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10/17 DTC Ad Spending Down
Media hurts as drug ad spending is seen less effective
drugmakers cut Rx ad spending in the first six months of this year. TNS Media Intelligence puts the drop at 3.9% to $2.4 billion
[USA Today]
10/17 Prasugrel Hit With Another Delay
FDA To Hold February Meeting On Lilly's Prasugrel
February advisory committee date means it is highly unlikely the FDA will decide on prasugrel before March, the newsletter speculates
[ Pharmalot]
Lilly Prasugrel Delay Could Extend Well Into 2009
FDA is looking at a February advisory committee for Lilly/Daiichi anti-clotting drug. Safety issues are one potential topic
[ Pink Sheet]
10/17 Raptiva Gets Black Box
FDA Issues Boxed Warning for Efalizumab
highlights the risk of life-threatening infections, including progressive multifocal leukoencephalopathy (PML) ...also include an increased risk of bacterial sepsis, viral meningitis, and invasive fungal disease
[MedPage]
See Also: Similar Report From AP/Yahoo
10/17 Sens Imply Stent Payola
Senators Probe Cardiologists' Ties to Stent Makers
writing to drug and device makers directly lately, asking them about their payments to docs, and we wouldn't be surprised if they're doing a bit of triangulation here and seeking info from the companies as well
[Wall Street Journal; FREE]
10/17 Pfizer Indicates It Wants To Increase Generics Biz
Pfizer Goes Generic
wants to be a bigger player in the rough-and-tumble, low-margins generics business -- and plans to start selling generic versions of competitors' off-patent drugs
[Wall Street Journal; FREE]
10/17 Dem Fundraiser Gets Special Treatment To Receive Tysabri Off-Label
Baron Receives Biogen Drug After Clinton Appeals
Baron doesn't fit all the criteria for the clinical trial, Aoki said. Biogen had decided not to provide the drug to patients for non-FDA-approved uses outside the trial
[Bloomberg]
10/17 Germans Need Multiple Doc Sign-Offs For Certain Drugs
Germany May Require Doctors to Review Prescriptions
Patients may need two doctors to sign off on prescriptions before their public health insurance will cover four expensive medicines for a potentially fatal lung condition
[Bloomberg]
10/17 FDA To Open Satellite Offices In China
FDA will open inspection office in China this year
plan for permanent outposts marks a break from the agency's current practice of sending inspectors abroad on individual assignments
[BusinessWeek]
10/17 Aspirin Conventional Wisdom Blown Away
Aspirin Doesn't Prevent First Heart Attack, Stroke
recommendations probably should be changed
they did not benefit from daily aspirin," Belch said. The study showed that aspirin is ineffective in primary prevention
[HealthDay]
10/17 Germany
Nicotine found to spur breast cancer growth
Boston.com
CVS Caremark Extends Tender Offer for Longs Drug Stores Shares by One Day
CVS Press Release
Genentech on Roche's Plans: Our Lips Are Sealed
CNBC
Teva Announces Sale of Its Israeli Veterinary Business to Phibro Animal Health
Teva Press Release
10/16 Gunning For Coumadin; 6 Wannabes; Hip Pocket Review Of
New Remedies to Treat Blood Clots Are Near
three drugs -- developed by Bayer AG in partnerships with Johnson & Johnson, Boehringer Ingelheim GmbH, and Pfizer Inc. in partnership with Bristol Myers-Squibb Co. -- are now in the late phases of clinical testing
[Wall Street Journal; $$$]
Editor's Note: Adds groovy spreadsheet; Vit K antagonists, heparins, direct thrombin inhibitors; useful for PowerPoint geeks with blood thinner presentation homework.
10/16 Ionsys; JNJ; Fentanyl Delivery System; Recalled In EU;
USA Launch Delayed
J&J Recalls Pain-Drug Device In Europe; US Launch Delayed
Ionsys is a needle-free device that attaches to the skin and delivers the drug fentanyl through the skin via an electrical field
potential defect that could lead to overdose
some were found to self-activate
[ NASDAQ]
See Also: Ionsys press release; Germany; explains what it is; differentiation factors.
See Also: Ionsys Images: Fig.1 | Fig. 2 | Fig. 3 | Fig. 4
10/16 Court: Bayer, Barr Generic Cipro Arrangement Kosher
US court upholds Bayer, Barr deal over Cipro
that paid Barr Pharmaceuticals to delay producing a generic version of the antibiotic drug Cipro
Federal Trade Commission considers agreements that delay the availability of cheaper generic versions of drugs a violation of antitrust law
[Reuters]
10/16 Whites Most Depressed, Hispanics Least
Major Depression Prevalence is Closely Correlated with Ethnic Status in the U.S.
