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3/21 Cost Explosion for Specialty Drugs; No Biogenerics in Sight; Plans Want Pay-for-Performance Contracts
Payers Aim to Rein in Specialty-Drug Spending ... Specialty-drug spending in the U.S. could reach $99 billion by 2010, nearly double the $54 billion spent in 2006 ... [ WSJ ]

3/21 Look Who's Pushing Reimportation
McCain's Health 'Jihad' May Cost Pfizer, Doctors ... McCain, the Republican presidential candidate, says crossing the border for less-expensive drugs will increase health-care access by lowering costs. Spending on doctor services can be cut too, he says, by paying set fees for disease treatments, not on the amount of care provided ... [ Bloomberg ]

3/21 Changes at the Top
Head of Drug Development at Novartis to Leave Company ... James Shannon, head of global drug development, is leaving the company and will be succeeded by Trevor Mundel ... [ WSJ ]

3/21 Green Light for Treanda
Cephalon gets FDA OK for Treanda ... Treanda is an injectable treatment for patients with chronic lymphocytic leukemia... Cephalon has also filed a new drug application for Treanda as a treatment for patients with non-Hodgkin's lymphoma. ... [ Philadelphia Business Journal ]

3/21 Epix Trial Fails
Epix stops work on depression drug candidate ... PRX-00023 was not significantly effective in a mid-stage trial in patients with major depressive disorder ... [ Boston Globe ]

3/21 Big Bet on Revlimid
Celgene's Cancer Drug Is Key ... Celgene is planning a "blitzkrieg of medical education programs (to) combat heavy detailing from the launch of Velcade," a rival treatment for multiple myeloma ... [ CNNMoney ]

3/21 Extavia Closer to Launch
EU agency backs Novartis drug Extavia for MS ... Extavia s the company's branded version of Bayer AG's Betaseron, interferon beta-1b ... [ Reuters ]

3/21 Neupro Recall
UCB Recalls Neupro Parkinson's Drug ... Neupro is delivered by skin patch, and UCB can't be sure the products pulled from the market were releasing the active ingredient correctly ... [ Bloomberg ]

3/21 Tocilizumab
Drug that relieves symptoms of rheumatoid arthritis by up to 70 per cent available next year ... Almost half of adults with moderate to severe symptoms had a 20 per cent reduction in their problem, while one-fifth gained the highest level of relief from using the drug, tocilizumab. ... [ Daily Mail ]

3/21 Another Chink in the Armor
AstraZeneca faces Seroquel generic threat next week ... Seroquel's various versions represent around 28% of AstraZeneca's annual earnings, with the 25-milligram dose that Teva is attempting to copy accounting for around 15% of U.S. sales of the drug. ... [ Marketwatch ]

3/21 Internet Drug News Miscellaneous Short Takes:
- Canada appeals court backs Pfizer Lipitor patent
Reuters
- India court declines Roche bid to stay copycat drug
Reuters

3/20 Update: Taps for TAP
Takeda, Abbott say to equally split joint venture ... Takeda and Abbott will split their long-standing joint venture equally, with Takeda receiving rights to blockbuster ulcer drug Prevacid and Abbott getting rights to prostate cancer drug Lupron. ... [ Reuters ]

3/20 No Quick Okay for Suggamadex
FDA delays review of Schering-Plough drug ... The FDA has extended the review period for Suggamadex so it can assess a clinical trial report on hypersensitivity reactions, one of two safety issues raised during the advisory panel's deliberations ... [ Star-Ledger ]

3/20 Facing 20 Years in Jail and a $250,000 Fine for Illegal Promotion
Drug company's ex-CEO indicted on federal charges ... A federal grand jury in San Francisco has indicted Dr. W. Scott Harkonen, former chief executive of InterMune, accusing him of illegally promoting Actimmune as a treatment for idiopathic pulmonary fibrosis ... [ Mercury News ]

3/20 Dietary Supplement for Joint Pain Used to Cut Chinese Heparin
Baxter's Heparin Contaminant Identified by U.S. FDA ... Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The oversulfated version found in the heparin was chemically modified to act like heparin. ... [ Bloomberg ]

3/20 No One is Watching the Kids
Study finds 98% of child drug trials lack independent safety checks ... Fewer than 2% of the 739 international drug trials on children published between 1996 and 2002 had committees of independent experts who would scrutinise data and warn, if necessary, that it was not safe to carry on. ... [ Guardian ]

