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Posts Tagged ‘alogliptin’

TODAY’S NEWS

Takeda to move forward with new alogliptin study – Takeda Pharmaceutical Co says it is all set to start an additional clinical trial demanded by US regulators on alogliptin, its investigational type 2 diabetes drug. The Japanese drugmaker noted that the US Food and Drug Administration has agreed to the study design for a cardiovascular outcomes trial, titled EXAMINE for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4) inhibitor also known as SYR-322. The study will involve 5,400 type 2 diabetes patients at around 1,000 facilities in the USA, Europe and Asiamore

Genzyme leukemia drug study: hard to interpret – “The lack of a randomized study combined with the heterogeneous patient population regarding AML prognostic factors makes interpretation of the study results difficult.” Food and Drug Administration staff said in an analysis prepared for the panel, which meets Tuesdaymore

Smoker’s lung treatment: coming soon from Forest and Nycomed? – An experimental once-daily tablet from Nycomed and Forest Laboratories improves lung function in people with “smoker’s lung” and may be a useful add-on to conventional inhaled drugs, experts said on Friday. Privately owned Swiss drugmaker Nycomed, which is working towards a multibillion-dollar flotation, hopes Daxas will reach the market in 2010 and believes it has blockbuster potentialmore

Pharmas that got hurt by debt shenanigans, including BMS and Teva. And, a rash of drug heists.

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Younger folks just don’t want to take their cholesterol meds.

JUST FOR FUN

A Danger sign you don’t want to see…
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I think it’s going to be more than 3 today…!

Does Lantus (Sanofi drug for diabetes) increase cancer risk?

Takeda‘s alogliptin (new diabetes treatment) – FDA says, more info please.

European Medicines Agency approves a variety pack of new drugs and expanded indications. Here’s the rundown.

Drug companies increasingly using Medical Science liaisons. In my industry crystal ball, I think MSL-type folks will increasingly replace pharma sales reps. More from the original WSJ article here.

Newest version of Elan rumors – Novartis perhaps buying the MS part of the portfolio? Could make sense, given Novartis’ recent entry into that therapeutic area.

Roche: bye-bye Accutane – Roche is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement...more

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J&J announces leadership transition – Johnson & Johnson appointed Sheri McCoy, leader of its surgical care group, on Thursday worldwide chairman of its pharmaceuticals group, effective Jan. 1. McCoy will replace Christine Poon, whose departure from J&J was announced last month. Poon, who has also served as J&J’s board vice chairman, plans to step down in March…more

Teva and AZ in a tiff about Crestor patents.

FDA to Takeda on Alogliptin review: Sorry, understaffed! – Takeda Pharmaceutical Co, Japan’s biggest drugmaker, said on Friday that U.S. health authorities have not been able to complete a review of a key diabetes drug candidate on schedule due to lack of resources…more

AZ‘s PurplePill website continues to generate impressive traffic numbers.

1 in 4 teenage girls have received Gardasil – Whether this means Merck’s HPV vaccine is making great inroads is unclear, but Gardasil does appear to be on its way to becoming accepted, according to the first federal government study of vaccination rates for the controversial shot…more

Rituxan OK’d for cancer treatmentRheumatoid arthritis drug Rituxan helps to fight cancer, but now its makers can actually share that with the world…more

Watson gets approval for Rapaflo for BPH – Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAFLO(TM) (silodosin), the company’s new alpha blocker for the treatment of the signs and symptoms of BPH…more

Neurontin: the gaffe that keeps on taking – Pfizer Inc  tried to suppress medical studies that did not support the use of its epilepsy drug Neurontin, internal Pfizer documents submitted in a U.S. lawsuit against the company showed…more

St. John’s Wort for depressiondoes he or doesn’t he?

Drug samples under attack!

Eli Lilly buying up ImClone.

Dendreon’s Provenge has some tantalizing data, but still must wait – Amid the stock sell-off, a bright spot appears and, of all things, it turns out to be Dendreon, the controversial and much-maligned little company that continues to press ahead with its Provenge prostate cancer vaccine…more

Another university looks at banning pharma gifts – A university medical school task force recommends prohibiting faculty, medical residents and students from receiving gifts from drug and device makers, according to an unreleased report obtained by The Minnesota Daily, the university’s newspaper. Docs would also be required to disclose all relationships with a drugmaker before writing a prescription and create a website to report conflicts…more

King and Alpharma start talking – Are you surprised? After the usual posturing and harsh language, the two drugmakers have agreed to a confidentiality agreement, according to a filing with the US Securities and Exchange Commission…more

Who should get Avastin? Genetic tests may tellGenetic tests could in future show who will respond best to Genentech and Roche’s blockbuster cancer drug Avastin — a positive development for patients but not necessarily for sales…more

Spiriva: more not-so-great mixed results – Spiriva, marketed by Pfizer and Boehringer Ingelheim, offered no advantage over an inhaled placebo for moderate-to-very-severe chronic obstructive pulmonary disease, or COPD, researchers reported on Sunday…more On the other hand, Novartis has a promising new COPD candidate doing well in mid-stage trials.

