Senators To FDA: Has Biosimliar Naming Policy Changed?
In the latest dust up over naming biosimilars, a bi-partisan group of US Senators today is sending a letter to the FDA to demand the agency explain why a seven-year-old policy toward determining names has gone missing from its web site. And their missive, which questions whether agency policy has changed, arrives as a contentious debate over naming these medications intensifies on both sides of the Atlantic.
Yesterday, the World Health Organization held a widely anticipated meeting in Geneva to begin a review of the naming issue. And last month, the trade group for generic drugmakers in the US filed a citizen’s petition ...
Source: Pharmalot - October 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Healthcare.Gov Contractor Is Also Assembling The Sunshine Site
For all those concerned with getting their houses in order now that the Sunshine Act has become reality, here is an interesting tidbit. The same primary contractor that was hired to assemble the problematic web site for the new health insurance marketplace was also retained this past summer to create the software platform for the new Open Payments web site, according to Healthy Buzz.
This web site, for those who may not recall, is supposed to be a repository where payments over $10 made to physicians by drug and device makers, as well as group purchasing organizations, can be accessed by the public. The posting process is ...
Source: Pharmalot - October 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Healthcare Fraud Recoveries Provide A Big Return For The US
Most people would agree that health care fraud is not a good thing, but there is a proverbial silver lining, of sorts. Chasing down the violators actually fills the US Treasury. In fiscal year 2012, for instance, the US Justice Department recovered more than $3 billion in settlement and judgments in civil cases involving health care fraud against the government (see this).
And now, a new report finds that every dollar invested by the federal government to investigate and prosecute health care fraud generates a healthy return. From 2008 to 2012, the feds spent $574.6 million to recover nearly $9.4 billion, which amounts to ...
Source: Pharmalot - October 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to the middle of the week. How is everything going so far? Busy as usual, we imagine. The Pharmalot corporate campus, of course, is no exception, where the to-do list is growing longer and there is never enough time. We trust you can relate. So why not cope as we do and reach for a cup or three of stimulation? Nothing like a little kick in the morning. In any event, time now to get cracking. So here are some tidbits. Have a smashing day and drop us a line if you run across anything intriguing...
Glaxo Sales In China Drop 61 Percent Due To Scandal (Reuters)
Flu Shots Tied To Lower Risk Of...
Source: Pharmalot - October 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Breathe Deeply: Did Insmed Release Dodgy Data For Its Drug?
Deciphering trial data can be a fascinating pastime, especially when the findings indicate a medication is truly capable of making a difference for patients. Other times, however, this activity can cause consternation if the results suggest something may be awry. Such may be the case with Phase III data released the other day by Insmed for its Arikace antibiotic for cystic fibrosis sufferers.
The drugmaker released a poster presentation showing that its experimental medication demonstrated statistical non-inferiority compared with an existing Novartis (NVS) treatment, which is another way of saying that Arikace was equally...
Source: Pharmalot - October 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Academics Want University To Probe A Suicide In Seroquel Trial
What contributed to the 2004 death of Dan Markinson? This nagging question has been asked ever since the troubled 26-year old committed suicide while participating in a clinical trial that was run by University of Minnesota researchers. The ensuing years have produced a lawsuit by his mother and probes that went nowhere amid charges of conflicts of interest and mismanagement at the school.
Now, a group of 171 academics have sent a letter asking the Faculty Senate, which is the governing body, to run a public investigation. Their hope is to pressure on the university - which has repeatedly dodged blame despite hounding from...
Source: Pharmalot - October 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Where Are Those Royalties? NYU Claims Pfizer Is A Deadbeat
In a bid to retrieve tens of millions of dollars over the next several years, New York University has filed a lawsuit against Pfizer, claiming the drugmaker failed to pay royalties on its Xalkori medication, which was approved two years ago by the FDA to treat non-small cell lung cancer along with a diagnostic kit.
The dispute is the latest example of a spat over the proceeds from research that is generated by academia but is commercialized by a drugmaker under a development deal. In this instance, NYU claims that Pfizer did not honor an agreement that was inherited as part of its 2003 acquisition of Pharmacia.
The agreeme...
Source: Pharmalot - October 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, folks, and how are you today? The sun is peeking through the clouds hovering over the Pharmalot corporate campus this morning, where the short people are, as usual, hustling off to the school houses, the leaves are blanketing the grounds and the official mascots are chasing down wild animals. Quite a scene. As for us, we are hustling a bit ourselves since we hope to attend an interesting panel later, which will require us to close the laptop for a spell. Nonetheless, we have the usual line up of items for you to peruse. So here you go. Have a grand day and stay in touch...
