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9/2 Allergan Hit with $600 Million Fine for Off-Label Promotion
Maker of Botox Settles Inquiry on Off-Label Use ... The agreement also required Allergan to drop its First Amendment lawsuit against the FDA, in which it had claimed free speech protections when giving doctors information about unapproved uses of Botox ... [NY Times]

9/2 Why Johnny Takes Powerful Shrink Meds
Child's Ordeal Shows Risks of Psychosis Drugs for Young ... Dangerous new trend: ready prescription-writing by doctors of more potent drugs to treat extremely young children, even infants, whose conditions rarely require such measures ... [NY Times]

9/2 A Father of Biotechnology, at age 64, May Take $300 MM and Pack It In
Genzyme's Termeer, Biotechnology Pioneer, May Sell ... "He's caught between a plant in Allston that is a disaster, Icahn in bed with him and Sanofi banging on the door," says one observer ... [Boomberg]

9/2 Meridia Faces FDA Safety Review Next Week
Prescription diet drug raises risk of heart attack, stroke ... A randomized study of 9,804 overweight or obese people found that the risk of a stroke, heart attack, cardiac arrest or cardiac death was 16% higher among people taking sibutramine compared with those taking a placebo ... [LA Times]
See also: NEJM editors call for removal of sibutramine from the US market [CardioBrief]

9/2 Pfizer Adds Another Orphan Drug Candidate; Drug Holds Off Need for Liver Transplant
Pfizer Picking Up FoldRx in Latest Rare Disease Buyout ... FoldRx recently submitted a marketing authorization application in Europe for tafamidis meglumine, a disease-modifying agent aimed at transthyretin amyloid polyneuropathy (ATTR-PN) ... [BioWorld]

9/2 Treatment Emerging for Nasty Chin Fat
Kythera Licenses Lucrative Fat Therapy to Bayer ... Kythera's leading drug candidate ATX-101 is entering phase III clinical trials in Europe in late 2010 for the reduction of localized fat under the chin ... [Biosmash]

9/2 Patient Support Website Catching a Buzz
Arnold Palmer fronts Centocor, Us TOO prostate cancer website ... Centocor Ortho Biotech, a division of Johnson & Johnson, doesn't "currently market any treatments for prostate cancer" but is in phase 3 trials with abiraterone acetate, a treatment for advanced metastatic prostate cancer ... [MM&M]
Direct link: My Prostate Cancer Roadmap website

9/2 Breast Cancer Claimants Get New Day in Court
Pennsylvania Court Reinstates HRT Lawsuits ... The ruling could restore as many as 1,000 mass tort lawsuits to the docket in Phildelphia Common Pleas Court ... [Pharmalot]

9/2 Chat Rooms Were Negative on Avandia before Mainstream Media
Avandia warning signs seen online as early as '04 ... Patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk ... [MM&M]

9/2 Provenge May Skate through CMS Confab without Major Damage
Medicare Meeting A Good Sign For Dendreon ... The speed with which the meeting was scheduled and the topics covered are a positive for the company ... [Forbes/Matthew Herper]

9/2 Internet Drug News
Miscellaneous Short Takes:
Diabetes drug can reduce risk of cancer, researchers find
LA Times
New test can diagnose tuberculosis in under 2 hours
Reuters
Graymark Healthcare to sell pharmacy unit to Walgreen
Reuters
Cardiome gets nod for marketing heart drug in EU
Reuters
Lilly's Evista patents upheld in appeals court ruling
Drug Store News


9/1 Cops Accuse Drug Rep Of Murdering District Manager Wife
- Scene described as bloodbath; alleged murder suicide plans fail:
Cops want murder charge in West Bloomfield bloodbath … Lisa Bennett was the manager of pharmaceutical representatives for Eli Lilly and Company and her husband, a one-time pharmaceutical rep ... [Detroit Free Press]
Editor's Note: Published reports claim alleged murderer Ellery Bates was the top salesperson for Merck