Peter Rost whistleblower suit against Pfizer gains new traction.

Good results for Remicade in combo treatment – Crohn’s disease patients taking Johnson & Johnson’s (JNJ.N: Quote, Profile, Research, Stock Buzz) Remicade either alone or with azathioprine experienced steroid-free remission in significantly greater numbers than those taking azathioprine alone, according to results of a clinical trial…more

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Fresh news from the ADA (American Diabetes Association):

Takeda’s alogliptin shows impressive results – Takeda Pharmaceutical Co Ltd’s  experimental diabetes drug alogliptin significantly lowers blood sugar alone and in combination with other common therapies, according to research presented on Saturday…more More detailed data here.

Sanofi’s experimental injectable diabetes drug shows promise – An experimental injectable type 2 diabetes drug being developed by Sanofi-Aventis SA was well tolerated and significantly improved blood sugar control compared with a placebo, according to data presented on Saturday…more

Head-to-head study of Byetta with an experimental Novo drug…very interesting – Novo Nordisk’s experimental type 2 diabetes drug, liraglutide, was superior in controlling blood sugar in a clinical trial to Eli Lilly and Co and Amylin Pharmaceuticals Inc’s Byetta, the Danish company said on Friday…more

Forbes.com has a bunch of follow-up articles growing out of the recent ASCO meeting:

:: Cancer Revolution, or Me-too Mess? Over the next decade, drug companies could either start selling more cancer drugs than at any time in history or face the biggest string of clinical failures ever…more

:: Cancer Drug Winners and LosersThe data presented at ASCO can have a huge impact both on the share prices of drug firms and on the long-term sales of their medicines. Here’s a roundup of the most important drug studies from the meeting and a look at how they will affect the companies involved…more

:: Novartis Steals the ShowNovartis is emerging as the surprise winner at this year’s annual meeting of the American Society of Clinical Oncology, the year’s biggest cancer conference…more

:: Can Cancer Cure Pfizer?The recovery of Pfizer, the world’s biggest pharmaceutical company, rests largely on how well Nicholson, 53, can get cancer-fighting drugs out of its research labs and into doctors’ offices…more

:: And, if you want the real short-form bullet-point summary, here’s the high-level ASCO overview from Pharma Exec.

In other news….

Crestor Gaining Market Share – AstraZeneca Plc’s cholesterol drug Crestor is gaining market share in the highly competitive U.S. market, following recent encouraging data and problems faced by rival medicine Vytorin…more

Arthritis Drugs Cause Concern – The U.S. Food and Drug Administration warned American consumers on Wednesday that it is looking into side effects of a class of arthritis drugs that could cause cancer in children…more

Novartis Buying into Antibiotics – Novartis said it’s going to pay $100 million up front, plus as much as $300 million more, for Protez Pharmaceuticals. Protez makes PZ-601, an antibiotic in Phase II development against potentially fatal drug-resistant infections, including the MRSA and ESBL strains…more

Actelion: Who’s circling? -Big drugmakers want to do a deal with Switzerland’s Actelion Ltd — the question is will it be a $1 billion-plus drug marketing alliance or a $7 billion-plus takeover?…more (hat tip: Pharmagossip)

Sexual Harassment and Drug Reps: Watch your Steps, Folks: (from PharmaGossip) Workers at pharmaceutical giant Eli Lilly may want to lay off the Cialis – a longtime saleswoman says she was canned after complaining about her boss’ sexist rants and the come-ons of her sales partner…more

Velcade: a cancer treatment with some potential for lupus? – Velcade, a drug used to treat cancer, might also work against the chronic autoimmune disease lupus, German researchers said on Sunday…more

And…here’s the weekly blog/news summary from Chris Truelove at PharmaLive.

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A ton of cancer news out of ASCO (American Society of Clinical Oncology). We’ll get to those in a minute. First, all the other stuff:

Pfizer’s Chantix running into heavy weather – Hundreds of patients taking Pfizer Inc‘s anti-smoking drug Chantix have reported serious accidents, vision problems and heart trouble, researchers said on Wednesday, sending shares of the world’s largest drugmaker to their lowest level since 1997…more

Takeda continues making deals; partnering with Alnylam – The Japanese drugmaker will pay that upfront to become Alnylam’s strategic partner for five years to use RNA interference, which offers a way to turn specific genes on and off, to develop treatments for cancer and metabolic disease…more

