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CLick HERE for Last Week's Pharma News Harvest
Pharmaceutical News Harvest
1/27 New FDA Rules on Brand and Generic Names in Promotion
FDA gives guidance on brand, generic names in ads
...
Where the brand name does not appear in running text, the scientific name must accompany the brand name in each instance. In the body copy, the scientific name may appear once per screen.
...
[MM&M]
1/27 Power Hitters On Deck
5 Big Drugs for 2012
...
The U.S. Food and Drug Administration could approve up to 45 new drug compounds in 2012, compared to 38 last year, that could generate U.S. sales of nearly $12 billion in 2017
...
[Barrons]
1/27 Big Bet on a Magic Bullet
Amgen Agrees to Purchase Micromet for $1.16 Billion to Gain Leukemia Drug
...
In a June trial, nine of 12 patients on blinatumomab reached complete remission from acute lymphoblastic leukemia, a cancer that affects about 5,760 people in the U.S. each year
...
[Bloomberg]
1/27 Most of Ranbaxy Manufacturing Shut Down
Federal injunction against Ranbaxy impacts US business, excludes generic Lipitor
...
Although the FDA has suspended exports of 30 drugs produced by Ranbaxy, the action does not appear to affect the company's generic version of Lipitor
...
[MedCity]
1/27 Essential Benefits Rules Will Not Be a High Hurdle for Prescription Plans
Drug benefits already exceed new federal standards
...
In the area of prescription drugs, plans are already offering much more coverage than the minimums established in HHS's essential-benefits policy
...
[The Hill]
1/27 Conventional Wisdom Overruled: Antidepressants Useful for Mild Disease Too
Medication helps some with mild depression
...
Researchers calculated that between three and eight people with non-severe depression would have to be treated with an antidepressant for one to benefit substantially from it
...
[Reuters]
1/27 EPO Alternative Peginesatide Close to FDA Decision
Affymax Prepares to Mount Challenge to Amgen Anemia Drug Monopoly
...
Pricing of this drug will be key to its market appeal... the Affymax drug is expected to cost about $6,000 a year
...
[xconomy]
1/27 "Branded Generics" Big Hits in India and China
Despite Generic Rivals, Branded Drugs Still Sell Well
...
Older medicines, whose U.S. patents have expired, have become a booming business for the pharmaceutical industry in emerging markets
...
[NY Times]
1/27 FDA Hits Cancer Claims
FDA chides Celgene, Novartis on drug promotion
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The complaints concern Celgene's breast cancer drug Abraxane and Novartis's cancer drug Gleevec
...
[Reuters]
1/27 2011 a Banner Year for Rare Disease Therapies
Innovative drug approvals up sharply in 2011, gov't increasingly funds infectious disease R&D
...
Drug companies are increasingly taking advantage of the commercial benefits of developing so-called orphan drugs, which include extra patent protections, higher pricing and a streamlined review process by FDA
...
[AP]
1/27 Internet Drug News Fast Takes:
Puerto Rico workers sue Pfizer, charging drug maker's retirement plans imprudently managed
Washington Post
Exercise may boost mood for some chronically ill
Reuters
Active Ingredient in Viagra Shrunk Disfiguring Growths in Kids
HealthDay
Brain Receptor in Eyes May Link Epilepsy, Cataracts and Antidepressants
University of Medicine and Dentistry of New Jersey
Steroids May Soothe Joints for RA Patients
Medpage Today
1/26 Vytorin Misses New Indication
FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin
...
The FDA decision appears to run counter to the advice it received from its own advisory committee last November, which voted 16-0 in favor of an indication for Vytorin in pre-dialysis patients.
...
[Cardiobrief]
1/26 Streetsweeper Investigative Report on Questcor
Questcor: A Bold Strategy Threatened by the Fine Print?
...
"The attitude there was: 'We're small. We're under the radar. And until we get caught, we're going to do anything we want.'
...