3/20 Only Specialist Physicians are Up to Date on Asthma; Generalists Use Antique Treatments
Asthma Medicines Often Not Prescribed as National Guidelines Recommend ... More than a decade after national guidelines were issued for asthma treatment, some patients still don't receive prescriptions for the inhalers that experts say offer the safest and most effective long-term control of the disease ... [ Ohio State University  ]

3/20 Takeover Rumors
Shire Gains After UBS Says AstraZeneca May Make Offer ... Shire last year got $1 billion from Adderall XR, an attention deficit hyperactivity disorder therapy that it sells alongside similar medicines Vyvanse and Daytrana ... [ Bloomberg ]

3/19 FDA Home Page Gets Makeover
About FDA.gov's Home Page Redesign … usability data pointed us to improvements to make the home page easier and more satisfying to use … layered" approach that allows you to find information quickly. Structure is improved to provide for easy scanning. Content is presented in plain language to make it more understandable …[FDA]

3/19 Spiriva: Meta Analysis Suggests Increased Stroke Risk
FDA Cites Excess Strokes with COPD Medicine … pooled data from 29 placebo-controlled trials of tiotropium (Spiriva HandiHaler) that revealed excess strokes among chronic obstructive pulmonary disease patients on active treatment …[Medpage]
See Also: FDA Communiqué
See Also: Early Communication: Ongoing Safety Review of Tiotropium

3/19 Roche Blinks In Mircera Royalty Dustup
Roche Offers Higher Royalty Fee To Amgen in Anemia Drug Dispute …  hoping to get its anemia drug Mircera onto the U.S. market despite a legal challenge from Amgen ... …[Wall Street Journal; $$$]
Roche accepts conditions on anemia drug ...Judge Young said Feb. 28 that he would allow Mircera's U.S. introduction if Roche agreed to pay Amgen a royalty of 22.5 percent of U.S. sales, compared with the 20 percent Roche had proposed …[BusinessWeek]
See Also: Amgen's Anemia Drug Showdown

3/19 Vytrorin Share Continues To Tailspin
Feb US Prescriptions For Vytorin, Zetia Dropped 13% Vs. Jan … total prescriptions for February were 2.8 million, versus 3.2 million in January ... steeper than the 7% decline in the broader market for cholesterol drugs …[Dow Jones]

3/19 JNJ Suberbug Antibiotic Gets Approvable Letter
But FDA Wants More Info
J&JPRD receives approvable letter from FDA for ceftobiprole for complicated skin infections … Ceftobiprole is reportedly used for the treatment of complicated skin and skin structure infections, including diabetic foot infections …[Comtex]
Basilea Dives as Key Drug Fails to Get FDA Approval … could not speculate about the timeframe for a FDA approval … FDA may have more questions (after the review of already submitted data…[Reuters]
See Also> Similar Report From Wall Street Journal; $$$
See Also: JNJ Press Release

3/19 Paper Detail Pieces? How Passé
Sales Force Report: Rep 2.0 … 100% of the drugmaker's sales force has been equipped with interactive detailing capabilities … By equipping all of its sales reps with interactive tools, AstraZeneca's field force has added valuable minutes to its sales calls and considerably improved its …[ MM&M]

3/19 States Sue Abbott, Solvay;
#37 Millio0n; Claim Conspiracy Blocked Generic Tricor
States allege Abbott blocked generic TriCor … alleging the drug makers illegally conspired to prevent and delay low-cost generic versions of their TriCor…[Reuters]
See Also> Similar Report From Bloomberg

3/19 TAP: Takeda To Buy Out Abbott
Takeda to buy out Abbott stake in TAP-Nikkei … final stages of talks with Abbott Laboratories … thought to be worth $3.04 billion to $5.07 billion…[Reuters]
See Also> Similar Report From Bloomberg

3/19 India's Indie Drugs
Test Time for India's Drugmakers … India's pharma companies are moving beyond generics to set their sights on the research and development of new drugs, but the risks are many…[AP/Yahoo]

3/19 $37 Million; CVS Settles Generic Switch Lawsuit
CVS  Pays Nearly $37 Million to Settle Generic Drug Switching Charges … allegedly charged the government up to 400 percent more for Medicaid patients by illegally changing generic Zantac® prescriptions from tablets to higher priced capsules … [ PRforLAW, LLC Press Release]
See Also: CVS Press Release

