What Drugs? Sanofi Battles Employees In France Over R&D Job Cuts
Teva Pharmaceuticals is not the only drugmaker facing stiff resistance this week among employees in its home country to planned layoffs. In France, Sanofi wants to shrink its R&D budget, but is encountering predictable levels of push back from both workers and the government, which is trying to preserve highly skilled workers and, of course, combat employment rates.
The situation may erupt today, when talks begin with unions, which have called for lab workers to walk off the job throughout the week in protest. At stake, at least initially, are 186 job cuts in research and 453 transfers to other sites, according to an i...
Source: Pharmalot - October 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Despite Depot Meds, Schizophrenia Patients Remain Non-Compliant
The failure among patients to take their meds is a costly matter. For instance, the avoidable cost opportunity for six prevalent diseases – including HIV, diabetes and high blood pressure - exceeded a whopping $105 billion last year, according to the IMS Institute for Healthcare Informatics. But with each disease comes different compliance – or adherence – issues.
Take schizophrenia, which can pose quite different challenges. About 45 percent of these patients do not follow physician instructions when taking their medications and this represents an increase of four percentage points over 2012, according to a recent s...
Source: Pharmalot - October 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, folks, and apologies for the late start, but we encountered a tech problem this morning that delayed our usual opening. But that is all behind us now, which means we must get cracking. After all, this is shaping up to be an especially busy week and we trust that you relate. To cope, yes, we are downing cups of stimulation. Our flavor today is Cinnamon Hazelnut Creme, a special blend that we found in the wilds of Pennsylvania. Meanwhile, here are some tidbits. We wish you luck conquering the world today and, as always, remind you to stay in touch...
Genzyme To Invest $80M In Fabrazyme Plant (Genetic Engineerin...
Source: Pharmalot - October 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Will An FDA Panel Recommend The Amarin Fish Oil Pill?
Will an FDA advisory panel recommend a wider indication for a prescription fish oil pill without an outcomes study to demonstrate the treatment can reduce the risk of cardiovascular events? This question, which is one of the more controversial unknowns to captivate biopharma investors for the past few months, will be answered on Wednesday when a committee meets to review Vascepa.
Here is the background: the pill is already approved for treating people with very high triglyceride levels, or more than 500 mg/dL, which is approximately 4 million people in the US. Amarin, however, hopes to win FDA approval to market Vascepa to...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
McClellan To The Rescue? J&J Adds Former FDA Commish On Board
For those keeping track of the relationships between the pharmaceutical industry and former FDA staffers, Johnson & Johnson has just added Mark McClellan, who served as agency commissioner from 2002 to 2004 and then headed the Centers for Medicaid & Medicare Services from 2004 to 2006, to its board of directors.
Such a move is unlikely to be seen as unusual because companies want people with specialized expertise and perspective to advise managerial teams. And McClellan, of course, does have a unique perspective,given that he brings high-level insights into regulatory and reimbursement policies to one of the world...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Teva Director: 'Generic Copaxone Will Come In 2015, If At All'
Last week, Teva Pharmaceuticals announced plans to accelerate a $2 billion cost-cutting plan by axing 5,000 jobs, or 10 percent of its global workforce. The move reflects as the drugmaker faces generic rivals as early as next year for its all-important Copaxone multiple sclerosis treatment, which generates about half of company earnings and dominates the MS market (back story). But Teva director Chaim Hurvitz tells Globes that the cuts, which is prompting Israeli workers to consider a strike (see this), are also due to higher taxes and may not be as bad as some Israelis fear. Here is an excerpt of his interview..
On the jo...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Bayer Challenges India, Again, Over A Compulsory License
File this under ‘If at first you don’t succeed…’ Seven months after India's Intellectual Property Appellate Board rejected an appeal from Bayer, which was fighting a compulsory license that permitted the sale of a generic version of its Nexavar cancer drug, the drugmaker has now filed a challenge with the Bombay High Court.
