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Pharmaceutical News Harvest
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7/24 Manufacturers Rake in Big Bucks from Part D
30% Higher Costs For Drugs Under US Medicare Program
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The report found that Medicare pays 30% more for drugs for dual eligible patients than does Medicaid, which has accounted for $3.7 billion in increased costs over two years.
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[ CNNMoney ]
7/24 Making HIV into a Chronic Disease
HIV-Infected Patients' Life Expectancy Increased by 13 Years
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A 20-year-old patient taking the drugs in 2005 could expect to live to 69.4 years of age, said researchers led by Robert Hogg of the British Columbia Centre for Excellence in HIV/AIDS. When this type of therapy began in 1996, a 20- year-old could only expect to live to 56.1 years, the research concluded.
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[ Bloomberg ]
7/24 FDA Wants Prescreen for Ziagen
US urges genetic test before using Glaxo AIDS drug
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AIDS patients should have a genetic test before treatment with GlaxoSmithKline drug Ziagen to see whether they face a higher risk of a potentially fatal reaction, U.S. regulators have asked
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[ Reuters ]
7/24 Talkin' Trash
Bristol comes out swinging at Lilly clot drug
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Bristol-Myers Squibb, which sells leading blood clot preventer Plavix has dismissed Eli Lilly's rival Effient drug as a "niche" product that has harmed or failed to help three groups of patients in a big study
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[ Reuters ]
7/24 Tests to Begin for "Significant New Advance" in Prostate Cancer
Prostate cancer drug trials to start in Belfast
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Some 15-20 men suffering from an advanced form of the deadly disease will be offered places when further trials on abiraterone begin at Belfast City Hospital in two-three months' time
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[ Belfast Telegraph ]
7/24 Isentress Starts Fighting When Other Drugs Have Failed
Drug Holds Promise Against AIDS
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Raltegravir (Isentress) almost doubles the likelihood that patients will beat back the AIDS virus despite being immune to other medications
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[ Washington Post ]
7/24 Earnings Roundup
Medco Profit Rises on Generic, Mail-Order Drug Use
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Generics, more profitable than brand-name versions, accounted for almost two-thirds of prescriptions Medco filled in the quarter, a record. Sales of specialty pharmaceuticals, such as Amgen Inc.'s arthritis drug Enbrel, grew by a third... Medco signed $4.6 billion in new contracts for 2009 so far this year
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[ Bloomberg ]
AmerisourceBergen falls to 3Q loss on PMSI sale
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Revenue for AmerisourceBergen Drug Corp. increased by 8 percent, and revenue for Bellco Health grew 3 percent. But the company took a one-time charge of $222 million after selling its PMSI workers' compensation business
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[ AP ]
Lilly, Bristol-Myers Profit on Psychiatric Drugs
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Antidepressant Cymbalta contributed $654.4 million, a 26 percent increase, while the impotence treatment Cialis generated $362.2 million, a 24 percent increase. The antipsychotic medicine Zyprexa, Lilly's biggest product, generated sales of $1.24 billion, up 2 percent... For BMS: sales of Abilify rose 28 percent to $529 million. Sales of the blood thinner Plavix climbed 17 percent to $1.39 billion
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[ Bloomberg ]
7/24 Nevirapine May Help HIV-Infected Mothers in Developing Countries
AIDS Prevention Trial on Breastfeeding Splits Researchers
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Breastfed babies who took daily HIV treatments for six weeks cut their risk of getting the AIDS virus from their infected mothers by 15 percent
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[ Bloomberg ]
7/24 Manage Your Meds with a Few Clicks
CVS launches online drug management tool
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If you're already a CVS customer and have no particular desire for an online tool that helps you find better prices at Wal-Mart or some other pharmacy, the new CVS prescription manager looks pretty useful.
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[ Dallas News ]
7/25 Internet Drug News
Miscellaneous Short Takes:
Genentech board committee reviewing Roche offer
Reuters
J&J gets exclusivity period on Topamax extended
AP
Glaxo Gives Harvard $25 Million for Stem Cell Study
Bloomberg
Barr challenges Cephalon patent on Fentora
CNNMoney
7/24 Stormy SEAS Prompt Quick Response
Merck and Schering-Plough prepare Vytorin letter
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The "Dear Doctor" letter affirms the companies' position that the spike in cancer deaths and higher incidence of cancer among Vytorin users in a recent study involving 1,873 people was an anomaly.
