Pharmaceutical News Harvest ™
<< Today's News |  Go Back One Week  >>

6/25 3 Million More Diabetics; New Number = 24 Million
Number of People with Diabetes Increases to 24 Million … increase of more than 3 million in approximately two years … indication that our efforts to increase awareness are working … [Department of Health and Human Services Communiqué]
Editor's Note: Adds demographic breakdown by Native American, African American, Latino, Caucasian and Asain.  Whites have the lowest prevalence at about 6.6%.

6/25 GSK Gets Nod For 4-In-1 Kids Vaccine
FDA Approves KINRIX(TM) - New Combination Vaccine for Children … diphtheria, tetanus, pertussis and polio diseases in one shot …[ GSK Press Release]

6/25 Prandin + Metformin Combo Pill Green Lighted
FDA Approves PrandiMet(TM), a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes … secretagogue replaglinide (also known as Prandin®) and metformin … 1 mg./500 mg. and 2 mg./500 mg …[Sciele Pharma Press Release]

6/25 Deal Allows Barr To Sell Generic Yasmin & Yaz
Bayer and Barr agree oral contraceptive deal … Barr said the deal would enable it to launch its authorized generic versions of Bayer's Yasmin and Yaz oral contraceptives years before the patents protecting them expired…[Reuters]
Bayer, Barr Sign Contract Allowing Generic Yasmin …[Bloomberg]
See Also: Barr Press Release

6/25 House Passes Bill To Slash Rates To Medicare Advantage
Medicare companies watch US bill impacting pay … $13 billion in cuts to private health plans that contract with the government for patients on Medicare … Republican bill in the Senate proposes smaller cuts, but would still include billions in cuts…[Reuters]

6/25 Vitamin D Joins Aspirin As Cardio Death Shield
Vitamin D deficiency linked to death from all causes: study … especially from cardiovascular disease … twice as many of the patients with vitamin D deficiency died during the course of the study … [AFP]
Editor's Note: Not exactly new; Circulation ran a similar report in January; [ see: Wang T, et al "Vitamin D deficiency and risk of cardiovascular disease" Circulation 2008; DOI: 10.1161/CIRCULATIONAHA.107.706127]

Chantix: Great Expectations Dashed; Exubera Curse?
Pfizer's Chantix Woes Bash Blockbuster Hopes … 30% fewer prescriptions for Chantix than they were a year ago … Early on, Pfizer itself placed a high-stakes bet on Chantix … critics question whether the drug works well enough to justify its risks …[The Street]

6/25 McKesson: $Multibillion Price Inflate  Suit; Settlement In Works
McKesson May Settle $15 Billion Suit Over Drug Prices … plaintiffs claim the scheme cost consumers $5 billion in unnecessary drug charges … McKesson and First DataBank agreed to change a reimbursement price only after a drug manufacturer actually increased its wholesale price…[Bloomberg]

6/25 McKesson Boss Gets Huge Pay Raise
McKesson CEO Hammergren's pay jumps to $26.8M ...McKesson earned a record $990 million in its fiscal year ending in March … 49-year-old chief executive's package included nearly $12 million in bonuses…[Newsday]

6/25 Insurance Companies Place Generic Drug ATM's In Doc Offices
Doctors embrace Highmark drug 'ATM' … Health insurers hoping to convince physicians to bypass their offices' brand name sample drug "closets" are embracing an ATM-like generic drug dispensing machine … PittsburgLive]

6/25 Internet Drug News Miscellaneous Short Takes:
Drug Lobby Spends $168 Million In '07
IndyStar
As FDA Delays Ruling on Eli Lilly Drug, Clock Ticks on Plavix Patent
Wall Street Journal; FREE
Goldman Sachs upgrades Novo Nordisk to "Buy"
AP
Will Bayer AG Overtake AstraZeneca in China Drug Sales?
Seeking Alpha
Medical Pot Ineffective as Acute Pain Treatment
HealthDay
SLV308: Experimental; New Hope For Parkinson's
HealthDay
Contrarians: Now Is Time To Buy Pfizer
Forbes
Melnyk loses bid to replace Biovail board: report
Reuters

6/24 Daiichi/Lilly Answer To Plavix DecisionDelayed Another 90 Days
FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel … new FDA action date for prasugrel is September 26, 2008. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery- opening procedure known as percutaneous coronary intervention (PCI)…[ Daiichi Sankyo Press Release]

6/24 Larger Meaning Of The Cordaptive Delay
Is Merck Flying Blind? … seems to have missed other lessons from the Vytorin mess …  big question raised is not just when Cordaptive will get approved ...Merck canceled a trial of the drug run by the same outside scientist--John Kastelein of the University of Amsterdam--who ran the Vytorin trial … instead of waiting for data, Merck decided, based on the study's design, that the trial was unlikely to provide a clear answer.[ Forbes;Matthew Herper ]
Editor's Note: Forbes implies that Merck has not learned from Vioxx or Vytorin in that they are not sure of how intrinsically safe laropiprant (the flushing reducing agent in Cordaptive) is as a solo entity regardless of how it behaves as part of a combo pill.  Also, the way they halted the above cited clinical trial makes them look bad.  Forbes implies that the outcome studies that are due out in 2013 may not be enough to convince FDA that Cordaptive is worthy of approval. 