9/1 September 17 = High Noon For Avastin Breast Indication
- Influential breast cancer expert says efficacy iffy, unfair to blame Obamacare:
Avastin and metastatic breast cancer: When science-based medicine collides with FDA regulation … classic case study of how messy science-based medicine can be when practiced in the public eye and debated among pharmaceutical companies, the government, and patient advocacy groups…[Science Based Medicine Blog]

9/1 Teenagers Do It All The Time, So Why Is Pharma Shy
- Why Don't Drug Companies Blog?
Slogging Through Blogging as a Highly Regulated Industry - Some Thoughts for Pharma in the Blogosphere … what accounts for the lack of pharma blogs?   …  blog posting is longer and there is more room for error on the regulatory front … Don't Talk About Products …[EyeOnPharma]
Editor's Note: EyeOnPharma is a blog we stumbled upon by accident.  We bookmarked it because of the quality of the content.

9/1 What Aisle Did The Cough Medicine Used To Be In?
- FDA watchers predict dextromethorphan heading behind the counter
FDA Considering 'Anti-'Robotripping' Rules … More likely, however, it will either require the drugs to be sold behind the counter or restrict purchases by those under the age of 18 …[AOL News]
Cough-Syrup Abuse by Kids May Draw FDA Restrictions for Pfizer, J&J Drugs … routine labeling changes or product packaging redesign will probably not reduce the present abuse trend." …[Bloomberg]

9/1 Expert Explains Why FDA's Calendar Is Written In Pencil
- It's not arbitrary; read below for objective criteria
When Does FDA Extend a PDUFA Date? .. when there is a "major amendment" made to an NDA which can be because the FDA has requested certain information (a solicited amendment) or because the sponsor of the compound submits an amendment because there is new data that has to go into the application, such as results from a study ….[EyeOnFDA]

9/1 Clotbuster Could Actually Living Up To Its Hype
- Pfizer's first R&D coup in years? Time will tell:
Pfizer Clot Drug Beats Aspirin in Research, May Enter $10 Billion Market … markedly improved safety profile compared to warfarin … Warfarin typically reduces the rate of stroke 40 percent more than aspirin …[Bloomberg]
Blood Thinner From Pfizer, Bristol Halves Stroke Rate In Study …[NASDAQ]
C`c`
9/1 Special Report: 21 Drugs Facing Approval Before 2011
Ass kicking database regarding who what when:
21 Drugs Facing FDA Approval Decisions … 21 drugs (impacting 27 different drug and biotech companies) with approval applications to be decided before year's end …[The Street]
Editor's Note: Portfolio manager Adam Feuerstein assembles database of 27 meds awaiting approval before year end; ldrug/indication, approval decision date and recent stock performance.  List includes obesity drugs, lupus drug, gout, cancer, others ...recommended.

9/1 Journalist: Why Amgen Should Make Genzyme Bid
Why Amgen Should Buy Genzyme … too-heavily dependent on its new bone drug Prolia … Genzyme's stable of rare disease products would provide instant diversification …[Forbes]

9/1 Sun Pharma Gets 2nd FDA Warn
Sun Pharmaceutical Unit Gets FDA Warning … second instance of U.S. regulatory action against the Indian drug maker's U.S. units …[Wall Street Journal]

9/1 Internet Drug News Miscellaneous Short Takes:
Sun Pharma Announces USFDA Approval for Generic Strattera® Capsules
Sun Press Release
Why Roche Employees Will Pay With Their Jobs for Cancer Drug Avastin's Success
BNET
Medscape.com tops with docs, says report
MM&M
Lumigan: Line Extension; New, Lower Strength Approved
Allergan Press Release
FDA To Baxter: Start Telling The Truth
Pharmalot
Medicis Announces Approval Of Additional Strengths Of Solodyn(R)
Medicis Press Release
Ahead of the Bell: Forest Labs antibiotic ceftaroline faces key FDA panel
AP
GSK, Valeant Pharma Epilepsy Drug Faces 3-Month Delay
Glaxo Press Release

