What's In A Name? Novartis Petitions FDA Over Biosimilar Nomenclatures
The mushrooming dispute over the sort of name that should be given to biosimilars gets more interesting all the time. Earlier this week, Novartis filed a petition with the FDA and requested that all such products share the same international non-proprietary name (INN) as the reference drugs, or original biologics.
In its 23-page petition, Novartis writes that “assigning different INNs to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk or other regulatory reservations that are purely hypothetical.” The drugmaker also ...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Not So Brilliant? Feds Probe AstraZeneca Over Brilinta Trial Data
Six months after a medical journal raised troubling questions about the reliability of a key study that was used to win approval for its Brilinta bloodthinner, AstraZeneca (AZN) says that the US Department of Justice has recently opened an inquiry into the trial, according to a filing with the US Securities and Exchange Commission. The disclosure was made in the most recent earnings report that was released today (see page 28).
An analysis last April in The International Journal of Cardiology found a host of disturbing issues with the so-called Plato trial. Nearly three years ago, the FDA questioned aspects of the study an...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone. We apologize for the late start, but we encountered a Halloween trick - otherwise known as yet another batch of tech problems. Nonetheless, we are scrambling to play catch up, especially since this is expected to be a busy day. After all, you never know when gremlins and ghouls will get in your way. So we are brewing a needed cup of stimulation - Pumpkin Spice, of course, in keeping with the day at hand. Please join us. Meanwhile, here is the latest batch of tidbits. Have a grand day...
J&J Ordered By Jury To Pay $4M Over Topamax Injury (Bloomberg News)
Moscow Claims Teva Halted Shipments Of C...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Does The FDA Really Enforce A Conflicts Policy For Advisory Panels?
Has the FDA articulated a clear policy for its advisory committee members who are asked to appear at conferences for industry insiders and discuss agency matters? The issue was raised last week after it became known that an FDA advisory chair had been slated to make such an appearance this coming February, which prompted the Public Citizen advocacy group to complain to the FDA.
Lynn Drake, a Harvard Medical School lecturer who chairs the Dermatologic and Ophthalmic Advisory Committee, was to have spoken about “The Pitfalls To Avoid As You Prepare For, And Present To, An Advisory Committee.” She was prominently featured...
Source: Pharmalot - October 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Where, Oh Where, Did The Clinical Trials Go? Many Are Unpublished
As the debate over releasing clinical trial data rages on, yet another study emerges indicating that nearly one-third of trials are not reported for five years after completion on the US government repository – known as ClinicalTrials.gov – as required with the passage of the FDA Amendments Act in 2007. And the findings are likely to add still more pressure on drugmakers to disclose clinical trial results.
Specifically, of 585 registered trials, 171 – or 29 percent – remain unpublished and there were nearly 300,000 patients enrolled. And non-publication was more common among trials that received industry funding th...
Source: Pharmalot - October 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Rescinds Special Protocol Agreement For Amarin Fish Oil Pill
In yet another blow to Amarin, the FDA has rescinded a special protocol agreement that the drugmaker was counting on to widen usage for its Vascepa prescription fish oil pill, according to a filing with the US Securities and Exchange Commission. The disclosure comes two weeks after an FDA advisory committee voted 9-to-2 against recommending broader use until an outcomes study is completed in 2016.
The decision by the FDA may finally put to rest what has been one of the more interesting stock stories in the biopharma universe this past year. Investors were captivated by the possibility that the company might market a potent...
Source: Pharmalot - October 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Teva CEO Resigns Amid Dispute With The Board; Who Will Take The Job?
Amid reported clashes with the board and accelerated plans to cut $2 billion in expenses, Teva Pharmaceuticals ceo Jeremy Levin has resigned and will be replaced by executive vp and chief financial officer Eyal Desheh on an interim basis. The move comes just two days after Levin emphatically refuted reports that he had threatened to resign and branded such talk as “rumors” and an “invention.”
His departure lays bare simmering disagreements – notably, with Teva chairman Phillip Frost - about the tactics needed to redirect the drugmaker, which is undergoing a large-scale reorganization that includes cutting 5,000 j...
Source: Pharmalot - October 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Welcome to the middle of the week, everyone. If you survive today, the odds may be greater of making it to the weekend, which would be a wonderful thing. But much can happen between now and then, yes? So, to fortify yourself, please join us as we indulge in a needed cup of stimulation. After all, there is always much to do. Speaking of which, here are a few items to get you started. Have a smashing day and stay in touch...
