And The Crystal Ball Says... Wall Street Forecasts Are Not So Accurate
File this under ‘you get what you pay for.’ Everyone loves to forecast. After all, a lot is riding on predictions, whether right or wrong. But how often is the crystal ball gazing generated by Wall Street analysts about prescription drug sales actually accurate? Well, it turns out, not so often, at least according to a new analysis by Nature Reviews Drug Discovery.
For instance, more than 60 percent of consensus analyst forecasts for more than 260 drugs that were launched between 2002 and 2010 missed by more than 40 percent of actual peak revenues. Some were under and some were over. And a significant number were overl...
Source: Pharmalot - October 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pay To Play? Drugmakers Paid To Attend Panel That Advised FDA
How much impact did Immpact have in shaping FDA thinking on testing the safety and effectiveness of prescription painkillers? For those unaware, Immpact is a behind-the-scenes panel run privately by a pair of academics, who have regularly invited agency officials, academics and drugmakers to Washington DC hotels for brainstorming sessions on fine tuning clinical trials. The panel acronym stands for Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (look here).
The drugmakers, however, were required to pay big fees to participate – as much as $35,000 to attend a single meeting. And this has raised ...
Source: Pharmalot - October 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharma Corruption Hurts Patient Care & Medical Knowledge: Rodwin Explains
Corruption is a sensitive, difficult and important topic no matter where it may surface. And the pharmaceutical industry is no exception, particularly after scandals over the past decade involving drug safety and the disclosure of clinical trial data. These episodes have prompted legislation, litigation and various other efforts to generate change. A new batch of papers published in The Journal of Law, Medicine & Ethics – and generated by the Edmund J. Safra Center for Ethics at Harvard University – reviews various ongoing issues and offer ideas for improvement. The suggestions, some of which are more likely to be ...
Source: Pharmalot - October 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Dust Up: Jury Ties Johnson & Johnson Powder To Ovarian Cancer
A federal jury in South Dakota late last week decided that Johnson & Johnson should warn consumers of the link between ovarian cancer and the use of its widely promoted talcum powder for feminine hygiene. In reaching the decision, the jury also determined that the product, Shower To Shower, contributed to the cancer contracted by a woman who used the powder for 32 years.
Deane Berg, 56, filed a lawsuit against the healthcare giant four years ago after learning about the link from a pamphlet that mentioned studies dating back decades that had shown an association between the talcum powder and ovarian cancer, The Argus-L...
Source: Pharmalot - October 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to another working week. We hope the weekend was refreshing, because another busy few days are on the way. You know, that routine of meetings and deadlines and phone calls and running about has now begun. So please join us as we hoist a needed cup of stimulation in order to cope. And, of course, here are some tidbits to start the process. Have a great day and do stay in touch...
Novo Nordisk To Invest $3.7 Billion On Diabetes Pill Portfolio (Reuters)
Sanofi CEO Sees A Return To Growth In The Fourth Quarter (Bloomberg News)
Ranbaxy Looks To Buy An FDA-Approved Plant In India (Economic Tim...
Source: Pharmalot - October 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Andrea Sloan, 'Poster Child' For Compassionate Use, Gets A Drug
One of the more contentious and high-profile fights over compassionate use in recent years may be drawing to a close. Andrea Sloan, who spent the past two months battling with BioMarin Pharmaceutical over access to a drug that she hoped to use to treat her Stage 3c ovarian cancer, says that she has been granted compassionate use by another company that she declines to name.
“These past months have been an amazing journey – exhilarating and exhausting all at once. While I have been pursuing one option, life has graced me with another. After months of hoping and praying, I am finally getting access to a promising new t...
Source: Pharmalot - October 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Should Drugmakers Pay Punitive Damages? Novartis Says No
Should a drugmaker not have to pay punitive damages for product liability because such penalties encroach on the ability of the FDA to enforce its authority? This is the question that Novartis hopes the US Supreme Court will answer in its upcoming session, although whether the justices will agree to review the issue is unclear. A decision may be known next week.
In arguing for a review, Novartis cites a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer (PFE), in state court after alleging damage caused by one if its drugs. The drugmaker unsucce...
