulin, Hyperglycemia, Hypoglycemia, Blood Sugar, Glucose Monitor, Avandia
Quote: del.icio.usDigg It!yahooFacebookTwitterRedditrssThe senators continue, "Based on this knowledge, GlaxoSmithKline had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GlaxoSmithKline executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk."GlaxoSmithKline, the comp...
Read article[$$] Glaxo a Buy Despite Avandia Scare
2010-02-23 03:03:58
Quote: DRUG SCARES HAVE derailed big pharmaceuticals in the past, so it's understandable that GlaxoSmithKline (ticker: GSK) shares are under pressure this morning. American depositary shares of U.K-based Glaxo are down 2.3% this morning to $37.38. The culprit is Avandia, Glaxo's diabetes drug. On Friday night, The New York Times reported that the future of the drug was a matter of "fierce debate" within the Food and Drug Administration because of ongoing concerns related to its effect on the heart. O...
Read articleNo More Pandemic Hysterics
2010-02-23 03:03:58
Keywords: Pandemic, Obama, Swine Flu, United States, Health
Quote: Meanwhile, in Canada, where British drug maker GlaxoSmithKline maintains its U.S.-focused flu vaccine facility, the company had to assure the local government that Canadians would be served from that manufacturing plant before Americans could receive any of their vaccine orders.Pandemic preparedness should be viewed as a matter of our national security, not solely a public health challenge, with an intensive effort to build domestic vaccine capacity to serve our population.Surprisingly, there is...
Read articleUPDATE - US FDA: No new conclusions on Glaxo's Avandia yet
2010-02-23 03:03:57
Keywords: Pharmaceuticals (sub-industry),United Kingdom,Western Europe,Europe,Washington / US Government News,Regulation and enforcement,Japan,Asia,Health and medicine,United States of America,General News,Politics International Affairs and Law,Domestic Politics,Bu
Quote: Food and Drug
Administration is reviewing data on possible heart risks with
GlaxoSmithKline Plc's (GSK.L) diabetes drug Avandia but has not
reached any new conclusions, the agency said on Monday. The FDA will hold a public meeting in July 2010 to discuss
the risks and benefits of the drug, but said in the meantime
doctors and patients should continue to use Avandia as
directed. "This work is ongoing and no new conclusions or
recommendations about the use of rosiglitazone (Avandia) in the
treatme...
Read articleFDA Faces More Pressure to Pull Avandia
2010-02-23 03:03:57
Quote: FAVOLE
WASHINGTON—The Food and Drug Administration, under fire from a new Senate report questioning the safety of GlaxoSmithKline PLC's diabetes drug Avandia, told doctors Monday that patients taking the medicine should stay on it unless their doctors say otherwise.
A leading member of Congress urged the FDA to pull the drug. Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA's budget, said: "I strongly urge the FDA to remove Avandia from ...
Read articleU.S. WATCH
2010-02-23 03:03:56
Quote: It is rated an "8.0 grade,'' or "very fine.''
—Associated PressFDA Says Avandia Still Safe for Patients The Food and Drug Administration, under fire from a new Senate report questioning the safety of GlaxoSmithKline PLC's diabetes drug Avandia, told doctors Monday that patients taking the medicine should stay on it unless their doctors say otherwise.
A leading member of Congress urged the FDA to pull the drug. Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel ...
Read article