Antibiotics: 'national threat' from steep rise in patients who are
resistant to drugs
A steep rise in the number of patients who do not respond to antibiotic treatment risks causing a “national health threat”, NHS officials have warned.Experts say the explosion in the use of antibiotics in the Western world to treat common ailments could become a “catastrophic threat” because increasingly bacteria have become resistant to the drugs, so they do not work when they are really needed.Officials said the scale of such infections had become a matter of “national concern” with 600 cases reported last year, compared with just five in 2006.Dame Sally Davies, the chief medical officer for England has previ...
Source: PharmaGossip - March 7, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Novartis and Roche fined over 180 mn euros by anti-trust
Italy's Antitrust authority said Wednesday that it had fined Swiss pharmaceutical companies Novartis and Roche a total of over 180 million euros for alleged collusion to manipulate the market in Italy."The two companies made an illegal agreement to hamper the spread of the use of a very cheap pharmaceutical, (Roche's) Avastin, in the treatment of the most widespread eye pathology among the elderly and other serious eye diseases, to favour a much more expensive product, (Novartis's) Lucentis, artificially differentiating the two products," read an Antitrust statement. It added that this had cost the Italian national health ...
Source: PharmaGossip - March 5, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Medtronic Sued by 1,000 Infuse Patients
by John FauberMedtronic said about 1,000 people have sued the company over its bone morphogenetic protein-2 (BMP-2) product, Infuse, and that many more lawsuits may be coming.In addition, several states now are looking into sales and marketing practices involving Infuse, which is used in spine surgery.In a statement, company spokesperson Cindy Resman said the cases are in early procedural stages, and none have resulted in a finding of liability against Medtronic.Some court rulings have led to dismissals and others have limited claims."Medtronic stands behind Infuse bone graft and will vigorously defend it in cour...
Source: PharmaGossip - March 5, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets
Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows.Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012.Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million.And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 m...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
"Underreporting research is scientific misconduct"
The AllTrials campaign is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Scienceand is being led in the US by Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice.The AllTrials campaign was launched in January 2013 and calls for all past and present clinical trials to be registered and their results reported. The campaign has published a detailed plan on how all clinical trials can be registered and all results report...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmafocus - Clinical studies still not being published
Half of all trials registered on a US clinical study database are not being published in public journals.This is according to a new report from Thomson Reuters Cortellis Clinical Trials, which found that of 600 studies chosen randomly from Clinicaltrials.gov - only 50% had their results published in a journal.ClinicalTrials.gov is the main registry and results database of publicly and privately supported clinical studies of human drug trials conducted around the world. The report called ‘Developments in Clinical Trials’, notes that lack or ambiguity in reporting clinical outcome achievement “could potential...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Lipitor Down, But Not Out: Pfizer Plans an OTC Version. Will It Benefit or Harm Consumers?
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - March 3, 2014 Category: Pharma Commentators Tags: generics Lipitor OTC Pfizer Source Type: blogs
“We deeply regret and apologize for the fact that our promotional activities were partially inappropriate,” - Takeda CEO
The president of Takeda Pharmaceutical Co. just acknowledged that the firm engaged in what has been described as so-called “inappropriate expressions” in the marketing of one of its blood pressure medications.Yasuchika Hasegawa, Takeda Pharmaceutical Co. president, recently announced in a news conference in Tokyo that the firm used what he described as “inappropriate expressions” in the way in which it promoted one of its drugs used in the treatment of high blood pressure, according to a The Wall Street Journal report. Mr. Hasegawa also said that while “inappropriate expressions” were used, his company did not ...
Source: PharmaGossip - March 3, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Lundbeck Limited, A Menarini Pharma, Bayer plc, HRA Pharma UK and GlaxoSmithKline breach the ABPI Code of Practice
Lundbeck Limited, A Menarini Pharma, Bayer plc, HRA Pharma UK and GlaxoSmithKline have each breached Clause 2 of the ABPI Code of Practice and are the subject of advertisements in the medical, pharmaceutical and nursing press.Lundbeck – Case AUTH/2617/7/13A Menarini – Case AUTH/2629/8/13Bayer plc – Case AUTH/2631/8/13For each sponsoring one or two speakers and paying for exhibition space at a meeting which was not primarily for educational purposes and the impression given by their involvement, each company was ruled in breach of the following clauses of the Code:Clause 2 - Bringing discre...
Source: PharmaGossip - March 2, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
The Sarah Palin of Pharma: Former Novartis Executive in Japan Says Docs are Masters, Drugmakers are Slaves
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - February 28, 2014 Category: Pharma Commentators Tags: Diddies and Spoofs Source Type: blogs
FDA Wakes Up to Social Media's Ability to Monitor Drug Adverse Events
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - February 27, 2014 Category: Pharma Commentators Tags: Adverse events FDA social media 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
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
Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - February 25, 2014 Category: Pharma Commentators Tags: Androgel Black Box Warning Low T Wolfe 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
