Results tagged “gsk” from Drugs & Medicaments

More evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.

The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.

by David Gutierrez

(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.

In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.

ZURICH (Reuters) -- U.S. regulators have asked for more data on Novartis AG's diabetes drug Galvus, potentially delaying any approval of the possible blockbuster by a year and sending shares tumbling.

The Food and Drug Administration has requested a further clinical study to show Galvus's safety and efficacy in patients with kidney impairment, Novartis (Charts) said Monday, but the drugmaker remains confident of getting approval for the medication.

"There are no details on the study requirements, but we would expect this study to take a minimum of 12 months to complete, taking likely U.S. approval beyond August '08," JPMorgan analyst Craig Maxwell said in a note.

Pharmaceutical giant GlaxoSmithKline (GSK) is being forced to recruit overseas because there is such a dire lack of science graduates in the UK, the drugs company has warned.

Dr Jackie Hunter, a senior vice-president at GSK, who leads one of the firm’s global drug development centres, said the UK was suffering from an acute shortage of qualified scientists, the Times reports. 

The situation meant GSK had to recruit from France, Spain, Germany and India.

 

Merck & Co., mired in multibillion litigation over its withdrawn painkiller Vioxx, has eliminated another legal headache, resolving several tax disputes with the Internal Revenue Service by agreeing to a $2.3 billion settlement.

In announcing the agreement Wednesday, the Whitehouse Station, N.J.-based company said the settlement resolves all outstanding tax disputes with the IRS, covering the years 1993 through 2006. Merck had faced potential taxes, interest and penalties totaling as much as $3.8 billion, but the agreement apparently reduced that amount.

Neither Merck nor the IRS would discuss the reduction.

LONDON, Jan. 29, 2007-Documents revealed tonight on BBC One's Panorama programme suggest that Britain's largest drugs company deliberately misled doctors about the safety and effectiveness of its antidepressant and promoted it as a treatment for children.

Panorama (8.30pm, Monday 29 January 2007, BBC One) has had exclusive access to thousands of internal memos which GlaxoSmithKline (GSK) released to lawyers involved in United States legal action against the company.

The documents show that as far back as the late Nineties there was an acknowledgement within GSK that tests had failed to prove that Seroxat was a safe or beneficial treatment for depressed children.

Adherex Technologies is paying GlaxoSmithKline a million dollars up front and a set of milestones in exchange for the outstanding options on the cancer drug eniluracil. GSK shuttered its development program for the therapy after it failed a Phase III trial in combination with 5-FU. Adherex, though, believes that the reason for the failure was an "unexpected dose- and schedule-dependent drug interaction that resulted in the inhibition of 5-FU's activation into an effective anticancer agent."

"While GSK's initial Phase III trials with the product failed, we now have data to support each element of our hypothesis as to why those trials failed," says William P. Peters, M.D., Ph.D., chairman and CEO of Adherex. "We expect to complete our Phase I dose-escalation trial in North America shortly and intend to begin our Phase II trial in breast cancer promptly thereafter. We also have a Phase I/II trial in hepatocellular cancer ongoing in Asia."

read the full press release 

Lilly (LLY) published data showing that Gemzar doubled the median disease-free survival time in patients with pancreatic cancer whose pancreases were surgically removed. In a trial involving 368 patients, the median disease-free survival was 13.4 months in the Gemzar cohort and 6.9 months among those who did not receive chemotherapy. Also, the cancer recurred within 4 years in 92% of those who received no post-surgical drug treatment, but only in 74% of the Gemzar group. Lilly was 3 cents lower at $52.85.

Shire plc (SHPGY) received FDA approval for Lialda, its mesalamine drug with MMX technology. The drug is the only once-daily oral therapy for patients with active, mild to moderate ulcerative colitis. Shire expects to launch Lialda in Q1 of 2007. Shire rose 65 cents to $64.20.

GlaxoSmithKline (GSK) was given a $63 million HHS contract to develop pre-pandemic and pandemic flu vaccines. Glaxo is doing research that combines new adjuvants in combination with antigens to provoke a strong immune response. The goal would be to extend a limited supply of flu vaccines in the face of a pandemic. GSK will also ship 15.5 million treatment courses of flu-drug Relenza for the US stockpile. GSK gained 69 cents to end the day at $55.23.

LONDON (Reuters) - SkyePharma (SKP.L) said on Wednesday that developing its biggest drug hope, Flutiform for asthma, was costing more than it expected and that it had arranged a new 35 million pound loan.

The drug delivery firm also said it was in exclusive talks with a potential buyer of its loss-making injectable drugs business and that it expected to reach a deal shortly.

SkyePharma has been hit by a string of delays in finding partners for its drugs and earlier this year a shareholder rebellion drove out founder and chairman Ian Gowrie-Smith.

