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Posts Tagged ‘GSK’

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TODAY’S NEWS

Big approval news for Gilead Sciences Gilead Sciences Inc., the world’s largest maker of HIV treatments, won U.S. approval of an inhaled antibiotic for lung infections in cystic fibrosis patients. The Food and Drug Administration cleared sales of the medicine, given the brand name Cayston, the company said today in a statement. Outside advisers to the FDA backed the product’s safety and effectiveness in a 15-2 vote on Dec. 10more

What is the future of “personalized medicine”? Probably, it’ll look a lot like this (encouraging story from NY Times). Plus, in a cooperative effort, Eli Lilly, Merck and Pfizer have formed an independent, not-for-profit company Asian Cancer Research Group (ACRG) to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asiamore

Of course, in this industry, there is often a mix of good news and bad – and “bad” usually means bad behavior by people who love dollars above sense: lack of openness at AZ?; secret tapes and GSK (plus, a “fixer” who spiked research?); research fraud by rogue doc; kickbacks and J&J; risk of depression assessment and Eli Lilly (are you alive? then you’re at risk!!!). Reminds me of some prior posts on the Gold-in Rule

Novartis looking to expand even more at East Hanover campus. Including themed food venues!

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PLUS

I’m feeling much safer now. FDA finally comes out against “ear candling“! Next up, perhaps – a prohibition of USB-to-nasal-passage uploads??

JUST FOR FUN

Delightful (and BIG) pictures from Vancouver Olympics. Love the colors in the very first one. From Boston.com’s very nice The Big Picture section.

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Teva aggressively seeking to “genericize” Merck‘s Singulair, Amgen‘s Neupogen.

Warren Buffet pulling back from pharma investments that contain 2 letters (P&G, J&J).

GSK‘s nausea drug Zofran may help with drug withdrawal symptomsGlaxoSmithKline Plc’s Zofran, approved to treat nausea and vomiting, appears to reduce symptoms of withdrawal from morphine, codeine, heroin, OxyContin and similar pain medicines, a study shows. The drug, which is now available as a generic called ondansetron, was used to treat eight men for morphine withdrawal, according to a study in the Journal of Pharmacogenetics and Genomics. Compared with placebo, the patients receiving ondansetron were less likely to experience anxiety, hot flashes, aches, restlessness, nausea and vomiting.

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Glaxo: more big cuts, and the U.S. HQ needle pointing south – GlaxoSmithKline (GSK) announced that it will reduce its sales personnel by 12% to 7,500 down from 8,500. The company will slash 1,800 jobs resulting in a total of 1,000 layoffs. Some positions have already been eliminated while other personnel will be reassigned to new areas. The company is also consolidating operations and moving personnel from its Philadelphia facility to Research Triangle Park in North Carolina, where it employs about 5,000 people…more

Gilead gets a boost from new HIV treatment guidelines – The DHHS named Gilead’s Truvada, a combination of the company’s HIV treatments Emtriva and Viread, the lone preferred regimen for previously untreated HIV patients. Gilead’s shares added 3.2% to $47.31 in regular trading…more

Genzyme pours serious cash into Osiris – Genzyme Corp. will pay Osiris Therapeutics Inc. as much as $1.38 billion to develop therapies that use stem cells to treat blood cancers, inflammation and joint damage. ..more

Amylin’s Byetta LAR gets extended delay for extended release – Shares of Amylin Pharmaceuticals have collapsed after it emerged that US regulators have rejected data for a once-weekly version of its diabetes drug Byetta…more

UCB gets OAB drug approval – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency…more

What does Jupiter have to do with cholesterol treatments? A lot!

But will Winnie be used to sell obesity treatments? Pooh characters as Seroquel sales aids? Hmmm…

Cephalon’s Treanda gets another indication – on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL)…more

CV Therapeutics’ Ranexa gets a first-line approval – CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa® (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes…more

Promising experimental Hep-C treatment in the Schering pipeline – results being reported.