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[ Forbes ]
7/24 "No Sacred Cows"
Witty unveils three-fold approach for GSK
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New initiatives include: partnership with South African generics company, to meet demand in emerging markets; GSK will solicit feedback on its pipeline from healthcare purchasers and venture capitalists; and GSK will break it research efforts into small teams who will compete internally for funding
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[ Financial Times ]
7/24 Onglyza Filed
Astra seeks approval for diabetes drug
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AstraZeneca has submitted a new drug application to U.S. authorities and applied for marketing clearance from European authorities for its new Onglyza diabetes treatment. AstraZeneca developed the product jointly with Bristol-Myers Squibb
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[ AP ]
7/24 Nexavar is Effective Treatment for Liver Cancer
Advanced Liver Cancer Patients Live Longer by Taking Anti-Cancer Drug Sorafenib
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Patients who received sorafenib lived a median of 10.7 months compared with 7.9 months for those who received a placebo. Time to cancer progression was also significantly longer in the treatment group: 5.5 vs. 2.8 months.
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[ Mount Sinai Medical Center ]
7/24 No Decision on Nplate
Amgen says US FDA decision on clot drug delayed
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Amgen is seeking approval to sell Nplate for adults who have not responded to other treatments for chronic immune, or idiopathic, thrombocytopenia purpura (ITP). No date has been set for a final response
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[ Reuters ]
7/24 Wyeth Earnings Report
Wyeth Tops Estimates Defending Ulcer Drug From Copies
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Sales of the ulcer drug, Protonix, dropped 59 percent, less than expected due to Wyeth's aggressive defense... Prevnar vaccine rose 9 percent to $691 million... Enbrel increased 36 percent outside the U.S. to 692 million. Enbrel revenue in the U.S, shared with Amgen, rose 6 percent to $284 million... Effexor goes off-patent this year
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[ Bloomberg ]
See also:
7/24 Pristiq Strategy Review
Interview: Wyeth sees big Pristiq sales, despite slow start
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Wyeth says insurer resistance to Pristiq tougher than expected... Wyeth in April said it expects to shift marketing away from Effexor this year and instead focus on Pristiq. Wyeth pharmaceutical head Joseph Mahady said, however, that Wyeth has no immediate plans to launch direct-to-consumer advertising for its new treatment
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[ Reuters ]
7/24 Pfizer Earnings Report
Pfizer Profit More Than Doubles on Sales Outside U.S.
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Lipitor revenue rose 9 percent globally to $3 billion... Sales of Chantix tumbled in the U.S. by 37 percent to $109 million... Lyrica increased 52 percent to $614 million... Celebrex gained 23 percent to $589 million
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[ Bloomberg ]
7/24 Industry Shrinkage
And The Next Pharma Plant To Close Will Be...
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Since January 2007, a total of 77 pharma industry sites employing more than 14,000 people were either closed or have been put on notice
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[ Pharmalot ]
7/24 Cheap DNA Scans for Myopathy Risk
Gene tied to muscle weakness from cholesterol drugs
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British researchers have located a gene responsible for muscle pain or weakness experienced by some people taking statin drugs to fight "bad" cholesterol
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[ Reuters ]
7/24 Internet Drug News
Miscellaneous Short Takes:
Dynavax inks flu vaccine deal with Novartis
San Francisco Business Times
Teva completes Bentley Pharmaceuticals acquisition
CNBC
Statins may help kidney transplant patients
Reuters
7/23 PBMs Push You into the Doughnut Hole
CMS Proposal Would Limit Industry Practice That Raises Costs for Some Medicare Drug Plan Beneficiaries
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Under lock-in pricing, PBMs charge a higher rate to insurers with whom they have contracted to administer their drug benefit than what they pay pharmacies to dispense the drugs to beneficiaries. This brings beneficiaries into the so-called "doughnut hole" coverage gap more quickly
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[ Kaiser Daily Health Policy Report ]
See also: > Generics Are Cheap, but They Could Be Cheaper [ WSJ Health Blog ]
7/23 RA Guideline Update
New Guidelines for Treating Rheumatoid Arthritis
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Methotrexate or leflunomide therapy is recommended for most RA patients ... Anti-TNF agents etanercept, infliximab, or adalimumab along with methotrexate can be used in new or early RA cases with worsening and severe symptoms
... Doctors should not prescribe anti-TNF agents to patients with a history of heart failure, lymphoma or multiple sclerosis.
