Pharmalot... Pharmalittle... Good Morning

Top of the morning to you. And a fine one it is, if a bit cold. But it is wintertime, so we are not surprised. Another thing that is unsurprising is the amount of goings-on now that the new year has sprung. So to celebrate - and to cope - we are brewing a delicious cup of stimulation and invite you to join us. After all, this may help tackle that to-do list. Meanwhile, here are some tidbits. Have a grand day and stay in touch...

Merck CEO Sees More Consolidation (Wall Street Journal)

Novartis Wins UK NICE OK For Lucentis After Price Cut (Bloomberg News)

Merck Resubmits Combo Cholesterol Pill To FDA (Associated Press)

Amgen Whistleblower Loses Bid To Challenge Aranesp Deal (Bloomberg News)

Synergy Reports Positive Results For Constipation Drug (Reuters)

Shortages Linked To Relapses In Hodgkin Lymphoma Patients (Pharma Times)

Bayer's Nexavar Meets Goal In Thyroid Cancer Trial (Reuters)

Salix Wins FDA Approval For Diarrhea Drug (Associated Press)

AbbVie To Add 175 Jobs In Ireland (Irish Examiner)

EDITOR'S NOTE: Please check this post for updates

kettle pic thx to mirahartford on flickr

2 Comments

Jan 3, 2013 - 9:11am
Pfizer previously filed a patent infringement suit against Merck on the combo pill. Even if FDA likes the new dossier I doubt they will approve before January, 2014, which is the 30 month expiry on the Paragraph IV challenge. Court does not need to make a decision before then.
Jan 5, 2013 - 7:52am
I really feel that the DOJ/EDNY/HHS/OIG/FBI could have done a better job for the United States and as such plead out greater settlement amounts both civil and criminal. I think that the recent events of Pfizer, GSK and Amgen is sending a scary precedent to the heritage of the FCA laws and eroding the very principles that the FCA was founded during the Lincoln administration. Each of the companies for mentioned defrauded Medicare/Medicaid out of billions of dollars while receiving only a slap on the hand and paying a relatively small fine. For instance, Amgen between the years of 2001-2011 the “complaint period" sold $44 billion dollars in ESA's (Epogen and Aranesp), $32 billion in GSA's(Neupogen and Neulasta) for a total of $77 billion dollars. During that time Amgen paid about $27 billion dollars in "illegal" kickbacks to the medical service providers i.e. “greedy doctors” (not including cash, lavish trips, ”over-fill", free goods, bogus honorariums, etc.) that took advantage of the huge "windfall profits" increasing the ESA usage by 300% and GSA usage by 500% (rate of cancer in the US grows at 2%) while putting cancer patients lives at risk. When I think about the 20-30% of patients with no co-pay assistance the financial burden is devastating. So when I see a settlement of $762 million dollars on $77 billion dollars in sales and Medicare/Medicaid (taxpayers) pay for the majority of this "greed", I do not feel that the punishment fits the crime. With this continued cat and mouse game between the DOJ and pharmaceutical/biological manufacturers, the American taxpayer should be outraged. Protracted investigations of over a decade by the DOJ leading to insignificant settlement agreements while beating "relators" out of their fair share of the rewards is unacceptable. Where is the accountability. There needs to be some serious changes in the FCA laws with a special focus on phamaceutical/biotech "outlaws" or we may see a time when no one will come forward and bring the truth into the light.