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Internet Drug News.com online since 1998 |
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5/11 Truvada Gets Panel Upvote for HIV Prevention
FDA panel recommends approval of drug to prevent HIV infection ... Studies presented to the FDAΥs Antiviral Drugs Advisory Committee show that Truvada reduced the risk of acquiring HIV by 42 to 73 percent among men who have sex with men and among HIV-negative heterosexual partners of people who are HIV positive ... [Washington Post]
5/11 Lorqess Wins in 18-4 Panel Vote; Major Step to Market
Arena Wins FDA Advisory Panel Backing for Obesity Pill ... The company won the backing of advisers to U.S. regulators for the weight-loss medicine the company is developing in a race to bring the first obesity pill to market in 13 years ... [Bloomberg]
5/11 Gifts to Docs Registry Postponed
Physician gift tracking by drug companies delayed until 2013 ... The regulations would require industry firms to track any transfers of value to physicians of more than $10, as well as smaller payments to doctors whose total transfers from a firm exceed $100 ... [American Medical News]
5/11 Revlimid Improves PFS, Perhaps Not OS or QoL
Drug delays progression in myeloma, but is it worth the cost? ... A disappointing finding was a 7% to 8% incidence of second primary cancers in the lenalidomide groups compared with 3% to 4% in the placebo groups ... [LA Times]
5/11 Tofacitinib Not Expected to Overwhelm Humira
Humira on solid ground, analysts say, despite vote on Pfizer hopeful ... The pill seems to suppress the immune system, and Pfizer is recommending patients be vaccinated with the shingles vaccine before going on tofacitinib ... [MM&M]
5/11 OIG Looking for Overbilling and Too Many Painkillers
Medicare billing flagged at 4 percent of U.S. pharmacies ... Miami, Los Angeles and Detroit were the metropolitan areas of the country found most likely to have pharmacies where billing was at issue. In Miami, questionable billing was found 19 percent of pharmacies ... [Reuters]
5/11 Affordable Care Act Brings Medicaid Doc Fees Up to Medicare Levels
Health law to raise Medicaid service fees ... states would receive more than $11 billion in new federal funds to use on Medicaid primary care delivery from 2013-2014 ... [The Hill]
5/11 Osteoporosis Drugs Useful for 3–5 Years; Maybe Not Beyond
Bone Drugs May Not Help Women Long Term, FDA Review Says ... The analysis of two previous studies of 2,342 post- menopausal women "showed little benefit of continued bisphosphonate treatment beyond five years" ... [Bloomberg]
5/11 How Big Buyers Get 60% Back When They Buy Nexium
Inside The Secret World Of Drug Company Rebates ... The size of the rebates average about 30% of a medicines sales and can be as low as single digits or as higher than 50% of gross sales. ... [Forbes]
5/11 Doxil Shortage Eases
J&J opens up Doxil rationing on 'limited' new supply ... A limited supply of the scarce treatment, used to treat ovarian and other cancers, has opened up ... [Fierce Pharma]
5/11 Why Drug Shortages Happen: The Case of Propofol
Propofol drug shortages: The economic problem of a generic injectable ... With the high barriers to entry into the market and the difficulty to make much money from selling a generic propofol, it's unlikely another company would or even could enter the market to address the propofol shortage ... [MedCity]
5/11 Internet Drug News Fast Takes:
FDA warns MS patients about risky treatment
Reuters
Cardinal Health Set for DEA Showdown Over Pain Pill Sales
Bloomberg
Drawing Test Predicts Stroke Mortality Risk
Medpage Today
GOP's big drug(maker) addiction
Politico
Biologic copy-cat drug development is rising, bringing pharmaceutical companies together
Medill Reports
5/10 Pfizer's Potential Blockbuster Tofacitinib, New Oral for RA, Passes Panel
U.S. FDA advisers back Pfizer arthritis drug ... The likely cheaper pill would compete with widely used injectable medicines, including Abbott Laboratories Inc's $8 billion-a-year biologic drug, Humira ... [Reuters]
5/10 Two New Diagnoses Dropped from DSM-5
Two proposed changes dropped from psychiatric guide ... Gone from the latest revision are "attenuated psychosis syndrome," intended to help identify individuals at risk of full-blown psychosis, and "mixed anxiety depressive disorder", a blend of anxiety and depression symptoms ... [Reuters]
5/10 J&J Files for Fifth Indication for Xarelto