3/19 Internet Drug News Miscellaneous Short Takes:
- China Has About 3,500 Drug Companies From More Than 5,000 in '04
Research & Markets Press Release
- Former InterMune CEO indicted for promoting Actimmune Off Label
NASDAQ
- NovoLog Insulin Approved for Kids Insulin Pumps
AP
- Biogen CEO Says Expects More Tysabri Brain Infection Cases
Reuters
- Analyst doesn't rule out AstraZeneca bid for Shire
MarketWatch
- Medco CEO Got $14.1 Million in 2007
AP

3/18 Enbrel Gets Black Box Regarding Tuberculosis
Amgen and Wyeth Announce Updates to U.S. Prescribing Information for Enbrel(R) … tuberculosis has been observed in patients receiving TNF-blocking agents, including ENBREL, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. …[Amgen Press Release]
See Also> Similar Report From CNN

3/18 Lilly: Dance With The One Who Brung 'Ya
Lilly returns to its roots … cut back its insulin sales force and saw its U.S. market share drop from 82 percent in 2000 to 43 percent in 2005 … replenishing its diabetes pipeline with a batch of licensing deals …[IndyStar]

3/18 FDA Experimental Hepatitis Vaccine Trial Halted
Dynavax says FDA puts clinical hold on Hepatitis B drug … Heplisav … patient receiving the vaccine was preliminarily diagnosed with Wegener's granulomatosis, a disease in which the blood vessels become inflamed…[Reuters]

3/18 Pharma Set To Emerge From Subterranean Share Prices
Get Ready for the Bounce … pretty much every big pharma name on the planet popping up when I ran this week's 52-week-lows search. Pfizer, GlaxoSmithKline, Merck, Lilly -- they're all in there this week …[Motley Fool]

3/18 What Has Three Faces & Sells Drugs?
Drug Sales Armies Beat Slow Retreat ...  less likely these days to send five reps to talk to a doctor about the same medicine, stopping instead at two or three…[Wall Street Journal FREE]
See Also: Accompanying Video

3/18 LA Times Publishes 4 Article Generic Drugs Exposé
Are Generics As Good As Brand-Name Meds? … Generic Pharmaceutical Association, dismisses the debate as "misinformation campaigns" masterminded by brand-name drugmakers … certain generic brands contain ingredients not found in the original and don't necessarily dissolve like Toprol XL …[Pharmalot]
See Also:  Generics: Just as good? … [LA Times]
See Also:  FDA standards for generics are questioned… [LA Times]
See Also: For some, generics may be more costly … [LA Times]
See Also:  Keeping generic drugs off the market… [LA Times]

3/18 Walgreens Beefs Up Its Onsite Doc Capacity
Walgreen Plans to Buy Health-Center Operators …  worksite-health-center operators as it builds a business of managing health centers and pharmacies at large-company worksites and rolls out a plan for drugstore clinics…[Wall Street Journal; $$$]

3/18 NY Times Reporter Publishes 432 Page Anti-Pharma Book
The Case for Another Drug War, Against Pharmaceutical Marketers' Dirty Tactics … How the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription Drugs … co-option of doctors and university researchers by aggressive, payola-dispensing drug company representatives …[Book Review; NY Times]
How Are You Feeling Today? … With barely controlled rage and cold hard data, Petersen identifies her target, the pharmaceutical industry (aka Big Pharma), and wastes no time piling up incriminating fact …[ Book Review; PopMatters.com]
See Also: Click HERE to view Amazon.com listing for above book.

3/18 Internet Drug News Miscellaneous Short Takes:
- Genta: FDA says available data on Genesense inadequate
MarketWatch
- Bristol Myers Looks To Sell Mead Johnson Baby Formula Business
Financial Times
- Doctors warn of superbug infection in face-lifts
Reuters
- Doctor shortage takes a toll in Japan
AFP
- 1 in 5 U.S. Seniors Struggles With Memory Lapses

HealthDay

3/17 FDA: Close To Identifying Heparin Contaminant;
Glucosaminoglycan-like Molecule Suspected:
FDA Says Contaminant in Blood Thinner Is Nearly Identified ...heparin-like molecule ... similar to the drug itself and was not detected until the new refined tests were developed … once they know exactly what the contaminant is, they will probably know whether it was deliberately added … [Washington Post]
Blood-Thinner Contaminant Traced to Chinese Plant ...structurally different from naturally-occurring heparin. The unknown material has approximately the same molecular weight as heparin and is similar in other ways … highly sulfated glucosaminoglycan-like (GAG-like) material …[HealthDay]