Takeda’s alogliptin diabetes drug looking good – Takeda Pharmaceutical’s experimental diabetes treatment, a successor to its best- selling Actos drug, showed promising signs in clinical trials that could lead to U.S. sales approval, analysts tracking the company said…more

Angiomax, from The Medicine’s Company, gets a very encouraging result for angioplasty clot prevention – A new clot-preventing drug called bivalirudin is much more effective than existing drugs at stopping clot formation during balloon angioplasty for severe heart attacks, reducing the risk of death by a third, researchers reported Thursday…more

Osteoporosis drug wars: Amgen says it beats Merck – Biotechnology company Amgen Inc. said Wednesday that a head-to-head study showed its late-stage osteoporosis drug denosumab was more effective than a competing drug from Merck & Co…more

IMS predicting seven upcoming potential blockbusters – Despite hollow pipelines across the industry in 2008, seven drugs could hypothetically reach blockbuster status, according to Doug Long, director of industry relations at IMS Health…more

GSK’s experimental blood drug looking not much different from placebo – GlaxoSmithKline’s (GSK) experimental drug Promacta (eltrombopag) failed to significantly lower bleeding in patients with the rare blood disorder it was designed to treat, the FDA said…more

Antidepressants help stroke victims? – Preventive use of antidepressants slashes the depression rate of stroke patients by more than half and could help them live years longer, a landmark study out Tuesday suggests…more

Cutting Alzheimer’s risk by a quarterAspirin and related painkillers called non-steroidal anti-inflammatory drugs all seem to work equally well to cut a person’s risk of developing Alzheimer’s disease, researchers said on Wednesday…more

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Now, onto ASCO:

A KRAS act – Among the 5,000 studies being discussed by 30,000 oncologists at this weekend’s meeting of American Society of Clinical Oncology, listen for the buzz over a single gene. It’s called KRAS, and a growing body of evidence suggests that cancers with the standard form of this gene respond better to an important class of cancer drugs than tumors with a common mutation of the gene…more

Erbitux adds to survival in lung cancerLung cancer patients treated in a large clinical trial with ImClone Systems Inc’s Erbitux and chemotherapy lived about five weeks longer than patients treated with chemotherapy alone, according to study results released on Saturday…more

Lilly’s Gemzar very effective with pancreatic cancerEli Lilly and Co’s chemotherapy drug Gemzar more than doubled the overall survival for early stage pancreatic cancer patients five years after surgery to remove their tumors, according to results from a long-term study released on Saturday…more

Can Celebrex help prevent development of lung cancer? Maybe – A high dose of the arthritis drug Celebrex showed early signs that it may help prevent lung cancer in heavy smokers, U.S. researchers said on Sunday…more

Effective vaccine for brain tumor? – A cancer vaccine more than doubled the survival time of people with the most common and deadly type of brain tumor, U.S. researchers said on Monday…more

Cancer drugs – less is more? It’s the year of less at the big American Society of Clinical Oncology meeting. Rather than buzzing about some promising new drug or treatment, lots of docs are talking about when patients shouldn’t get treated with particular drugs…more

Novartis’ experimental RAD-001: very promising – Early proof-of-concept studies presented today show RAD001 (everolimus) may offer a novel treatment strategy for breast cancer by enhancing the efficacy of, and overcoming resistance to, several commonly used breast cancer treatments…more

Novartis’ Zometa helps stave off breast cancer – A drug used to strengthen the bones of women with breast cancer helped cut the risk of the cancer returning by 36 percent, European researchers said on Saturday…more

Merck’s experimental osteoporosis drug helps cancer patients – Drug maker Merck & Co. on Tuesday said a mid-stage trial of an osteoporosis drug in women with breast cancer reduced the breakdown of bone…more

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So, who is getting all those free drug samples, anyway? The poor, or the wealthy insured? A recent study puts this to the test.

Some refreshing candor – Novartis CEO Dan Vasella admits that he uses Lipitor (Pfizer‘s cholesterol drug) instead of Novartis’ Lescol. Medical responsibility triumphs over marketing spin!

Prasugrel, a promising Lilly/Daiichi Sankyo drug, is about to be submitted to the FDA. This will be an interesting one – the drug has blockbuster potential, but will it be fast-tracked – or side-tracked?

Very promising new Hepatitis B treatment may be on the horizon.

Breaking news from Chicago – two new filings. Takeda‘s DPP-4 inhibitor (Alogliptin, for diabetes) has now been filed for approval, as well as TAP‘s new GERD treatment.

Sciele gets approval for new formulations of its Sular HBP drug.

Mylan gets the OK to market a generic version of Zyrtec.

Who needs sleep? Just snort the latest sleep-replacement chemical!

BD gets the go-ahead for a rapid staph test, quickly identifying the presence of antibiotic-resistant strains.

The latest lawsuits for off-label promotion – Pfizer and LipitorAmgen and Enbrel.

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