[Street Sweeper]
1/26 FDA Sentinel Data on on Effient Launch
Why the Prasugrel Launch Was Worse Than it Looked: A Sentinel Case Study
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The analysis suggests about 10% of users of Effient had a contraindication for the agent — a contraindication which Lilly was specifically required to emphasize in its launch materials
...
[The RPM Report / First Take ]
1/26 Gilenya Link to Cardiac Deaths?
Drug giant Novartis under investigation following patient deaths
...
The pharmaceutical company Novartis is under investigation by the European Union following the deaths of 11 patients who took the drug Gilenya.
...
[Digital Journal]
1/26 Best Drug Prices a Tap Away
Mobile app reveals price differences of Rxs across local pharmacies
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The app includes more than 1,000 of the most popular brand-name and generic drugs, consisting of more than 95% of the most commonly prescribed drugs
...
[Drug Store News]
1/26 Prevacid No Help for Asthma
Heartburn drug ineffective for children's asthma
...
Children on prescription Prevacid pills had more colds, sore throats and bronchitis infections than those given dummy pills. There were also signs that children given Prevacid were prone to broken bones
...
[AP]
1/26 Avastin Study
2 drugs used to treat breast cancer are linked to tumors in mice
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The research team found that the lack of oxygen also triggered more aggressive growth of the tumor's stem cells
...
[Detroit Free Press]
1/26 Stent Business Down, Abbott Fires Hundreds
Abbott Labs cuts 700 jobs amid drop in heart stent orders, posts higher 4Q profit
...
Most of the layoffs will affect employees who manufacture the company's heart stents and diagnostic tests
...
[Washington Post]
1/26 Lose Your Spouse? We Have a Pill for That
Grief Could Join List of Disorders
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A proposed change to the diagnosis of depression in the DSM would characterize grieving as a disorder and greatly increase the number of people treated for it
...
[NY Times]
1/26 Kaiser Study Clears HPV4 Vaccine
Gardasil doesn't cause autoimmune conditions
...
Researchers used electronic health records to conduct an observational safety study of 189,629 females ages 9 to 26 years in California who were followed for six months after receiving each dose of Gardasil
...
[Drug Store News]
1/26 Rapid DNA Sequencer Becomes Takeover Target
Roche Makes Hostile $5.7 Billion Offer for Illumina to Bolster Diagnostics
...
Roche would gain technology for reading the genetic makeup of tumors, potentially allowing the company to offer treatment specific to individual patients
...
[Bloomberg]
1/26 Internet Drug News Fast Takes:
Doctors Refer More Patients to Specialists
NY Times
Huge Study Finds Risk Factors Do In Fact Predict Risk
Cardiobrief
1/25 No Big Overtime Payday for NVS Reps
Novartis to pay $99 mln in sales rep overtime case
...
The U.S. Supreme Court is likely by this summer to address the same issue after another federal appeals court said similarly situated workers at a unit of Britain's GlaxoSmithKline Plc were not entitled to overtime pay
...
[Thompson Reuters]
1/25 Fabrazyme Factory Gets Nod; Start Pumping It Out Soon
Sanofi's Genzyme Receives FDA Approval of Framingham Plant
will begin moving the most severely affected patients in Europe to a full dose of Fabrazyme this quarter
[BusinessWeek]
Sanofi's Genzyme wins approval for Framingham site
U.S.-based plant that will produce Fabrazyme, aiming to get patients back on their required dosages of the rare disease drug
[Reuters]
1/25 7 Weeks Post Patent Expiry Lipitor Falls to 32% Share
Pfizer's Lipitor Plan Might Not Be 'Worth It,' Watson CEO Says
dropped to 32 percent in the seventh week of competition from 41 percent in the second week
strategy to keep its market share of cholesterol pill Lipitor may boost revenue without aiding profit
[Bloomberg]
1/25 Levaquin: 3rd Tendon Case To Go To Trial Winds Down
Plaintiff: should have warned despite FDA's saying label was kosher
J&J Unit Didn't Hide Levaquin Health Risks, Company Lawyer Says at Trial ... claims J&J should have enhanced the drug's warning before the FDA required
3,700 claims involving Levaquin
J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year.
label from day one in 1996 was adequate
[Bloomberg]
1/25 Abuse Resistant Oxycodone Pill Hits Drugstore Shelves
Acura Gains as Oxycodone Pill to Deter Abuse Reaches Market: Chicago Mover
short-acting oxycodone pill Oxecta with tamper- resistant properties uses Acura's Aversion Technology, exclusively licensed to Pfizer in the U.S.