Johnson & Johnson hoping to increase marketability of clot-preventing drug by seeking regulatory approval for another use ... The company has applied to the FDA to market Xarelto to lower risk of clots forming around stents propping open arteries in the heart ... [Star-Ledger]
5/10 GSK Launches Tender Offer for Benlysta Maker
Glaxo to Begin Hostile Offer for Human Genome Sciences ... The offer by Glaxo values Human Genome at about 11 times estimated 2012 sales. Acquirers paid a median of 41 times sales for biotech companies in the past year ... [Bloomberg]
5/10 FDA Proposes an Even Faster Fast Track
U.S. may speed approval of "breakthrough" drugs ... U.S. drug regulators would be able to label treatments that show a big effect early in development as "breakthrough" therapies, and work with companies to speed up clinical trials ... [Reuters]
5/10 Pain Foundation Shuts Down After Congressional Spotlight
Senate probes ties among narcoticsmakers, pain organizations ... The drugmakers contacted by Senators Grassley and Baucus include Johnson & Johnson, which sells Duragesic; Purdue Pharma, which makes OxyContin; and Endo Pharmaceuticals, which sells Percocet and Opana ... [FiercePharma]
5/10 Requests for OTC Drug Orders Jamming Up Physician Offices
Doctors pressured to write prescriptions for OTC drugs ... Lawmakers are being asked to rescind a health reform provision that prevents patients from using flexible spending account money on medications without a doctor's order ... [American Medical News]
5/10 Long-Acting Abilify (Monthly Injection) Tested Successfully
Antipsychotic Does Well in Depot Version ... 9.6% of patients receiving depot aripiprazole showed signs of impending relapse compared with 36.8% of the placebo group ... [Medpage Today]
5/10 Overtime for Reps Cause Rejected by Seventh Circuit (Illinois, Indiana, Wisconsin)
Court Rebuffs Labor Dept. On Sales Rep Overtime ... The Seventh Circuit Court of Appeals rejected the idea that drug companies must provide overtime pay to their sales representatives ... [Forbes]
5/10 Lipitor is Over as Second Wave of Generics Hits
Goodbye, Lipitor. Pfizer Bids a Farewell ... The company is no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online ... [$$WSJ]
5/10 Internet Drug News Fast Takes:
Teva profit beats forecasts on U.S. drug sales
Chicago Tribune
Nursing Hormone Could Give Viagra a Run for Its Money
Minyanville
Dendreon Meets Expectations with $82M in 1st Quarter Provenge Sales
xconomy
Biogen MS drug application accepted by U.S., EU regulators
Reuters
Drug Labels Often Lack Pediatric Information
Pharmalot
5/9 FDA: Panel Votes 11:0 To Reject Arcalyst For Gout Indication
Regeneron's Arcalyst Fails to Win Panel Backing for Gout advisory panel voted 11-0 against approval of the injection, citing inadequate safety data benefit may be too small to justify a 1 in 244 risk of developing cancer [Bloomberg]
5/9 Locaserin Pre Panel Meeting Documents:
Cardio Safety, Efficacy Concerns
US FDA staff focus on safety of Arena obesity pill 5 percent of their weight compared to placebo, meeting the FDA's threshold, according to a combined analysis of three clinical trials But if any of the trials were analyzed alone, the drug did not meet the bar [Reuters]
5/9 Humira Replaces Lipitor As Top Selling Drug
- Pfizer had a chance to own it way back when, but ...
Humira Could Have Been a Pfizer Drug far fewer patients than Lipitor, the high cost of this biological medicine is such that Humira's sales are projected to exceed $9 billion this year ironically, this drug could have been Pfizer's [Forbes]
En Tells the tale of how Pfizer had not one but two chances to own the rights to Humira.
5/9 Pfizer Arthritis Pill Vote Wednesday; Do-Or-Die Product For PFE
Pfizer's Must-Win FDA Vote efficacy shouldn't be a huge sticking point. Pfizer might have trouble getting the higher dose approved safety issues have knocked down tofacitinib's sales potential substantially go after patients that have failed other treatments [Motley Fool]
5/9 Truvada: Take It And Be HIV Proof ? Gilead Seeks New Indication
FDA meeting Thursday; $11K per year may cause PBM headaches
Gilead's Truvada Pill Is Safe for HIV Prevention heterosexual couples where one person was infected, the risk was reduced by 75 percent mostly be given to people at high risk for infection [ Bloomberg]
FDA staff: Gilead's Truvada may help reduce HIV risk drug is only partly effective against HIV and that using it to prevent infection could cause protection from the virus to falter if patients fail to adhere to treatment [Reuters]
Editors Note: FDA better be certain that if people are non-compliant, we are not going to breed NRTI resistant HIV bugs.
