Clot Wars contd. oneboringoldman nails it
http://1boringoldman.com/index.php/2014/02/24/how-many-examples/ (Source: PharmaGossip)
Source: PharmaGossip - February 27, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Boehringer Kept Pradaxa Analysis From FDA, Records Show
Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.The F...
Source: PharmaGossip - February 26, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
BREAKING NEWS: Novartis to close Horsham site later this year
Novartis will cease all operations at its Horsham site later this year it was confirmed today (Wednesday February 26).The pharmaceutical giant announced in November 2013 that it was consulting on the closure of the site, off Parsonage Road, with nearly 400 jobs at risk.Following that announcement Novartis, which is one of the largest employers in the town, said today it expected research operations to cease by the end of June.A spokesperson for Novartis said: “Following the announcement we made in November 2013 about the possible future of the R&D site in Horsham, we can now confirm that we will closing the site late...
Source: PharmaGossip - February 26, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Public Citizen Petitions FDA for a Black Box Warning on Testosterone
Products
WASHINGTON - February 25 - Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.The urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug ind...
Source: PharmaGossip - February 25, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Kerching - another whistleblower wins
By Jonathan Stempel(Reuters) - CareFusion Corp agreed to pay $40.1 million to settle a federal government lawsuit accusing it of paying kickbacks to boost sales of a pre-surgical skin treatment, and marketing the product for unapproved uses.The accord announced on Thursday by the U.S. Department of Justice resolves allegations that CareFusion violated the federal False Claims Act by paying $11.6 million to a doctor to promote its ChloraPrep product to healthcare providers.That doctor, Charles Denham, received the kickbacks while serving as co-chair of the safe practices committee of the nonprofit National Quality Forum, wh...
Source: PharmaGossip - February 24, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Endo Health to Pay $192.7M in Settlement
Endo Health will pay almost $193 million to resolve claims that it improperly marketed the shingles treatment Lidoderm for unapproved uses like treating lower back pain.The Malvern, Pa., drugmaker will pay $171.9 million in civil false claims settlements largely to the federal government, with $34.2 million from that total going to 47 states and the District of Columbia. Endo also agreed to pay $20.8 million as part of a deferred prosecution agreement.Federal prosecutors said Friday that Endo Health Solutions Inc. marketed the drug for unapproved uses between 2002 and 2006.Endo said it was pleased to resolve the issue, and...
Source: PharmaGossip - February 24, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Here’s Why Novartis’ Japanese Unit Was Raided
Last month, the Japanese Health Ministry filed a complaint against Switzerland-based drugmaker Novartis AG’s (NYSE:NVS) Japan unit after the company used allegedly false data to advertise for its best-selling blood pressure drug, Diovan, theWall Street Journal reports.Reuters reports that prosecutors in Tokyo broke into the company’s offices in Japan on Wednesday as part of a criminal investigation of the company following charges that the drugmaker violated the law by releasing misleading advertisements.The advertisements in question cited research which the Japanese Health...
Source: PharmaGossip - February 23, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
GlaxoChinaGate contd. - Enter the British Serious Fraud Office Dragon
This article appeared in the South China Morning Post print edition as UK fraud office probes firms over briberyhttp://www.scmp.com/business/companies/article/1432456/gsk-rolls-royce-may-be-british-serious-fraud-offices-hit-list (Source: PharmaGossip)
Source: PharmaGossip - February 21, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Reuters Exclusive: Bayer, Novartis, others eye Merck's consumer health
unit - sources
By Olivia Oran, Soyoung Kim and Anjuli DaviesNEW YORK/LONDON (Reuters) - A handful of consumer and healthcare companies including Bayer AG and Novartis are exploring a deal for Merck & Co Inc's consumer healthcare business, as they seek to gain scale in a fragmented industry, according to several people familiar with the matter.Reckitt Benckiser Group PLC and Procter & Gamble Co are also among the parties that have held discussions with Merck about buying the unit, best known for Coppertone sunscreen and Claritin allergy medicine, the sources said this week.The Merck business, which also includes Dr. Scholl's ...
Source: PharmaGossip - February 20, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Blowing smoke
Glaxo Memo Shows Drug Industry Lobbying on E-CigarettesGlaxoSmithKline Plc (GSK) is pushing for more stringent regulation of electronic cigarettes, which compete with its Nicorette gum and other smoking cessation products, according to e-mails from a company executive.Europe should follow the lead of the U.K., which plans to require e-cigarettes to be licensed as medicines much the way other nicotine-replacement therapy products are, wrote Sophie Crousse, the Brussels-based vice president of European public affairs for Glaxo’s consumer health-care division.Related: Glaxo Sees 2014 Profit, Sales Rising...
Source: PharmaGossip - February 20, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
For your consideration
(Source: PharmaGossip)
Source: PharmaGossip - February 19, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Top of the Pops
Investigation: Pradaxa most complained about U.S. drug; blamed for deaths, life-threatening injuriesCLEVELAND - A Five On Your Side Investigation found Pradaxa, a popular blood thinner, is the most complained about drug in the United States.Our research found more complaints were filed with the FDA about Pradaxa than any other prescription drug in both 2011 and 2012.Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a...
Source: PharmaGossip - February 19, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Oh dear.
Pharma’s reputation ‘getting worse’Published on 17/02/14 at 08:14amGSK was among 33 companies listed in the surveyThe pharma industry’s reputation is getting worse - at least, in the eyes of 800 patient groups - according to a new international survey by PatientView.Of those which responded to questioning in November and December last year, 35.4% said that multinational pharma companies had either an ‘excellent’ or ‘good’ reputation in 2013.While this is about the same result as in 2012, it is well below 2011 when 41% of respondents gave that answer.The survey defined corporate reputation as “the extent t...
Source: PharmaGossip - February 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Three Ways to Make US Cancer Care More Affordable
By Cathy NewmanNational GeographicPUBLISHED FEBRUARY 14, 2014The malady of rising medical costs is acute, especially in the field of oncology. As populations age, new cancer cases are expected to reach 21.4 million in 2030, while treatment costs are projected to increase 40 percent by 2020.Is there a remedy? In the February 14 issue of the Lancet Oncology, doctors Ronan J. Kelly and Thomas J. Smith of the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institutions in Baltimore suggest that costs can be contained without increasing risk to patients. We spoke with Dr. Smith.The United States spends tw...
Source: PharmaGossip - February 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharma companies shouldn't conduct clinical trials: Peter C Gøtzsche
Allowing pharmaceutical companies to conduct drug trials is the equivalent of a defendant alone presenting all the evidence to determine whether he is guilty or not, argues Peter C Gøtzsche, co-founder of The Cochrane Collaboration, a global independent network of health practitioners, researchers, patient advocates and others, and author of the recently released Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. In a candid email interview withIndulekha Aravind, Denmark-based Gøtzsche, who is a specialist in internal medicine and has also worked with clinical trials and regulatory a...
Source: PharmaGossip - February 16, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