[Bloomberg]
1/25 Under Siege From Critics Paula Deen Publicist Quits
Deen rep out of the kitchen
disagreed with Deen's dramatic turnabout, after years of promoting fatty foods, to announcing she has a deal with a diabetes drug company [Novo Nordisk] and will be promoting lighter food
[NY Post]
1/25 Experts Debate Otherwise Healthy People Taking Statins
Should Healthy People Take Cholesterol Drugs to Prevent Heart Disease?
doctors argue that studies don't show that taking statins leads to longer life, and they say that much of the research into the question is fundamentally flawed
[WSJ]
Editors Note: 2,100 words; 2 doctors argue pros and cons of prophylactic statin therapy.
1/25 JNJ: Formerly Recalled Brands Slowly Come Back
J&J Still Sees Impact of McNeil Recalls, But Brands Are Coming Back
avoided a third consecutive year of sales declines in 2011 -- sales rose 5.6%, to $65 billion
company began shipping Tylenol Cold & Flu Severe caplets in September
[WSJ FREE]
1/25 Internet Drug News Fast Takes
Watson buys Indian Generic Drug Company Ascent Pharma for $395.6 mln
Reuters
IMS Acquires PharmARC in India, Strengthening Global Services
IMS Press Release
Heartburn Meds Won't Help, May Harm Kids With Asthma
HealthDay
3 Pharmaceutical Buyout Targets to Consider in 2012
Motley Fool
1/24 Biomarin's $400K Per Year Drug For Dwarfs
- Effects 30K people worldwide
BioMarin's Dwarfism Medicine Marks Growth of $400,000 Rare-Disease Drugs
growing field of companies looking to profit by treating rare diseases. They develop medicines for as few as 5,000 to 10,000 patients worldwide and make returns by charging as much as $400,000 a year
[Bloomberg]
Editors Note: Watch this company; someone's going to buy it.
1/24 Embryo Stem Cells In Eyeball Somewhat Restores Sight
- 2 patients; both report dramatic results
Embryonic stem cells improve sight of legally blind women
first time a scientific study has been published about the results of an embryonic stem cell trial
couldn't take a walk, go shopping or cook by herself
after surgery in one eye, she cooks, shops and walks
"I can even read my own writing now
[CNN]
Study: Stem cells may aid vision in blind people
[AP]
1/24 Jim Cramer (Mad Money) Says Pharma Turn Around Is Here
- Imbecilic investment guru says time to buy Merck
Is Big Pharma Turning Around?
"After years where the prospects for these companies kept deteriorating, they can finally look forward to a future that's brighter than the recent past."
[CNBC]
1/24 Takeda: Regulators Approve Subcutaneous Velocade Jab
- Allegedly fewer pesky nerve side effects
FDA OKs Millennium's Velcade Injection
new formulation of Takeda's multiple myeloma drug Velcade that doctors can administer as a shot under the skin instead of as an intravenous infusion
reduce nerve pain and numbness that is the most bothersome side
[The Street]
See Also: Takeda Press Release
1/24 Inhaled Version Of Loxapine Delayed 3 Months: Alexza Tailspins
FDA extends review of Alexza product, shares fall ...hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration -- with loxapine, an anti-psychotic
[ Reuters]
1/24 Motrin Labeling Anomaly Means JNJ On The Hook For Millions
- RX ibprofen lists Stevens Johnson, OTC does not
J&J Must Face Lawsuits Over OTC Motrin Labeling
J&J maintained that its hands were effectively tied, because the FDA did not require the sort of language that the families insist should have appeared in the labeling
[Pharmalot]
Motrin May Have to Warn About Skin Loss
listed the possible SJS link on its prescription Motrin labels since 1983
neither disease is mentioned on FDA-approved labels for the over-the-counter and children's versions of Motrin.
