Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is on the way. Yes, the middle of the week is here and, as always, there is much to do. Of course, this can be a good thing, unless you planned to take the day off. If not, then it's time to get cracking. So grab a cup of something stimulating and dig in to the menu of tidbits below. Meanwhile, we hope your day is filled with accomplishments and do stay in touch by writing to ed@pharmalot.com We accept classified information...
Roche And AstraZeneca To Share Early Trial Data (The Wall Street Journal)
Astellas Signs $490M Pact With Cytokinetics (Pharma Times)
Common Meds With Caffe...
Source: Pharmalot - June 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Big Pharma Gets Its Money's Worth: Study by Pharma-Funded Researchers Reports Invalid Data to Show that NRT Works When the Correct Study Data Show No Effect
In this study, the loss to follow-up was substantial (58%). Thus, failure to use an intent-to-treat analysis heavily biases the results.Even in the heavily-biased 2008 Clinical Practice Guideline update, intent-to-treat analyses were exclusively relied upon in evaluating the effectiveness of NRT. The intent-to-treat analysis is also used in a new clinical trial which will be released later today that evaluates the effectiveness of electronic cigarettes. In fact, intent-to-treat analyses are the basis for all comparisons of the effectiveness of different smoking cessation medications and approaches.So what are the actual re...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - June 24, 2013 Category: Health Medicine and Bioethics Commentators Source Type: blogs
Top Line Results: No Cardiovascular Benefits Found For Saxagliptin
Top line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on September 2 by Deepak Bhatt. … Click here to read the full story on Forbes. (Source: CardioBrief)
Source: CardioBrief - June 19, 2013 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes AstraZeneca Bristol Myers Squibb Dipeptidyl peptidase-4 inhibitor European Society of Cardiology food and drug administration Onglyza Saxagliptin Source Type: blogs
A Bristol-Myers And AstraZeneca Diabetes Trial Is A 'Dud'
In a setback to an important joint venture between Bristol-Myers Squibb (BMY) and AstraZeneca (AZN), the top-line results of a large, late-stage study of their Onglyza diabetes drug failed to show superiority in reducing cardiovascular deaths, heart attacks and strokes compared to a placebo in Type 2 diabetes patients with cardiovascular risk factors (read this).
At the same time, the findings of the so-called SAVOR study, which examined more than 16,000 patients, also indicated that Onglyza did not cause cardiovascular harm, which is a key FDA litmus test for diabetes pills since heart risks are a common concern for diabe...
Source: Pharmalot - June 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
For AZ's Onglyza SAVOUR is not a saviour
AstraZeneca has suffered another drug trial setback.
Its diabetes drug Onglyza, developed with Bristol-Myers Squibb, failed to reduce heart risks or strokes in a large scale clinical trial. Despite investor hopes, the Savor trial showed the drug was no better than placebo or standard treatments.
Panmure Gordon analyst Savvas Neophytou issued a hold recommendation on the shares, which have dipped 2.5p to £32.48, saying:
AstraZeneca's eagerly anticipated Savor trial has read out without success in providing a differentiation on cardiovascular risk for diabetes product Onglyza.
This disappointment should be moderat...
Source: PharmaGossip - June 19, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
ADA's Ratner: We Expect Patient Level Data From All Drugmakers
Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs called GLP-1 inhibitors and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. The outcome was inconclusive, but the FDA may want further studies. Meanwhile, the American Diabetes Association called for drugmakers that sell these meds to release patient-level data that can be used for an independent review (back stories here, here and here). Whether the drugmakers - Merck, Bristol-Myers Squibb, AstraZeneca, Eli ...
Source: Pharmalot - June 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Bernard Munos on The Last Twelve Years of Pharma
Bernard Munos (ex-Lilly, now consulting) is out with a paper reviewing the approved drugs from 2000 to 2012. What's the current state of the industry? Is the upturn in drug approvals over the last two years real, or an artifact? And is it enough to keep things going?
Over that twelve-year span, the average drug approvals ran at 27 per year. Half of all the new drugs were in three therapeutic areas: cancer, infectious disease, and CNS. And as far as mechanisms go, there were about 190 different ones, by Munos' count. The most crowded category was (as might have been guessed) the 17 tyrosine kinase inhibitors, but 85% of th...
