Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We apologize for our absence yesterday, but we were speaking on a panel at the Harvard University School of Public Health, which was hosting a conference on clinical trial data sharing and transparency. Yes, it seemed to go well, thank you. Now, though, there are the usual matters to occupy us. And so, we are quaffing a cup of needed stimulation before we leave the greater Boston environs to return to the blessed Pharmalot corporate campus for another long weekend. This explains the appearance of the weekly jobs column, which usually runs on Friday. Meanwhile, here are some tidbits. ...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pfizer Peels Back The Curtain On Clinical Trial Data
In response to the growing debate over disclosure of clinical trial data, Pfizer has announced an updated policy and web site that will publish large amounts of information and offer a procedure for independent researchers to obtain study data for analysis. And the drugmaker boasts that its effort exceeds the voluntary aims recently articulated by industry trade groups in the US and Europe.
“Pfizer’s expanded policy, which you can read here, is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient priva...
Source: Pharmalot - December 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Provenge Vaccine, A Hedge Fund Manager And The SEC
In a curious postscript to the long-running saga that has been the Provenge vaccine, the US Securities and Exchange Commission has levied a $25,000 fine on a former hedge fund analyst, who caused a stir by writing a medical study that questioned the benefit of the medicine and, subsequently, claimed she received threatening remarks on investor message boards.
The agency had charged Marie Huber, who co-authored a paper last year in the Journal of the National Cancer Institute, with making misleading statements about her activities and violating the Securities Act for her role in disseminating the study. The SEC cease-and-de...
Source: Pharmalot - December 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Are Drugmakers Earning Returns On Their R&D Investments?
Once again, another report attempts to take stock of the pharmaceutical industry and the return on its many investments. And the latest finding suggests drugmakers are struggling, despite doing reasonably well at bringing new medicines to the marketplace, according to Deloitte and Thomson Reuters, which analyzed the 12 largest life sciences companies based on their R&D spending.
So what did they learn? First, there is the good news. There were 105 products launched since 2010 with a projected value of $770 billion, and 167 assets with a projected value of $819 billion made it to late-stage development also since 2010. ...
Source: Pharmalot - December 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
That Flushing Sound: Pharma Sues Again Over A Take Back Program
For the second time, the pharmaceutical industry is challenging a local government over an ordinance that requires drugmakers to cover the cost of a prescription drug ‘take back,’ or disposal program. This time, the trade groups representing brand-name drugmakers, biotechs, generic drugmakers and over-the-counter purveyors have filed a lawsuit against the King County Board of Health in Washington (here is the lawsuit).
The move comes shortly after a federal judge dismissed another industry lawsuit that charged officials in Alameda County, California, acted inappropriately last year in passing such an ordinance, which w...
Source: Pharmalot - December 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone. Another busy day is on the way. This is to be expected, though, yes? After all, not much gets accomplished when one is sitting still. Just the same, we are able to enjoy a warm sun hovering over the Pharmalot corporate campus, where the mascots are lounging, the short people are hustling off, as usual, to their houses of learning and another cup of stimulation is brewing in the cafeteria. And this is our signal to get cracking. Meanwhile, here are some items of interest. Hope you have a grand day and keep us in mind if you run across anything interesting...
Biosimilars Are Slow To Take Off In Euro...
Source: Pharmalot - December 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
More Pharma Jobs Are Disappearing: Forest And Eisai Cut Back
Yet another round of cutbacks in the pharmaceutical industry is unfolding.
The latest to shrink operations is Forest Laboratories, which is slashing expenses by $500 million over the next three years in what its new ceo Brent Saunders is calling Project Rejuvenate. Of that, $270 million will come from R&D, $150 million targets marketing and $80 million would come from general and administrative expenses (here is the statement).
Looked at another way, $110 million in savings will come from layoffs, which are expected to number about 500 positions, although the sales force and employees with "key responsibility" for subm...
Source: Pharmalot - December 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Issues New Draft Guidances For Compounding Pharmacies
Just days after President Obama signed into law a bill that was designed to bolster FDA oversight of compounding pharmacies (back story with a link to the bill), the agency has issued no fewer than three new draft guidances that cover reporting procedures, registration requirements, conditions under the law that would determine when a compounded drug is exempt from certain other provisions and enforcement actions the FDA may take.
The guidances appear after the FDA has spent the past year scrambling to recover from a scandal involving a fungal meningitis outbreak that was traced to the New England Compounding Center. So fa...
