Congress Writes CMS To Change Sunshine Rule For Textbooks
A bi-partisan group of more than two dozen members of Congress has written the US Centers for Medicare & Medicaid Services to demand the agency modify the reporting requirements of the Sunshine Act, so that medical textbooks and peer-reviewed journal reprints are excluded from the data that must be collected by drug and device makers.
The move comes one month after dozens of national and medical societies - including the American Medical Association, the American Academy of Family Physicians, the American College of Cardiology and the American Society of Clinical Oncology - made the same request and threatened to file ...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The FDA, The Avandia Diabetes Pill And Meta-Analyses
Following years of high-stakes drama, the FDA has loosened restrictions on the Avandia diabetes pill, which has been under the equivalent of regulatory lock and key after a protracted and heated debate over the extent to which the GlaxoSmithKline drug may cause cardiovascular risks.
The action caps a long-running episode that shined a harsh spotlight on agency decision-making and the practices of the pharmaceutical industry. The Avandia debate not only laid bare the political and scientific rifts that sometimes take place among FDA officials, but also became a prime example of how drugmakers do not always disclose unflatte...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? Gray skies are hovering over the Pharmalot corporate campus this morning as we await what prognosticators say will be a blustery storm. Nonetheless, our spirits remain sunny. Why? We will repeat the mantra taught us years ago by the Morning Mayor: 'Every brand day should be unwrapped like a precious gift.' Sometimes, living life with a little urgency is a good thing. Anyway, enough philosophy. There is work to do. Time to hoist the cup of stimulation and attack the to-do list. Here are some tidbits. Hope you have a grand day...
Bayer In Talks To Buy Algeta For $2.4 Billion (Bloomberg...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What Copaxone Profits? Yet Another Troubling Leak At Teva
Yet another leak is plaguing Teva Pharmaceuticals. This time, the drugmaker is chafing over a report in an Israeli business publication called The Marker that published an internal, five-year forecast showing that profits from its all-important Copaxone multiple sclerosis drug will drop 42 percent in 2014.
Teva issued a statement maintaining the numbers were from an “outdated presentation” that is “incomplete and does not reflect our full analysis.” The drugmaker “is extremely disappointed that confidential, potentially misleading and obsolete information was made public at this time and intends to investigate ...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Canadian Universities Sacrifice Principles In Industry Deals: Report
A new report that examined a dozen collaborations between academia and industry in Canada found that Canadian universities are striking research agreements that place “unacceptable limits on academic freedom and sacrifice fundamental academic principles,” according to the Canadian Association of University Teachers. Of course, the term of each differs, but one of the agreements singled out for criticism involves Pfizer.
Specifically, a collaborative research agreement was made within the Vancouver Prostate Centre between the drugmaker, the University of British Columbia and the British Columbia Cancer Agency. Pfizer ag...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
If Drug Prices Were Lower, Maine Would Not Need A Law: Wellman Explains
Earlier this year, Maine passed a law that allows its citizens to purchase prescription medications from a Canadian broker that deals with licensed retail pharmacies in Canada, the UK, Australia and New Zealand. The effort, which had backing from both Democrats and Republicans in the state legislature, reinstated a law that a former attorney general had declared illegal. The new law, however, is being challenged in court by trade groups for drugmakers and pharmacists, which worry the initiative may be duplicated in other states (back story with lawsuit link). So far, though, the program seems to be working, at least accord...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Advocates Try To Block Gilead Patent For Hep C Drug In India
In the latest tussle over access to medicines, patient advocates in India are attempting to prevent Gilead Sciences from obtaining a patent for its forthcoming hepatitis C treatment, which is called sofosbuvir, over concerns that pricing will make the drug out of reach for many people. The filing argues that elements of the Gilead patent application are actually not original and, therefore, should be rejected.
“Old science, existing compound,” says Tahir Amin, an attorney director of the The Initiative for Medicines, Access & Knowledge in a statement. “India’s patent law doesn’t give monopolies for old scienc...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
EU To Fine J&J And Novartis Over A Pay-To-Delay Deal
One year after filing a complaint against Johnson & Johnson and Novartis (NVS) - and its Sandoz generic subsidiary - for allegedly conspiring to delay the generic introduction of a prescription drug in the Netherlands, the European Commission is set to fine the drugmakers, Reuters writes. The medicine that has been the subject of their probe is a version of the fentanyl pain patch.
