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Pharmaceutical News Harvest ™

7/30 Profits Beat Expectations? Must be Time to Cut Jobs
Amgen Says It Will Cut More Than 2,400 Jobs Worldwide .... Amgen announced today it would cut 2,400 to 2,900 employees, or 12 percent to 15 percent of its total workforce, with the firings beginning this year and continuing through 2015. Most of the job reductions will come in the U.S. .... [Bloomberg]

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7/30 D.O.'s Will Help Fill Primary Care Gap
Osteopathic Schools Turn Out Nearly a Third of All Med School Grads .... The boom in osteopathy is striking. In 1980, there were just 14 schools across the country and 4,940 students. Now there are 30 schools, including state universities in New Jersey, Ohio, Oklahoma, Texas, West Virginia and Michigan, offering instruction at 40 different locations to more than 23,000 students .... [NY Times]

7/30 Pfizer Weighing Options on Next Acquisition
Pfizer leaves investors guessing on intentions for Astra .... The largest U.S. drugmaker reported higher-than-expected second-quarter revenue, helped by growing demand for its cancer medicines. But overall sales fell on competition with newer rival drugs and cheaper generics .... [Reuters]

7/30 Duexis and Vimovo Kicked Off Formularies
Access to Horizon Pharma Drugs Cut By Two Leading PBMs .... Horizon estimates 20-30% of its Duexis and Vimovo prescriptions could be at risk by being excluded from the Express Scripts and CVS Caremark formularies. Starting next year, customers of both PBMS won't be reimbursed for the drugs and will have to pay full price if they still want them .... [The Street/Adam Feuerstein]

7/30 20 CDC Quarantine Stations at Airports First Line of Defense Against Ebola
Ebola's Escape From Africa Unlikely Though Not Impossible .... People who may have been in contact with the virus are generally monitored for fever for 21 days, the CDC said. Only about 50 percent of patients show extreme symptoms that can include bleeding from the eyes, ears and nose. Others have only a fever as an early symptom. .... [Bloomberg]

7/30 Physicians Nervous About What Sunshine Will Show
Doctors want to know how CMS plans to display Sunshine payment data .... Physician and industry trade groups are asking the agency to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research .... [MM&M]

7/30 Generic Approval Delays Will Keep Costs High for Patients
Is FDA 'Buried' Under a Backlog of Generic Drug Applications? .... "...They are on track to receive more than 1,500 [applications] this fiscal year," says Robert Pollack, a former acting deputy director of the FDA Office of Generic Drugs..."The estimates were for between 800 and 850 applications" .... [Pharmalot]

7/30 Gilead's 2nd Quarter Profits Were 56% of Revenues
Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined .... The weekly number of new patients going on Sovaldi has been gradually slowing, from more than 2,900 in February and March to about 1,600-1,800 in late June and early July .... [San Jose Mercury News]

7/30 Imbruvica for Chronic Lymphocytic Leukemia
J&J's Imbruvica wins new cancer indication .... Chronic lymphocytic leukaemia is estimated to be diagnosed in just under 16,000 people each year in the US and is expected to be the cause of 4,600 deaths in the country during 2014 .... [PMLiVE]

7/30 FDA May Use Web Search Data to Find Drug AEs
Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes' .... In a new research letter, two FDA researchers argue that "Internet search logs" could be substantially useful to the agency's drug regulatory staff in determining which drugs might have unforeseen adverse events .... [Regulatory Focus]

7/30 Internet Drug News Fast Takes:
Google's New Moonshot Project: the Human Body
More than 10 Colleges of Pharmacy Will Close in the Next 20 Years! UNLESS…
Pharmacist Activist
$15 billion annual public funding system for doctor training needs overhaul, says IOM
National Academy of Sciences
Drug Naming Process Gets New Scrutiny From FDA
Roll Call
FDA Rejects AcelRx Painkiller Dispensing Device
The Street/Adam Feuerstein

Fast Takes
Ebola only a plane ride away from USA
USA Today
2nd American infected with Ebola amid fears of outbreak spread
Letrezole: Cancer Drug Shows Promise as Infertility Treatment
Glaxo Has No Plans to Spin Off Consumer Health-Care Division

HDL Boosting Drugs Not Too Useful In Preventing Heart Attack, Death
Drugs to increase 'good' cholesterol may not cut deaths … Even if HDL is carrying cholesterol away from the coronary arteries, that doesn't mean that any therapy that raises HDL is automatically protective … After all, the therapy could just be blocking cholesterol traveling on HDL from exiting …[Reuters]