Source: Pharmalot - December 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
AIDS Group Sues Abbott And AbbVie Over 340B Drug Discounts
Once again, the AIDS Healthcare Foundation has filed a lawsuit against a drugmaker for allegedly failing to offer required discounts on prescription medicines as part of the 340B Drug Pricing Program. The latest complaint accuses Abbott Laboratories and its AbbVie spin off of overcharging by more than $2 million for HIV drugs between 2005 and 2013 (here is the lawsuit).
This is the second time in recent weeks that AHF, which is an outspoken advocate for expanding services to patients, has filed such a lawsuit against a drugmaker. In October, the medical care provider made nearly identical charges against Johnson & John...
Source: Pharmalot - December 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
India Looks To Tighten Rules For Filing Pharma Patents
In a move that is likely to concern brand-name drugmakers, the Indian Patent Office is considering a proposal that would require the generic drug names assigned by the World Health Organization to be disclosed on patent applications, according to The Economic Times. And if the proposal is approved, India would become the first country to mandate this condition.
The requirement would make it easier for patent examiners, generic drugmakers and patient advocates to block what some call ‘frivolous’ incremental patents from being granted and also make it more difficult for brand-name drugmakers to receive patents for increm...
Source: Pharmalot - December 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and welcome back from what was a long weekend on this side of the pond. We hope you had a swell time and feel relaxed because, as you know, that ovewhelming routine of meetings and deadlines has now returned. Sobering, is it not? But as you know, one way to fortify yourself is to quaffe a trusty cup of stimulation. So please join us as we indulge. Meanwhile, here are some tidbits to get you going. Have a grand day and stay in touch...
Shire Strikes Deal With Sandoz To Supply Generical Adderall XR (Reuters)
Takeda Taps Glaxo Exec As CEO Candidate (Pharma Times)
Merck To Close Plant In Ireland And Cut 570 Jo...
Source: Pharmalot - December 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
White House Pushes 12-Year Exclusivity For Biologics In Trade Talks
As the latest round of the Trans Pacific Partnership trade talks ended in Salt Lake City, the US Trade Representative has been circulating documents that show the US is pushing for an agreement that would include 12 years of product exclusivity for new biologics, according to sources.
The move contradicts White House budget proposals over the past three years that called for shrinking the 12-year exclusivity period, which was created by Biologics Price Competition and Innovation Act of 2009, to seven years. In doing so, the White House articulated hopes of saving $3 billion over 10 years for various federal health programs...
Source: Pharmalot - November 27, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What Quality Control? FDA Bans Another Wockhardt Facility
In the latest sign that a big drugmaker from India will have a hard time getting off the regulatory radar screen, the FDA has issued yet another import alert for a Wockhardt manufacturing plant. The latest ban targets products made at a facility in Chikalthana and comes just six months after the agency issued an alert regarding Wockhardt medicines made at a site in Waluj (see the FDA notice here).
As noted previously, Wockhardt quality-control problems have concerned regulators all year. The UK’s Medicines and Healthcare Products Regulatory Agency recently withdrew certification for the plants, which means that Wockhardt...
Source: Pharmalot - November 27, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Pass The Turkey
And so, the time has come to finally take a break, or a swig, if you wish, thanks to the holiday on this side of the pond. Two holidays, in our case. As you might imagine, this will be a chance to catch up with some of our treasured people, take stock and simply enjoy life, however briefly. And of course, we will engage in our most important Thanksgiving tradition – the repeated playing of ‘Alice’s Restaurant’ by the wry Arlo Guthrie (click here to watch Arlo reprise the tune). After all, there is nothing more inspiring than a little irreverance, and a good melody. But remember, watch where you toss your garbage.ar...
Source: Pharmalot - November 27, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
You Call That Efficacy? FDA Warns Amgen For Aranesp Promotion
For the past dozen years, Amgen has been marketing Aranesp to treat anemia caused by chronic kidney disease. So by now, one might expect the biotech to know how to successfully compile promotional material that is distributed to physicians. But apparently not, at least according to the FDA, which last week sent a letter chastising Amgen for committing some basic mistakes.
What went wrong? The Amgen mailer omitted important risk information, suggested that Aranesp is useful in a broader range of conditions or patients than has been demonstrated by evidence and made unsubstantiated efficacy claims, according to the November ...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
