4/29 Want Chemo? You Must Pay Before Treatment
… M.D. Anderson says it went to a new upfront-collection system for initial visits in 2005 after its unpaid patient bills jumped by $18 million to $52 million …[Wall Street Journal]
See Also: 3 minute video

4/29 Cordaptive; Mk-0524a; Merck Gets Non-Approvable Letter
Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) … agency rejected the proposed trade name CORDAPTIVE for MK-0524A … expects to pursue the alternative trade name TREDAPTIVE for use in the United States …[ Merck Press Release]

4/29 Artificial Blood Linked To Heart Attack, Death
New Study Blasts FDA for Allowing Human Testing of Risky Artificial Blood … patients given blood substitutes faced a 30 percent greater risk of death and a 171 percent increased risk of heart attack compared …[ABC]
Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death … 30% statistically significant increase in mortality risk. There was also a statistically significant 2.7-fold increase in MI risk associated with these products … [JAMA. 2008;299(19):(doi:10.1001/jama.299.19.jrv80007]

4/29 Fosamax Linked To Heart Problems
Osteoporosis drug Fosamax may double risk of heart trouble ...dose of caution for doctors and patients, particularly those who are at relatively low risk of bone fracture but are at a high risk of diabetes or cardiovascular problems …[Seattle Times]

4/29 Lipitor: YTD Sales Down 13.6%; Rolling 3 Down 7%
Pfizer's Lipitor Continues To Lose Ground  … Year-to-date U.S. Lipitor prescription volume through April 18 declined 13.6% from the year-earlier period … LIPITOR SALES: $3.1 billion for three months ended March 31, down 7% from a year earlier …[NASDAQ]

4/29 Phenytoin Linked To Bone Loss
Epilepsy Drug Increases Bone Loss …  associated with a 2.6% decrease in bone density in the femoral neck of the hip whereas other epilepsy drugs were not associated with change …[ Medpage]
Editor's Note: Adds short audio clip.
4/29 Mylan COO's Undeserved MBA Scandal Fallout Continues
Two WVU academic leaders resign … comes less than a week after an independent panel released a scathing assessment of West Virginia University's decision to retroactively award an executive MBA degree to Mylan COO Heather Bresch … [Pittsburgh Business Times]

4/29 Association of American Medical Colleges Report Urges Crackdown On Drug Reps, Food, Speaking Fees In Teaching Hospitals
Doctors Should Spurn Offers of Free Food, Travel, Report Finds …  recommend visits to physicians by pharmaceutical representatives occur only by appointment or at the doctor's invitation, and that the visitors be restricted to non-patient areas…[Bloomberg]
Stop the Med School Free-Pizza Madness! … should "strongly discourage" faculty from participating on industry speakers' bureaus…[Wall Street Journal; FREE]
See Also> Similar Report From NY Times

4/29 Class 1 Recall Of Bertek Digoxin Tablets
Actavis Totowa recalls all lots of Bertek and UDL Laboratories Digitek® as precaution … distributed by Mylan Pharmaceuticals Inc., under a "Bertek" … tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate …[FDA Press Release]]
See Also: MedWatch Communiqué

4/29 19 Kids Die So Far; Enterovirus Spreading Through China
China steps up monitoring of deadly virus outbreak … killed 19 children and spread panic … enterovirus 71, or EV71, which can cause hand, foot and mouth disease, began spreading in Anhui province's Fuyang city from early March…no vaccine or antiviral agent available to treat or prevent the virus ...[Reuters]

4/29 Internet Drug News Miscellaneous Short Takes:
Pharmacy owner could face 130 years in prison for Medicare fraud
Drug Topics
Apotex Sues FDA to Recover Its 180-Day Exclusivity on Generic Plavix
Seeking Alpha
Teva Announces Approval of Generic Flolan(R) for Injection
Teva Press Release
Lupin Announces Launch of Suprax(R) 400mg Tablets
Lupin Press Release