8/31 PTSD; Bereaved Soldier Families Blame Seroquel
- Families fear conspiracy to hide side effects; seek congressional probe
Questions loom over drug given to sleepless vets … died while taking the pills, raising concerns among some military families that the government is not being up front about the drug's risks …[AP]

8/31 Forest Bipolar Drug Hits Iceberg
- 3x side effects as placebo but similar efficacy
Results from a Phase II Study of Cariprazine for the Treatment of Bipolar Depression … overall difference observed between the drug-treated and placebo-treated groups was not statistically significant … 9% of patients discontinued the study early due to adverse events in the high dose study arm compared to 3% in the placebo arm …[Forest Press Release]

8/31 Suicide As Side Effect: 30,000 Foot View
- Disincentives regarding suicide as side effect
Medicine's Suicide Problem … Trials in at-risk patients would cost millions of dollars and could take years to perform; they might yield murky results-or worse …  35,000 Americans commit suicide …[Forbes]

8/31 Roche: Mega Layoff Speculation
- R&D failures, 20% share drop mean something's got to give
Roche Says No Decision on Job Cuts This Week … FDA might also revoke approval for Roche's blockbuster breast cancer drug Avastin …[ABC]
Roche Seen Under Pressure To Slash Costs After R&D Setbacks … setbacks such as the discontinuation of experimental drug ocrelizumab in rheumatoid arthritis and the failure to extend the use of cancer drug Avastin in areas such as gastric cancer…[Wall Street Journal]

8/31 What's A Few $Billion Between Friends
-Analyst doubts Genzyme rosy prediction for experimental MS pill
Genzyme Touts Value Of MS Drug, But View May Be Optimistic  … Genzyme expects Campath to immediately capture a quarter of the global MS drug market, which it estimates to be $13 billion in 2012 …[NASDAQ]
Editor's Note: Adds Analyst estimate for Campath is less than $1 Bln.

8/31 The Japanese Read Right to Left
- So what?
Global Report: Advertising that Travels … Languages, cultures and federal regulations aside, is marketing pharmaceutical products outside of the US all that different? Ben Comer talks global strategy with the experts …[MM&M]

8/31 Slightly Hostile But No Blood yet
- Sanofi Genzyme buyout dance continues
Sanofi Chief Extends Hand to Bypass Genzyme `Brick Wall' … Sanofi wants "a meeting of reasonable minds to actually sit down together and discuss what the options are …[Bloomberg]
Genzyme: Whitworth, Icahn Could Push Sanofi to $80 … deal will get done, probably north of $80 a share, and it may take five or six months … chances of a deal getting done have improved … [Wall Street Journal; $$$]

8/31 BNET: NY Times Was Remiss On Vetting Depression Article
- 3-year-olds and depression
Meet the Queen of "Preschool Depression" -- and Her Drug Company Backers … failed to disclose her past ties when it published "Preschool Depression," a study she did on 3- to 6-year-olds …[BNET Pharma]
Can Preschoolers Be Depressed? … Though research does not support the use of antidepressants in children this young, medication of preschoolers, often off label, is on the rise.…[NY Times]

8/31 Internet Drug News Miscellaneous Short Takes:
Drug Makers on the Trail of an Alternative to Steroids
NY Times
Maggots, Manure at Iowa Egg Farms Tied to Salmonella
Bloomberg
MedImmune receives complete response letter on motavizumab
AZN Press Release
Blacks more prone to blood clots after stents
Reuters 
Sanofi's Experimental Oral Multiple Sclerosis Treatment Reduces Relapses
Bloomberg

8/30 FEDS Crack Down On Non-Inferiority Trials
- FDA's afraid they lead to *Bio-Creep.
U.S. FDA gets tougher with certain drug trials …  critics question the benefit of approving a new drug if it is simply shown to be no worse than something already available …[Reuters]
*Editor's Note: Click HERE fort an explanation of Bio-Creep

