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11/21 Promacta Approved
Glaxo wins U.S. approval for platelet drug ... Promacta, also known by the chemical name eltrombopag, is approved for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy ... [ Reuters ]

11/21 AZN Layoffs in Manufacturing in Europe; New Jobs in China; No Changes (for now) in US
AstraZeneca to cut 1,400 jobs ... The company's site in Macclesfield, England will see 250 job losses by 2010, while facilities in Spain, Belgium and Sweden will close. ... [ Telegraph (UK) ]

11/21 Even 'Targeted Therapies' Have Significant Risks
FDA 'black box' warning advised for cancer drug Avastin ... About 12% of people who take Avastin develop blood clots in the veins, a rate that's about 30% higher than among cancer patients not taking it ... [ USA Today ]

11/21 Changing of the Guard at House Energy and Commerce Committee
Will Waxman, the New Boss, Be the Same as the Old Boss? ... Incoming House committe chair Henry Waxman has been a bulldog on drug issues, as much as outgoing Rep. John Dingell. Waxman is trying to derail efforts by the FDA and industry that would ease rules against off-label promotion of medicines ... [ WSJ Health Blog ]

11/21 Uloric, for Gout, Gets Positive Signal
FDA sees no heart risk with Takeda gout drug ... The FDA finding was released ahead of an advisory panel meeting. Takeda's febuxostat is a treatment for hyperuricemia, a build up of uric acid that can lead to swollen joints and arthritis flare-ups ... [ Reuters ]

11/21 Oral Med Works as Well as Chemo for Grim Diagnosis
Iressa Proves Just as Effective as Chemotherapy for Lung Cancer ... When comparing all treated lung cancer patients, median overall survival for those receiving Iressa was 7.6 months and one-year survival was 32 percent, compared to 8 months and a 34 percent one-year survival for those taking chemotherapy ... [ University of Texas M. D. Anderson Cancer Center ]

11/21 Little Blue Pill Won't Be OTC in Europe
Viagra Stays Behind EU Counters ... Pfizer believes Viagra meets all the criteria for nonprescription status under the European Commission's guidelines, but decided to withdraw the application after concerns were raised by the European Medicines Agency ... [ Forbes ]

11/21 Motesanib Trial Halted
Amgen Drug for Lung Cancer Suspended After Deaths ... The trial was halted after an independent monitoring committee's review of 600 patients found higher early mortality rates among those getting the experimental cancer drug motesanib compared with those on a placebo. Amgen and Takeda were testing motesanib as a first-line treatment in combination with chemotherapy ... [ Bloomberg ]

11/21 Sodium Oxybate Successful in Phase III
Jazz, UCB Say Treatment Helps Fibromyalgia Patients ... Sodium oxybate helped patients achieve a 30 percent reduction in pain compared with a placebo in a study... Five percent or more patients suffered side effects such as dizziness, diarrhea and vomiting ... [ Bloomberg ]

11/21 Keeping the Faith in Biotech
Personal medicine is goal of Eli Lilly & Co ... Lilly chair Sidney Taurel (who was CEO 1998-2008) maintains that the future of the pharmaceutical industry rests not with blockbuster drugs but with targeted therapies that work for smaller groups of people based on their biological makeup. He acknowledged progress has been much slower than expected ... [ Arizona Republic ]

11/21 Internet Drug News
Miscellaneous Short Takes:
AstraZeneca wins first round in Teva litigation
Forbes
Abbott settles lawsuit related to its cholesterol drugs
Reuters
U.S. panel votes against Arpida antibiotic iclaprim
Reuters
Roche ordered to pay $13M to users of acne drug
AP
Vanda Pharmaceuticals takes second shot at FDA approval for schizophrenia treatment iloperidone
Washington Business Journal

11/20 Negotiations for Major Health Reform Get Rolling
Health Insurers Want Mandatory Coverage for Americans ... The health insurance industry proposed guaranteeing coverage for every American, regardless of medical condition, in return for an enforceable requirement that everyone have a policy. ... [ Bloomberg ]

