Pharmalot... Pharmalittle... Good Morning
Rise and shine, another day is on the way. And while this may be midsummer, we are as busy as ever. After all, the world is still spinning, yes? So before you get dizzy at the thought, please join us for a delicious and invigorating cup or two of stimulation. Truth be told, we can never get enough. Meanwhile, we have gathered another menu of tidbits for you. By the way, we would like to note that we will be off tomorrow and would like to wish you a happy weekend in advance. Catch you soon... J&J Ordered To Repay A Chinese Dealer For Monopolistic Practices (Xinhua News) Sanofi Cuts Forecast After A Big Earnings Miss (Bl...
Source: Pharmalot - August 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

The Curious Case Of AstraZeneca v. ACE
By GUEST BLOGGER | Published: JULY 31, 2013 by Mike Kelly and Andrew Dupre Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned. From 2003 to 2012, AstraZeneca Plc was locked in one of the largest mass tort litigations in the United States, defending its blockbuster second generation atypical antipsychotic product Seroquel from allegations of failure-to-warn of risks of metabolic injury such as diabetes mellitus Type II.  AstraZeneca prevailed on the lone case to reach a jury, won an additional nine cases during pretrial proceedings nationwide–losing none, and then end...
Source: PharmaGossip - August 1, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Diabetes Drugs Pancreatic Cancer Risk Not Backed By Existing Evidence: FDA
In yet another boost to several large drugmakers, the FDA has decided that there is no evidence that to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer, an FDA spokeswoman says. The decision comes several days after the European Medicines Agency reached the same conclusion (here is the EMA statement). “The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the exten...
Source: Pharmalot - July 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
And so, the middle of the week has arrived. There are, of course, two ways to view this: Is the glass half full or half empty? While you ponder, please join us for a delicious cup of stimulation as we attack our stack of reading matter and attempt to catch up with interesting people. Meanwhile, here are a few items to help you on your way. We hope you have a grand day and do stay in touch. Manning and Snowden aside, we accept classified documents... Budget Cuts Force US To Cut Back Health Care Fraud Probes (The Washington Post) Cubist Buys Trius Therapeutics And Optimer Pharma For $1.6 Billion (Bloomberg News) AstraZeneca ...
Source: Pharmalot - July 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

UK pharma shows signs of dangerous addiction
GlaxoSmithKline doesn't seem to be able to kick the bribery habitGlaxoSmithKline offices in Shanghai. Photograph: Aly Song/REUTERSThe last time anyone remembers a row over Brits forcing drugs on the Chinese market, it ended with our boys taking Hong Kong. But anyone predicting that British interests will emerge from the latest China crisis with comparable benefits to those of the opium wars has surely been smoking some pretty muscular gear.To recap: last week, UK pharma firm GlaxoSmithKline admitted that Chinese doctors were bribed by its execs with cash and sexual favours in return for prescribing the company's ...
Source: PharmaGossip - July 28, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

The Glaxo-China Bribery Scandal: A New Policeman Walks The Beat - by Robert Radick
When it comes to allegations of foreign bribery, what a difference a week can make.  Just over ten days ago, a new player in the world of international bribery – the Chinese Ministry of Public Security – announced that it was investigating senior executives in the Chinese division of British pharmaceutical company GlaxoSmithKlinefor allegedly offering bribes to officials and doctors in order to boost company sales.  GSK responded at the time with the respect and deference that one would anticipate, stating that it takes “all allegations of bribery and corruption seriously” and that it would...
Source: PharmaGossip - July 28, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

EMA Decides No Risk Of Pancreatic Cancer With Diabetes Drugs
In a decision that is a big boost to several drugmakers, the European Medicines Agency has concluded that there is no evidence to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The review took place in response to a ruckus caused by a study published in Diabetes four months ago that found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. The researchers examined the pancreas of 20 deceased human organ donors with type 2 diabetes (here is the abstract). However...
Source: Pharmalot - July 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

More Behind-the-Scenes Maneuvering. How Wonderful.
This is exactly the kind of headline the drug industry does not need. Via FierceBiotech, here's a story in The Guardian on the recent efforts to get companies to disclose more about the clinical trial results for investigational drugs. GSK is the company that seems to have done the most in this regard, but the European Medicines Agency (EMA) is proposing mandatory disclosure of trial results into a public database. That's a lot further than most companies are willing to go - so what to do? The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European...
Source: In the Pipeline - July 26, 2013 Category: Chemists Tags: Why Everyone Loves Us Source Type: blogs

