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 Medac Pharma hired Terri Shoemaker as ceo and president. Previously, she ...
Source: Pharmalot - October 18, 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. As you know, this is our signal to daydream about weekend plans and, once again, we will get a headstart since we are rolling in the sidewalks early today. Why? We have an abundance of holiday time that must be taken, or lost, in coming weeks. Nonetheless, we are stopping by to sort out a few loose ends. Meanwhile, we look forward to a leisurely break so we can nap, spend time with our short poeple and promenade with the officials mascots. And you? This is a lovely time of year to enjoy the outdoors. Maybe a drive in the country is in order or a long walk to take in s...
Source: Pharmalot - October 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Why Express Scripts Tossed 48 Drugs Off Its Formulary: Miller Explains
For the first time, Express Scripts (ESRX) has excluded a few dozen medicines from its national preferred formulary. The move, which the pharmacy benefits manager says had been signaled to drugmakers, comes in the wake of rising prices for brand-name medications, increasingly narrow formularies elsewhere and greater use of co-pay cards. We spoke with Steven Miller, chief medical officer at the PBM, about the factors behind the process. This is an edited version..
Pharmalot: So you’ve eliminated some drugs from the formulary. To what extent is this a new move?
Miller: This year what’s unique is that we have a small numb...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Do You See Any Eyedrops? DAs Sue Novartis Over Packaging
File this under ‘Now you see it, now you don’t.” A group of district attorneys representing five California counties have filed a lawsuit accusing Novartis and its Alcon eye-care products unit with deceptive advertising for selling Zaditor eye drops in “substantially” empty boxes for the past four years.
How so? The drops were sold in large boxes disproportionate to the small amount of product contained, the product was not viewable to the consumer and the interior of the packages had false walls and inserts, according to the lawsuit (here it is).
In other words, the packaging gave the impression that there was a...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Will The Bleeding Stop? Pradaxa Topped FDA Side Effect Reports
Will the bleeding stop? Last year, the FDA concluded that bleeding rates associated with Pradaxa, a relatively new bloodthinner, were no higher than among patients given warfarin, a decades-old medical standard. The assessment was designed to allay concerns that Pradaxa, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, but has been linked to hundreds of deaths.
Meanwhile, a new analysis finds that Pradaxa, which was approved two years ago by the FDA, generated the largest number of adverse events reported directly to the agency during 2012. In all, there were 683 such reports...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What Merger? Roche CEO Says A Deal With Novartis Is Moot
Just one month after a Roche director tantalizingly suggested that a merger with Novartis may make sense “from an objective standpoint” and lead to a “pharmaceutical champion,” Roche ceo Severin Schwann has tossed the proverbial glass of cold water on the notion.
Why? The families that control 50 percent of Roche voting shares are not interested.
“Nothing has changed with regards to Roche’s position toward Novartis,” he told the media during a conference call to discuss earnings, according to Bloomberg News. “The familiar Hoffmann and Oeri have repeatedly stated they’re committed to Roche’s independence...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, folks, and how are you today? Yet another busy day is unfolding here on the Pharmalot corporate campus, where the leaves are blanketing the grounds and the short people are, as always, hustling off to the local schoolhouses for what we hope is an education. As for us, we are busy downing another cup of stimulation, since we are scrambling to keep up with our to-do list. We suspect that you can relate. A treadmill is a treadmill. Meanwhile, here are some tidbits to get you started. Have a smashing time conquering the world and do stay in touch...
UK's MHRA Recalls Five Wockhardt Drugs Over Plant Problems (Reut...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Whither Amarin? FDA Panel Rejects Wider Use For Its Fish Oil Pill
In a huge setback for Amarin, an FDA advisory committee voted 9-to-2 against recommending broader use of the Vascepa prescription fish oil pill. Specifically, the panel believes the agency should wait for the results of an ongoing outcomes study to determine whether its pill can demonstrate definitive evidence that there are cardiovascular benefits. That study is expected to be completed in 2016.