6/24 Sanofi 5-In-1 Kid Vaccine Gets Nod
U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R) … first 5-in-1 pediatric combination for immunization against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b …[Sanofi Press Release]

6/24 Calling All Brits: No Rx Needed For Ye Olde Birth Control Pill
Contraceptive pill available online in Britain … Women in Britain can for the first time get the contraceptive pill legally online without having to see medics first … Patients have to fill in a health questionnaire and a doctor from the website can ask follow-up questions … [Reuters]
Editor's Note: In order for this to work in the USA, we would need special leglistation shielding providers from lawsuits. 

6/24 Doughnut Hole Propels Shift Toward Generics; Was 50% Now 63%
Generic Drugs Now Own 63% of Medicare Part D Market - Up from 50% Less Than Three Years Ago … Among those in the coverage gap who discontinue their brands, only 6% returned to their branded medication after leaving the gap …[ Wolters Kluwer Health Press Release]
See Also: Click Here To Read The Actual White Paper Cited Above

6/24 Pfizer Scheme: Inject Stem Cells Into Sick Eyeballs
Pfizer Eyes New Use For Stem Cells … may be able to stave off diabetes-induced retina damage, a leading cause of blindness … single injection could stave off further blood-vessel damage for years, preserving eyesight that would otherwise be lost …[Forbes]
See Also> Similar Report From Boston Globe

6/24 Long Considered Recession Safe Haven, Big Pharma Circles Drain
Even Defensive Names Take Hits … big-name drug makers have been struggling as patents on blockbuster drugs expire, paving the way for more generic competition…[Wall Street Journal]

6/24 Alleged Fraudmeister Fen-Phen Lawyers Find Out Soon If They ...
Final arguments in Ky. diet drug settlement case … Three lawyers accused of defrauding their clients in a $200 million diet drug settlement were greedy, a prosecutor charged Monday during closing arguments of their high-profile trial. But a defense attorney said the attorneys did not commit any crime…[Philly.com]
Editor's Note: The above named defendants are charged with stealing $65 million from their clients.

6/24 MK-0974 Matches Triptan For Migraine Relief
Merck Migraine Drug Comparable To AstraZeneca Drug In Study … MK-0974, was superior to a fake drug, or placebo, in relieving migraines, with similar rates of side effects ...analysts believe MK-0974 could reach $1 billion in annual sales.
... plans to submit its drug for U.S. regulatory approval next year …[NASDAQ]
Would you like to learn More About MK-0974? Click Here

6/24 FDA Hotshot Embroiled In Financial Matter Steps Down
FDA Regulatory Affairs Chief Glavin To Retire … official whose sizeable bonuses were among those criticized by lawmakers last year will retire soon, according to an internal agency memo …[ iStockAnalyst]

6/24  Novo Enlists Emisphere To Develop P.O. GLP-1's
Emisphere shares jump on Novo Nordisk deal … Novo Nordisk will use Emisphere's technology to make oral forms of diabetes treatments. Novo Nordisk is currently developing the injectable GLP-1 treatment liraglutide, which works by lowering blood-sugar levels …[CNN]

6/24 Internet Drug News Miscellaneous Short Takes:
Anti-Vaccine Activists Have Gardasil In Crosshairs
Time
Stiefel To Buy Barrier
Star Ledger
GNLB: To Continue Collaboration w/Novartis; Gilead Terminates Collaboration
Dow Jones
Chest pain common a year after heart attack: study
Reuters

6/23 Vytorin/Zetia Sales Decay Seems To Have Stabilized
Merck/Schering Cholesterol Drug Prescrptns Down 1.1% In May … dropped 11% from March to April and have declined 23% since January … [NASDAQ]

6/23 Cordaptive: Dead In The Water Until 2013
A lengthy delay for Merck medicine … succeeded in lessening the flushing side-effect, but only marginally … FDA's hesitation over the drug appears to be a combination of its minimal benefit to patients as well as the agency's new cautiousness, … [Star Ledger]
Long Delay Seen For Merck's Cholesterol Drug … FDA wants to see so-called "outcomes" data before it approves the drug. This would seem to confirm the belief that FDA is becoming more stringent about cholesterol drugs in the wake of the controversy over the " Enhance" trial …[Dow Jones]
Editor's Note: Adds that FDA wants a name change.
See Also> Similar Report From Wall Street Journal; $$$
Editor's Note: Dow Jones report adds that EU regulators have suggested approval and that final adjudication is expected this summer.
Editor's Note: Here's what we to say about Cordaptive on 4/30/08  … "Considering that the lipid lowering market is flush with proven products FDA is not in any rush to green light new lipid lowering agents; the last thing they want is another Vytorin … "

