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CLick HERE for Last Week's Pharma News Harvest
Pharmaceutical News Harvest
2/3 30,000 Jobs Lost at AstraZeneca in Past Five Years
AstraZeneca announces another 7,300 job cuts as it warns of tough year ahead
...
The Anglo-Swedish company said its full-year profit was $10 billion, up from $8.1 billion a year earlier
...
[Washington Post]
See also: AstraZeneca job cuts expose dilemma facing the pharmaceutical industry [Guardian]
2/3 BioScrip Buyout
Walgreens fortifies its specialty pharmacy arm
...
BioScrip's community specialty pharmacy business is a national network with 30 locations in 16 states
...
[Drug Store News]
2/3 Cancer Drug Shortages Expected to Get Worse
Drug Shortages Cause Cancer Patients To Die Sooner
...
46 percent of the oncologists surveyed report that there were times in the past year when patients were unable to receive timely treatment due to product shortages, and 31 percent report this occurs each month
...
[Pharmalot]
2/3 Opening Arguments in Risperdal Case
J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says
...
Researchers at J&J's Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators
...
[Bloomberg]
2/3 Ella May Become Esmya, to Treat Fibroids
New Drug Treats Fibroids With Fewer Side Effects
...
Ulipristal acetate was found to be as effective as monthly injections of the drug Lupron for reducing heavy bleeding in women with uterine fibroids
...
[WebMD]
2/3 Generic Cliff Will Cut TV Drug Spending Further
Drug Makers Dial Down TV Advertising
...
Branded drug spending on television advertising fell 23 percent to $2.4 billion from the beginning of 2007 to the end of last year
...
[NY Times]
2/3 Diabetes Meds Drive Merck Profits
Merck results buoyed by sales of Januvia franchise
...
The strength of the diabetes line helped dilute the impact of lesser performing drugs, specifically Remicade which saw sales tank 28%
...
[MM&M]
2/3 For Those with AFib, Eliquis Better at Stopping Strokes
Experimental Drug Might Beat Aspirin in Preventing Repeat Strokes
...
Among those taking apixaban who had a prior history of stroke or mini-stroke, only 2.4 percent went on to experience a subsequent stroke or blood clot. By contrast, that figure rose to more than 9 percent among similar patients receiving daily aspirin.
...
[HealthDay]
2/3 Less Chance of Brain Bleed with Xarelto
New Anti-Clotting Drug May Cut Brain Bleeding Risk
...
People who took a new anticoagulant called rivaroxaban were about one-third less likely to experience bleeding in the brain than those who took warfarin
...
[HealthDay]
2/3 Janumet XR — Once a Day
Merck wins approval for extended release Janumet
...
U.S. approval for an extended-release version of its diabetes drug Janumet designed to be taken once a day, instead of twice a day
...
[Boston.com]
2/3 Expanded Gleevec Indication
FDA Adds Longer GIST Therapy to Imatinib Label
...
The longer overall survival among those who received 36 months of imatinib treatment after surgery represents a 55% reduced risk of death
...
[Oncology Report]
2/3 Internet Drug News Fast Takes:
Magnetic Therapy for Depression Becoming More Popular
Loyola University Health System
Ulcer-causing bug tied to higher diabetes risk
Reuters
Rick Santorum Tells Sick Kid Market Should Should Set Drug Prices
ABC News
Male and Female Behavior Deconstructed
University of California, San Francisco (UCSF)
2/2 CEO, Chairman Out at Dendreon; John Johnson, a Practiced Turnaround Hand, Takes Over
Why CEO Replacement Is Good News For Dendreon
...
The move signals a recognition that Dendreon may need to make significant changes in its strategy for marketing Provenge
...
[Forbes/Matthew Herper]
2/2 The World Really Needs an Alzheimer's Treatment; Does Lilly Have It?
Lilly Alzheimer's drug an unlikely ace in the hole
...
Lilly's latest contender, solanezumab, is designed to bind to and mop up a protein called amyloid beta, the main component of amyloid plaque deposits in the brains of patients with Alzheimer's disease
...
[Reuters]
See also—Lilly Pipeline Preview: Lilly Has Earned Its Lousy Rep [Seeking Alpha]
2/2 New Home for Zomig
Impax Labs licenses Astrazeneca's migraine drug in US
...