3/17 FDA Plans Permanent Inspectors In China
U.S. Regulators to Place Drug Inspectors in China … inspectors will work out of consular offices in Beijing, Shanghai and Guangzhou if approval is granted by Chinese authorities…expanded effort to keep contaminated food and drugs off U.S. shelves … [Bloomberg]

3/17 Stem Cell Market Pegged At $8.5 Billion By Decade End
Market for adult stem cells multiplies … stem cell products were virtually non-existent three years ago but are projected at $87 million in sales this year. Look ahead a decade, and the market could reach $8.5 billion, akin to the annual sales of the cholesterol drug Lipitor …[ Chicago Tribune]

3/17 Lexapro: 60% Of Forest Revenues; 4 Years Left On Patent
Forest's Lexapro Seen Growing Until 2012 Cliff …  launched Lexapro in 2002 to treat depression and quickly had a blockbuster on its hands that now accounts for about 60% of its revenue …[NASDAQ]

3/17 Zyprexa Jury Shown Damaging Lilly E-Mail
Eli Lilly denies NYT report on Zyprexa … that said a senior executive had encouraged the promotion of its schizophrenia drug Zyprexa for a use not approved by federal regulators…[Reuters]
Eli Lilly E-Mail Discussed Unapproved Use of Drug … "The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population," Mr. Lechleiter wrote in the message …[NY Times]
In e-mail, Zyprexa touted for youths … Before 2007, no so-called atypical antipsychotics had been approved for adolescents ..."seize the opportunity" to market its antipsychotic drug Zyprexa to teenagers and children in 2003, the state of Alaska claimed in a triala…[IndyStar]
See Also: Lilly Press Release

3/17 Analyst Pooh Pooh's Talk Of Pfizer/Shire Tie Up
Shire climbs on talk of Pfizer bid interest … some analysts thought a tie-up was unlikely … attention deficit hyperactivity disorder (ADHD) and enzyme replacement therapies did not fit with Pfizer's drugs portfolio …[Reuters]

3/17 Long Acting Prograf Faces 6-Month Delay
Astellas' Daily Prograf Moves Closer to U.S. Approval … Japan's second-largest drugmaker, moved closer to gaining U.S. approval for a once-daily version of its Prograf … submitted additional data to the FDA in July on liver patients, and on kidney transplant patients in September…[Bloomberg]
Astellas sees U.S. delay on transplant drug Advagraf … approval for the immunosuppressant drug will be delayed for at least another six months … modified release version of Prograf, needs to be given once a day and was approved in Europe…[Reuters]

3/17 Cerezyme: $300K Per Year; Experts Say Cut Dose To Save $$$
Cutting Dosage of Costly Drug Spurs a Debate … Cerezyme, is used to treat a rare inherited enzyme deficiency called Gaucher disease. Some experts say that for most patients, as little as one-fourth the standard top dose would work, saving the health care system more than $200,000… [ NY Times;   Free Registration Required]

3/17 Internet Drug News Miscellaneous Short Takes:
As Wyeth Struggles, Execs' Pay Falls
Wall Street Journal; FREE
Two Pfizer Execs Retire With a Combined $56.8 Million
Wall Street Journal; FREE
Pfizer CEO Receives $12.6M in 2007
AP
Abbott's Absorbable Heart Stent Effective, Study Says
Bloomberg
Eliot Spitzer and the Price-Placebo Effect
Washington Post

3/14 FDA Findings on Anemia Drugs Could Have Been Worse, But Will Take Away a Big Chunk of Business
FDA Panel Wants Limits on Anemia Drugs ... Cancer experts on the FDA panel overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with uncurable forms of cancer... [ AP ]
See also: FDA Panel Backs Anemia Drugs for Cancer Patients, but With Limits  … [ WSJ ]
See also: Amgen dodges bullet, but Aranesp sales seen falling ...  [ Reuters ]

3/14 Lilly Extends Pipeline; Buys Experimental …
Eli Lilly Buys Rights to Diabetes Drugs ... Transition Therapeutics's drugs are gastrin-based therapies to treat diabetes ... [ AP ]

3/14 Former Lilly Drug Rep Testifies To Congress
Ex-Drug Sales Rep Tells All ... To sell their drugs, pharmaceutical companies hire former cheerleaders and ex-models to wine and dine doctors, exaggerate the drug's benefits and underplay their side-effects, a former sales rep told a Congressional committee ... [ ABC News ]