11/20 Elan "Will Run Out of Money in 2 Years"
Elan seeks deals to raise cash ... In the nine months ended September 2008, Elan posted a net loss of $240.5 million. It is burning cash at a rate of more than $300 million a year, and it has $1.7 billion in debt that comes due over the next five years ... [ Reuters ]

11/20 MRSA Treatment Passes Panel
Theravance Wins U.S. Panel's Backing for Antibiotic ... Outside advisers to the Food and Drug Administration voted 21-5 that the once-a-day infusion, telavancin, is safe and effective against methicillin-resistant Staphylococcus aureus (MRSA) ... [ Bloomberg ]

11/20 A Lot of Kids are on Atypicals
US panel urges study of antipsychotics in children ... Atypical antipsychotics, are increasingly being prescribed to children for unapproved uses, such as attention deficit hyperactivity disorder, or ADHD.... Children and teens now make up nearly 25 percent of all patients who fill a prescription for Risperdal... ... [ Reuters ]

11/20 Novartis Scrambles to Make Its Numbers
Novartis to Combine Heart Pills as Afinitor Cancer Drug Delayed ... Novartis said it will combine the newer heart pill Tekturna with Diovan as well as other treatments, and plans to bring them to market before Diovan's 2012 patent loss. The experimental cancer drug Afinitor may reach the market in the first quarter of 2009 ... [ Bloomberg ]

11/20 Can You Skip Phase II?
Novartis could cut drug development by a year ... Novartis's new approach, which uses disease models to predict measurable markers and responses, could apply in areas like oncology and genetic diseases and allow mid-stage trials to be shortened or even, in some cases, omitted completely ... [ Reuters ]

11/20 What Happens When Governments Negotiate Drug Prices
UK government secures 3.9 pct cut in drug prices ... prices paid by the UK's state health service will be cut by 1.9 percent more in January 2010.... A flexible element has been added which will allow drug companies to supply drugs to the NHS at lower initial prices, with the option of higher charges if they prove to be of additional benefit to patients ... [ Reuters ]

11/20 Rough Day for AZN
AstraZeneca hit by double Pulmicort, Zactima blow ... Teva has received FDA approval and can launch a generic copy of Pulmicort Respules... Also, AstraZeneca released study results showing that cancer drug Zactima will be useful in about 40 percent of second line patients suffering from non small cell lung cancer. The drug will not be the home run the company needed ... [ Reuters ]

11/20 Hormone Wars Continue
Nevada sues drug manufacturers for trade practices ... The suit contends that Wyeth and Pfizer intentionally minimized the risks and exaggerated the benefits of their hormone therapy drugs, resulting in over-prescribing and a dramatic increase in hormone-positive breast cancers in post-menopausal women ... [ CNN Money ]

11/20 Allegra Settlement
Teva paying more than $30M to settle Sanofi-Aventis suit ... Agreement is to settle patent infringement litigation over Teva's and Barr's U.S. generic versions of Aventis Pharmaceuticals' Allegra allergy medicine. ... [ Philadelphia Business Journal ]

11/20 Internet Drug News
Miscellaneous Short Takes:
Study Suggests Attending Religious Services Sharply Cuts Risk of Death
Albert Einstein College of Medicine of Yeshiva University
Gleevec May Treat Type 1 Diabetes
HealthDay
US teen lives 118 days without heart
Reuters
ADHD Medications Do Not Cause Genetic Damage in Children
NIH News Release
Sanofi Reps' Morale Hits New Low as Layoff Rumors Circulate
bnet