Whites have a higher rate of depression, whereas Hispanics generally have lower rates
California, Texas, Arizona and Florida Are Four of the Five States With the Lowest Prevalent Rates of Depression
[Decision Resources Press Release]
Editor's Note: What do the above 4 states have in common? It's the sun, son.
10/16 Lilly Launches Next-Generation Forteo Pen Delivery Device
Lilly Launches New FORTEO Delivery Device
new design includes a larger and wider body; fewer steps to complete an injection with no priming necessary; and color-coded parts to enhance patient training
[Lilly Press Release]
10/16 Xience; Abbott's Stent Is Kicking A$$ 3 Months Post Launch
Abbott profit soars; new stent has explosive sales
No. 1 stent on the U.S. market, with share in the mid-to-upper 20s
[Reuters]
Editor's Note: Adds performance report card, analysts' sanguine comments regarding key franchises,
Abbott Looks Like the New Stent King
market-leading DES in the U.S." Not bad, considering that the stent was just approved in early July
[Wall Street Journal; FREE]
10/16 Lame Duck Hopes For Pre-Emption Legacy
Bush Rule Changes Could Block Product-Safety Suits
Bush Administration officials are using their last days in office to rewrite a wide array of federal rules in order to block product safety
[Wall Street Journal; $$$]
Editor's Note: Adds information regarding upcoming Supreme Court case involving pre-emption.
10/16 Wyeth Delays Depression Submission For Pristiq In Europe
Wyeth calls off European Marketing Authorization Application for depression drug desvenlafaxine
lready been approved for the treatment of MDD in adults in the United States, Australia and Brazil
[RTT]
Wyeth puts off European OK for depression drug
decided against pursuing European approval for its depression treatment for now after consulting with regulators
[Reuters]
10/16 Internet Drug News Miscellaneous Short Takes:
Merck Vaccine Factory Functional; Licensing Is Next Step
Merck Press Release
AZN Partners With Colombia University To Invent CNS Meds
AZN Press Release
FDA Grants Orphan Drug Status to Reata's RTA 402 for Pancreatic Cancer
Reata Press Release
Analysts forecast strong 3Q HIV drug sales
AP
Genentech climbs after reporting growing cancer drug sales
MarketWatch
10/15 If You Take Cordarone Take It Long Term So You Don't Die
Taking Cordarone for short time not an option
shorter periods of time did little to ease side effects and left patients with a higher risk of premature death
[Reuters]
10/15 "Aspirin with Heart Advantage" Pols Imply Effort To Mislead
Lawmakers expand probe to Bayer aspirin adverts
combination product that includes a dietary supplement, appears to go against a U.S. Food and Drug Administration's request not to advertise such products
[Reuters]
Dems question cholesterol claims on Bayer product
defied recommendations from federal health regulators and added dietary health claims to its over-the-counter pain reliever aspirin
[AP]
10/15 Malaria: Kid-Unfriendly Dosage Forms -> Greater Mortality, BUT Now ...
Sweetened pill could help children beat malaria
young children cannot swallow whole tablets and crushing them can weaken the medicine. The crushed pills also taste bitter when mixed with water
Coartem, made up of artemether and lumefantrine, is the most widely used anti-malaria medicine in Africa
[Reuters]
10/15 Brits Play Hardball With GSK regarding Tykerb (lapatinib)
NICE snubs Glaxo's pay-for-performance plan
isn't backing off its tough stance on cancer meds
straight-armed GlaxoSmithKline's breast cancer treatment Tyverb--for the second time--despite an innovative pricing proposal from GSK
[ FiercePharma]
See Also: Glaxo Drug Hits U.K. Insurance Hurdle
[Wall Street Journal; $$$]
See Also: GSK Responds To NICE's 2nd Technology Appraisal Consultation Document On The Use Of Tyverb, In Combination With Capecitabine
would result in patients in the UK being disadvantaged compared to several other European countries that have already acknowledged the value of lapatinib and are reimbursing the medicine,
[GSK Press Release]
Editor's Note: Tyverb is marketed as Tykerb in the USA. According toRxUSA one Tykerb pill (150mg) retails for $25.67. The dose is 5 pills per day for 21 days in combination with capecitabine 2,000 mg/m2/day.
Regardless of genuine value, development and marketing costs, envelope pushing prices cause the lay public, media and policy makers to feel they are being overcharged. Perception is reality to these people.
The higher that cancer drug prices go, the more likely that the political price control debate will heat up. Problem is, you don't know how much you can charge until you charge too much and there is a Pandora's backlash.
In the late 80's and early 90's high prices and frequent price increases irreversibly hurt pharma's image and caused a payor mutiny that lead to restrictive formulary controls, contracting and media smearing.