LONDON & WALTHAM, Mass.--(BUSINESS WIRE) -- GlaxoSmithKline plc (GSK) and PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS) announced today execution of a definitive agreement providing for GSK to acquire all outstanding shares of PRAECIS’ common stock for a cash purchase price of US $5.00 per share or a total of approximately $54.8 million for the entire equity interest of PRAECIS.

“PRAECIS has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities,” said Allen Oliff, Senior Vice President, Molecular Discovery Research, GSK.

Danish biotechnology company Genmab A/S signed a deal Tuesday worth up to US$2.1 billion (€1.6 billion) with pharmaceutical giant GlaxoSmithKline PLC for the global commercialization of a leukemia treatment.

The agreement for the HuMax-CD20 antibody includes an initial license fee of 582 million kroner (€78 million; US$102 million), Glaxo buying a stake of just over 10 percent in Genmab and milestone payments totaling 9 billion kroner (€1.2 billion; US$1.6 billion).

GlaxoSmithKline will invest 2.03 billion kroner (€272 million) for the 4.47 million Genmab shares.

Analysts said the value of the deal was much higher than expected, and could mean that Genmab will be profitable as early as next year.

by Dr. Peter Breggin

On December 13, 2006 the FDA's Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.

Now the agency has given advanced notice of its new findings--antidepressants, all of them according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.

The pharmaceutical giant has agreed to acquire Domantis for £230m (€340m). The UK based company have developed miniature antibodies that can overcome the restrictions in therapeutic applications commonly seen with larger biomolecules.

They achieved this miniaturisation by only producing the small part of the antibody or domain that actually binds to the target, disregarding the extra part of the protein. These domain fragments are up to 13 times smaller than normal antibodies (around 110 amino acids long).

Traditionally, pharmaceutical companies have concentrated on developing small molecule drugs. However, there is a growing trend towards developing so-called biopharmaceuticals: large molecules such as antibodies, vaccines and other therapeutic proteins. However, the increased size means that they have to be administered by injection or infusion, in contrast to orally administered small molecules.

WASHINGTON (AP) - Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday.

The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses.

In the study, researchers at Parkland Hospital in Dallas gave 170 pregnant women the drug valacyclovir to see if the drug would reduce herpes outbreaks at birth. The virus can be fatal to newborns if infected during delivery.

LONDON, Dec 1 (Reuters) - GlaxoSmithKline Plc (GSK.L) said on Friday it had won European regulatory approval to sell its Hycamtin medicine as a treatment for cervical cancer in combination with another cancer drug, cisplatin.

The decision was expected after European regulators signalled last month that they intended to approve the new combination treatment.

U.S. regulators approved the combination drug in June.

© Reuters 2006

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets has announced the addition of Espicom Business Intelligence’s New Drug Futures: Respiratory Chapter to their offering.

This chapter of New Drug Futures evaluates, compares and contrasts the prospects for the compounds that will revolutionise the pharmaceutical industry over the next 5 years and beyond in the respiratory sector. The report includes unique sales forecasts by major product.

The Respiratory market is the fourth largest therapeutic category by sales and generated nearly US$32.4 billion (+8% YoY) in 2005. Sales grew steadily in the US, which accounted for around 54% of global respiratory sales, driven by growth in Advair, GlaxoSmithKline's leading combination therapy for the treatment of asthma/COPD and Merck's Singulair for the treatment of asthma and allergic rhinitis. Sales in Europe are now growing steadily; around 5% following the uptake of new treatments such as Symbicort (AstraZeneca) and Alvesco (Altana/sanofi-aventis) which have yet to be approved in the US markets.

The asthma drug AstraZeneca Plc. plans to bring to the United States next year could be just what the doctor ordered for the pharmaceutical giant as it works to rebuild a drug development pipeline hamstrung by the termination of several once-promising prospects.

In mid-2007, AstraZeneca, whose U.S. headquarters is in Fairfax and which employs about 5,000 statewide, plans to roll out Symbicort.

Symbicort is an asthma inhaler that combines two drugs to treat both the swelling of the airways and constriction of the muscles around the airways.

GlaxoSmithKline Plc's new breast cancer pill Tykerb will receive a priority review from U.S. regulators in a move that should speed its path onto the world's biggest drugs market next year, it said on Thursday.

Priority review designation requires the U.S. Food and Drug Administration to decide on a drug application six months after submission. Tykerb was filed for U.S. approval on Sept. 18.

The oral cancer treatment is a potential rival to the blockbuster Herceptin, which is given by injection, and is a key new medicine for Europe's biggest drugmaker. Glaxo hopes it will confirm its arrival as a major force in oncology.