A Few Dozen Here, A Few Hundred There... More Pharma Layoffs
For those keeping tabs, there are still more layoffs to report in the pharmaceutical industry. The latest cuts involve as many as 270 information technology jobs at an AstraZeneca (AZN) facility in the UK, The Macclesfield Express reports. The move was actually foreshadowed several months ago, when the drugmaker disclosed plans to eliminate 4,900 R&D, sales and marketing, and administrative jobs (back story).
Meanwhile, Actavis, the generic drugmaker that earlier this year acquired Watson Pharmaceuticals, is eliminating about 300 sales reps - about 30 percent of its staff - and 54 jobs from Corona, California, accordin...
Source: Pharmalot - November 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
J&J Fights Claims That Bill Weldon Was Paid Too Much
The Bill Weldon legacy lives on, at least in court.
More than a year after Weldon retired as Johnson & Johnson ceo, a simmering dispute continues in a New Jersey federal court, where a J&J shareholder has filed a so-called derivative lawsuit that claims the healthcare giant provided a “lavish” compensation package that was not in keeping with his performance and belied the storied company credo.
The dispute hinges on a series of widely publicized transgressions that have plagued Johnson & Johnson for the past several years – countless product recalls, illegal marketing practices for prescription medicines...
Source: Pharmalot - November 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Top of the morning to you. Another bright, shiny day is unfolding here on the chilly Pharmalot corporate campus, where the falling leaves are blanketing the grounds and we are trying to keep warm with a cup of stimulation. As always, a busy day lies ahead and we trust that you can relate. So, time to get cracking, as they say. After all, it is only the middle of the week. So here are a few items of interest. Hope you day goes well and do stay in touch...
FDA Panel Backs Biomarin Rare Disease Drug (Bloomberg News)
Amgen Cholesterol Drug Appears Safe And Effective: Study (Reuters)
Google's Calico Adds Roche Exec As R&D H...
Source: Pharmalot - November 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Hip Hip Hooray? J&J To Pay $2.5B For 8,000 Hip Implant Suits
After several months of haggling, Johnson & Johnson is proposing to pay nearly $2.5 billion to settle approximately 8,000 lawsuits in the US in which people claim they suffered harm caused by the controversial ASR hip replacements sold by its DePuy unit. The settlement was filed today with a federal court in Toledo, Ohio.
The proposal reflects hopes by J&J to resolve the litigation by early next year, given that the number of product recalls and lawsuits are climbing. Three years ago, the DePuy unit recalled 93,000 implanted hips worldwide, including 37,000 in the US, after an exceedingly high failure rate of 12 pe...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Obamacare Delays May Hamper Spending On Medicines
Now that the patent cliff has faded into the rear view mirror for most drugmakers, the pharmaceutical industry should expect some heady growth. For instance, total global spending on medicines will exceed $1 trillion for the first time next year and hit $1.2 trillion by 2017, according to a new report from IMS Institute for Health Informatics.
Not surprisingly, though, this growth will differ geographically. In the US, for instance, Obamacare will have a substantial impact. Depending upon moves by employers, healthcare providers and patients, a worst-case scenario would result in $300 billion to $320 billion in spending in...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Sisters Claim Merck's Gardasil Vaccine Caused Ovary Problems
Six years ago, Madelyne and Olivia Meylor were vaccinated with Gardasil. Like millions of parents, their mother agreed to have the teenage sisters vaccinated to ward off the human papillomavirus that can lead to cervical cancer. But within a couple of years, both were diagnosed with premature ovarian failure and were told they will be unable to get pregnant. They now experience signs of menopause.
And so, the Meylor family has filed a claim with the National Vaccine Injury Compensation Program in what appears to be the first case before the federal program to allege that Gardasil is responsible for this type of injury. As ...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
EMA Clears Roche For Failing To Report Side Effects
After spending a year investigating Roche for a failure to report tens of thousands of adverse events in connection with various drugs, the European Medicines Agency has concluded its review and “has not identified any important new safety concerns.”