Reckitt Benckiser : Condoms, Sexual Lubricants, Lysol Yes; Suboxone No
- Plans spinoff of pharma unit
Reckitt Benckiser to Spin Off Pharmaceutical Unit … Addiction treatment is not "a space we want to be in … once accounted for a fifth of earnings … pushing further into consumer health-care through acquisitions and new products …[Bloomberb]

harma Trade Zine: Sanofi Makes Sense To Co Market Inhaled Insulin
Lack of marketing partner delays Afrezza launch …   Sanofi, could have the most to gain from a co-promotion deal. While Eli Lilly and Novo Nordisk both already sell blockbuster fast-acting insulins, sales of Sanofi fast-acting mealtime insulin Apidra lag behind its competitors in the category …  [MM&M]

Zalviso FDA Shoots Down Much Ballyhooed Painkiller Dispensing Device
FDA Rejects AcelRx Painkiller Dispensing Device (Update) … "Shelf life" refers to the stability of the painkilling sufentanil tabs in the Zalviso system …  FDA is apparently worried about a high error rate involving the optical sensor in the device …[The Street]

Caremark Shill  Claims  Solvaldi Boosts Health Insurance Premiums
$200 - $300 For Every Man Woman And Child In the USA
New Expensive Treatments for Hepatitis C Infection …  simple math is that treatment of patients with HCV could add $200 to $300 per year to every insured American's health insurance premium for each of the next 5 years … Gilead has a monopoly, and its investors expect it to make a profit …  approaches to control costs for high-priced medications need to be developed and evaluated …[JAMA]
Related: Express Scripts Trying To Shame Gilead Into Reducing Sovaldi Price: Who Is Really The Greedy One? … Just as Express Scripts is questioning Gilead's Sovaldi pricing, perhaps Express Scripts clients should be questioning if having a pharmacy benefit manager actually provides any benefit …  Express Scripts made enough of its own money last year, raking in revenue close to $25 billion, enough to pay for the CEO's $50 million compensation package …[Seeking Alpha]

Fast Takes
GSK seeks approval for world's first malaria vaccine
Amgen, Bayer's  Nexavar Fails Late-Stage Breast Cancer Study
Company Press Release
U.S. HIV cases dropped 33% over the last decade
LA Times

Novo:  Basal Insulin Tresiba + GLP1 Fixed Dose Combo Nears
E.U. Green Light
Novo's blockbuster diabetes combo nears EU approval … to be marketed as Xultophy, is a fixed-dose combo of Victoza and  insulin degludec, a once-daily treatment sold outside the U.S. as Tresiba … company doesn't expect a U.S. launch for its next-gen insulin until 2017 …[Fierce Pharma]

7/28 Bad News For Drug Reps: Access To Docs Continues To Shrink
Rep access continues to shrink … no longer safe-haven specialties, and specialists such as dermatologists, gastroenterologists  … change has been swift: ZS reported last year that 84% of dermatologists and 63% of gastroenterologists were rep-accessible. This year, these percentages have dropped to 67% of dermatologists and 47% of gastroenterologists …[MM&M]

Merck Plans To Lay Off Hundreds Of Sales Reps
Merck Cuts 600 Sales Reps as Part of its Ongoing Reorganization … eliminating 600 jobs by the end of next month … spokeswoman says most of the layoffs involve sales reps that are based around the country and is a part of a broader cost-cutting initiative …[Pharmalot]
See Also:  Merck Message Board Thread Regarding Layoffs; Cafι Pharma

Glaxo Bribe Allegations Spread To  Syria
- Trips, money, food; small change compared to $480 Mln China allegations
FBI Interviews Glaxo Employees …  bribed Syrian doctors and pharmacists over the past five years … cash payments, speaking fees, trips ...Doctors promoting Glaxo's cold and flu products were paid $2,500 in cash, while $2,500 was paid to a national dental association in return for …[WSJ]

MannKind Tumbles;  Analyst Says Inhaled Insulin Over Hyped,
MannKind Pharma Gets Hedge Fund Treatment, Traders Rally Defence … [inhaled insulin]  will fail in part because earlier attempts have, and because the drug will be more expensive than standard injections … likely to flop given strong negative warnings on its labels, including about potential lung cancer. He also doubted MannKind's ability to strike a lucrative sales partnership …[StockTwits]
MannKind Afrezza Partnership News Coming Within Weeks …  may be forced to say something about the state of Afrezza partnership discussions very soon, even if no deal is in place … company is almost certainly pushing very hard to get that deal closed before it must report second-quarter financials …[The Street]
Editor's Note: Since June 1st, insiders have dumped 3.195 million shares valued at more than $28 Mln.  If they had a solid co-marketing deal would they have sold so many shares?