Reckitt Benckiser Starts A Strategic Review...
Source: Pharmalot - October 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Eisai To UK: NICE Must Change Coverage Criteria Or Else
For the second time this year, Eisai is lashing out publicly over regulatory decisions. The latest outburst is directed at the UK, where the Japanese drugmaker is threatening to reduce investment if the National Institute for Health and Care Excellence, or NICE, refuses to change its criteria for recommending reimbursement for medicines. The agency is often criticized for lengthy and restrictive decisions.
“When we meet your government and talk to (UK health secretary) Jeremy Hunt, we tell him that unless you improve this, we will withdraw our investment in the UK," Eisai deputy president Yutaka Tsuchiya, tells The Teleg...
Source: Pharmalot - October 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Changing Biosimilar Naming Rules Is A 'Delay Tactic:' Ramachandra Explains
Tomorrow, the World Health Organization will hold a closely watched meeting to sort out the debate over names for biosimilars. Specifically, the agency is being asked to determine whether the system that has been used for small molecule drugs – using the same international non-proprietary name , or INN, for both brand and generics – should be applied to biologics. Brand-name drugmakers and biotechs want to biosimilars to have unique non-proprietary, or generic, names to distinguish the medicines from the original biologics. In their view, distinct names would lessen confusion in the marketplace and, therefore, ensure p...
Source: Pharmalot - October 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Rejects Petition For Guidance On Shared REMS Programs
File this under ‘nice try, but…’ Four months ago, a Nestle unit called Prometheus Laboratories asked the FDA for assistance on a nagging and potentially important question - what should a brand-name drugmaker do when an aspiring generic rival wants to negotiate the terms of a shared risk management program and the talks go nowhere?
Unless there is an undue burden, a 2007 law stipulates that the drugmakers should work together on coordinating a shared REMS program, but there is actually no guidance for navigating what can be a very complicated situation. And so, as we reported last June, Prometheus Laboratories filed ...
Source: Pharmalot - October 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Bristol-Myers Researcher Falsified Data In Grants And PhD Thesis
A Bristol-Myers Squibb researcher faked or falsified data in grant applications to the US National Institutes of Health and American Heart Association, as well as his PhD thesis and two published papers, according to the US Department of Health & Human Services Office of Research Integrity (see this). The disclosure was first reported by Retraction Watch.
Instances of falsified data have caused considerable embarrassment to other large drugmakers this year. Both Novartis (NVS) and GlaxoSmithKline (GSK) were embroiled in scandals in Japan and China, respectively (read here and here). However, the examples cited by the O...
Source: Pharmalot - October 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and nice to see you again. How was the weekend break? We hope you had a relaxing respite. Ours was quite pleasant, thank you. Now, though, the time has come to return to the familiar routine of deadlines, meetings and the like. As always, we are coping by brewing a cup or more of delicious and needed stimulation and, of course, invite you to join us. Firing up the neurons is de rigeur at this hour. Meanwhile, here are some tidbits to get you started. Have a grand day and do stay in touch...
FDA Approves Actelion Drug For PAH (Pharma Times)
Ranbaxy And Wockhardt Fire Employees After FDA Actions (Live...
Source: Pharmalot - October 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Op-Ed: For Each Day Of The Shutdown, FDA Lost Two Days
For 16 days, the US government was largely closed for business. In the scheme of things, this may seem like a blip, but of course, there will be reverberations for some time. What may be the likely impact on the biopharmaceutical industry, though? After all, the FDA and NIH already have heavy workloads. Can they compensate for lost time? Steve Brozak, president at WBB Securities, an independent research firm, and Anne Marie Noronha, a director at the firm, offer a sobering view…
The government shutdown could not have lasted forever. And it did not. After 16 tense days, Congress announced a deal to restore government oper...
Source: Pharmalot - October 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Simcere Hires Former Glaxo R&D Exec Mired In Data Scandal
Raise your hand if you remember Jingwu Zang? If not, here is a reminder. Until four months ago, he was a senior vp and head of R&D at GlaxoSmithKline in Shanghai, China, but was dismissed after the drugmaker conducted an internal probe into a scientific paper that was discovered to have contained fabricated data. He was listed as an author.
The disclosure greatly embarrassed Glaxo (GSK), which also placed several other employees on leave and sought to have the paper, which was published three years ago in Nature Medicine, retracted. [UPDATE: A Glaxo spokeswoman says five employees have since left the drugmaker.] The pa...
Source: Pharmalot - October 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