“The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” the EMA says in a statement. The regulator adds that Roche is expected to ensure such data are included and considered in routine pharmacovigilance activities, though. The so-called “infringement procedure” was conducted by the agency’s Pha...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? A bright shiny sun is warming the otherwise chilly Pharmalot corporate campus, where the leaves continue to fall, the official mascots are greeting passersby and the short people are hustling off, as always, to their houses of learning. As for us we are in the midst of our usual routine which, of course, includes brewing a cup or two of stimulation. Feel free to do the same. Meanwhile, here are some tidbits to get the day started. Hope yours goes well and you conquer the world. But do stay in touch...
J&J Told To Pay $11M For Birth Defects Caused By Topamax (Bloomberg News)
Long-...
Source: Pharmalot - November 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
US Senate Passes Compounding And Track-And-Trace Bill
After months of negotiating, the US Senate has finally passed legislation that gives the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Barack Obama for his signature (here is the bill).
As reported previously, the Drug Quality and Security Bill was drafted in the wake of a scandal last year involving a fungal meningitis outbreak that was traced to the New England Compounding Center. So far, the...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Biotech Products Are Filling The Pharma Pipelines: Study
Over the past decade, the pharmaceutical industry has shifted emphasis from small molecule compounds to biotech products for a few good reasons. For one, much of the low-hanging fruit has already been picked when it comes to developing blockbuster pills for some widespread afflictions. Moreover, biotech medicines can generally command much higher price tags.
The results of this shift can be seen in a new analysis. Biotech products, which accounted for 7 percent of revenue generated by the 10 top selling pharmaceutical and biotech products worldwide in 2001, accounted for 71 percent of the 10 best-selling products last year...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Glaxo 'Falls Short Of Open Data Disclosure:' Jureidini Explains
Over the past few months, a group of researchers has been haggling with GlaxoSmithKline over access to detailed data for an infamous 2001 study of its Paxil antidepressant called 329 that tested the pill for treating depression in adolescents. The researchers, who are led by Jon Jureidini, a clinical professor of psychiatry at the University of Adelaide in Australia, want a 1998 clinical study report that they hope to reanalyze and republish. The original results reported that Paxil was effective, but the trial actually missed its endpoints and figured in a ghostwriting controversy (here is the study). As a result, Glaxo s...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
By The Numbers? Flawed Cholesterol Calculator May Boost Statins
The latest by-the-numbers approach for assessing cholesterol and cardiovascular risk apparently does not add up. The new online calculator that the American College of Cardiology and American Heart Association last week recommended for determining treatment apparently overestimates the risks and, as a result, may mistakenly suggest that millions of people should be taking statins.
The problems were actually noticed a year ago by a pair of Harvard Medical School professors, when the National Institute of Health circulated the proposed guidelines, according to The New York Times. However, their findings apparently were never...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Whither Sanofi R&D? Another Setback For An Oncology Drug
For the second time in the past several months, Sanofi is scuttling development of a cancer drug, underscoring the difficulty the drugmaker is having in transforming its R&D operations. The latest setback involves a myelofibrosis treatment called fedratinib; Sanofi has ended clinical trials and will not make a regulatory filing after receiving case reports of encephalopathy that prompted talks with the FDA (read Sanofi statement here).
Last June, Sanofi found that another medication, iniparib, failed to help newly diagnosed non-small lung-cancer patients in a late-stage trial, prompting the drugmaker to discontinue res...
Source: Pharmalot - November 18, 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 respite was relaxing and refreshing because, as you know, the drumbeat of meetings and deadlines has now returned. This was expected, of course. Just the same, the moment calls for a cup or more of stimulation. After all, the nerves could use a little fortification. So please join us. We like to think that we do not drink alone. Meanwhile, here are some tidbits, as always. Hope you have a grand day and drop us a line if you run across something fascinating...
Ranbaxy Hopes To Sell Generics In Japan (BioSpectrum Asia)
Princeton May Use Novartis...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pennsylvania Moves Closer To Adopting Biosimilar Legislation
Biotechs fighting to thwart biosimilar substitution have just moved closer to achieving their goal in one big state. A Pennsylvania senate committee has approved a bill that would make it harder for pharmacists to substitute biosimilars that the FDA has approved as interchangeable with a biologic. The bill, which would require physician notification, now goes to the full senate for a vote (here is the bill).
The committee vote is only an interim step, of course, but if the legislation becomes law, it would be a significant victory for Amgen (AMGN) and Genentech, which have been lobbying more than a dozen states in hopes of...
Source: Pharmalot - November 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