11/19 Doc Data Mining Outlawed In NH; Court Reinstates Ban
Court Upholds New Hampshire Data-Mining Ban … move that will likely embolden other states … IMS and SDI, which owns Verispan, said: "We are disappointed with the First Circuit Court of Appeals decision …[Pharmalot]
New Hampshire Prevails on Law Guarding Prescription Privacy … rebuffing the drug industry's argument that the law infringes free speech. … "In our view, the portions of the law at issue here regulate conduct, not speech …[Wall Street Journal; FREE]
Federal Court Upholds Drug Privacy Law … sale of prescription data, in which individual patients' identities have been removed, has become a lucrative industry. The information is purchased from pharmacy chains and the companies that manage drug benefits for employers…[NY Times; Stephanie Saul]
Editor's Note: This ruling is a body blow for IMS and Verispan but mild blow to the drug companies; zip code data will still be available so it's not the end of the world.   

This matter is heading to Supreme Court; if they take it, there is a strong chance that IMS will prevail; patient identifying details are cloaked and docs have the opportunity to opt out.  But in the meanwhile, we predict that anti-data mining laws will spread  rapidly.   It's a great sound byte story and  no-downside opportunity for politicians to strike out at a slow moving target.

11/19
Granny Doesn't Understand Her Doughnut Hole
Kaiser Daily Health Policy Report … 27% said that the information they received had confused them … 26% of Medicare beneficiaries who had reached the doughnut hole said that they received no information about the coverage gap…[ KaiserNetwork.org]

11/19
Avastin:  Blood Clot Risk Upped 33%
Avastin raises risk of blood clots in veins-study … by a third when added to chemotherapy … cancer patients already have an elevated risk of blood clots in the body's veins, known as venous thromboembolism…[Reuters]

11/19
XTL Biopharma Plunges 93% After Bicifadine Disappoints
XTL Biopharma plunges on Bicifadine trial failure … crashed 93% on both the TASE and Nasdaq after the failure of the Phase 2b clinical trial for Bicifadine for the treatment of diabetic neuropathic pain …[Globes Israel]
See Also: Similar Report From Reuters

11/19
FDA: Wrinkle Filler Labels Need Long Term Side Effect Warnings
Wrinkle Fillers Need New Warnings, U.S. Panel Says … should carry warnings about scarring, tissue damage and other serious complications … modified to reflect what we're learning further about the products'' through post-approval studies…[Bloomberg]
See Also: Similar Report From AP

11/19
FDA: From Now On, Cardiac Side Effects Take Center Stage
Heart risk big worry for FDA: official … rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration's top worries and is changing how the agency weighs new medicines…[Reuters]
Editor's Note: Mentions soon-to-be updated cardio data rules for diabetic meds.  This is important -- if you have a diabetic drug in the approval queue you have cause for concern unless you have solid 18-month outcome data.  Out gut feeling is that long-acting Byetta and Liraglutide face unanticipated delays.  A lot rides on who the Obama administration appoints to head FDA and how long it's going to take to get him into the driver's seat. 

11/19
Company Who Markets Blacks Only CHF Pill Reinvents Itself
NitroMed to merge with Archemix … became known for marketing a heart medicine for blacks called BiDil, is attempting to reinvent itself … merged company will be called Archemix, and NitroMed Chief Executive Kenneth M. Bate will serve as chief executive …[Boston.com]
See Also: BiDil Press Release

11/19
There Will Be Blood
Top 5 layoffs of 2008 … Merck - 8,400 jobs … Schering-Plough - 5,500 jobs … Wyeth - 5,000 jobs … UCB Pharma - 2000 jobs ... Abbott - 1,000 jobs …[Fierce Pharma]

11/19
Internet Drug News Miscellaneous Short Takes:
J&J consolidation splits Rx brands between two holding companies
MM&M
How a Drug Maker Tries to Outwit Generics
Wall Street Journal
Study finds ginkgo biloba does not prevent dementia
LA Times
Mylan Gets Nod For Generic Sarafem
Mylan Press Release
Cimzia(R): significant clinical benefits for mono- and combination therapy in patients with rheumatoid arthritis
UCB Press Release
AstraZeneca appoints new U.S. Skipper
AZN Press Release
Lilly Sues Impax To Protect Cymbalta Patent
Impax Press Release
Too little sleep tied to increased cancer risk
Reuters

