God Save The Queen: Shire Is Latest To Cut R&D Jobs In The UK
One day after the pharmaceutical industry begrudgingly agreed to a new UK government policy that places caps on prescription drug prices, yet another drugmaker has signaled plans to eliminate part of its workforce in the country. This time, Shire Pharmaceuticals is reportedly reviewing its R&D operations with an eye toward axing 180 employees in Basingstoke, UK.
The drugmaker is taking this step as part of an R&D overhaul that involves focusing its early stage drug development primarily on rare diseases, although some of those programs are now being discontinued as a result. In announcing the cuts, Shire (SHPG) ins...
Source: Pharmalot - November 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
San Francisco Voters OK Measure For Lowering Drug Prices
In a first-of-its-kind vote that may prove largely symbolic, San Francisco voters overwhelming approved a ballot measure that requires city officials to hold talks with drugmakers about pricing for ‘essential medicines.’ Known as the Prescription Drug Purchasing Initiative, the measure was approved by approximately 80 percent of those voting.
To what extent the effort will become anything more than a symbolic gesture, however, remains to be seen. The initiative requires the city to use “all available opportunities to reduce the city’s cost of prescription drugs,” and also instructs state and federal representativ...
Source: Pharmalot - November 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FTC OKs Rule Change For Patent Deals Over Pharma Objections
In a decision that will disappoint the pharmaceutical industry, the US Federal Trade Commission has issued final changes to a so-called pre-merger notification rule that requires drugmakers to report certain proposed acquisitions of exclusive patent rights for an antitrust review. These reviews are conducted, of course, by both the FTC and the US Department of Justice.
The revised rule, which drew objections from the PhRMA trade group, is designed to clarify when a transfer of exclusive rights to a patent results in a potentially reportable asset acquisition under the Hart Scott Rodino Act, according to an FTC statement. T...
Source: Pharmalot - November 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another hectic day is on the way. And this may be a soggy one, unfortunately. But we will persevere, nonetheless, as our spirits remain sunny. Once again, let us recall what the Morning Mayor used to say: Every brand new day should be unwrapped like a precious gift. How bad can a little rain and cloudy skies really be? While you ponder, here are some tidbits. As always, have a great day and do stay in touch...
Glaxo Sells The Bad With The Good In New Safety Push (Bloomberg News)
Bayer Seeks Wider Use For Eylea Eye Drug In Europe (Reuters)
Novartis To Boost Boston R&D HQ By 150 Jobs (The Boston...
Source: Pharmalot - November 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
UK And Pharma Reach Deal To Cap Prices, But Bitterness Remains
For the first time, the UK has instituted a pricing policy on brand-name prescription drugs that comes with a cap. Under the five-year plan, the Pharmaceutical Price Regulation Scheme, or PPRS, drugmakers have agreed that the costs for their medicines will remain flat in 2014 and 2015, but will rise no more than 2 percent in the following three years.
The UK pursued such a deal in order to keep a lid on drug costs, which exceeded $19 billion in 2011 and 2012. The UK Department of Health noted that the growth in prescription drug expenditures averaged five percent in previous years. The previous agreement generated savings ...
Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Catalyst Pharma Fights Greed Charges Over An Orphan Drug
For the past month, shares in a small developer of novel drugs called Catalyst Pharmaceutical Partners have given up roughly half their value amid an unusual public relations war with a privately held drugmaker over a potentially lucrative market for an orphan medication. But the tale has some twists that include a decommissioned nuclear reactor and free dosing for existing patients.
Here is the situation: Catalyst licensed a drug from Biomarin Pharmaceuticals called Firdapse to treatment Lambert-Eaton Myasthenic Syndrome, or LEMS, a rare autoimmune disorder that is characterized by muscle weakness and often associated wit...
Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Can 'Low T' Drugs Cause The Big 'H,' As In Heart Attack?
Maybe a little ‘Low T’ is something men can live with. How so? For the past several years, elixirs for boosting testosterone levels have been widely touted for curing low sex drives amid controversy over their benefits and research suggesting the malady is less common that advertising suggests. Now, though, a new study finds that the drugs raised the risk of a heart attack, stroke or death by 29 percent.
The study, which was published in the Journal of the American Medical Association, reviewed data from more than 8,700 men who underwent an angiography at one of 76 cardiac catheterization labs in the US Veterans Affair...
Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
McKesson Pays Wisconsin $14M Over Inflated Pricing Charges
Yet another settlement has been reached in litigation over average wholesale pricing and Medicaid fraud. In the latest deal, Wisconsin will receive nearly $14 million from McKesson, the pharmaceutical wholesaler, and First DataBank, which publishes prices that are used by most state Medicaid programs to set payment rates for pharmaceuticals.
The state had filed a lawsuit a year ago that claimed the companies violated the Wisconsin Medicaid fraud statute, Deceptive Trade Practices Act, and False Claims Act by inflating reported prices for more than 1,700 brand-name drugs in order to increase pharmacy reimbursement from the ...
Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We are cruising along here at the Pharmalot corporate campus, where the sun is shining and the scenery offers a dazzling array of autumn colors. The view is enough to cause us to daydream unendlessly, but alas, there is work to be done. You know the feeling, yes? So please join us for a needed cup of stimulation so our attention is focused properly. Meanwhile, here are some tidbits. Have a grand day and we hope you accomplish much...
FDA Puts Partial Clinical Hold On Curis Cancer Drug (Bloomberg News)
Japan Limits Scope Of Online Pharmaceutical Sales (The Wall Street Journal)
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Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Leak!! Jeremy Levin Irked Teva Directors With Polygraph Tests
This reportedly occurred amid a simmering dispute over the extent to which the board was involved in day-to-day affairs. Levin, by the way, was not a board member.
Now, though, a new report suggests the level of enmity ran deeper. Six months ago, Levin demanded an investigation into leaks that he apparently believed were emanating from the board room and hired a firm to conduct polygraph tests of each Teva director, according to Globes. They were also questioned about their telephone conversations.
Every candidate who was considered a potential successor to Frost was required to participate. The probe put Teva directors on...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Johnson & Johnson, Risperdal And A Lack Of Clinical Trial Disclosure
In the wake of the $2.2 billion settlement that Johnson & Johnson will pay to resolve both criminal and civil charges leveled by US authorities has focused attention on off-label marketing practices and kickbacks paid to physicians and a nursing home pharmacy (back story with links). But court documents reveal another troubling issue – withholding clinical trial data.
The disclosure comes amid a heated debate over the extent to which drugmakers are willing to disclose trial data. The pharmaceutical industry is, by and large, fighting a proposal by the European Medicines Agency (read here and here) as well as a separa...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What The Probe Into The Brilinta Trial May Mean For AstraZeneca
The drumbeat of investigations launched by this or that government agency into a big drugmaker is often shrugged off, at least by investors, who play wait-and-see since the outcome of such probes can amount to nothing. However, the news that the US Department of Justice is investigating a key trial for the Brilinta bloodthinner sold by AstraZeneca prompted a cautious response from one analyst.
What are the feds looking at? As we wrote last week, the inquiry is focused on the PLATO trial, which was used to win FDA approval. There were no other details, but the disclosure came six months after a small group of researchers ra...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
China Has Still Not Issued FDA Visas To Boost Inspection Staff
For the past year, the FDA has been frustrated over an inability to obtain visas from China for its staffers to work on a long-term basis in the country. And the protracted delay has prevented the agency from proceeding with plans to increase inspections, bolster regulatory practices and collaborate with Chinese authorities on public health strategies.
The US State Department, you may recall, formally notified the Chinese Ministry of Foreign Affairs last fall about obtaining visas for additional inspectors, a move made possible by an extra $10 million in FDA funding. But since January, the agency has waited for visas and t...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What Bonus? Former Lilly Rep Files Lawsuit Over Incentive Pay
Should drugmakers pay temporary sales reps a prorated bonus if they leave before their contract expires? One former Eli Lilly rep is tussling with the drugmaker over this issue and, having failed to collect, has filed a lawsuit that seeks class action status, a move that could prompt dozens more people to pursue back pay.
The case was filed by Leslie Pinciaro Dudley, who worked for Lilly as a rep in Jacksonville, Florida, from early 2011 through early 2013. And her agreement, which referred to her as a ‘fixed duration employee,’ indicated Lilly would pay her various bonuses. But after her contract expired, she was told...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is on the way. The Pharmalot corporate campus has been buzzing with activity as the short people hustle off to their respective schoolhouses and the official mascots frolic among the weeds and leaves blanketing the grounds. As for us, we are sorting out the to-do list for the day, and it is a long list. We suspect that you can relate. So no time to dally. Let us all quaffe a cup of stimulation together and peruse the tidbits. Have a smashing day and keep us in mind if you hear something intriguing...
Novartis To Close UK Plant That Employs 400 Workers (West Sussex County Times)
Im...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