GlaxoChinaGate contd. - the Chinese police reveal details
Related News•Lower drug prices expected following GSK China investigations•GSK executives in China to handle the scandal•Travel ban on director of GSK•Shanghai closes travel agency over GSK case•GSK probe indicates tightened drug sector supervisionhttp://www.readability.com/read?url=http%3A//news.xinhuanet.com/english/indepth/2013-07/26/c_132574386.htmBEIJING, July 26 (Xinhua) -- The Chinese police on Thursday revealed details of GlaxoSmithKline (GSK) China's alleged bribery and tax-related violations that pushed up drug prices and disrupted market order.After the Ministry of Public Security (MPS) announced on Ju...
Source: PharmaGossip - July 26, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

More Astra staff held in China as GSK crisis deepens
Two more AstraZeneca sales executives have been arrested by Chinese police, but the drugs giant still maintains the swoop had nothing to do with China’s wide-ranging crackdown on bribery in the pharmaceutical industry.Police first visited Astra’s Shanghai headquarters on Friday, days after rival GlaxoSmithKline faced allegations of a multimillion-pound bribery scandal, and detained a sales executive.Officials in China yesterday released that worker but took away two more senior employees, both thought to be district sales managers. One is understood to be an American citizen.“We still have no reason to believe that t...
Source: PharmaGossip - July 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is under way. And this one is feeling a bit damp, thanks to a spot of rain that has descended on the Pharmalot corporate campus. No complaints, though, since the humidity is low and a cool breeze is wafting by our mandatory cup of stimulation. All of which is to say that the time has come to get cracking. So here are some items of interest. Have a wonderful day and do stay in touch... Two More AstraZeneca Employees Are Questioned In China (Reuters) Teva Developing New Medicines To Treat Brain Disorders (Reuters) Medicine Shortages Are Worsening In Ireland (Pharma Times) AMRI Recei...
Source: Pharmalot - July 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

How to lower Big Pharma's drug prices the Chinese way
British drug giant GlaxoSmithKline (GSK) will lower the prices of its products on the mainland and has admitted that some of its senior executives appear to have broken the law there.Meanwhile, the mainland's crackdown on pharmaceutical firms widened to AstraZeneca.UK ministers are aware of the investigation. We remain in regular contact with GSK and the Chinese authoritiesMATTHEW FORBES, DEPUTY BRITISH CONSUL IN SHANGHAIThe Shanghai office of the Anglo-Swedish firm was visited by the Shanghai Public Security Bureau "regarding a local police matter focused on a sales representative", a spokesman for the company said. "This...
Source: PharmaGossip - July 23, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity
I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence.An article in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against suppression and manipulation of clinical research. In summary,The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.More specifically,The strategy was drawn up by two large trade groups, the Pharmaceutical Res...
Source: Health Care Renewal - July 23, 2013 Category: Health Medicine and Bioethics Commentators Tags: PhRMA deception health care corruption manipulating clinical research patient advocacy groups public relations suppression of medical research conflicts of interest Source Type: blogs

Update on the Bribery Scandal
This Reuters story may be telling people everything they need to know in the first paragraph: British drugmaker GlaxoSmithKline said on Monday some of its executives in China appeared to have broken the law in a bribery scandal, as it promised changes in its business model that would lower the cost of medicine in the country. GSK is the latest in a string of multinationals to be targeted by Chinese authorities over alleged corruption, price-fixing and quality controls. Chinese police visited the Shanghai office of another British drugmaker, AstraZeneca, a company spokeswoman said on Monday. They arrived on Friday and to...
Source: In the Pipeline - July 22, 2013 Category: Chemists Tags: Business and Markets Source Type: blogs

ChinaGate: Glaxo Issues A Mea Culpa And AstraZeneca Is Questioned
More bad news for GlaxoSmithKline. Over the weekend, the embattled drugmaker found itself scrambling on several fronts to contain the damage from a bribery scandal in China. Abbas Hussain, Glaxo president of international operations (pictured left), who met with Chinese authorities, issued a formal statement admitting that "certain senior execs" in the Chinese unit "acted outside of our processes and controls, which breaches Chinese law." And to appease the Chinese, he adds that certain chainges to be made to operations there will result in lower prices on medicines. At the same time, the drugmaker has reportedly met with ...
Source: Pharmalot - July 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs