7/2 Lantus Study Rushed to Press
Sanofi Stock Drop Spurred Rush to Publish Lantus Data ... Sanofi-Aventis's three-day stock decline last week prompted the European Association for the Study of Diabetes to publish research on the French drugmaker's Lantus insulin a week ahead of schedule. ... [ Bloomberg ]

7/2 Drop Your Daily Aspirin and Take a Statin -- BMJ Study
Study Supports Wider Use of Statins ... A meta-analysis of 10 trials involving more than 70,000 participants found that statin therapy reduced overall mortality by 12 percent, major coronary events by 30 percent and strokes by 19 percent ... [ HealthDay ]

7/2 New Partnership Advances Oral MS Treatment
Biogen Buys Rights to Acorda's MS Pill Outside U.S. ... Biogen, based in Cambridge, Massachusetts, is racing Merck KGaA and Novartis AG to market the first pill for MS, a debilitating nervous-system disease currently managed by injected drugs that generate $6 billion a year worldwide ... [ Bloomberg ]

7/2 MA and VT Ban Physician Gifts, Most All Meals
Two States Restrict Firms' Gifts to Doctors ... As of July 1, in Massachusetts and Vermont, pharmaceutical companies and medical-device makers will be banned from giving doctors such gifts as resort trips or even coffee mugs ... [ $$WSJ ]

7/2 Dreaded 'Complete Response' Letter for Menveo
Novartis sees FDA decision on Menveo early 2010 ... Menveo, which the firm wants to sell to adults and adolescents, is one of two Novartis vaccines against meningococcal infection in late-stage development viewed as potential best-sellers ... [ Reuters ]

7/2 Vasotec and Cozaar Protect Ye Diabetic Eyeballs
Blood pressure drugs slow eye problems in diabetes ... Diabetic retinopathy progressed significantly in 38 percent of the volunteers getting a placebo compared to only 25 percent who took enalapril and 21 percent who got losartan. ... [ Reuters ]

7/2 JAMA Pours Cold Water On Crestor Hopes:
CRP Not a Cause of Heart Disease; Don't Medicate It
Findings of Genetics Study Does Not Support Causal Association of C-Reactive Protein With CHD ... Researchers: "this study suggests that development of therapeutic strategies targeting specific reductions in plasma levels of CRP are unlikely to be fruitful" ... [ American Medical Association ]

7/2 Internet Drug News Miscellaneous Short Takes:
U.S. group questions AstraZeneca's Crestor patent
Reuters
AstraZeneca's Iressa gets E.U. marketing authorization
Marketwatch
Discovery Labs says lung drug unlikely to get FDA nod
Reuters
A Combination of Common Genetic Variations Can Lead to Schizophrenia
University of North Carolina at Chapel Hill School of Medicine
Importation amendment dies in utero
Drug Store News
Teva launches version of JNJ birth control pill Ortho Tri-Cyclen
AP

7/1 FDA Panel: Ban Some Combo Acetaminophen Products,
Reduce Maximum Recommended Daily Dose, Make High-Dose Rx Only
OTC Combo Products Get Breathing Room
U.S. advisers call for ban of some pain drugs … voted 20-17 to urge the agency to eliminate such products, which include Vicodin and Percocet …[Reuters]
FDA Panel Recommends Smaller Doses of Painkillers … recommended the maximum daily dose be lowered to 2,600 milligrams from 4,000 milligrams … 500 milligram doses of the drug be available in prescription only …[Wall Street Journal]
FDA Advisers Urge Smaller Doses of Acetaminophen … voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams … 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription … voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu …[HealthDay]
See Also: Similar Report From NASDAQ

Smells Like Entrée To Therapeutic Substitution; TNF Blockers In Crosshairs
J&J, Abbott, Amgen Drugs Warrant Study, IOM Says … Remicade from J&J, and Enbrel, marketed by Wyeth and Amgen, in a family of medicines linked to cancer …[Bloomberg]
Report: Cost Should Play Role In Comparing Medical Treatments … highest priority recommendations is to study the effectiveness of biologics in treating Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis … [NASDAQ]


7/1 Sleepy Rodents May Hold Key To Ambien Sleep-Eating, Sleep-Driving
Discovery could explain awakenings that occur with Ambien … During an awakening, a person can do all types of normal activities ranging from eating breakfast to driving into work. Most will have no recollection …[ Examiner.com]

7/1 Sutent For Colon Cancer:  Lack Of Efficacy Spurs Pfizer To Stop
Pfizer Discontinues Phase 3 Trial of Sutent® in Metastatic Colorectal Cancer … addition of sunitinib to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival …[Pfizer Press Release]

7/1 FDA Green Lights Injectable Iron Replacement Product
FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients … treatment of iron deficiency anemia in adult patients with chronic kidney disease … recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later … [AMAG Pharmaceuticals Press Release]
Editor's Note:  Adds that it will be available in 2 weeks; 80-person sales force.