....
[ University of Alabama at Birmingham ]
7/23 Congressional Pile-on
U.S. lawmakers probe FDA approval of Ranbaxy drugs
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Usual suspects Reps. Dingell and Stupak are investigating whether the FDA knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data
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[ Reuters ]
7/23 A Brand-New Clean Bill of Health
US FDA, CDC back Merck's Gardasil shot as safe
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The agencies reviewed more than 9,700 reports of health problems following Gardasil injections. Six percent of the cases were deemed serious events, including 20 deaths. FDA and CDC found no common thread in the deaths to link them to the vaccine.
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[ Reuters ]
7/23 When the Sh*t Hits the Grandma and Grandpa
Pandemic Flu: Most Nursing Homes Don't Have Plan
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If influenza pandemic hits the United States, acute care hospitals are likely to be overwhelmed. Nursing homes may then be expected to assist with the patient overflow, but a new study in the Journal of the American Medical Association suggests that many are not prepared for such a task.
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[ University of Michigan Health System ]
7/23 The Latest on Roche–Genentech
Roche-Genentech deal could spark worker defections [ Reuters ]
Genentech CEO sells 90,000 shares prior to Roche bid [ Reuters ]
7/23 Veto Signalled for FDA Tobacco Control
Bush administration opposes tobacco regulation
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According to a letter from HHS Secretary Leavitt, the Bush administration will try to block broadly popular legislation to give federal health authorities the power to regulate tobacco products
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[ AP ]
7/23 Do They Have Anything for Women Who Are Just in a Bad Mood?
Viagra May Help Women Restore Orgasms Lost to Antidepressants
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Almost three times as many women on antidepressants taking the impotence pill had orgasms compared with those given a placebo
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[ Bloomberg ]
7/23 Internet Drug News
Miscellaneous Short Takes:
Gilead Sciences starts clinical trial of elvitegravir, an HIV treatment
San Francisco Business Times
PPF's Zentiva withdrawal leaves way clear for Sanofi's 1.45 bln euro bid
Marketwatch
Xanodyne's Zipsor, a controlled-release pain management drug, on track for FDA approval
Business Courier of Cincinnati
7/22 More Doom and Gloom for Vytorin
Merck, Schering Vytorin Cancer Scare May Sink Sales Further
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In the SEAS study, 158 patients developed cancer, 9.9 percent of those getting Vytorin compared with 7 percent given placebo. Deaths from cancer were also slightly higher in those given Vytorin. The main thrust of the SEAS study was to test Vytorin as a treatment for aortic stenosis — but the drug did not show a benefit vs. placebo for that condition
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[ Bloomberg ]
See also: > Vytorin study raises new questions about cholesterol drug [ LA Times ]
7/22 Roche Wants the Whole Goose
Roche Offers $43.7 Billion for Rest of Genentech
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The deal risks disrupting the culture at Genentech that even Roche has said helped account for the success of the California biotechnology company in bringing innovative new drugs to market. Drugs developed by Genentech, particularly the cancer medicines Avastin, Rituxan and Herceptin, accounted for nearly a third of Roche's overall 2007 sales
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[ NY Times ]
See also: > Roche's Schwan Seeks Bargain as Genentech Investors Demand More [ Bloomberg ]
See also: > Why Genentech will say 'yes' to Roche [ Fortune ]
7/22 Topamax Warning
Epilepsy Drug May Increase Risk of Birth Defects
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Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects
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[ American Academy of Neurology ]
7/22 Silver Bullet for Prostate Cancer?
New pill helps shrink prostate tumors
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Cougar Biotechnology Inc's drug abiraterone delayed a worsening of the disease by a median of 400 days
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[ Reuters ]
7/22 Repurposing an Old Russian Hayfever Drug
Have scientists discovered a cure for Alzheimer's?
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A single 20mg pill of the drug, called Dimebon, taken three times a day, appears to be twice as effective in improving cognitive performance and preventing deterioration in memory as existing drugs.