[Courthouse News Service]
1/24 Internet Drug News Fast Takes
B. Braun Becomes the First to Deliver FDA-Approved 2g Cefazolin Dose
Braun Press Release
Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray
Perrigo
New DNA Analysis Machine: 1/4 Of The Price, 9x Faster
Forbes
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1/23 Gilenya Under Investigation After 11 Deaths; Novartis Hammered
- Novartis updates warnings regarding cardio monitoring
Novartis drug investigated after 11 deaths
didn't know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines
not all the deaths were heart related
[AP]
Related: Teva Rises to Eight-Month High on Novartis News: Tel Aviv Mover
[Bloomberg]
1/23 Pharma's Answer To Reefer Brownies Inches Forward
Pot-based prescription drug looks for FDA OK
mouth spray it hopes to market in the U.S. as a treatment for cancer pain
approved in Canada, New Zealand and eight European countries
relieving muscle spasms associated with multiple sclerosis
[AP]
1/23 Tysabri: Newly OK'd Screening Test Could Double Sales
- Sales, schmales: test means quantum leap for patient safety
Biogen, Elan Win U.S. FDA Approval of Tysabri Label Change to Target Use
clearance to modify the label of their multiple-sclerosis shot Tysabri with new safety information that may double the treatment's worldwide sales
[Bloomberg]
FDA approves test to help screen for risk of rare brain infection in patients taking Tysabri
John Cunningham virus is harmless in most people, but can become dangerous in patients taking immune system-suppressing drugs like Tysabri.
[Chicago Tribune]
See Also: Biogen Press Release
1/23 Overseas Bribery Settlements Approach US Shores
- Pharma's dilemma: many settle even if they're not guilty
Pharma groups brace for costly settlements
brought by US agencies for alleged bribery and aggressive marketing practices
AstraZeneca, Actavis, Sanofi, Roche and PharmaSwiss are among the companies drawn into a corruption probe opened in Serbia in 2010
[FT]
1/23 Pharma To FDA: Tell Us What We Need To Get Diet Pill Approved
Drug lobby wants clearer FDA rules for diet pills
industry may stop investing in medicines to treat diseases like diabetes or obesity without more explicit guidelines from U.S
[AP]
1/23 Abbott, Medtronic Win Drawn Out Stent Patent Battle
Abbott Labs Wins Ruling Over J&J, Wyeth in Xience Stent Case on Patents
invalidated two patents for heart devices controlled by Johnson & Johnson Cordis unit
drug coating limits the growth of scar tissue that could re-clog the arteries. J&J pioneered the market
last year said it would leave the global market altogether
[Bloomberg]
**** Not Pharmaceutical, But Most Interesting ***********
8 Examples How Google Robbed Other People's Inventions
Forbes
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1/23 Top 10 Pharma Layoffs Of 2011
Top 10 pharma layoffs of 2011
annual layoff report provides key figures, dates and themes related to the industry's top 10 layoffs
Merck/Schering-Plough and Pfizer/Wyeth mergers triggered enormous workforce reductions. Sanofi kept the theme of merger-related layoffs alive in 2011 ...[FiercePharma]
1/23 Paula Deen Fallout Continues - Media Weighs In Pro & Con
- Silent 3 Yrs she had diabetes until she inked deal to hype drug
- Fans say buttery cooking no different from high-end New York restaurants
Paula Deen's Preventable Marketing Disease
like a man admitting he's a sex addict after inking a deal with Viagra
Had she announced her malady and dedicated herself to change, both prescriptive (possibly with Victoza) and lifestyle, her marketing opportunities would have been endless
[HuffPost]
God, guns and grease! Northern snobbery fuels the Paula Deen fingerpointing