3/14 Canada Permits Zyprexa Generic
Lilly Loses Bid to Block Zyprexa Generic in Canada ... Novopharm, a subsidiary of Teva, challenged the validity of Lilly's patent for olanzapine, a main ingredient in the drug, and won at trial June 5. Lilly's appeal of that ruling was turned down March 13. ... [ Bloomberg ]

3/14 Fever, Headache, and Chills Make Roche Feel Great
Flu Resurgence Spurs Profit Gains at Roche, Glaxo ... By the end of the U.S. and European flu seasons, prescriptions for Roche's Tamiflu may have surged 200 percent from last year. GSK (Advair) and AstraZeneca (Symbicort) also will show increases ... [ Bloomberg ]

3/14 Whatever Happened to Sneaking Dad's Beer?
For Adolescents, Inhalants Are Drug of Choice ... Inhaling common household products such as shoe polish, glue, aerosol air fresheners, hair sprays, nail polish, paint solvents, degreasers, gasoline and lighter fluid now appears to be the preferred way to get high among 12 to 14 year olds ... [ Washington Post ]

3/14 Cooties (Seed Ticks) Cause of Dangerous Response to Erbitux
Study finds immune system can cause reaction to cancer drug ... As many as 22 percent of patients treated with Erbitux in Tennessee and North Carolina reported some kind of reaction, including anaphylaxis... ... [ Reuters ]

3/14 SSRIs Beat Placebo
Antidepressants may suppress OCD ... Selective serotonin reuptake inhibitors are more effective than placebo for obsessive compulsive disorder, according to a new systematic review... ... [ Reuters ]

3/14 Internet Drug News Miscellaneous Short Takes:
- Wyeth Sues Watson over Generic Lybrel
AP
- Novartis sued in Calif. after Triaminic Recall
Reuters
- EU: Wyeth withdraws desvenlafaxine hot flash drug filing
CNN Money
- Sun Gets FDA Tentative OK for Generic Gemzar
FDA News

3/13 With Friends Like These...
Drug Firms Woo Democrats, Helping Defeat Their Bills ... Democrats in Congress have been unable to move legislation to allow reimportation or price negotiation for Medicare Part D. Their failure is due to a redoubled lobbying effort from PhRMA to court Democrats while halting their initiatives ... [ Washington Post ]

3/13 Generics, Biologics Up, Blockbusters a Vanishing Breed
Drug Sales in U.S. Grow at Slower Pace as Generic Use Surges ... According to IMS Health, sales of medicine rose 3.8 percent to $286.5 billion in 2007, compared with an 8 percent increase a year earlier ... [ Bloomberg ]

3/13 Nplate Moves Closer to Approval
FDA panel backs Amgen drug for blood disorder ... The benefits of the injectable drug, called Nplate, outweigh the risks for treating chronic immune thrombocytopenia purpura ... [ Reuters ]

3/13 Avastin and Proteinuria Risk
Doctors See How Cancer Drug Can Damage Kidneys ... serious damage occurs in only 1 percent to 2 percent of users … caused by inhibition of the growth of tiny blood vessels. Proteinuria can be found in anywhere from 21 percent to 64 percent of people given Avastin ... [ Washington Post ]

3/13 Ground Rules for New Provenge Trial Laid
Dendreon and FDA bump up trial timeline ... the FDA has agreed to an accelerated timeline for its late-stage clinical trial of Provenge, the biotechnology company's prostate cancer treatment candidate .... [ Business Week ]

3/13 Dear Doctor for Prezista
J&J, FDA warn of liver risk with HIV drug patients ... The letter, sent by J&J's Tibotec Therapeutics unit to doctors this month, cited cases of drug-induced hepatitis as well as liver injury and death. .... [ Reuters ]

3/13 Humana's Part D Models Blow Up
Humana Cuts Earnings Forecast on Higher Costs ... Disclosure of higher-than-expected Medicare drug costs by the Louisville, Ky., health-insurance and managed-care provider followed an earnings warning earlier this week by WellPoint .... [ Wall Street Journal ]

3/13 Pharmaceutical Care
Paying Pharmacists to Keep Diabetics On Track ... improving diabetics' health on the front end cuts the rate of expensive hospital procedures that are more common when diabetes is poorly controlled .... [ Wall Street Journal Health Blog ]

3/13 Internet Drug News Miscellaneous Short Takes:
- Wyeth's methylnaltrexone for post-op ileus found flunks
Philadelphia Business Journal
- Barr's generic for Taxol approved
CNNMoney
- Daiichi Sankyo's Injectafer Drug 'Non-approvable'
Bloomberg

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