5/9 Internet Drug News Fast Takes
Sanofi Chemist Is Jailed For Stealing Trade Secrets
Pharmalot
Docs say Viagra and Cialis get top honors for most trusted pharmaceutical brands
MM&M
Half of drug labels missing dose, safety info for kids
Reuters
Can Dendreon's New Management Turn Things Around?
Motley Fool
5/8 Depakote Off Label: Abbott Lands 2nd Largest Fine Ever
- Drug rep whistle blower will pocket 10's of million$
Abbott To Pay $1.6 Billion To Settle Depakote Marketing Probes specialized sales force trained to market Depakote in nursing homes for the treatment of aggression and agitation in elderly dementia patients ... [Dow Jones]
Abbott to pay $1.6 billion for Depakote marketing investigation of Depakote sales and marketing practices dating back to 1998 "despite the absence of credible scientific evidence that Depakote was safe and effective for that use [Reuters]
5/8 Pfizer Hypes Efficacy Of Extended Release Pristiq
New Study of Depression Drug patients who received 50 milligrams a day of Pristiq showed a relapse probability of 14.3% compared with 30.2% for the group taking a placebo [WSJ]
5/8 Depakote: Abbott's 3rd Fraudulent Marketing Fine
- Pattern of fraud inclused includes nutrition products (2003), Lupron (2001)
In Latest Drug Sales Case, Abbott Will Pay $1.5 Billion 2003, sales people worked with providers of medical care to bilk government health insurance 2001 ...paid what at the time was a record $875 million settlement following a long-running investigation into the sales of the prostate cancer drug Lupron [Forbes]
5/8 JNJ Continues To Pay Weldon $1 Mln Per Year Despite
His Stepping Down As CE0
- Gorsky gets $1.2 Mln to be CEO to run actually JNJ
J&J Chairman Weldon's Salary Cut To $1 Million After Stepping Down As CEO all day-to-day management and operational responsibilities are being transferred to Gorsky Weldon will work closely with Gorsky to ensure a seamless leadership transition [ NASDAQ]
&J Chairman Weldon's Salary Cut To $1 Million After Stepping Down As CEO not a member of the J&J executive committee duties as chairman will include working with the board of directors, facilitating communication between the board and management [Fox Business News]
5/8 Pfizer Arthritis Pill: FDA Staffers Highlight Efficacy, Safety Concerns
Pfizer Arthritis Pill Raises Safety Concerns, FDA Staff Says increased risks of serious infections and malignancies, in particular a higher chance of lymphoma data the FDA saw also didn't show that the pill stopped the disease from progressing [Bloomberg]
Editors Note: We would be amazed if the panel does not vote to approve this product (tofacitinib). The auto-immune experts have been going goo-goo ga-ga over Tofacitinib for at least year. It also has potential use for psoriasis, inflammatory bowel disease, and other immunological diseases, as well as for the prevention of organ transplant rejection.
See Also: Tofacitinib monograph
5/8 Roche Pulls Plug On 16,000 Patient HDL Escalator Trial
- Another CETP inhibitor bites the dust
Roche Halts Trial of Cholesterol Drug failure of the drug, dalcetrapib, was also another blow to the so-called HDL hypothesis stopping a 16,000-patient trial of dalcetrapib on the advice of a safety monitoring board ...drug had proved ineffective [WSJ]
5/8 Bayer's Hair Is On Fire Regarding How The Indians
Nationalized Nexavar Recipe
Bayer challenges India cancer drug ruling "damages the international patent system and endangers pharmaceutical research We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients [AFP]
Editorial Comment: The top 10% of India's population enjoys 31.1% of the country's income. In 2010, there were 153K Indians with net worths of $1 Mln or more. 73K Indians have a net worth of $5.5 Mln or more. India has 48 "dollar billionaires" - all who benefit from cut rate drugs. Bayer is indeed getting screwed. India has many rich people who can afford to pay full price for their cancer drugs.
5/8 Internet Drug News Fast Takes
Novartis Says Acromegaly Drug Met Primary Goal In Late-Stage Study
RTT
Vertex Cystic Fibrosis Combo Aids Breathing in Patients
Bloomberg