Deen's notorious reliance on sugar and butterfat is no more debilitating than the chic cuisine of the Hamptons or the Michelin-starred meals of New York
[Fox News]
1/23 Internet Drug News Fast Takes
After The Risperdal Trial, J&J Looks More Like Humpty-Dumpty
Ed Siverman Via Forbes
AstraZeneca May Rethink Aversion to Big Deals After Setbacks
Bloomberg
Cambridge biotech Alnylam to lay off one third of workers
Boston Business Journal
1/20 Feds Reject Much Anticipated Diabetes Drug
- Dapagliflozin tricked kidneys to absorb glucose and excrete it in urine
- Body blow for AZN, punch in nose for BMS
- Companies "remain committed" to drug's development
U.S. rebuffs AstraZeneca, Bristol on diabetes drug
dims prospects for the once-a-day drug, which is seeking to compete in an already well-supplied diabetes market
FDA panel of outside experts voted against recommending approval over concerns about cancer risks and liver injury
[Reuters]
See Also: Dapagliflozin Monograph | Dapagliflozin Lit Search | News For Dapagliflozin
See Also: BMS Press Release
1/20 Hollwood Options Drug Rep Whistleblower Book - Movie Likely
New Regency Options Whistleblower Tale 'Blood Feud' (Exclusive)
real-life thriller about the anti-anemia drug Procrit -- and the Johnson & Johnson pharmaceutical rep who helped sell it until he came to believe it was causing harm
[The Wrap]
Factoid: The JNJ rep who blew the whistle was Mark Duxbury. Click HERE for description of illicit tactics Procrit reps allegedly used to push Procrit. The FEDs are looking for $3Bln in damages. Duxbury stands to pocket hundreds of millions of dollars. The case was dropped and revived in a legal decision that went all the way to the Supreme Court. I am guessing that they won't make the movie until the case is settled.
1/20 Roche Melanoma Pill Causes Cancer But There's Good News
Roche melanoma pill spurs growth of other cancers
third of advanced melanoma patients who take Roche Holding's pill Zelboraf develop a less deadly form of skin cancer
second melanoma drug that blocks a different mutation
helped to solve this problem in lab mice
[Reuters]
1/20 Osteoporosis Is So Slow, Bone Density Retests Can Wait
Patients With Normal Bone Density Can Delay Retests, Study Suggests
Bone loss and osteoporosis develop so slowly in most women whose bones test normal at age 65 that many can safely wait as long as 15 years
[ NY Times]
1/20 Genentech Runs Voluntary Corrective Ads for Boniva
Genentech Runs Voluntary Corrective Ads for Boniva
Genentech wasn't required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway
[PharmExec]
1/20 Preference For Reps Versus E-Detail Differs By Specialty
Sales Rep vs. eDetail: Consider the Practice Area
oncologists and family medicine practitioners said they were better educated by eDetails, whereas cardiologists and allergy/immunology docs said in-person reps provided a better education
[PharmExec]
1/20 Forest: Lexapro, Namenda Near Cliff Danger Looms Unless
This Company is Quickly Approaching the Patent Cliff
going to lose patent exclusivity on Lexapro this year and Namenda in 2015
77% of Forest Labs' sales will be at risk from generic competitors within three years
[Motley Fool]
1/20 Internet Drug News Fast Takes
J&J to pay $158 million to settle charges it improper marketed Risperdal in Texas
Reuters
Merck to settle Canada Vioxx suits for up to C$37M
AP
Study Hints That Statins Might Fight Breast Cancer
HealthDay
Antidepressants Might Raise Fall Risk in Nursing Homes
HealthDay
Novo Nordisk Named to FORTUNE'S '100 Best Companies to Work For' List for Fourth Consecutive Year
Novo Press Release
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