4/28 Singulair/Claritin Combo Pill Gets Not-Approvable Letter
FDA rejects Schering-Merck combo allergy drug … received a "not-approvable" letter from the FDA … declined to elaborate on why the FDA rejected the product or say if the two companies planned to resubmit…[Reuters]

4/28 AstraZeneca Urges Feds To Review DTC Spots
AstraZeneca pushes for reviews of TV drug ads … pushed for the ad-review program to address criticism that their widespread promotions led to unnecessary prescribing and at times ventured into hype…[Reuters]

4/28 VIDEO: Pharma's Patent Woes … Many profitable pharmaceuticals will soon lose their patents, and drugmakers are scrambling for replacements …[CNN/MONEY]

4/28 FDA Write-Up Of Merck Vaccine Plant Details Serious Concerns
FDA report shows problems at Merck vaccine plant … U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices …[Philadelphia Inquirer]
: adds details regarding unwanted fibers on vaccine stoppers, contaminated lots of PEDVAX and ProQuad.

4/28 Cordaptive: Merck Niaspan To Face FDA Panel Monday
U.S. approval seen near for Merck cholesterol drug …  combines long-acting niacin with a novel anti-flushing agent … European regulators recommended approval of Cordaptive, which will be sold there under the brand name Tredaptive…[Reuters]
See Also: Patients Treated with Merck's Investigational Extended-Release Niacin/Laropiprant (CORDAPTIVE™) Reported Significantly Less Flushing Than Patients Treated with Niaspan™ in Phase III Study … One tablet of CORDAPTIVE contains 1 g of Merck-developed ER niacin and 20 mg of laropiprant …[Merck Press Release]
See Also: Medline Search For "laropiprant"
Editor's Note: Laropiprant is a selective antagonist of the prostaglandin D2 receptor subtype 1 (DP1), which may mediate niacin-induced vasodilation …[Clinical Pharmacology & Therapeutics (2007) 81, 849-857. doi:10.1038/sj.clpt.6100180]

4/28 Mylan COO MBA Wasn't Earned,  Will Be Rescinded
Panel: Mylan Exec, Governor's Daughter, Didn't Earn MBA ...COO, Heather Bresch, is the daughter of West Virginia Gov. Joe Manchin … improperly awarded an executive MBA by West Virginia University … university now says it will rescind the degree ……[Wall Street Journal]
Panel: WVU improperly granted degree to governor's daughter … [AP]

4/28 5-Fluorouracil Blamed For Memory Problems
Common Chemotherapy Drug Linked to Memory Problems … 'Chemo brain' a routine side effect of treatment with drug 5-fluorouracil … Up to 50 percent of women with breast cancer reported having cognitive problems a year after chemotherapy treatment ended …[HealthDay]

4/28 Quest To Extend Lipitor Patent Suffers Setback
US Patent Office Rejects Pfizer Lipitor Patent Request Again ...latest setback in Pfizer's attempt to extend Lipitor's U.S. market exclusivity by about 15 months, to June 2011. Another Lipitor patent remains in effect until March 2010, after which the drug would become subject to generic competition …[NASDAQ]

4/28 Physician Only Website Launches New Journal review Product
Publishers partner with Sermo for "World's largest journal club"  … Sermo, the physician online community, formally launched its "Discuss on Sermo" initiative, by which journal publishers provide links to articles and research and can facilitate discussions on them among their readers and Sermo members …[MM&M]

4/28 Internet Drug News Miscellaneous Short Takes:
Wyeth chairman Robert Essner to retire June '08
MM&M
More states consider bans on gifts to physicians
MM&M

MedlinePlus

HealthDay
Neupro(R) Patch Gets Nod For Restless Legs Syndrome In EU
UCB Press Release
Trasylol: Bayer Faces 78 Lawsuits
Reuters
Vyvanse forecast disappoints, shares fall
Reuters
Bristol-Myers, Medarex cancer drug hits delay
Reuters

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