Sticking Point: FDA Rejects Novo Nordisk Insulin
In a huge setback to Novo Nordisk, the FDA has rejected its new Tresiba insulin and wants a cardiovascular outcomes trial before a new review can be completed, a move that is widely expected to delay approval for at least two years. The rejection comes less than a month after European regulators approved Tresiba, which Novo has been counting on to bolster its standing in the hyper-competitive diabetes market. “It’s not a good day for diabetes patients in the US, it’s not a good day for Novo Nordisk and for Novo Nordisk shareholders,” Novo ceo Lars Soerensen said on a conference call with analysts earlier today. “...
Source: Pharmalot - February 11, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Diabetes Insulin Novo Nordisk Sanofi Triseba Source Type: blogs

Avandia - Glaxo resists UK claims despite settlement with victims in US
Families face battle with GSK over dangerous diabetes drug Tuesday 29 January 2013 21.04 GMT Sarah Boseley, health editor Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US. The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems. A scientist with the Food and ...
Source: PharmaGossip - February 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

CorpWatch : Medical Trial Data Activists Score Win Over Glaxo
Pills. Photo: e-magineart.com. Used under Creative Commons licenseAll data on completed medical experiments are to be made available to the general public by GlaxoSmithKline, the biggest UK pharmaceutical company. The announcement is a major win for the AllTrials campaign mounted by healthcare activists as well as researchers that has gathered widespread support. “There is a fundamental lack of scientific progress because clinical trial evidence is being withheld,” Carl Heneghan, the director of the Centre for Evidence-Based Medicine at the University of Oxford said when the campaign was launched last month. “The mis...
Source: PharmaGossip - February 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Let the sun shine in contd.
What the Sunshine Act Means for Health Care Transparency Part of the Afordable Care Act was designed to allow anyone to look up which doctors are getting how much from which companies. Curious whether a prescription or medical device your doctor is recommending comes from a manufacturer who has been paying your doctor? Good news, then: The federal government has finally developed a plan for how the Physician Payments Sunshine Act will work. The Sunshine Act, made federal law as part of the Affordable Care Act in 2010, was designed to allow anyone -- patients, doctors, journal editors -- to look up which doctors are getti...
Source: PharmaGossip - February 7, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Hey GSK - what's the difference between Avandia in the US and the UK?
Express Solicitors pursues GlaxoSmithKline Northenden personal injury practice Express Solicitors is pursuing GlaxoSmithKline for damages on behalf of clients who took diabetes drug Avandia Law firm Express Solicitors is taking on pharmaceutical giant GlaxoSmithKline as it seeks damages for clients who took a diabetes drug linked to causing heart attacks and strokes. The Northenden personal injury practice is acting for 31 people who took Avandia or had relatives who were prescribed the medication, also known as Rosiglitazone. The drug had its European licence removed in 2010 because of evidence it could cause side eff...
Source: PharmaGossip - February 7, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Hey GSK - what's a weekend boondoggle?
Louisiana attorney general files second suit against GlaxoSmithKline over off-label drug use GlaxoSmithKline allegedly marketed nine drugs illegally for uses that have not been approved by the Food and Drug Administration and provided doctors with "consulting fees," expensive meals and "weekend boondoggles" to convince them to prescribe those brands, according to a lawsuit filed this week by Louisiana Attorney General Buddy Caldwell. These practices cost the state's Medicaid and medical assistance programs millions of dollars and subjected patients to "non-approved, ineffective and unsafe uses" of the drugs, according to ...
Source: PharmaGossip - February 7, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Glaxo Clashes With PhRMA Over Data Disclosure
Just how heated can the controversy over disclosing clinical trial get? One day after the US pharmaceutical industry trade group bashed the cry to release patient-level data, GlaxoSmithKline has come out in support of the notion. The support by the drugmaker comes four months after the drugmaker declared a new openness in the wake of a huge scandal over data disclosure that contributed to a $3 billion settlement with the US government last year. The ideological clash between the Pharmaceutical Research and Manufacturers of America and one of the world’s largest drugmakers centers on a petition drive called AllTrials ...
Source: Pharmalot - February 5, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia BMJ Clinical Trials GlaxoSmithKline Phrma Roche Tamiflu Source Type: blogs