Although the panelists agreed that Vascepa significantly lowers triglyceride levels, they expressed uncertainty about whether that can translate into fewer heart attacks. "I am wary of approving a drug that has a potential mark...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Most US Med Schools Have Mediocre Conflict Of Interest Policies
Over the past several years, medical schools have come under withering scrutiny for their relationships with drug and device makers. A new study, however, indicates that US medical schools are improving, but nearly two-thirds still lacked policies to limit financial ties in at least one area that was examined, including gifts, meals, samples, and payments for travel, consulting, and speaking.
For instance, policies that were classified as moderate, permissive or non-existent remain the norm in 11 of 12 areas. Nearly a third of medical schools still have no policy prohibiting ghostwriting. And most either do not have a poli...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Who's A Freier? Teva Freezes Israeli Job Cuts Amid Government Pressure
Faced with an outcry over plans to eliminate 800 jobs in Israel as part of a global cost-cutting campaign, Teva Pharmaceuticals has temporarily frozen plans to fire those workers while talks are held simultaneously with the government and a key labor union, according to reports.
The drugmaker, which is one of the biggest employers in Israel, backed off amid outrage that the government provided roughly $3.4 billion in tax breaks between 2006 and 2011 in order to encourage capital investment, while not paying any corporate taxes. Teva employs about 8,000 people in Israel.
“I’m not pleased with the tax benefits that the l...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Dear FDA, Be Reasonable And Define The Word 'Reasonable'
In response to increasing recalcitrance when staffers inspect manufacturing facilities, the FDA last July issued a draft guidance to spell out the circumstances when a drugmaker can expect to run into trouble. This may occur when facilities or documents are not made available or an inspector is prevented from accessing certain rooms or the premises altogether. After all, no one likes to get the bum’s rush (back story with link to the draft guidance).
The draft guidance received attention quickly because the FDA noted that inspection delays can cause a drug made at the given facility to be considered adulterated. Not surp...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Former Bayer Employee Can Proceed With Whistleblower Lawsuit
A federal appeals court has given a former Bayer employee a second chance at pressing a whistleblower lawsuit that accuses the drugmaker of illegally and deceptively marketing its Baycol cholesterol drug. However, the suit can only proceed on the grounds that Bayer cheated the US Department of Defense, not federal healthcare programs such as Medicare and Medicaid, of millions of dollars.
The lawsuit, which was filed seven years ago by a former market research manager named Laurie Simpson, may become a coda in the troubled saga of the cholesterol pill. Amid controversy, Bayer withdrew Baycol in 2001 after 52 deaths and hund...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, the middle of the week is here. If you can make it through today, the rest should be downhill, yes? Well, we are among the optimists, after all. Meanwhile, there is much to do, as always. So, no time to waste. Please join us as we reach for that needed cup of stimulation and brace for another round of phone calls, meetings and document reading. We trust you can relate. To help you along, yes, we have some tidbits. Have a grand day and do keep us in mind when something fascinating pops up...
Regeneron Drug Lowers Cholesterol In Late-Stage Trial (Reuters)
Glaxo Exec Assists China In Bribery Probe, B...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Woman Loses Bid To Sue Hospira Over Ongoing Drug Shortage
Last year, a woman named Jennifer Lacognata filed a lawsuit in which she charged that Hospira breached its responsibility to provide patients with a needed medicine that was in short supply. Her argument highlighted a dilemma resulting from a large and persistent number of shortages over the past two years of numerous medications needed for treating various ailments (see the list).
Due to Hospira manufacturing problems, Lacognata was unable to obtain an injectable drug called Aquasol A to treat her vitamin A deficiency. The purpose in filing her lawsuit was to hold drugmakers accountable for ongoing product shortages that ...
Source: Pharmalot - October 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Chinese Bribery Scandal Is Starting To Hurt Big Pharma
Ever since the bribery scandal in China erupted four months ago, there has been growing acceptance among multi-national drugmakers that the Chinese government probes into marketing practices were going to hurt business. But how bad is it?
None of the largest drugmakers are offering specifics, but they did provide some predictably dour assessments to one Wall Street analyst. Of nine multinational drugmakers queried, seven acknowledged the bribery scandal has been a drag on operations in China. One large drugmaker, for instance, noted that prescribers are reluctant to grant access to sales reps.
Which ones are hurting? Of co...
Source: Pharmalot - October 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