Sanofi Earnings Hurt By Vaccine Glitch And China Scandal (Reuters)
Merck Looks To Bring Back Zilmax Animal Feed Additive (Reuters)
Glaxo To Close New Jersey Toothpaste Plant (The Star-Ledger of NJ)
Quest...
Source: Pharmalot - October 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Vertex Cuts 15 Percent Of Its Workforce On Plunging Hep C Sales
How competitive is the market for hepatitis C treatments? In May 2011, Vertex Pharmaceuticals won FDA approval to sell its Incivek medication to treat people who have the most common strain. The drug became one of the fastest-selling medicines ever, generating more than $450 million in the fourth quarter that year, and helped Vertex become a hot stock on Wall Street.
Now, Vertex is cutting 370 jobs, or 15 percent of its workforce, thanks to plummeting Incivek sales. The drugmaker acknowledged today that the number of hepatitis C patients being treated with Incivek has dropped quickly as a new generation of medicines is a...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Doctors To HHS: Exclude Textbooks And Reprints From Sunshine Act, Or Else
As drug and device makers begin collecting data to comply with the Sunshine Act, dozens of national and medical societies are asking the US Department of Health & Human Services to modify the reporting requirements so that medical textbooks and peer-reviewed journal reprints are excluded. And if HHS refuses to comply, the groups are considering seeking help from Congress and, possibly, filing a lawsuit.
The Sunshine Act, you may recall, establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organiz...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Gimme Data: Oncologists Gear Up To Track Drugs Costs & Outcomes
As added emphasis is placed on achieving improved outcomes and lowering health care costs, especially for such widespread and expensive ailments as cancer, more healthcare providers can, of course, be expected to crunch numbers. Yet a new survey finds that only 37 percent of oncology providers – primarily, large group practices and hospitals - have sufficient system data reporting capabilities.
To be specific, one third lack the proficiency to aggregate or analyze data, and 47 percent are unable to share data within their organization. Overall, just 11 percent have advanced data capabilities, but this is expected to jump...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Moving Too Fast? Expedited Drug Approvals Raise Questions
Over the past few years, the FDA has been hurtling toward increasingly speedier approvals for certain drugs as a growing cadre of patients, investors and politicians demand the agency move faster to satisfy unmet medical needs. As a result, the approach taken for approving drugs for AIDS, cancer and other life-threatening conditions is gradually being applied to treatments for a wider variety of illnesses.
To some, this view is a welcome, if overdue, shift in thinking. In fiscal year 2012, the FDA reported that more than half of the drugs approved were done so through expedited reviews – fast track or priority reviews, o...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? Hopefully, all is well. As for us, things are humming here at the Pharmalot corporate campus, where our to-do list is overflowing and our calendar is filling quickly. But, as they say, being busy is a good thing. While there is time, we are grabbing a cup of stimulation, although changing gears today to enjoy a spot of tea with milk and honey. Whatever you fancy, please join us. Meanwhile, here are some tidbits to get you started. Have a grand day and do stay in touch...
Indian Court To Hear Bayer Compulsory Licensing Appeal (PharmaBiz)
Pfizer Tussles With Pharmacist Over Audi...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
That Flushing Sound: PhRMA To Appeal Take-Back Lawsuit Loss
If at first you don’t succeed… The Pharmaceutical Research and Manufacturers of America plans to appeal a decision in which a federal judge last month dismissed its lawsuit charging a California county acted inappropriately by passing an ordinance that requires drugmakers to cover the cost of a prescription drug ‘take back,’ or disposal program. A PhRMA spokeswoman confirms a report on California Healthline that the trade group will file an appeal, although documents have not yet been filed in court.
Now for some background: The tussle over the Alameda County ordinance has been closely watched by other local govern...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Amid Dispute With The Board, Teva CEO Denies He May Resign
Is there a dispute between the Teva Pharmaceuticals management and the board over day-to-day involvement? And did Teva ceo Jeremy Levin really threaten to resign? This is the buzz created by an Israeli television report that the Teva Executive Committee sent a letter urging the board to back off. This was followed by a denial that Levin considered resigning.
The hubbub comes two weeks after Teva accelerated a $2 billion reorganization by eliminating 10 percent of its global workforce, or 5,000 jobs, including about 800 in Israel, where the drugmaker is based (back story). Three months ago, a US court invalidated the 2015 p...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