Obesity drugs: everybody bails out – For those of you hoping that America’s obesity crisis could be solved with a pill, think again. Pfizer announced late Wednesday that it is scrapping its anti-fat drug, the as-yet unnamed “CP-945,598,” for essentially political reasons. Sanofi-Aventis today also announced that it was ending its trials on Acomplia/Zimulti, an obesity pill that was approved and then yanked in Europe. And Merck a couple of weeks ago pulled its fat pill taranabant, from its pipeline…more

Why did J&J consolidate its drug advertising biz between 2 big agency holding companies?

Big Pharma’s loss may be Little Pharma’s gain - as big drugmakers continue to trim jobs, smaller biopharmaceutical makers and specialty pharma are benefiting from the downsizing, according to David Poling, director of state business operations at Aerotek, a staffing firm…more

The 10 weirdest drug stories of the month.

First glimpse of the secrets of the cancer genome. Fascinating.

If you’re not up on the latest pharma/legal issue called pre-emption, you need to be. Go here for the latest.

Want even more news? Chris Truelove over at Pharmalive has a big roundup this week – lots of interesting tidbits and links..

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From Forbes magazine, an article on the encouraging progress being made by pharma companies on the vaccine front:

A new golden age of vaccines is at hand, promising inoculations against malaria, meningitis and much more.

Vaccine researcher Ripley Ballou was an eager human guinea pig. As part of a six-man experiment at the Walter Reed Army Institute of Research in 1987, he had himself injected four times with a genetically engineered malaria vaccine. Then he taped to his arm a styrofoam cup. In it were five mosquitoes infected with malaria.

Ten days later Ballou got violently ill, with uncontrollable chills, profuse sweats and headaches that felt like “a 9-inch spike through my head,” he says. The experimental vaccine protected only one of the six volunteers in the trial. Even after drugs quelled the infection, Ballou felt run-down for weeks.

But that lone success provided inspiration for a far more potent malaria vaccine that 20 years later is finally set to go into giant clinical trials next year at GlaxoSmithkline, where Ballou now works. If successful, it could be the first vaccine for a scourge that has plagued mankind since ancient times. “This vaccine will have a huge impact,” predicts Jean Stephenne, chief of GlaxoSmithkline’s vaccine unit.

Glaxo’s malaria shot is at the forefront of a vaccine renaissance. The revolution in genomics and molecular biology has rescued a segment of the drug industry that for decades was viewed as a low-margin backwater beset by litigation and regulation. Drugmakers are producing vaccines that weren’t possible before–and getting a premium price for them. In diseases for which there is no private vaccine market, such as pandemic influenza, or for which cases are concentrated in poor countries, such as malaria and tuberculosis, governments and public-private partnerships have stepped in to subsidize development.

The resurgence couldn’t have come too soon. Mayo Clinic vaccine researcher Gregory Poland counts more than a dozen new diseases that have emerged in the last few decades: HIV, Lyme disease, West Nile virus, avian influenza. The vaccine boom, he says, “is shaking up the market.”

The $13 billion global vaccine business will grow 18% a year to $30 billion in 2011, predicts Lehman Brothers (nyse: LEH news people ), well above the 4.4% annual growth expected for the drug industry overall. Merck (nyse: MRK news people ) introduced three new vaccines last year, including Gardasil to ward off cervical cancer, while GlaxoSmithkline promises seven over the next five years, including a Gardasil competitor now awaiting approval from the Food & Drug Administration. AstraZeneca (nyse: AZN news people ) bought vaccinemaker MedImmune for $15.6 billion in June, while Pfizer (nyse: PFE news people ) last fall bought PowderMed, a British firm testing a needle-free inoculation. Sanofi-Aventis (nyse: SNY news people ) spent $150 million for a new plant that will double its flu shot production capacity in the United States to 100 million doses.

A new adult and adolescent vaccine market will make up a big portion of that growth. Diseases such as antibiotic-resistant hospital infections and genital herpes have become hot targets. One company, VaxInnate, is testing a universal flu vaccine that would work against all strains and wouldn’t have to be taken every year. Ultimately, researchers envision shots to stave off chronic diseases such as cancer and atherosclerosis. One exception to the optimism is aids; a promising Merck vaccine failed in a recent study.

Modern vaccines date back to British doctor Edward Jenner’s 1796 work immunizing children using pus from cowpox blisters. Ensuing vaccines were nothing more than a dead or weakened strain of a pathogen such as polio, mumps or measles that trains the body to generate protective antibodies. By the 1980s vaccines had wiped out so many diseases, and vaccine prices had fallen so far, some companies gave up searching for new ones. Vaccines were also dogged by safety issues, including the swine flu vaccine fiasco of 1976, and by the dubious theory of a link between autism and the mercury once used in a vaccine preservative.

But in 2000 Wyeth scored a huge hit with Prevnar, the first vaccine for infants against pneumococcal bacteria, a common cause of pneumonia and ear infections. It uses a clever linking technology to hook together a diphtheria protein to sugars from the surface of seven pneumococcal strains. The resulting compound is easily spotted by the infant’s immune system. Pneumococcal infections in young kids plunged 77% after Prevnar’s debut. Sales should hit $2.5 billion this year, thanks in part to its premium $311 price for four doses. (An influenza shot costs only $15.) Wyeth is testing a second-generation version that covers six more strains.

The subsequent mapping of the genomes of many nasty pathogens has opened up wholly new approaches to vaccine discovery. In the late 1990s Novartis (nyse: NVS news people ) researchers decoded the genome of the Neisseria meningitidis B bacterium, which is responsible for one-third of cases of meningococcal meningitis. There are vaccines for other meningococcus strains, but a vaccine for the group B strains had been eluding microbiologists because their surface sugars are identical to human ones. After Novartis sorted through 2,000 proteins in the genomic database, it found five proteins that, when injected into laboratory mice, generated antibodies against at least 66 of 85 group B strains, according to a 2006 study. The vaccine is now in midstage human trials. Wyeth and Sanofi-Aventis have competing efforts.

Austria’s Intercell has spent the last several years gathering blood samples from patients who have survived staph infections to determine which antibodies they had in common. A vaccine based on its findings is now in early human trials at Intercell’s partner Merck.

Malaria is one of the toughest foes of all. The shifty parasite morphs into four different forms once inside the body and spends most of its time hiding inside cells where the immune system can’t get to it. It took Glaxo 20 years to make significant progress with the malaria vaccine that failed to protect Ripley Ballou. First Glaxo researcher Joe D. Cohen took the malaria surface protein used in Ballou’s vaccine and fused it to a protein from the hepatitis B virus, creating a harmless particle that looked like a virus to the immune system. That helped, but not enough. So Glaxo added adjuvants, substances that bolster immune response, including a bacterial wall extract and a detergentlike substance from the soapbark tree. In 1997 it hit the jackpot with an adjuvant combo that protected six of seven volunteers.

In a 2004 trial of 2,000 children in Mozambique the Glaxo vaccine slashed severe malaria cases by about half. Last month a smaller trial in infants (who are most vulnerable to malaria) found it prevented infection in 65%. Now Glaxo is gearing up to test it on 16,000 kids in seven African countries. One huge question is how long the protection will last. Glaxo has already spent $300 million on the vaccine and the Bill & Melinda Gates Foundation has kicked in another $108 million. Trial results could come in 2011. Glaxo is confident of success. It has revamped a giant factory in Belgium to produce tens of millions of doses.

Glaxo’s Stephenne hopes to sell huge quantities of malaria vaccine for a modest profit, while using its adjuvant components for more lucrative vaccines, such as one to prevent lung cancer recurrence. The cancer vaccine is now in final-stage trials.

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