Zomig, which comes in forms of orally disintegrating tablets, nasal spray, and conventional tablets, reported 2011 U.S. net sales of $163 million
...
[Reuters]
2/2 You Never Thought $75,000 Would be a Bargain for a Pill
Price Restraint in Oncology?
...
Roche is pricing vismodegib at $7,500 per month, with an expected average duration of therapy of 10 months. That's $75,000—but it isn't over $100,000 like Yervoy, Xalkori, and Adcetris
...
[RPM Report/First Take]
2/2 Big User Fee Hike
Device Makers Said to Double FDA Fees to Produce Faster Reviews
...
The FDA took 73 days on average in 2010 to complete less- stringent reviews of devices that pose a low- to moderate-risk to patients, compared with 80 days before companies paid fees in 2001
...
[Bloomberg]
2/2 Pharma Leads in Helping
The Generosity of Drug Companies
...
In her Forbes article entitled "America's Most Generous Companies" (October 10, 2010), Jacquelyn Smith reported that in 2009, according to The Chronicle of Philanthropy, six of the top 10 corporations were pharmaceutical companies
...
[Dr. John LaMattina blog]
2/2 Medivation's MDV3100 is Latest Successful Prostate Cancer Treatment
New Prostate Cancer Medication Improves Survival in a Large Trial
...
Medivation's MDV3100 extended survival by nearly five months in a 1,199-patient study
...
[WSJ (video)]
2/2 New Round of Publicity for a Club Drug that Has a Great Positive Effect
New Depression Drugs Offer Hope For Toughest Cases
...
"Special K," which is actually an FDA-approved anesthetic named ketamine, can relieve even suicidal depression in a matter of hours. And it works on many patients who haven't responded to current antidepressants like Prozac
...
[NPR Morning Edition]
2/2 Writing a Prescription for a Brand, When a Generic is Available, is an Uphill Battle
Docs Are Surrendering To Generics: Survey
...
70 percent of family physicians and internists responded that they often do not specify 'dispense as written' on prescriptions, and 4 percent never do
...
[Pharmalot]
2/2 Hamburg Doesn't Want Help with Panels After All
No need to loosen conflict rules, U.S. FDA head says
...
Lawmakers had proposed bills that would change the rules to make it easier to find more qualified people and speed the review of drugs or devices
...
[Reuters]
2/2 Internet Drug News Fast Takes:
Rx text alerts arrive from CVS/pharmacy
Drug Store News
Educational intervention helps doctors and patients split statin tablets to save money for patients and payers
AHRQ
Newer antidepressants equally effective in treating major depressive disorder
AHRQ
J&J's Zytiga for Prostate Cancer Too Expensive, U.K. Cost Agency Says
Bloomberg
2/1 Pfizer Recalls 1 Mln Packs Generic Norgestrel, Ethinyl Estradiol:
- Too many sugar pills or maybe too few
Pfizer recalls 28 lots of birth control pills
some packets of the drugs had too many active tablets, while others had too few. ...could leave women with an inadequate dose of the hormone-based drugs ... risk that they will get pregnant
[AP]
2/1 Bydureon Priced Considerably Lower Than Victoza
Diabetes Drug Injected Weekly Wins F.D.A. Approval
wholesale price of Bydureon would be $323.44 for four doses, or about $4,200 a year
$3,400 for the low dose of Victoza and $5,000 for the high dose ..[NY times]
2/1 [For DM's & Drug Reps Only]: Rank & Yank 101
- History of forced rankings explained
'Rank and Yank' Retains Vocal Fans
sales manager for the consumer health-care division of GlaxoSmithKline ...practiced forced ranking on a regional basis ...managers met before Christmas each year to spar over which employees got which ratings--a grueling process that could take an entire day. "It was like being in court--the more you prepared, the better chance your people had of reaching the top of the scale
[WSJ; FREE]
2/1 Musical Executives: 2 JNJ OTC Bigwigs Ousted
- Heads finally begin to roll
2 execs out at J&J's troubled consumer business
one week after J&J said a McNeil Consumer Healthcare factory, shuttered since April 2010 for a top-to-bottom makeover, won't reopen until 2013
[AP]
2/1 Vertex Gets Nod For Kalydeco (ivacaftor)
To Treat Rare Cystic Fibrosis Variant
- Only costs $800 per day means hope for 1,200 sufferers
FDA approves Vertex cystic fibrosis drug, shares jump
only about 4 percent of patients
Vertex's second product approved in the United States in less than nine months after the hepatitis C treatment Incivek
[Reuters]
Drug approved to treat cystic fibrosis' root cause
rare form of the disease that affects just 1,200 people in the U.S
twice-a-day pill is
$294,000 for a year's supply,
[AP]
Editors Note: 50% USA market penetration (600 patients) could add $176 Mln per year to Vertex coffers.
See Also: Kalydeco PI | Patient Leaflet
2/1 FDA Panel Wants Suicide, Anaphylaxis Warning On Focalin Label
- FDA appears hesitant
Experts want suicide risk warning on ADHD drug
Focalin already warns patients that they may have new psychotic or manic symptoms
only Strattera's label mentions thoughts of suicide as a side effect, as part of a restrictive "black box" warning
[Reuters]
Editors Note: Only Strattera's label mentions suicidal thoughts, although no suicides occurred during clinical trials.
2/1 Internet Drug News Fast Takes
EU: Positive Opinion of Priligy (dapoxetine) For Premature Ejaculation
Furiex Pharma Press Release
McKesson Buys Medicine Shoppe Canada for $918 Million
Bloomberg
Merck Wins Patent Ruling Over Sandoz Version of Cancidas
Bloomberg
Zyprexa sales declining faster than expected in face of generics
Bloomberg
Stem Cells May Further Hepatitis C Research
HealthDay
Metformin Might Cut Pancreatic Cancer Risk: Study
HealthDay
1/31 Big 8 Pharma Stocks: Up 34% Last 12 Months
- Outpaced S&P 11x
US pharma: keep taking the tablets
average return of the eight-largest US pure-play pharmaceuticals and biotechnology companies by market value is a dizzy 34%... compared with the S&P 500's buzz-killing 3%
[FT.com]
1/31 Pfizer To File For Conjugated Estrogen + SERM Combo; Analysts Yawn
- Pregnant horse derived estrogen + bazedoxifene for menopause symptoms
Pfizer to seek OK for long-stalled menopause drug
analysts and doctors question whether regulators will approve it ... market potential could be limited by continued safety concerns
reduce menopausal symptoms including hot flashes and to prevent bone-thinning osteoporosis
[Market Watch]
Editors Note: Click HERE for brief monograph regarding Aprela | Bazedoxifene monograph
Editors Note: Wyeth (a pfizer legacy company) had originally planned to Aprela in 2007. Analysts don't expect Aprela to be a big drug.
1/31 AZN: Thousands More Face Layoffs
- R&D to be hit hard
AstraZeneca May Shed Thousands More Jobs
looming patent expirations on some of its biggest sellers, notably the Crestor cholesterol pill, the Nexium acid reflux med and the Seroquel
[Pharmalot]
'Axe hovers over AstraZeneca jobs'
Analysts have estimated that up to 3,000 posts could be axed across the group
Two years ago, Astra said more than 10,000 roles would be lost globally by 2014
[Manchester Evening News]
1/31 Vismodegib: Roche Gets Nod For Once Daily Oral Skin Cancer Drug
Roche Skin Cancer Drug Gains Approval
to treat advanced cases of basal-cell skin cancer
$7,500 for a monthly supply
patients would be on Erivedge for about 10 months
targets what researchers call the hedgehog pathway, a channel that cells use to communicate
[WSJ]
See Also: Genentech Press Release
Editors Note: Click Here to educate yourself about the hedgehog signaling pathway
1/31 Internet Drug News Fast Takes
Teva's Cephalon recalls Treanda leukemia drug
Globes (Israel)
FDA Accused of Snooping on E-Mail of Employees Who Complained to Congress
Wash Post
Vertex Falls as Analyst Cuts Hep C Sales Estimate
Bloomberg
Watson Announces New Jersey-Based Global R&D Technology Center
Watson Press Release
1/30 Bydureon Approved After Long Delay
- Anyone's guess who will help Amylin sell it
U.S. FDA approves Amylin's diabetes drug
FDA had rejected Bydureon twice before, most recently in October 2010
watching whether Amylin will be able to pull off a successful launch without the help of long-time partner Eli Lilly
[Reuters]
FDA Approves BYDUREON -- The First and Only Once-Weekly Treatment for Type 2 Diabetes
[Amylin Press Release]
See Also: Amylin Package Insert
Editor's Notes: Bydureon comes with a black box warning regarding risk of Thyroid C-Cell Tumors (just like Victoza). Bydureon is dosed 2 mg by subcutaneous injection once every seven days (weekly), at any time of day without regard to meals.