11/18 
Ranbaxy, FDA Smoke Peace Pipe
Ranbaxy hopeful of an early resolution to USFDA ban … We have responded at the end of last week and we are hopeful that we will be able to work with them and find an early resolution to the issues that are currently open …[Economic Time India]
See Also: Similar Report From Reuters

11/18
Nuvocid: Safe But Teratagenicity Could Be Issue
Targanta drug appears similar to rival-US FDA staff … adults with complicated skin infections from a variety of bacteria, including some resistant to other antibiotics such as vancomycin…[Reuters]
Theravance rises ahead of US drug review … Issues for panel discussion include possible harm to the kidneys and the potential for birth defects, the FDA staff said. Limb malformations were seen in animal …[Reuters]
FDA notes pregnancy risks with Theravance drug …[AP]

11/18
Merck: Oral Growth Hormone Secretagogue Fails To Slow Alzheimer's
Growth Hormone No Help Against Alzheimer's Progression … Stimulating growth hormone secretion in Alzheimer's patients did nothing to help clear beta-amyloid plaques or halt disease progression … [MedPage Today]
See Also: Similar Report From Reuters

11/18
Solvay Joins The "I Dumped My Accomplia-Like Med Club"
Solvay discontinues research into potential obesity compound … SLV319 was in phase-two development … discontinuation is not related to any adverse events or the efficacy …[Hayes Pharma]
Tough regulatory climate sees Solvay end trials of SLV319 … selective cannabinoid type 1 antagonist … same reason given by Pfizer earlier this month when it ended a Phase III … for its cannabinoid receptor antagonist known as CP-945,598 …[Pharma Times]

11/18
Slimming Pills: Still The Holy Grail
Despite failures, search for obesity drugs still looks golden … Designers of anti-obesity drugs have suffered three major setbacks, but the potential reward from treating the world's fat epidemic is so great that their quest is unlikely to be deterred …[AFP]

11/18
Inhaled Remodulin Fails In Pulmonary Hypertension Trial
United Therapeutics shares plunge on failed study … 14 percent of the patients dropped out of the study because of adverse events and 19 percent were unable to handle more than the smallest dose of the drug, which proved ineffective …[Boston.com]

11/18
Lilly Sells Pulmonary Hypertension Rights To Cialis For $150 Mln
Lilly Licenses U.S. Rights for Tadalafil PAH Indication to United Therapeutics … agreement related to the U.S. commercialization rights for the pulmonary arterial hypertension (PAH) indication … PAH indication is currently under regulatory review in the United States, Canada, Mexico, Japan and the European Union ..[Eli Lilly]
Lilly Sells Rights for Key Cialis Ingredient … licensed the U.S. commercialization rights for the active ingredient in its erectile-dysfunction drug to United Therapeutics Corp. for uses as a high-blood-pressure treatment…[Wall Street Journal; $$$]
See Also> Similar Report From IndyStar

11/18
JNJ Shoots Self In Foot With Foray Into Social Media Marketing
Twitter Moms Create a Motrin-Sized Headache for J&J … Motrin united moms alright--only they united against J&J … Motrin united moms alright--only they united against J&J …[
TechTicker]
J&J Gets Caught in a Sling Over Internet Motrin Ad … uproar in the Internet's social networking space that left the healthcare giant apologizing to its most important customers: Moms…[Wall Street Journal; FREE]

