Advocate Groups Reach Out to President's Science Advisors Ahead of Antibiotics Meeting | Food Safety News
The President’s Council of Advisors on Science and Technology (PCAST) will meet Friday to discuss its work on antibiotic resistance and nanotechnology and to hear from speakers about oceans policy.A group of public health, consumer, and environmental protection organizations have sent a letter to PCAST expressing concern that the U.S. Food and Drug Administration’s Guidance for Industry #213 and a proposed Veterinary Feed Directive (VFD) rule do not go far enough in addressing antibiotic overuse on farms.By March, FDA had heard from 25 of the 26 drug manufacturers affected by Guidance #213...
Source: PharmaGossip - July 8, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Larry Husten writes
Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In ItalyIn response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck . The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.MSD Italy, the Italian arm of the company, sent two “cease and desist” letter...
Source: PharmaGossip - July 7, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Investigators Face Trial Amid GSK Sex Tape Revelations
South China Morning Post’s Toh Han Shih reports that British/Chinese-American corporate investigator couple Peter Humphrey and Yu Yingzheng, who werearrested last summer during a bribery investigation into their clients GlaxoSmithKline, will stand trial in Shanghai on July 29th.Chinese prosecutors originally wanted to charge Humphrey and Yu with several offences, including some relating to illegal business operations.But they decided to drop all of them except for one of illegally buying information, a source close to the family said.Although each faced only one charge, they risked being jailed if found guilty, the ...
Source: PharmaGossip - July 1, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Tokyo prosecutor to charge Novartis Japan unit as well as ex-employee over manipulating data
(Reuters) - Tokyo prosecutors said on Tuesday they will charge the Japanese unit of Novartis AG and a former employee in connection with allegations of data manipulation in promoting its best-selling blood pressure drug Diovan.The prosecutors office said in a statement that it had decided to arrest Nobuo Shiraishi on allegations he gave false data to researchers whose work was used for advertising. Shiraishi was initially detained in June.The prosecutor also said that Novartis Pharma KK, the Swiss drugmaker's wholly owned local subsidiary, will be charged in connection with the case under a provision that alleges responsib...
Source: PharmaGossip - July 1, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

GlaxoChinaGate contd. - sex, lies and video - Who made and who leaked the Mark Reilly Sex Tape?
A covert sex tape involving a senior executive and his Chinese lover was the trigger for a major investigation into corruption at British drugs giant GlaxoSmith-Kline, it was revealed yesterday. The video of married Mark Reilly and his girlfriend was filmed by secret camera and emailed anonymously to board members of the pharmaceutical firm. It led to an investigation that has rocked the £76billion company – which stands accused of bribing doctors and other health officials in China with £320million of gifts, including sexual favours from prostitutes, to persuade them to prescribe its drugs.Mr Reilly, who ran...
Source: PharmaGossip - June 30, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Dutch farmers use less antibiotics
The use of antibiotics in livestock in the Netherlands was further reduced in 2013. This is according to figures from the Dutch Authority of Veterinary Medicines (SDa). At the same time, an international conference is being held to further reduce antibiotic resistance.Photo: Henk RiswickBetween 2012 and 2013, the use of antibiotics in the Dutch pig industry dropped the most, by 30%. Also in the poultry sector, less antibiotics were uses - 25% less compared to 2012. In the veal calf sector, antibiotic use decreased by 15%. In the cattle industry, the antibiotic use remained stable. The decrease in the use of antibiotic...
Source: PharmaGossip - June 29, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Know what this is?
Answer : here (Source: PharmaGossip)
Source: PharmaGossip - June 27, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

AllTrials Flyer
http://www.alltrials.net/wp-content/uploads/2014/06/AllTrials-poster-leaflet-Oct-2013.pdf (Source: PharmaGossip)
Source: PharmaGossip - June 21, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Christopher Snowbeck writes
Medtronic's Covidien deal spurs debate about corporate taxesIs Medtronic's massive international corporate merger a billion-dollar tax dodge, an indictment of the U.S. tax code, or a business-savvy work-around that would spur investment and growth in the Twin Cities?The answer depends on who you talk to.The $42.9 billion cash-and-stock purchase of Covidien, announced Sunday, comes with plans for Medtronic to decamp its executive suite to Ireland, where Covidien is based.It also will nearly double the size of the Fridley-based medical device maker, and likely result in no significant change in its 8,000-strong Twin Cities w...
Source: PharmaGossip - June 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Cartoon - New Yorker
(Source: PharmaGossip)
Source: PharmaGossip - June 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Baron and Budd Announces $177 Million Settlement for Seven States Against Avandia Manufacturer GlaxoSmithKline
DALLAS, Jun 13, 2014 (BUSINESS WIRE) -- The national law firm of Baron and Budd has reached a $177 million settlement with GlaxoSmithKline on behalf of the states of Kentucky, Maryland, Mississippi, New Mexico, South Carolina, Utah and West Virginia regarding the deceptive advertising of the diabetes drug Avandia. This result represents the largest settlement of a pharmaceutical case ever for several of the involved states, and a much higher settlement for each individual state than what they would otherwise have received in a multistate settlement reached in 2012. Baron and Budd attorneys Russell Budd, Burton LeBlanc, Lau...
Source: PharmaGossip - June 13, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Things that make you go hmmm! EMA policy on transparency is “strikingly” similar to deal struck with drug company, say experts
Peter Doshihttp://www.bmj.com/content/348/bmj.g3852?sso=A US drug company seems to have influenced the European Medicines Agency’s (EMA) draft policy on access to clinical trial data, which academics have claimed keeps too much information hidden.Documents obtained by The BMJ under a freedom of information request showed a significant overlap between what the US drug giant AbbVie had agreed with the EMA could be released about its drug adalimumab (marketed as Humira) and the agency’s draft policy on providing public access to drug company data.In 2012 the EMA announced a new, “proactive” transparency poli...
Source: PharmaGossip - June 12, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Former Novartis Japan Employee Held for Data Manipulation
A former employee of Novartis AG (NOVN)’s Japanese unit was arrested in Tokyo on charges of manipulating data on a drug study, the latest setback for the pharmaceutical company in the country.Nobuo Shirahashi, who was a director of the unit’s scientific affairs department, violated pharmaceutical law by understating side effects in a study that evaluated hypertension drug Diovan’s efficacy in cutting stroke risk and getting researchers to publish it, the Tokyo prosecutors office said in a faxed statement today.Shirahashi couldn’t be reached and Novartis Japan declined to make contact information for him or his...
Source: PharmaGossip - June 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Happy Medcomms Day!
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000335 (Source: PharmaGossip)
Source: PharmaGossip - June 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs

Don't mess with Cali Attorney General Kamala D. Harris
SAN FRANCISCO – Attorney General Kamala D. Harris today announced a $105 million multistate settlement with GlaxoSmithKline, LLC (GSK) to resolve allegations that the company unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin. California’s portion of the settlement is the largest of any state, at $7,087,897.For the first time in a settlement with a large pharmaceutical manufacturer, GSK is prohibited from providing incentive payments to its salespeople, which serve to encourage off-label promotion of drugs, and from using paid doctors to promote its products.“Patient care is u...
Source: PharmaGossip - June 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs