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Posts Tagged ‘Gilead’

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TODAY’S NEWS

Hugely encouraging results for Novartis‘ new experimental (oral) MS treatment – Novartis’ Gilena has delivered an impressive performance in a Phase III trial in patients multiple sclerosis, cutting relapse rates by 62% in treatment-naïve patients and sustaining its effects for more than two years. Importantly, data from the two-year FREEDOMS study, presented at the American Academy of Neurology annual meeting, also showed that relapse rates were reduced by a significant 44% in patients who had previously been treated with other drugs for MS, highlighting the potential benefit of switching therapiesmore

Gilead starts late stage testing of “4-in-1” HIV pill.

An interesting account of regulatory “unintended consequences.” How to make a cheap drug very expensive.

Cephalon hopes to gain more cheddar by adding some Swiss. Sorry – couldn’t resist…

Celgene: the new “big kid” on the block.

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An amusing patient health video made by J&J. Well worth 4 minutes of your time. The Appointment.

JUST FOR FUN

Oldie but goodie from The Onion – American to start charging fees to Non-passengers.

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TODAY’S NEWS

Big news on the leukemia front: NovartisTasigna gets priority FDA review for newly-diagnosed patients; and Roche/Genentech‘s Rituxan approved for CLL.

A quarter of new prescriptions go unfilled.

Statins: cardiovascular benefits far outweigh the diabetes risks – Statin drugs raise the risk of diabetes significantly, but the danger appeared puny compared with their cardiovascular benefits, researchers found in a meta-analysismore

Gilead looking to ride a Quad to victory in HIV – Gilead Sciences has gone some way to ensuring that its dominance of the HIV market continues after phase II data from its “Quad” pill presented at the Conference on Retroviruses and Opportunistic Infections showed non-inferiority to its second best-selling drug, Atriplamore

Pharma eMarketing round-up: some great links and a big, thought-provoking question.

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Even Me-Too Drugs get the blues

JUST FOR FUN

I don’t recommend you try this at home! But what happens when an iMac meets a house fire? The result is…surprising, to say the least!

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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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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? – After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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