11/18
Internet Drug News Miscellaneous Short Takes:
Fitch cuts Merck's Ratings Outlook to "Negative" from "Stable"
NASDAQ
Nucleoside Reverse Transcriptase Inhibitors Trigger Inflammation Linked to Diabetes, Study Says
Bloomberg
FDA throws 90-day delay on Myozyme decision; Genzyme; orphan drug
Boston.com
FDA nixes state appeal to ban multi-dose vials
Newsday
Amylin shares rise on Byetta prescriptions boost
AP
Recession or Not, We Still Need Drugs
Smart Money
Mylan: Tentative Approval for the Generic Effexor XR(R)
Mylan
Too little sleep tied to increased cancer risk
Reuters
China's Major Depression Drug Market will Triple by 2012
Decision Resources
Jury Awards $16.5 Million in Fentanyl Death Case
Company Press Release
Gleevec, Sutent halt type 1 diabetes in mice
Reuters

11/17
Merck Plans 15,000 Patient Januvia Long Term Effects Trial
Merck Rolls the Dice on New Januvia Study … won't be known until 2015 … being done after a Food and Drug Administration advisory committee voted a few months ago overwhelmingly in favor of doing heart side-effect studies on new diabetes drugs …[CNBC]

11/17
FDA Document Highlights Body Filler Side Effects
Wrinkle Fillers Linked to `Serious' Side Effects … serious and unexpected'' side effects such as the inability to control facial muscles, disfigurement and rare life-threatening allergic reactions …[Bloomberg]
FDA Reports Side Effects Linked to Wrinkle Fillers … FDA briefing listed 930 reports of side effects for injectable wrinkle fillers such as Restylane and Juvederm … …[Wall Street Journal; FREE]

11/17
Narcotic Analgesics: Is Embeda Better?  FDA Staffers Underwhelmed
US panel sees some Alpharma pain drug benefit … unclear from the company's data whether enough naltrexone would be absorbed in certain situations, such as when ALO-01 was chewed or snorted … …[Reuters]
Editor's Note: Adds that the tablets contain a dose of naltrexone that is allegedly released only if the tablet is pulverized; and will be sold as "Embeda".

11/17
Vytorin TRx's Increase Slightly To 2.12 Mln In October
Sales of Vytorin & Zetia Are Bad, but Not Getting Worse … actually rose ever so slightly, from 2,171,000 in Sept. to 2,186,000 in October (slightly more than half the total in each month came from Vytorin …[Wall Street Journal; FREE]

11/17
Upstart Insulin Maker Inches Toward Big Leagues
Biodel Reports Protective Effects of VIAject(TM) Insulin on Microvascular Function in Patients with Type 2 Diabetes … VIAject™ is an ultra-rapid-acting injectable human insulin intended for meal-time use by patients with Type 1 or Type 2 diabetes… shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs …[Biodel Press Release]

11/17
Part D: pen Enrollment Period Begins
Enrollment for Medicare Drug Plans Begins Again … standalone plans that only cover medications will see premiums increase by an average of $7.40 a month, from $29.89 in 2008 to $37.29 in 2009 … from $10.30 a month to as much as $136.80 a month …[ HealthDay]

11/17
DTC Spending Down $6.3%
Drug ads targeting consumers down this year, with less spending for new drugs … peaked at $5.43 billion in 2006, then dipped by 3 percent last year to $5.26 billion … down 6.3 percent at $3.18 billion ….[ AP]

11/17
Zyrtec : Only 27% Of Patients Switched To OTC
Most Zyrtec users didn't switch to OTC … The majority of Zyrtec OTC users (84%) came to the brand from other OTC products … only 27% of prescription Zyrtec patients switched to Zyrtec OTC ..[ MM&M]

11/17
Internet Drug News Miscellaneous Short Takes:
MedPac to Congress: Make pharmas report all samples to HHS
MM&M
US judge dismisses Seroquel suit alleging fraudulent marketing
Scrip
Cipla maintains No.1 position in Indian mkt
Business Standard India
Unions: CVS Caremark ignored privacy to push Januvia over cheaper diabetes meds
AP
FDA Approves BANZEL(TM) (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
Eisai Press Release
UBS downgrades Glaxo on stock value
AP
Union group speaks out against CVS practices
Reuters
Gilead says Teva asks for generic Truvada approval
AP