A fine has been expected after European antitrust regulators opened their two years ago as part of a widening crackdown on such deals (back story). The concern has picked up steam in recent years as governments attempt to grapple with rising...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to the working week. We had a longer-than-usual weekend break and must now play catch up as a result. This is a familiar phenomenon, yes? The world never stops spinning even when we hit the pause button. And so, we are fortifying ourselves with that ever-familiar cup of stimulation and invite you to join us. And why not? If the temperature where you are is anything like the chilly Pharmalot corporate campus, what have you got to lose? While you ponder, here are some tidbits. Have a great day and do stay in touch...
Orexigen Weight-Loss Pill Passes Safety Hurdle (TheStreet)
Biogen Wins Ad...
Source: Pharmalot - November 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Sam Waksal, A Hepatitis C Medicine And An FDA Warning Letter
As a new batch of hepatitis C treatments emerges from the pharmaceutical pipeline, drugmakers are scrambling to position themselves to grab a chunk of what Wall Street estimates could be a $15 billion market. And Kadmon Pharmaceuticals is no exception, although its prized possession is an older treatment called Ribasphere that is currently used as part of a combination treatment and is being tested with forthcoming medicines.
Kadmon, however, may have been a bit too eager to ensure the medical community is aware of Ribasphere, a name for ribavirin. The FDA has issued a scathing warning letter in response to a letter the dr...
Source: Pharmalot - November 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Two Dozen Drugmakers Pay $88M To Louisiana Over Inflated Prices
Ending three years of litigation, the Louisiana attorney general has reached an $88.4 million settlement with 25 drugmakers that were accused of filing misleading prices in an effort to increase the payments they received from the state Medicaid program. The state had alleged that some average wholesale prices were more than 5,000 percent higher than the true cost of a medicine (here is the lawsuit)
The agreement marks the final step that began with a lawsuit against more than 100 drugmakers and their subsidiaries three years ago over average wholesale pricing, which has spawned numerous investigations and lawsuits by va...
Source: Pharmalot - November 21, 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 Rho hired Gail Fowler as vp of operations. Previously, she was vp, clinic...
Source: Pharmalot - November 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? As always, we are careening off the walls as we attempt to hustle the short people off to their schoolhouses, tending to the ever-hungry official mascots and readying ourselves for the day. We trust you relate, in some way. So let us all now reach for that treasured cup of stimulation to fortify the neurons. And by the way, we will be taking a day off tomorrow, so we are running our weekly jobs column earlier than usual. Meanwhile, have a grand day and see you soon...
Pfizer To Close Manufacturing Plant In Puerto Rico (Associated Press)
Amicus Amends Fabry Drug Pact With Glaxo...
Source: Pharmalot - November 21, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Researchers Back Pedal From Their Own Risperdal Study
In the wake of the $2.2 billion settlement by Johnson & Johnson to resolve criminal and civil charges for illegal marketing of the Risperdal antipsychotic pill (more here), two of the authors of a medical paper that was used to inappropriately market the medicine are back peddling from the publication, according to The Chronicle of Higher Education.
Denis Daneman, a professor and chair of pediatrics at the University of Toronto, asked The Journal of Clinical Psychiatry, which published the article a decade ago, to retract the article or remove his name. But the publisher declined to do so, maintaining that the article ...
Source: Pharmalot - November 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Researchers Back Peddle From Their Own Risperdal Study
In the wake of the $2.2 billion settlement by Johnson & Johnson to resolve criminal and civil charges for illegal marketing of the Risperdal antipsychotic pill (more here), two of the authors of a medical paper that was used to inappropriately market the medicine are back peddling from the publication, according to The Chronicle of Higher Education.
Denis Daneman, a professor and chair of pediatrics at the University of Toronto, asked The Journal of Clinical Psychiatry, which published the article a decade ago, to retract the article or remove his name. But the publisher declined to do so, maintaining that the article ...
Source: Pharmalot - November 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