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[ Independent (U.K.) ]
7/22 Enbrel for Alzheimer's
Drug restores speech in Alzheimer's; experts worry
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Alzheimer's patients given a popular rheumatoid arthritis drug showed seemingly dramatic improvements in a small study, but some doctors worried that the early findings will raise premature hopes in patients and their families
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[ Reuters ]
7/22 One Swing and You're Out
Outcry at NHS drug watchdog's plan to cut arthritis treatments
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The National Institute for Health and Clinical Excellence (Nice), is expected to issue a final appraisal document — the last draft before definitive guidance is issued — stating that patients who do not respond to one powerful drug for rheumatoid arthritis cannot try another of the same type.
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[ Telegraph (U.K.) ]
7/22 EARNINGS ROUND-UP
Merck withholds forecasts after cholesterol study
[ Reuters ]
Schering-Plough profit falls, but beats forecast
[ Reuters ]
7/22 Sanofi Takes Vitamins
Sanofi to Buy Primary Consumer Unit for A$560 Million
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Sydney, Australia-based Primary distributes vitamin supplements to more than 3,500 health food stores and pharmacies with brands including Nature's Own, Cenovis and Bio-Organics.
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[ Bloomberg ]
7/22 Internet Drug News
Miscellaneous Short Takes:
Gene Variations May Predict Antidepressant Response
HealthDay
CSL Shares Slump After Merck Reports Lower Sales of Gardasil
Bloomberg
7/20 Time To Feed Juggerxnaut: Teva In Talks To Buy Barr:
Teva signs $7.46b takeover of Barr
world's biggest generic drug maker, is acquiring Barr Pharmaceuticals, the fourth largest generic firm in the U.S., for $7.46 billion
acquisition will give it a 24% share of the U.S. market and 16% of generic drug sales around the globe
[Ha'aretz, Israel]
Will Teva, The 'Mighty Israeli PacMan,' See a Rival Bidder for Barr Pharma?
key remaining question is whether another company like Sandoz or Actavis or even a company that is not so obvious, i.e., not currently a player in the generics industry, chooses to bid as well
[Wall Street Journal; FREE]
Teva/Barr Combination Creates Biosimilar Force
Teva's $7.46 billion acquisition of Barr will result in a generics powerhouse, expanding U.S. leadership and geographic footprint
[Pink Sheet $$$]
Editor's Speculation: With the weak dollar the American companies are up for grabs at bargain prices. Look at Watson - last July it was selling for $33 - it closed at $28 and change last week. (down 15%). Mylan - last July it was trading at $17 last week it closed at $12.75 (Down 25%). What's the Euro doing? Up 14% (rolling 12).
7/20 Ranbaxy Boss Blames Problems On Global Conspiracy
Ranbaxy Says Drugmaker Tried to Foil Daiichi Purchase
Clearly, there is a multinational company which tried to scuttle the deal,'' Ranbaxy Chief Executive Officer Malvinder Singh
[Bloomberg]
7/20 Zentiva: Sanofi Rebuffed, Sanofi Not Worried
Zentiva rejects Sanofi Aventis bid
Sanofi offer fails to reflect the underlying value of Zentiva and its future prospects
recommended its shareholders reject offer
[ Canadian Press]
Sanofi Calm As Zentiva Slams Offer
[Forbes]
7/20 Canada Novartis: Timolol Eyedrop Recall; Some May Be Too Strong
Novartis unit recalling prescription eye drops
Timolol Ophthalmic Solution in 0.25 percent and 0.5 percent strengths, may contain more of the active ingredient than indicated
[CNN]
Editor's Note: Important to Americans? Yup - people buy drugs from Canada Pandering politicians think it's a good idea. This is an I-told-you-so scenario that FDA dreads. Who do the patients call for advice? The UPS man? If you suspect you have mislabeled Novartis timolol eyedrops you should call Health Canada's public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709
7/20 Prostate Cancer: Blacks Suffer Mysterious Treatment Discrimination
Racial disparity seen in prostate cancer treatment'
doctors offered prostate removal or radiation to white men 91 percent of the time, they offered it to black men in 85 percent of cases
[Reuters]
Please note: due to technical issues, last week's Pharmaceutical News Harvest (TM) is unavailable; we are working to rectify this issue. Thank you.
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