Let's hope that the same phenomenon doesn't repeat itself with oncology products (or other specialty products).
10/15 What Disease Sufferers Are Most Likely To Sit Through Webcasts?
Top Condition Groups Shifting Their TV Viewing Online
Acne and attention deficit hyperactivity disorder (ADHD) patients are the condition groups most likely to watch streaming or downloaded television programs on the Internet
[Manhattan Research]
Editor's Note: Eczema, bipolar and allergies were also in the top 5. There are all persistent incurable non-lethal ailments with many treatment options. I would imaging that hairloss is also up there.
10/15 Pharmalot: Pfizer Big Layoff Explored Including Many Reps
Pfizer's Desperate Times & Desperate Measures
laying off still more employees - a large number of reps
sign that more job cuts are coming, sources say Pfizer recently extended its severance package program
[Pharmalot]
10/15 Pharma Hedges Its Campaign Donation Bets
Drug Industry, Having Long Smiled on G.O.P., Now Splits Donations Equally
After favoring Republicans by a ratio of more than two to one for most of the last decade, pharmaceutical companies and others in the health care industry are now splitting their contributions evenly between the two major parties
[ NY Times; Free Registration Required ]
10/15 MSRA: Contributing Factors Include Age, Obesity, GI Surgery...
Surgeons Faced with Killer Infections - Topic of Discussion at American College of Surgeons Meeting in San Francisco This Week
aging population and the obesity/diabetes epidemic present higher risk factors for SSIs especially in patients undergoing colon and gastric surgeries
[ HHC.com]
See Also: Contemporary Guide to Surgical Infections
10/15 Internet Drug News Miscellaneous Short Takes:
Top 20% of endocrinologists write lion's share of new oral diabetes scripts: SDI
MM&M
Paliperidone Palmitate Launch Unlikely Until 2010, J&J Says
The Pink Sheet Daily
Par slashes staff as Schwarz, AMDL expand
MM&M
Par Pharma resizes generic unit; to cut 190 jobs; COO resigns - update
MM&M
Generic Monoclonal Antibodies in Onc Will Approach Blockbuster Status by 2017
Decision Resources
India's Ranbaxy says to close Daiichi deal by Dec
Reuters
10/14 Merck: FDA Said Vioxx Was Safe So It's Not Fair To Sue Us
NJ Supreme Court To Hear Vioxx Preemption
Merck had argued the McDarby case warranted reversal, because Superior Court Judge Carol Higbee shouldn't have let jurors second-guess the FDA's approval of a label that didn't warn of heart attack risks
[Pharmalot]
10/14 Vioxx Heart Risk Evaporates One Year Post-Discontinuation
Long-term study confirms Vioxx heart risks
good news is the data suggests that the risk doesn't persist forever
risk goes away a year after people stop taking it
[Reuters]
10/14 How Avastin Dodged The Primetime DVR Bullet
Genentech's Avastin Goes Primetime
character on the show has just been told she has cancer that has spread
might not be an example of formal product placement. Maybe one of the scriptwriters or medical consultants on the show just threw it in there for authenticity
[ CNBC]
Editor's Note: " I don't care doc, I want the one on TV; you know - Grey's Anatomy".
10/14 I Don't Have The Money So I Ain't Taking No Cancer Drugs
Thomson Reuters Survey Finds Cancer Patients Forgoing Treatment Because of Cost
25 Percent of Late-Stage Patients Earning Under $40,000 Annually Say They Have Chosen Not to Undergo Recommended Care
12.3 percent said they have passed up recommended treatment because it was too expensive
[ Thomson Press Release]
10/14 Cachexia Medicine Meets Target
GTx's Ostarine meets targets in Phase II Cancer Cachexia study
statistically significant increase in lean body mass compared to placebo
clinically meaningful increases (greater than 1 kg)
[ NASDAQ]
10/14 Jpurnalist: How Come They Still Sell Evra Parches?
Why Is J&J's Ortho Evra Patch Still on Sale?
Once a pattern emerged of young women being felled by pulmonary embolisms and strokes, J&J's reps began a rearguard action to assure doctors the patch was safe, and the company even bought up URLs with anti-patch sentiments (such as PatchSucks.com)
[BNET
10/14 Internet Drug News Miscellaneous Short Takes:
Abbott Labs to repurchase $5 billion in stock
Abbott Press Release
No Caffeine - Breast Cancer Link
Reuters
Peeds: Double Vit D Recommendations To 400IU
AP
King extends tender offer to acquire Alpharma
King Press Release
10/13 Gardasil: Moderate Penetration Among Teen Girls
Merck's Gardasil Given to 1 in 4 Teenage Girls
But the uptake of the vaccine ... appears to be slowing this year. Sales were off 9% in the second quarter
[Wall Street Journal; FREE]
Merck's Gardasil Given to 25% of Teen Girls in 2007
$100 million marketing campaign by the drugmaker
If you look at the 13- to 18-year-olds, you really see a tremendous uptake
2.5 million girls ages 13 to 17 had gotten the first of three doses
[Bloomberg]
Editor's Note: Only 1% of Latina girls have gotten the vaccine according to US News & World News reports blogger Deborah Kotz.