The license was issued last year after Indian authorities determined that Nexavar pricing was deemed too expensive for most people in India. The license was issued to Natco, a large Indian generic drugmaker, which must pay Bayer 7 percent royalties on its sales. The challenge is not a surprise, ...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
UK Regulator Cites Another Wockhardt Plant For Problems
For the second time in four months, UK’s Medicines and Healthcare Products Regulatory Agency has tagged Wockhardt for manufacturing problems at a key facility. The latest infraction led the regulator to withdraw certification for the same facility that prompted the FDA to issue a warning letter last July after employees played hide-and-seek with requested documents, among other things (back story).
"We have issued a statement of non-compliance against Wockhardt’s site in Chikalthana, India after recent inspections identified a number of manufacturing issues that breach Good Manufacturing Practice (GMP) guidelines,” a...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and nice to see you again. We are back from an extended weekend, of sorts, since we did stop to provide coverage of breaking news at one point. In any event, the extra time away was enjoyable and we hope that you similarly had a refreshing break. Now, of course, the routine of meetings and deadlines has resumed. After all, we are in the midst of the busy season. So please join us as we grab a cup of stimulation and get started on the ever-growing to-do list. And, of course, here are some items to help you along. Have a great day and stay in touch...
Merck KGgA Explores Risk Sharing Deals For Clinical Trial...
Source: Pharmalot - October 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Just Say No: California Gov Vetoes Biosimilar Substitution Bill
After months of intense lobbying by rival groups of drugmakers, California Governor Jerry Brown over the weekend vetoed a controversial bill that would have allowed substitutions for interchangeable biosimilars - which are medicines based on brand-name biologics - but only if certain conditions are met by prescribing physicians and pharmacies.
The bill emerged as part of a multi-state campaign by some drugmakers to draw clear lines for allowing substitution, even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic. Many biologics are priced at tens ...
Source: Pharmalot - October 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
US Senator Wants To Probe FDA Over 'Pay To Play' Meetings
A US Senator wants to open an investigation into a behind-the-scenes panel called IMMPACT, which is run privately by a pair of academics, who hold brainstorming sessions with FDA officials and drugmakers on ways to improve clinical trials, notably involving prescription painkillers. The panel acronym stands for Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (look here).
Why? The drugmakers were required to pay big fees to participate – as much as $35,000 to attend a single meeting. The disclosure, which was made in various reports earlier this week, has raised uncomfortable questions for the FD...
Source: Pharmalot - October 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Really?! Ranbaxy Wins FDA Clearance For Important US Facility
In a rare bit of good news for Ranbaxy Laboratories, the generic drugmaker says its Ohm Laboratories facility in New Jersey successfully passed an FDA inspection. The move is significant because the plant is the only Ranbaxy manufacturing facility that is permitted to supply products to the US market after three plants in India were prevented from doing so thanks to serious quality-control issues.
The FDA endorsement means that Ranbaxy can use the Ohm facility to file for FDA approvals for drugs, such as a generic version of the widely used Diovan heart drug sold by Novartis (NVS). Ranbaxy had been expected to win agency a...
Source: Pharmalot - October 11, 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 Melinta Therapeutics hired Lyn Baranowski as senior vp, corporate develop...
Source: Pharmalot - October 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week will soon draw to a close. This is, as you know, our treasured signal to daydream about weekend plans. Today, however, the daydreaming begins early because we are officially off today, although we have obviously stopped for a few moments to conduct some business here. In any event, our agenda is filled with excitement, such as celebrating a birthday with one of the Pharmalot ancestors and taking Mrs. Pharmalot to yet another installment in our 'Let's-See-Them-Before-They-Die' concert series. But what about you? Anything interesting planned? How about catching up with someone special or reading ...
Source: Pharmalot - October 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
CSL Pays $64M To Settle Antitrust Suit Over Plasma Pricing
After four years of litigation, CSL has agreed to pay $64 million to settle antitrust lawsuits in which several hospitals claimed the plasma products supplier conspired with a key rival to artificially raise prices and constrict supplies even as patient demand rose. Also settling is the Plasma Protein Therapeutics Association industry trade group.
At issue were allegations that CSL, which is based in Australia, used the closely controlled trade group as a cover to hold meetings with Baxter International to discuss pricing plans and market domination. The two manufacturers are the world's largest suppliers of plasma-derivat...
Source: Pharmalot - October 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