A Tough Push For Clinical Trial Disclosure In Europe
As the debate over clinical trial transparency heats up, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent. And one of her suggestions is already meeting with some resistance from the pharmaceutical industry. Specifically, lead legislator Glenis Willmott wants full clinical studies – not summaries – to be submitted and, therefore, available for disclosure. “Your rappoteur is the opinion that a sample summary of the results from...
Source: Pharmalot - February 4, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized ABPI Avandia Ben Goldacre BMJ British Medical Journal Clinical Trials Eureopan Parliament GlaxoSmthKline Phrma Roche Tamiflu Source Type: blogs

Glaxo Refuses To Settle With UK Avandia Patients
Although GlaxoSmithKline agreed to settle lawsuits filed in the US by people who claimed they were harmed by the controversial Avandia diabetes pill, which was linked to heart attacks and strokes, the drugmaker is reportedly refusing to adopt the same approach in the UK. Instead, Glaxo is preparing to fight at least four complaints that have so far been filed in court. “It is very disappointing,” Daniel Slade, an attorney who represents 19 families, tells The Guardian. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evide...
Source: Pharmalot - January 30, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia GlaxoSmithKline Merck Vioxx Source Type: blogs

Avandia - the battle continues
Families face battle with GSK over dangerous diabetes drug Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US. The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems. A scientist with the Food and Drug Administration estimated that Avandia could have been respon...
Source: PharmaGossip - January 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Avandia - how bad was it/ is it?
http://ethicalnag.org/2013/01/21/avandia-a-very-short-history-of-a-very-bad-drug/ It's still available in the US! (Source: PharmaGossip)
Source: PharmaGossip - January 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

An Attempt to Exhume the "Ethical Drug Industry"
When was the last time you heard "ethical" and "drug industry" in the same sentence? These days, you are more likely to see "unethical" linked closely with the drug industry that during the time of its birth during the Civil War in the U.S. used "ethical" to distinguish its products from quack medicines. Here's a piece of drug industry history from "The Evolution of Pharmaceuticals in the United States," which I found by Google search:"Frederick Stearns was [an] important industry pioneer. He started a manufacturing facility in Detroit in 1855 and it was an important supplier of medicines during the Civil War. Stearns also...
Source: Pharma Marketing Blog - January 23, 2013 Category: Pharma Commentators Tags: Ethics Source Type: blogs

GSK's seven percent solution
Glaxo Plaintiff Lawyers Settle Dispute Over $143 Million Lawyers who won what may be a $2.3 billion settlement with GlaxoSmithKline Plc (GSK) over its Avandia diabetes drug resolved their own fight over the allocation of more than $143 million in legal fees. Eight lawyers on a court-appointed fee committee agreed to take a smaller portion of the fee fund after nine objectors challenged their payouts, a special master assigned to review the recommendations said in court papers made public Jan. 18 in federal court in Philadelphia. The fee committee had asked for 71 percent of the fund set aside by U.S. District Judge Cynth...
Source: PharmaGossip - January 22, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Voluntary Industry Code For Releasing Trial Data?
In the latest move to pressure the pharmaceutical industry to release clinical trial data, the Health Committee at the UK’s National Institute for Health and Clinical Excellence has issued a report calling for drugmakers to place all information in “the public domain” and create a voluntary code for publicly releasing trial data for drugs once they have been reviewed and made available for clinical use. “The committee believes there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data about the efficacy and s...
Source: Pharmalot - January 18, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia BMJ Clinical Trial Data GlaxoSmithKline Roche Tamiflu Source Type: blogs

A New J&J Diabetes Pill, Heart Risks & FDA Approval
Another horse race is under way in the diabetes market and Johnson & Johnson is hoping to become the first entrant to sell a treatment known as a SGLT2 inhibitor. The question is whether an unclear cardiovascular risk will prompt the FDA to await final results of a key study, which would delay J&J from selling its drug and intensify the battle. In advance of an FDA advisory committee meeting this week, agency medical reviewers released a briefing document that noted a concern of high major adverse cardiovascular events during the first 30 days after taking J&J’s canagliflozin in its CANVAS cardiovascul...
Source: Pharmalot - January 8, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized AstraZeneca Avandia Boehringer Ingelheim Bristol Myers Squibb Diabetes Eli Lilly FDA GlaxoSmithKline Januvia JJ Johnson & Johnson Merck Type 2 Diabetes Source Type: blogs