7/1 Experts Debate Interpretation of Lantus Data
Mixed Message on Insulin Glargine Cancer Risk … Studies examining a possible cancer link to insulin glargine (Lantus) produced mixed conclusions that drew quick, reassuring responses from diabetes authorities …[medpage TODAY]
Sanofi Faces Headache Over Studies on Lantus … likely to create a long-term headache for drug giant Sanofi-Aventis SA, even as some medical experts caution that the studies are inconclusive … Investors will likely remain cautious until more data are published…[Wall Street Journal]

7/1 Sanofi Re-Org: Streamline R&D, Voluntary  Separations
Sanofi Revamps R&D to Spur Innovation, Find New Drugs  ...esist the temptation to favor products developed in-house … doesn't plan any layoffs, even as it reduces employment…[Bloomberg]
Sanofi remodels R&D, no forced layoffs … Eight out of 27 R&D sites will close worldwide … focus on diabetes, cancer and age-linked diseases as well as anti-inflammatory and anti-infectious diseases … …[Reuters]

7/1 Multaq Decision Still Up In The Air
Sanofi has not received any U.S. news yet on Multaq … No FDA news yet on experimental heart drug Multaq … Awaiting final marketing decision, no other comment…[Reuters]

7/1 Cephalon Submits Nuvigil For Eastbound (NOT Westbound) Jet Lag
Cephalon Submits NUVIGIL SNDA for Excessive Sleepiness Associated with Jet Lag … indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel … 70 million American travelers experience jet lag annually …[Cephalon Press Release]
Editor's Note: That's a curious indication.

7/1 Anti-Angiogenic Drugs Encouraged Metastasis: Who, What, Why
Metastasis: When Good Drugs Do Bad Things … Two papers in Cancer Cell have shown that, despite positive effects on established localized tumours, inhibition of angiogenesis can result in increased tumour invasion and metastasis …[Medscape - Free Reg. Reqd.]

7/1 Internet Drug News Miscellaneous Short Takes:
Pozen Submits Naproxen/ Nexium Combo Pill
RTT
Analyst: Geron Deal Much Ado About Nothing; Good Stock To Short
The Street
FDA Calendar Updates: POZN, AZN , SNY, CEPH, APPY, CYTR
Biomed Reports
The 15 most promising biotech companies
Fierce Biotech
Obama-Proof: Pfizer, Bristol-Myers and Teva
The Street
WHO says Tamiflu-resistant H1N1 "isolated case"
Reuters

6/30 IMS, Verispan, SDI Lose Bid To Block Anti-Doc Data Mining Law
Court denies bid to limit Vt. law on prescription data ...denied a request by three drug data-miners and the Pharmaceutical Research and Manufacturers  ...goes into effect July 1 …[ModernHealthcare.com]
US top court won't review prescription privacy law … Reuters

6/30 Critics: Cancer Drugs Overpriced Relative To Efficacy
Cost-Effectiveness of Cancer Drugs Is Questioned … expensive cancer drugs to prolong patients' lives by just weeks or months was called into question … [Wall Street Journal; $$$]
Lilly Erbitux Cancer Drug Not Worth Price, U.S. Scientists Say … [Bloomberg]
See Also: Above cited article (abstract)

6/30 Critics Refute Data Linking Lantus To Cancer
Sanofi's Lantus Cancer Scare Shows How Enormous Power Lies With Few Experts ...results were provocative but far from convincing ...data are not being championed by a U.S. safety hawk like the Cleveland Clinic's Steve Nissen or FDA's David Graham…[Bnet Pharma]
Sanofi dismissive of "poor quality" Lantus studies … warns against risk from "junk science" … studies highlighting a possible link between cancer and its long-acting insulin drug Lantus for diabetes were "of poor quality" …[Reuters]
                             
6/30 Tysabri: Biogen Reports 13th Incidence Of PML
Biogen Reports a 13th Sick Patient on MS Drug … 10 cases since -- including three this month -- have frustrated Biogen's aim of making Tysabri into a blockbuster drug…[Wall Street Journal; $$$]

6/30 Abbott To Pay JNJ $1.67 Bln: Humira Infringed Anti-TNF Patent
Centocor Ortho Biotech Inc. Awarded $1.67 Billion Patent Jury Verdict from Abbott Laboratories … patent in question relates to the company's anti-TNF class of arthritis treatments, and is co-owned by New York University and Centocor…[ JNJ Press Release]

6/30 Drugmakers' Reaction To Possible Acetaminophen Crackdown
Acetaminophen Worries: The End of NyQuil as We Know It? … little difference between the maximum recommended daily dose and a potentially harmful dose … consumers may not know acetaminophen is in their medicine…[Wall Street Journal; FREE]
Drug cos at odds with FDA over acetaminophen risk … acetaminophen-containing products, which were $2.6 billion in 2008 … Instead, the FDA should require approval of nonprescription acetaminophen products before they could be sold…[Reuters]

6/30 Internet Drug News Miscellaneous Short Takes:
Merck Resolves Shipping Delays For Shingles Vaccine Zostavax
NASDAQ
Jury rejects Accutane-made-me-kill-my-girlfriend defense
AP
Denmark finds 1st case of H1N1 resistance to Tamiflu
Reuters
Roche: Tamiflu Still Works Despite One Case of Resistance
Wall Street Journal; FREE
AMAG expects FDA action on anemia drug within days
Reuters
Did Demerol cause Michael Jackson's cardiac arrest and death?
KevinMD

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6/29 Former Pfizer Rep's Book To Be Hollywood Movie
Gyllenhaal, Hathaway back for 'Love' … humorous memoir that shined a light on the practices of the pharmaceutical industry … The filmmakers hope to begin shooting in the fall …[HollywoodReporter]
Editor's Note:  Read more about Jamie Riedy and the book that made him almost famous and hopefully rich.