6/23 Prasugrel's Has Date With Destiny This Thursday (6/26/08)
Prasugrel: FDA set to weigh in, high chance for approval with label warnings - cardiologists … FDA is expected to rule on approval before the drug's PDUFA date of 26 June … concern over the bleeding risk could lead to a narrow label or black box warning, and cardiologists admitted the risk was too significant to ignore …[ FT]

6/23 Pfizer Sinks To $17.33/ Share
Pfizer Closes At Multi-Year Low …[Dow Jones]

6/23 Pfizer: No Way Gonna Buy Ranbaxy
Pfizer Inc: No Intention Of Buying Ranbaxy … we normally do not comment on market rumors or speculation, I can tell you that we have no intention of buying the company (Ranbaxy) …[Dow Jones]

6/23 Avodart/Flomax Combo Pill Green Lighted
GlaxoSmithKline prostate drug combination approved … combination of Avodart and tamsulosin at diagnosis allows doctors to simultaneously treat the patient's prostate on two fronts by reducing prostate size and rapidly improving symptoms …[AP]
See Also: GSK Press Release

6/23 Promacta Delayed 3 Months
Ligand says FDA extends blood-clot drug review … additional three months to review its experimental blood-clotting drug Promacta … key issue for the FDA in prior statements was the absence of long-term safety data and concerns over the potential for liver toxicity …[AP]

6/23 Investigation of Glaxo's Paxil widens
U.S. Probe of Glaxo's Paxil Widens … probe of marketing and safety research, appears to be widening. … activities by company representatives involving the promotion of Paxil's safety and efficacy for teens and children…[Wall Street Journal; $$$]
Related: FDA Got Left Out on Paxil Risk Documents … Litigation over GlaxoSmithKline's handling of information about the suicide risk from antidepressant Paxil has turned up some documents that say a lot about why the FDA often seems to be in the dark when problems with drugs surface…[Wall Street Journal; FREE]

6/23 Velcade Gets Nod For Earlier Use
Takeda wins US OK for expanded Velcade use … 30 percent of previously-untreated patients had complete remission of their cancer after receiving Velcade … second most common hematological cancer  ...56,000 Americans living with the disease…[Bloomberg]
FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma …[ Takeda Press Release]

6/23 FDA: 4 More Imaging Agent Linked Deaths Since October
FDA says deaths with heart imaging drugs continue … since October it has received four reports of patients dying after receiving injections of the drug Definity. One patient with congestive heart failure died within five minutes of receiving the drug …[AP]
FDA: Concerns remain over heart imaging agents … Optison, made by GE Healthcare, and Definity, made by privately-held Lantheus Medical Imaging … Four more deaths in patients given the Lantheus product…[Reuters]

6/23 Neurontin Suicides Trial Bombshell: Company Ignored Expert's Plea
For Depression Warning As Early As 1995
Neurontin Should Have Had Depression Warning, Neurologist Says … According to The Wall Street Journal, various lawsuits have been consolidated in the federal court in which plaintiffs allege more than 100 suicides were connected to Neurontin usage …[News Inferno]
Early Neurontin Link to Depression Was Ignored …[Wall Street Journal; FREE]

6/23 China, India Outsourcing Comes Under Fire From Dem Senator
Senator Wants FDA Probe of India, China Pharma … claims drugmakers are taking advantage of lower safety standards in India and China … Most of the outsourced work relates to active pharmaceutical ingredients, the basic chemical of the drug …[BusinessWeek]

6/23 Internet Drug News Miscellaneous Short Takes:
Price keeps doctors from electronic record-keeping
Philly.com
GSK Update on FDA Review of Promacta(R) (Eltrombopag)
GSK Press Release
Gleevec may improve stroke treatment: study
Reuters
The Vytorin trial: Cholesterol conspiracies and contortions
Salem Gazette
Biovail stock falls after analyst cuts rating
AP


***********************************
**** Do You Want To Trade Links? ***
***********************************
We are developing a Pharmaceutical Internet Resources page.

Do you have a quality pharma oriented website? 
Do you want to trade links with us? 

If your site has content other than just selling something, and it is a quality site we want to trade links with you.  E-Mail the webmaster of you want to trade links.
*****************************************************

Click HERE For Last Week's News, week before that, etc.  ->