Source: In the Pipeline - June 18, 2013 Category: Chemists Tags: Drug Development Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Top of the morning to you. A shiny day is unfolding here on the Pharmalot corporate campus, where are the birds are chirping, the official mascots are fertilizing the assorted weeds and short people are hustling off to their final rounds of learning at the schoolhouses. As for us, we are foraging through notes and documents as we prepare for interesting conversations. Busy, busy, as they say. We trust you relate. So grab your cup of stimulation and dig in to the latest line-up of tidbits. Have a great day and feel free to write us at ed@pharmalot.com if you hear anything interesting...
Obesity Is Not A Disease: AMA Council...
Source: Pharmalot - June 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
READER POLL: Should Diabetes Drugmakers Provide Patient-Level Data?
Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. The outcome was inconclusive, but the FDA may want further studies.
The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia (MRK); Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also sold by Bristol-Myers; the Tradjenta med sold by Eli Lilly (LLY) and Boehr...
Source: Pharmalot - June 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Welcome to the working week. We hope the weekend respite was relaxing and provided an opportunity to enjoy life a wee bit. Now, though, that familiar routine of meetings and deadlines has returned. Summer may be edging closer, but this is likely to be a busy week. To fortify ourselves, we are, of course, reaching for a cup of stimulation, and trying a delicious new flavor today - Hazelnut Cinnamon. Feel free to join us with whatever strikes your fancy. Meanwhile, here is the usual menu of tidbits. Hope your day goes well and do stay in touch...
Johnson & Johnson Pays $650M For Aragon Pharmaceuticals (Associated Press)
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Source: Pharmalot - June 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Diabetes Drugs Under Scrutiny As FDA Considers Another Study
As a two-day NIH workshop gets underway to examine the safety of several widely used diabetes drugs, the FDA is considering whether to run a study to determine whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that have generated considerable controversy.
“A review of FDA-required epidemiological studies submitted to (the FDA) have provided conflicting results and do not provide reliable evidence to refute or support a causal link between GLP-1 based therapies and risk of acute pancreatitis,” wrote Solomon Iyasu, who heads one of the FDA e...
Source: Pharmalot - June 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another day has arrived. Not only that, but the rain has stopped, at least for now. Whatever the weather forecast might say, though, our spirits remain sunny. As the Morning Mayor taught us long ago: 'Every brand new day should be unwrapped like a precious gift.' So while you tug on the ribbon, we will reach for the mandatory cup of stimulation and get on with foraging for interesting developments. Meanwhile, here are a few tidbits. Have a grand day and thanks to all for providing some useful tips lately...
AstraZeneca And Takeda To Bid On Israeli Biotech Incubator (Globes)
FDA Approves Sanofi Fou...
Source: Pharmalot - June 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? - BMJ
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3680 (Published 10 June 2013)
Cite this as: BMJ 2013;346:f3680Article
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Deborah Cohen, investigations editor
Author Affiliations
dcohen@bmj.com
Incretin mimetics have been called “the darlings of diabetes treatment” and they may soon also be licensed for treating obesity. But a BMJ investigation has found growing safety concerns linked to the drugs’ mechanism of action. Deborah Cohenasks why patients and doctors have not been told.
They’ve been touted as th...
Source: PharmaGossip - June 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Welcome to the working week. Once again, another weekend respite has come and gone very quickly. Nonetheless, we hope you found it refreshing, if not invigorating, because that familiar routine of meetings and deadlines and varied pressures has now returned. To cope - yes - we are downing a cup or three of needed stimulation and, as always, invite you to join us. Firing up those neurons is a necessary and welcome step right now. Meanwhile, here are some tidbits. Hope your day goes well and do stay in touch...
AstraZeneca Buys Pearl Therapeutics For $1.1B For COPD Drug (Pharma Times)
Elan Board Rejects $6.7B Offer From Roya...
Source: Pharmalot - June 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Dollars for Doctors in New Hampshire
In another ProPublica-created story, Fosters.com recently did a local piece using the Dollars for Docs database to cover "payments doctors receive from drug makers"—one of the more neutral titles we have seen in a long time, maybe ever (sadly). The article notes that companies paid more than $3.1 million to New Hampshire doctors over the past four years for speaking and consulting work—however, the figure does not include payments for meals, travel or research work. More than 120 physicians in New Hampshire have earned at least $1,000 the data shows. Most received a relatively small sum — the median value was abou...
Source: Policy and Medicine - June 10, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