Source: Pharmalot - October 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Boehringer Ingelheim To Close Troubled Ben Venue Unit For Good
REPEATING FROM LAST NIGHT: More than two years after Ben Venue Laboratories began encountering serious quality control issues that resulted in numerous product shortages, the troubled manufacturer is closing down permanently by the end of the year. The move comes less than a year after Ben Venue, which is owned Boehringer Ingelheim, a large, privately held drugmaker, entered into a consent decree with the FDA.
“Despite the ongoing support of the US FDA, the tremendous dedication of employees and significant investments in facility upgrades, the company cannot return to sustainable production,” according to a statement ...
Source: Pharmalot - October 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Up And Down The Ladder... Job Changes
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?
And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Ra Pharmaceuticals hired Pamela Esposito as chief business officer. Most ...
Source: Pharmalot - October 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week is about to come to an end. Not a moment too soon, yes? This is, as you may recall, our signal to daydream about weekend plans. Normally, our agenda is quite modest, but we are feeling somewhat ambitious. We look forward to spending grown-up time with Mrs. Pharmalot, taking the short people to soccer matches and there will also be another installment in our 'Let's-See-Them-Before-They-Die' concert series. But what about you? This is a lovely time of year to find a few apples or pumpkins, or simply venture afar to quiet places where other humans cannot be found. You could stay close to home with...
Source: Pharmalot - October 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Issues First Warning For Failing To Pay Generic Facility Fees
In response to ongoing concerns about generic drug oversight and a backlog of applications, the FDA was granted authority to charge user fees to generic drugmakers. The hope was to collect $299 million during the first fiscal year, which just ended. Of course, this sort of plan only works if drugmakers acknowledge their activities – called self-identifying in FDA lingo - and pay a fee.
Not surprisingly, some drugmakers have not paid their fees and the FDA was, in fact, keeping tabs on the holdouts by posting a list of those in arrears. In fact, there are now more than three dozen companies on the list, as of today. Among...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Government Shutdown, Rare Diseases And A Gala Dinner
The US government may be shut down, but disease does not distinguish between Republicans and Democrats (so we are told). So what better way to honor the politicians who stand by patients with rare diseases - no matter what happens in this great, wide world - than to hold a sw.y dinner and bestow awards? This is what the Rare Disease Legislative Alliance plans on October 10.
The advocacy group is hosting the RareVoice Awards Gala, which is supposed to provide an opportunity to strengthen relationships with members of Congress and congressional and government agency staff. “This year's celebration will be a well-deserved ...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Novartis Worries Its Reputation Will Sink Over Diovan Scandal
To what extent the Diovan scandal in Japan will hurt Novartis remains unclear, but one executive concedes that the mess is not going to burnish the corporate reputation. The acknowledgment comes after a government panel earlier this week found the drugmaker may have violated Japanese law by using faulty data to promote its widely used heart drug, an offense that could lead to various penalties (here is the report).
In his second set of public remarks in the past week, David Epstein, who heads the Novartis pharmaceutical business, again apologized and also noted Diovan sales have fallen in Japan. But he insisted he is more ...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
PhRMA Sues The Feds Over 340B Discounts On Orphan Drugs
Once again, the 340B Drug Pricing Program is at the center of a controversy. The latest flap involves discounts that the US Health Resources and Services Administration established for a select group of hospitals in order for them to obtain orphan drugs, which are medications that were approved by the FDA to treat rare diseases. An HRSA rule governing orphan drug discounts went into effect this week.
In response, the PhRMA trade group has filed a lawsuit against HRSA and accused the agency of erroneously interpreting a provision of the Affordable Care Act that defines the extent of the discounts to be made available for or...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, folks, and how are you today? Another shiny day is unfolding here on the Pharmalot corporate campus as the short people begin their respective treks to the local schoolhouses, the official mascots pursue rabbit trails on the official grounds and we brew yet another delightful cup of needed stimulation. Yes, it is a busy morning. So what else is new, as they say? So, time to get cracking. As always, we have provided a few tidbits to jumpstart your own agenda and hope that you have another smashing day of accomplishments. Cheers, everyone...
Eli Lilly Execs Say Costs Must Be Cut To Meet Financial Goals (Reuters...
Source: Pharmalot - October 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
