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Archive for the ‘Boehringer Ingelheim’ Category

TODAY’S NEWS

B-I gets (European) clearance for extended-release Parkinson’s drug formulation.

Avodart + Flomax – a good combo for your prostate? – The drug was shown, when given with tamsulosin, to have benefits for men with prostate enlargement. In the four-year CombAT study Avodart (dutasteride) and tamsulosin together showed a 66% reduction in the risk of acute urinary retention (AUR) or benign prostatic hyperplasia (BPH)-related surgery compared to tamsulosin alone. And the GSK-sponsored study, published online in European Urology, found a 20% risk reduction in these factors compared to Avodart on its own. Part of the results’ significance lies in the fact that tamsulosin is the active ingredient in Boehringer Ingelheim‘s Flomax, one of Avodart’s rivals in this therapy areamore

Glaxo starts getting hit with judgments over Paxil/birth defect link – A Pennsylvania state court jury deliberated seven hours before finding the drug maker failed to properly warn docs and pregnant women about the risks of the antidepressant. This was the first of 600 cases, by the waymore

From NPR – Selling Sickness: How drugs ads changed healthcare – It used to work like this: Doctors decided what to prescribe. Drug companies — through medical advertisers — tried to influence doctors. Patients did what they were toldmore

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This is an imaginative and well-structured presentation on the U.S. healthcare system, in simple terms: Healthcare Napkins (named by BusinessWeek as one of the world’s best presentations of 2009)

JUST FOR FUN

Business buzzwords – one of the best collections you’ll ever see, in one “memo”! Deep-dive breakout.Coming up this month:

Oct. 26-27 – Kru Research’s e-Patient Connections conference, Philadelphia, PA. I’ll be speaking and live-blogging. Here’s a discount code to save $500 off your registration: SW500

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Where to get your overview of Social Media in Pharma? Right here: http://bit.ly/socialrx

TODAY’S NEWS

Pharma’s new hot properties - vaccines.

Boehringer Ingelheim pressing forward with its experimental DPP-4 inhibitor for diabetes – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the conclusion of the linagliptin pivotal Phase III clinical trials, including more than 4,000 patients in 40 countries worldwide. Phase II data for linagliptin were presented earlier this year at the annual American Diabetes Association (ADA) Scientific Sessions. Full results from the Phase III trials will be presented at international scientific congresses in 2010 and beyond...more

Merck’s diabetes drug Januvia significantly lowers blood sugar – A post-hoc analysis, presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed ‘Januvia®’ (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two yearsmore

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Has the game changed in a dramatic way in pharma social media? I think it may be likely – my initial thoughts on Google’s Sidewiki tool, which allows user commentary on ANY site.

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See the newly-re-launched Impactiviti Collection e-newsletter! Here’s a link to the on-line sample; you can sign up to receive the Connection (~every two weeks) right here.

TODAY’S NEWS

Pfizer and Wyeth to sell off some Animal Health assets to Boehringer-Ingelheim.

Speaking of B-I, here’s a presentation from them on how they successfully use Twitter. Boehringer is one of the more engaged and interactive companies in the space.

Eli Lilly‘s Alimta improves survival for lung cancer.

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Podcast today discussing latest social media in pharma developments, and upcoming Digital Pharma conference in October. Archived here.

JUST FOR FUN

Is it candy? Or medicine? This poster‘s both funny and a bit…scary.

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TODAY’S NEWS

AstraZeneca’s experimental drug may bring serious competition to Plavix - AstraZeneca‘s new pill Brilinta for preventing heart attacks works better than Plavix, the world’s second biggest selling drug, without increasing the amount of life-threatening bleeding, researchers said on Sundaymore

B-I‘s new drug Praxada poised to finally provide an alternative to warfarin – Patients at risk of stroke due to an erratic heartbeat should soon have a viable alternative to 50-year-old warfarin, after a new pill from Boehringer Ingelheim beat expectations in a major clinical studymore Plus, new B-I drug for COPD is looking promising.

Encouraging results for Angiomax in cardiac mortality/survival study – The Medicines Company today announced the publication of one-year results from the landmark HORIZONS-AMI Trial. The trial showed that patients who had suffered the most severe form of heart attack and received angioplasty were significantly less likely to suffer cardiac death and had significantly better overall survival if treated with Angiomax (bivalirudin) compared with those treated with heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI)more

FDA to Allos: not so sure about your lymphoma data – Food and Drug Administration reviewers, in a summary prepared for an advisory panel, said their two issues with Allos’ application were “the clinical significance of tumor response and duration of response” as well as “whether the benefit:risk ratio is favorable” for Folotynmore

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Couldn’t stop myself from including a link to this press release – can you discover what in the world the product being discussed is for? Neither can I…

JUST FOR FUN

Turn up your speakers, sit back for a minute or two, and just enjoy this remarkable video. Rain.

On a personal note: Next week one of my sons joins the Marines. Some thoughts from a proud Dad.

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TODAY’S NEWS

Amylin to be led by former Novartis exec – Amylin Pharmaceuticals has taken another step forward in its long & storied history. The company has announced that former Novartis executive Paulo Costa will become its new chairmanmore

An interesting lawsuit: individual suing Celgene for blockbuster drug idea – In 1996, Beth Jacobson was watching her husband, a 35-year-old cardiologist, die from the blood cancer multiple myelomamore

Gene variation impacts 1/3 of Plavix patients? – A common gene variation explains why many people are not helped by the widely prescribed blood thinner Plavix, U.S. researchers said on Tuesday in a study confirming earlier research and paving the way for tests to screen patients before they get the drugmore

From the rumor mill – Glaxo eyeing Human Genome Sciences? And, is B-I cutting a major percentage of its sales force in the U.S.? (can anyone confirm or deny with facts?)

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Are placebos getting more effective? What’s going on here? - From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebomore

JUST FOR FUN

Who’s got the better colors? An eye-popping series of 3 photos you’ll enjoy!

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GSK and Pfizer join forces to create a new company focused on HIV. I really like the idea here – I think highly-focused companies can be much more nimble and effective.

Dendreon finally gets some good clinical news about experimental prostate cancer treatment Provenge.

B-I launches new unbranded website for TIA (mini-stroke) sufferers.

If there was any doubt as to who was taking over whom (Roche/Genetech), let’s put that to rest.

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BREAKING RUMORPfizer in talks to acquire Wyeth.

Will contract sales reps rule in the future? Revenues are now following a “cyclical pattern surrounding patent expirations,” In Vivo quotes Ryan as saying. So pharma companies need to have sales forces that can follow the same kind of cycle, shrinking as revenues sink, she suggests.

Merck’s Januvia + metformin for diabetes, 2 years in – looking good. Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed.

Hmmm…will names of BI reps who signed onto a class action suit become known to their bosses?

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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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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…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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