Strattera Gets Breathing Room
- Another judge issues ruling to temporarily block generic launch.
Federal Court Extends Block On Generic Of Lilly's Strattera … until a further ruling from the judge. An earlier order from a lower court blocking the launch was slated to expire after two weeks …[NASDAQ]

8/30 AHA Journal: Actos Just As Risky As Avandia
- Similar rates of cardio risk, death; data hints possible class effect.
One TZD No Safer than Another …  (Actos) carries cardiac risk similar to that found for embattled sister compound rosiglitazone (Avandia), according to an analysis of an administrative claims database …[MedpageToday]
Diabetes Drugs From Takeda, GSK Found to Pose Similar Risks … 4 percent of patients taking either medication suffered either a heart attack, heart failure, both, or died …[Seeking Alpha]

8/30 Novartis Gets Nod For Tekturna + Amlodipine Combo Pill
- Tekturna heir apparent replacement franchise for Diovan as patent clock ticks.
Novartis receives FDA approval of Tekamlo™, a single-pill combination of aliskiren and amlodipine to treat high blood pressure …  available in four strengths as once-daily tablets containing aliskiren and amlodipine:  150 mg/5 mg tablets, 150 mg/10 mg tablets, 300 mg/5 mg tablets and 300 mg/10 mg tablets … only approved direct renin inhibitor, Tekturna, with the widely prescribed calcium channel blocker, amlodipine …[Novartis Press Release]

8/30 PremPro: Pfizer Settles Out Of Court Rather Than Face Jury Again
- Avoids risk mega punitive damage replay.
Pfizer Settles Prempro Case on Breast Cancer Before Retrial on Damages … avoiding a second punitive damages trial … lost seven of the 12 Prempro cases juries have considered since the cases began going to trial ...[Bloomberg]
Editor's Note:  Originally the plaintiff had been awarded $29 mln but Pfizer succeeded in getting the ruling overturned.

Genzyme Confident Regarding Cerezyme, Fabrazyme Supplies
- Confident on Cerezyme, not so confident on Fabrazyme.
Genzyme to end rationing of Cerezyme in September … hopes will prove it is emerging from a manufacturing crisis that decimated its shares and helped make the company an acquisition target … [Reuters]
Genzyme Says U.S. Enzyme Dosing Will Return to Normal … normal dosing generally means getting the drug twice a month ...patients have been getting the drug once a month during the shortage …[Wall Street Journal]
Genzyme will double shipments of rationed drugs …[Boston Globe]

8/30 Worked For HIV, Why Not Cancer?
- Upcoming FDA guidelines could make it easier for pharma to release cocktails.
Cocktails Are Next For Cancer-Drug Makers … wouldn't have been possible just five years ago, when FDA rules required that the merit of each active ingredient be proved before it could be added to a combination …[BusinessWeek]

8/30 Cost Crackdown At Acquisition Level Backfires
Heart expert says cost cuts may undermine drug R&D … promoting cheap generics in the way European governments are now doing could jeopardize the long-term supply of new heart drugs…[Reuters]

8/30 Pharma Online Spend Flat
- FDA regs seen as chief culprit.
Pharma's share of US online adspend stuck at 4%, says study …  pharma online ad spend will rise 10.6% to hit $1 billion this year and grow to $1.5 billion in 2014 … Online DTC marketing will grow as a piece of the promotional spending pie, but not dramatically …[MM&M]

8/30 Internet Drug News Miscellaneous Short Takes:
EU probes swine flu vaccine -  narcolepsy link
Reuters
CEO: J&J let down public, must work to build trust
AP
Vanda Tests Drug For Blind People With Sleep Disorder
Forbes
Sanofi-Aventis and Genzyme: Walking Away?
In The Pipeline
A Recall a Week, That's All We Ask
Motley Fool
Pockets of Profit in Health-Care Stocks
Investopedia
Some Fake ADHD to Get Meds, Special Treatment
HealthDay
Doctors look for orange-size lump, find 56-pounder
AP
Drugs block Ebola, Marburg viruses in tests
LA Times

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