Antibiotics - Elizabeth Warren isn't satisfied
New voluntary rules to limit the use of antibiotics in agriculture aren’t enough to satisfy Senator Elizabeth Warren (D-Mass.). The Food and Drug Administration announced the rules in December, asking pharmaceutical makers to relabel drugs so that they require a prescription and asking farmers to use them only to treat, control, and prevent disease in livestock, not to add weight. But Warren is now questioning the effectiveness of the FDA’s plan.The guidelines resulted from concern at the agency that overuse of antibiotics on farms might create drug-resistant bacteria, which can infect not only livestock but also human...
Source: PharmaGossip - March 14, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
What ails Big Pharma?
By Katherine EbanOne of America's most far-seeing companies, Vertex Pharmaceuticals, the biopharmaceutical startup so memorably chronicled in journalist Barry Werth's classic book, The Billion Dollar Molecule: The Quest for the Perfect Drug, is back.Or rather, twenty years later, Werth is back with the sequel, The Antidote: Inside the World of New Pharma. The book revisits Vertex as the company grows into adolescence and actually achieves its goal of bringing a drug to market. Even though there is less drama this time and more mundane human-resource type challenges, Werth's excellent writing takes the reader deep into the ...
Source: PharmaGossip - March 13, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
The One Thousand Dollar Pill
An innovative hepatitis C drug that was only recently hailed as a breakthrough treatment is facing skepticism from some health care experts, as they consider whether it is worth the $1,000-a-pill price set by manufacturer Gilead Sciences. A panel of California medical experts voted Monday that Gilead's Sovaldi represents a "low value" treatment when compared with older drugs for the blood borne virus. The vote was part of a broader review of new hepatitis C drugs by the California Technology Assessment Forum. The insurer-affiliated group assesses the costs and effectiveness of new medical treatments. The group estimates th...
Source: PharmaGossip - March 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Teva and The Reinstein Connection
The U.S. business of Teva Pharmaceuticals Industries Ltd. and a subsidiary have agreed to pay $27.6 million to settle allegations of improper payments, the Justice Department said Tuesday.Teva unit Ivax LLC in 2003 allegedly paid a doctor in Illinois to switch his patients to a generic antipsychotic medication the business produced, according to the Justice Department.Teva, an Israeli company specializing in generic drugs, acquired Ivax for more than $7 billion in early 2006.The physician, Michael J. Reinstein, received payments, as well as a Miami vacation for his family and several employees, under an illegal consulting ...
Source: PharmaGossip - March 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
NJ jury orders drugmaker Roche to pay $1.5M at Accutane trial
Drugmaker Roche must pay more than $1.5 million in damages to a woman who developed bowel disease after using the company’s Accutane acne medicine, a jury ruled in her retrial.Officials of Basel, Switzerland-based Roche failed to properly warn Kamie Kendall’s doctors that Accutane could cause ulcerative colitis and were liable for her injuries, jurors in state court in New Jersey concluded today.It was the second trial of Kendall’s Accutane claims. A New Jersey appeals court overturned a $10.5 million verdict in 2010, ruling that a judge improperly barred Roche from using evidence about the medication’s use. Roche ...
Source: PharmaGossip - March 11, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Directions
(Source: PharmaGossip)
Source: PharmaGossip - March 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Las Vegas trial starts Monday in multibillion-dollar liability case against Actos
By CARRI GEER THEVENOTLAS VEGAS REVIEW-JOURNALTwo Clark County women are among thousands of plaintiffs across the country who have filed product liability lawsuits against the maker of the diabetes drug Actos.Delores Cipriano, 81, of Henderson and Bertha Triana, 80, of Las Vegas each filed lawsuits last year in District Court against Takeda Pharmaceuticals, a Japanese company that makes the prescription drug pioglitazone under the trade name Actos. Both women allege their bladder cancer was caused by the medication.Their cases have been combined, and their lawyers are scheduled to present opening statements to a jury this ...
Source: PharmaGossip - March 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
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
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
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
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
"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
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
“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