Similarities to Victoza: Black box regarding C-Cell Thyroid Tumors; not approved for use with insulin; not recommended for 1st line; not studied significantly in patients with history of pancreatitis; similar rates of headache, nausea, diarrhea.
Differences From Victoza: Must be reconstituted. Only comes in one strength (versus 3 for Victoza). PI citations regarding monotherapy A1c deductions: Bydureon @24 weeks = -1.6%. Victoza 1.8mg @52 weeks = -1.1%. Bydureon needles: (23G 5/16"; 2 needles included with each unit of use).
Bydureon reps will likely focus in once-per-week administration, no need for titration, and 1.6% A1C reduction @24 weeks versus Victoza's monotherapy A1C reduction of 1.1% @52 weeks.
Victoza reps may focus on Bydureon's larger needle diameter and reconstitution requirements and or weight loss/ efficacy statistics cited on the head to head comparison of Bydureon to Victoza known as the Duration 6 trial.
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1/30 Axitinib: FDA Green Ligts Targeted Drug For Advanced Kidney Cancer
US FDA approves Pfizer's Inlyta for kidney cancer
blocking certain receptors that can influence tumor growth
effective as Nexavar, a kidney cancer treatment sold by Bayer
common side effects with Inlyta included diarrhea, high blood pressure, loss of voicem
[Reuters]
1/30 Express Moves Brand-Name Lipitor To 3rd Tier Starting Wed
Benefit Manager's Lipitor Move Highlights Pressure On Pfizer
starting Feb. 1
generic might cost $10 while a tier 2 drug costs $30 and a tier 3 costs $60
formulary change won't raise co-pays for mail-order
[Dow Jones]
Editors Note: Patients using the Lipitor coupon can reduce their co-pay by $50 per prescription to $10.
1/30 Proposed Medicaid Regs Increase Mandated Rebate to 23%0
- Pharmacy reimbursement would also be slashed
States could rake in millions in cost savings
$18 billion can be saved on prescription drugs in five years
[Delaware Online]
Medicaid Prescription Drug Rule Saves $17.7 Billion, U.S. Says
drugmakers now pay rebates of at least 15 percent
minimum rebate would rise to 23 ... generic-drug manufacturers rebates would rise from 11 to 13 percent
[Bloomberg]
1/30 Warning Regarding IV Acetaminophen Overdoses
IV Acetaminophen Linked to More Child Overdoses
confusion over measurement guidelines -- milligrams vs. milliliters ... can result in the accidental administration of doses that are up to 10 times
[HealthDay]
1/30 190K Patient Study Clears Gardasil Of Autoimmunogenicity
Study: No link between HPV vaccine and autoimmune disorders
such as rheumatoid arthritis, lupus, type 1 diabetes or multiple sclerosis, according to a two-year study that included nearly 190,000 girls and women
[USA Today]
1/30 JNJ Prevails In Levaquin Tendon Jury Trial
Johnson & Johnson Wins Jury Verdict Over Levaquin Warning
third straight trial win
J&J and its unit failed to provide reasonably adequate warnings, while also ruling that this wasn't the cause of Straka's injuries
[BusinessWeek]
1/30 Internet Drug News Fast Takes
Statins May Stave Off Liver Cancer in People With Hepatitis B
HealthDay
J&J recalls Aveeno Baby Calming Comfort Lotion
Reuters
Amgen to buy non-Hodgkin's drug developer Micromet for $1.16 billion
LA Times
GlaxoSmithKline Seeking Acquisition in Turkey
Bloomberg
Teva Declines the Most in a Month on Competition, Recall
Bloomberg
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