6/29 FDA Is Determined To Crack Down On Acetaminophen Hep Tox Risk
US FDA To Discuss Liver Risks With Tylenol,Other Painkillers ...reduce recommended dosing levels, limit the number of pills or liquid in each drug containing acetaminophen, and eliminate medicines that combine acetaminophen with other ingredients .. [NASDAQ]

6/29 Roche Yanks Accutane Over Bowel Disease Lawsuits
Roche Pulls Accutane Off Market After Jury Verdicts … 5,000 personal-injury claims over Accutane … users allege drugmakerafailed to properly warn them the medicine could cause inflammatory bowel disease …pulled off the market in 11 other countries  …[Bloomberg]

6/29 MSL Off-Label Spiel: Research Free Speech Or Marketing Tactic?
Drug Firms' Medical Staffs Say What Salespeople Can't  … pharma companies have the impression if you just hire somebody [with a professional degree] and you call them an MSL, it doesn't matter what they say."…[Wall Street Journal; $$$]
Editor's Note:  Adds that number of sales reps has dropped to 90K in 2008 from 106K in 2006; adds that MSL's earn 50% more than primary care sales reps.

6/29 Takeda; Alogliptin Delayed As Expected Till Q1 2012
Takeda's Diabetes Drug Alogliptin Rejected by FDA …  delayed until March 2012 or later … Takeda expects to take 2 years to submit test results … largely expected after the U.S. Food and Drug Administration (FDA) said in March it wanted more data…[Bloomberg]
Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes …[Takeda Press Release]

6/29 Saxagliptin Gets CHMP Thumbs Up
ONGLYZA Receives Positive Opinion From CHMP … positive opinion on ONGLYZA will now be reviewed by the European Commission which has the authority to approve medicines for the European Union … [NASDAQ]

6/29 Sanofi Boss Explains Expansion Plans: 
Generics, Animal, Consumer; No Mega Urge To Mega Merge
Sanofi-Aventis seeks more generic acquisitions … seeking to buy more generic drugs companies as part of broader acquisition plans to seek full control rather than the partnerships ...also expressed interest in expanding its consumer and animal health …[FT.com]

6/29 Long Acting Insulin Analogs Linked To Cancer Risk
Novo Nordisk distances itself from Lantus scare … Lantus and Levemir are both long-acting insulin analogues, but Levemir was launched more recently than Lantus and so was not assessed in the European registry studies….[Reuters]
Sanofi says new data inconclusive on Lantus risk … rumours that a damaging analysis of the product's safety was shortly to be published in a major medical journal … no definitive conclusions on possible cancer link … Company says just been made aware of new data … [Reuters]
See Also:  Sanofi-aventis Stands Behind the Safety of Lantus(R)
See Also:  Novo Nordisk Insulin Analogs Have Proven Safety Profiles

6/29 Delaware Blinks:  Welfare Rx Reimbursement Cut Less Than Threatened
Delaware, Walgreen battle over Medicaid dollars … After two months of talks and even an industry lawsuit, Delaware still plans to reduce the amount it reimburses pharmacies for filling Medicaid prescriptions, though by half as much as it previously intended…[Reuters]

6/29 Murderer Blames Zoloft
Neb. inmate's suit over Zoloft latest in a series ...20-to-40-year sentence and will be eligible for parole in 2022 ...started arguing while having sex because she suggested they have a second child….[Philly.com]

6/29 Internet Drug News Miscellaneous Short Takes:
Smell-Loss Drug Escaped FDA Review Under Homeopathic Label
Bloomberg
Cimzia Wins EU Approval For  Rheumatoid Arthritis
UCB Press Release
SIMPONI Receives Positive Opinion From CHMP for Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Schering Plough Press Release
Aclasta Indications expanded in EU
Genetic Engineering & Biotechnology News
Seretide Irish Patent Invalidated
Reuters
Pharmacist Comes To Defense Of Accutane Murderer
Pittsburgh Tribune Review
Dermatologist rips Accutane killing defense
Pittsburgh Post-Gazette
Gilead gets positive nod on cystic fibrosis drug
AP
Black Enterprise Magazine Names Aetna as One of the Best Companies for Diversity
Aetna Press Release
NY Post: Jackson was on Xanax, Dilaudis, Soma, Zoloft, Vicodin, Vistaril, Paxil, Prilosec & Demerol
NY Post
             

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