10/13 Woman (Sheri McCoy) To Head Up JNJ World-Wide Pharma Biz
J&J Veteran to Lead Drug Unit
49 years old, who currently heads the health-care conglomerate's surgical-care unit
chemical engineer by training
background doesn't specifically include pharmaceuticals
[Wall Street Journal]
See Also: JNJ Press Release
Editor's Note: Click Here for color photo of Ms McCoy ; she looks a little like Harry Potter author HJ Rawlings (after she had her face fixed up).
10/13 Top 10 Most Visited Drug Web Sites
AstraZeneca's Purplepill.com Tops the List of Most Visited Pharmaceutical Brand Web Sites in Q2 2008
up 55 percent from a year ago
marketing muscle appears to have helped generate strong site visitation
[ MareketWatch]
Editor's Note: Excellent report for all you statisto-nerds; lists top 10 most visited drug web sites in terms of unique visitors. AZN has 2 on the top ten.
See Also: Similar Report From Wall Street Journal FREE
10/13 Once-Per-Day Version Of Seroquel Gets New Indication
FDA approves AstraZeneca's SEROQUEL XR® for the treatment of bipolar depression and bipolar mania
acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex
.[ AZN Press Release]
See Also: Similar Report From Reuters
10/13 FDA Needs Additional Time To Review Takeda's Answer To Januvia
FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA. Takeda remains confident
[Takeda Press Release]
10/13 ViroPharma Novel Angioedema Drug Gets Green Light
Cinryze(TM) Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
(C1 inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency
[ViroPharma Press Release]
Cinryze Approved: A Significant Catalyst for Viropharma, Lev Pharmaceuticals
rare but life-threatening disorder known as hereditary angioedema ...should be able to generate some revenue (although it will not be huge) in the fourth quarter of 2008 with revenues building to $150-200 million in 2009
[Seeking Alpha]
10/13 Restylane; New Labeling; Beefed Up Longevity Claim Gets Nod
Medicis Announces FDA Approval of PMA Supplement for RESTYLANE ...based on clinical data which highlights RESTYLANE(R)'s duration effect up to 18 months in 97% of patients with repeated treatment
[Medicis Press Release]
FDA OKs new effectiveness claims for Medicis drug
[AP]
10/13 AIDS Vaccine: Back To The Drawing Board; Scientists Admit Hubris
AIDS vaccine focus shifts after disappointments
Fundamentally we don't understand enough about the human immune system and we don't know how the immune system deals with HIV
Approaches focusing on "neutralizing antibodies" that would allow the human immune system to block infection completely, are likely to take precedence
[Reuters]
10/13 Now Boston Scientific Stent Finally Gets Approved
FDA approves long-delayed Boston Scientific stent
Taxus Liberte stent, long-delayed by warning letter
company said it will launch Taxus Liberte in the U.S. early next month. The stent has been available in Europe since 2005
[AP]
10/13 Tamoxifen Has Bone Protect Powers
Tamoxifen Cuts Fracture Risk: Study
The fracture risk goes right back up once you stop it. The good news is, it reduces fracture risk when you are on it. Once you stop, you are not protected."
[ HealthDay]
10/13 Internet Drug News Miscellaneous Short Takes:
Evra: J&J Paid $68 Million to Settle Birth-Control Cases
Bloomberg
Santarus Commences GLUMETZA Promotion
Santarus Press Release
Wyeth Wins Another Fenfluramine Lawsuit
Wyeth Press Release
US Appeals court upholds Roche anemia drug ban
Reuters
FDA Approves Kogenate FS Treatment for Routine Prophylaxis in Hemophilia A Kids
Bayer Press Release
Federal Circuit Affirms Merck's Victory in Trusopt/Cosopt Case
Seeking Alpha
Prostate Watson Pharma receives FDA approval for Rapaflo Plans 'Q1 Launch
MarketWatch
Big Pharma Embraces the Contentious Cancer Business
BusinessWeek
Merck's rotavirus vaccine Rotateq gains WHO pre-qualification status
Dow Jones
FDA OK's New Injection Site For RISPERDAL(R) CONSTA(R)
Company Press Release
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