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Morgan Stanley to Drug Companies: "Exit Research"; Pfizer and GSK: "We Hear You!"


Yesterday, I wrote on PharmaQbD.com about a new Morgan Stanley report which suggests that small-molecule drug manufacturers (and to a lesser degree biologics manufacturers) have very little financial incentive to perform their own research and development activities. The old arguments about keeping certain core competencies in-house and managing risks don't hold water anymore, the report says.

From 'On Pharma'

Emil at IFPAC: A Tuesday of Varied and Multivariate Talks


Emil Ciurczak reports on Tuesday at IFPAC 2010 in Baltimore:

The talks started in earnest today, with five concurrent sessions. Most were dedicated to pharmaceutical applications, so it was “interesting” to try to cover many of them. One session, in particular, caught my attention: "New Directions and Modeling". Since it made numerous references to chemometrics/multivariate modeling, I had to check it out. In the interest of brevity, I will merely highlight a few of the better talks throughout the day.

From 'On Pharma'

GSK Plays Hardball with UK Over Tax Incentives


With global economies struggling it only gives drug manufacturers with sizable investment dollars more leverage to pit local and national governments against each other to see who can offer up the sweetest packages to earn the right to that money. GSK is playing tough with the UK over how it will invest going forward, demanding better tax incentives, patent support, etc. If not, GSK's Andrew Witty hints that Ireland, Belgium, Singapore and other locales are only more than happy to oblige.

From 'On Pharma'

As H1N1 Vaccines Approved, Fears Subside


A few weeks back we posted a list of the companies that were manufacturing H1N1 vaccines, and since that time many of them have been approved, either in the U.S. or abroad. Here's an update:

From 'On Pharma'

Who Is Manufacturing the H1N1 Vaccine?


It's a matter of weeks now until we begin to see: a) to what degree the H1N1 pandemic will again ramp up; b) which manufacturers will have developed vaccines in time to address the need; and c) if those vaccines will work against the dominant strain that develops.

From 'On Pharma'

Are GSK, BMS, and J&J Pharma's Most Ethical?


If you put credence in Swiss firm Covalence's annual ethics rankings, yes, GSK, BMS, and J&J are the most ethical companies in the Pharmaceuticals and Biotech sector. The list looks like this:

1. GSK

2. BMS

3. J&J

4. Abbott

5. Novartis

6. Roche

7. Boehringer Ingelheim

8. Astra Zeneca

9. Pfizer

From 'On Pharma'

GSK and Spitzer: Schadenfreude?


Have been away from the epicenter of political corruption for a while.  New York is quite a bit tamer on that score than Chicago.  Not so its tabloid headline writing (especially at the New York Post), which is as brilliant as it is uncivilized.  I was shocked to hear about New York governor Spitzer's recent problems; so, too, were the non-dyslexic headline writers at the Post, who reacted with the trashy but memorable, HO NO!  (It's challenging to come up with headlines that succinct. ) New York Daily News' "Pay for Luv Guv" wasn't even in the same league. 

Had to wonder whether anyone at GSK, the company that Spitzer had pursued so vigorously, might be quietly savoring this moment.  Especially since the U.K. recently dismissed charges that the company had intentionally hidden safety information about its anti-depressant, Paxil/Seroxat. 

The Financial Times recently published an interesting analysis (Read here) calling for more transparency.  The U.K. case, which lasted for for years, has helped raise the bar for clinical data transparency, the FT reports although it acknowledges that loopholes remain. 

But Spitzer had fired the first shot in calling for data transparency here in the U.S., through a civil lawsuit filed in 2004 (for reportage from the Washington Post, click here)  requiring that more clinical trial results be made openly available to the public.  The case was settled for $2.5 million. He had also pursued GSK for filing frivolous IP infringement claims to prevent generic versions of Paxil from reaching the market.  That case was settled for $14 million).

Spitzer, when he was state Attorney General, also heard from the second Wyeth Prevnar whistleblower, Anthony Sokol, who had alleged manufacturing and quality issues, and claimed the company had violated consent decree requirements. 

The Wall Street Journal Health Blog reported recently (click here to read) that Sokol's, the second such case involving Prevnar manufacturing, was filed late in 2006, and only recently disclosed by the company, and that the first whistleblower, Mark Livingston, has appealed the decision that had been made in his case.

AMS

From 'On Pharma'

The World According to Jack Bauer


I spent the majority of my Christmas break catching up on last season's episodes of 24. After countless hours of the U.S. under enemy attack and the Counter-Terrorist Unit saving the day, I am pretty much convinced that if you are guilty...Jack Bauer will find you.

GSK, AstraZeneca and Eli Lilly...let's hope you are all found innocent in allegedly paying bribes to Saddam Hussein's deposed Iraqi regime.

For the full story click here.

MV

From 'On Pharma'

Changing the R&D Culture at GSK: A Profile of Moncef Slaoui


The Financial Times recently published a profile of GSK's new research head, vaccine expert Moncef Slaoui, who was born in Morocco.  Click here to read. 

Some noteable "sound byte" quotes: 

"We've done well on the structure, but more is required on the behavior...." and

"The science is overridden by management.  We should move away from industrialized R&D. " 

From 'On Pharma'

GSK, BMS and a Pharma Downsizing Update


GSK just announced today that it would be eliminating 900 jobs at its facility in Cidra, Puerto Rico. More from the International Herald Tribune.  But Pharmalot reports that BMS will be announcing major cuts in December.

Unfortunately, it is far from the only pharma or bio company in job-cutting mode.

Pharmalot, In the Pipeline and FierceBiotech  each offered an assessment recently. 

(Ed Silverman, who has mastered the art of teleportation, or else has had himself cloned,  is posting to his blog all while leading a panel discussion at a DTC event in New Jersey, which started yesterday and is winding down today.  Among the topics to be addressed: How much influence do pharma blogs have?

They certainly wielded a lot of power last Spring, when Peter Rost's blog led to changes at AstraZeneca.  Summer and Fall seemed to bring less serious postings all around. Will pharma itself join the party?  Not until more companies get over their fear of FDA, adverse reaction reporting and other leaks...which means it may take quite a while.

However, more media outlets continue to launch new blogs. Putman will be introducing two new blogs soon:  

  • Poor Emil's Almanac, written by our award winning and irreverent columnist, the NIR expert Emil Ciurczak (who has also started up his own website, Thenirprof.com)
  • The Oncology drug blog, which will be written by experts in the oncology drug development field.  That blog will debut with musings from Dr. Craig Dees, CEO of Provectus and will be run by managing editor, Heidi Parsons.

And for you chemists and API experts out there, our online expert and columnist Girish Malhotra, now traveling in India,  has just started up his own blog.

AMS

From 'On Pharma'