Brand Website Visitors Take More Drugs
- The more they click the more they refill
Brand websites drive new patients to scripts--and old patients to refills … best shot at persuading new patients to start a drug--and current patients to keep taking it … Refill rates for patients who dropped by a brand site were 14.7 points higher than for patients who didn't … [Fierce Pharma Marketing]

Acetaminophen No Better Than Placebo for Back Pain
Acetaminophen No Better Than Placebo for Back Pain … two-thirds of adults have lower back pain at some point in their lives, and most are told to take acetaminophen, sold under brand names like Tylenol  …[NY Times]

7/25 Targiniq Approved, Comes with Built-In Buzz Kill
FDA approves new opioid pain reliever designed to be hard to abuse .... Purdue Pharma's Targiniq ER combines a long-acting form of the opioid analgesic oxycodone with the medication naloxone, which is commonly used to reverse the effects of an opioid overdose .... [Los Angeles Times]

7/25 CDC Wants at Least 80% of Young People to Get HPV Shot; Reality: Only 38%
Too few U.S. youth getting vaccine for sexually transmitted virus .... In 2013, 37.6 percent of girls ages 13-17 got the recommended three doses of the vaccine against human papillomavirus.... that was up from 33.4 percent in 2012 but far short of the CDC's goal of an 80 percent vaccination rate .... [Reuters]

7/25 Zerenex Helps Dialysis Patients; Reduces Need for Anemia Drugs; FDA Response Due Sept. 7
Keryx drug improves phosphorus, iron in kidney patients .... Over the four-week efficacy assessment period, mean serum phosphorus for Zerenex patients dropped by 2.2 milligrams per deciliter compared with placebo patients .... [Reuters]

7/25 Exposing Hidden Wrongs, Or Buying a Lawsuit Lottery Ticket?
Are Serial Whistleblowers Useful Tipsters or Only in it for the Money? .... Critics say incentives provided in the U.S. False Claims Act encourage people to file lawsuits that often go nowhere. Of the 5,400 lawsuits filed from fiscal 1987 through 2010 that had outcomes, 74% did not result in settlements or judgments .... [WSJ/Pharmalot]

7/25 Flonase Allergy Relief Now OTC
FDA approves GSK's Flonase as an OTC treatment .... Around 50 million people in the United States suffer from nasal allergies, and in 2010, Americans with allergic rhintis spent approximately $17.5 billion on health-related costs .... [Drug Store News]

7/25 Already on Sale in 40 Countries, Zarzio to Apply for Approval as First US Biosimilar
FDA to review Neupogen biosimilar .... Sandoz said in its 2013 annual report that Zarzio was the first biosimilar to "overtake its reference product" .... [MM&M]

7/25 Sarepta CSO Out; Speculation on Why
The Story Behind Sarepta's Firing of its Top Scientist .... I'm told there's been significant disagreements within Sarepta's executive team about strategy and the pace of the work on new exon-skipping drugs. The result: Krieg is gone .... [The Street/Adam Feuerstein]

7/25 Injectable Dantrolene Sodium for Rapid Treatment of Malignant Hyperthermia
FDA approves Eagle's malignant hyperthermia treatment Ryanodex .... Ryanodex (dantrolene sodium) for injectable suspension to treat malignant hyperthermia (MH), along with the appropriate supportive measures .... [Pharmaceutical Business Review]

7/25 Oncology Market New Territory for Gilead
Can Gilead break into cancer? With Zydelig approval, it gets its chance .... Cancer docs are a different breed from infectious disease specialists, hepatologists and others who treat HIV and hep C. According to ZS Associates research, oncologists are the the toughest for reps to reach .... [Fierce Pharma]

7/25 Bet on Pfizer Bustin' a Move Soon
Pfizer Needs to Do a Deal, Analyst Says .... Without an acquisition by the end of 2015, only 38% of Pfizer's revenue will come from the U.S. — the lowest of any of its peers. For a pharmaceutical company, that's dicey because the U.S. is the only market where drug companies can dictate their own prices .... [WSJ/MoneyBeat]

7/25 Internet Drug News Fast Takes:
Acetaminophen No Better Than Placebo for Back Pain
New York Times
Moderate Alcohol Intake May Lower Abdominal Aortic Aneurysm Risk
MedPage Today
New Database Tracks Lou Gehrig's Disease
NBC News
Modern Healthcare ranks the highest-paid physician specialties
Advisory Board
Biogen Idec MS drug is approved by European regulators
Boston Globe

7/24 Brands Using REMS to Deny Supplies to Generics Makers
Abuse of U.S. generic-drug rules costs billions .... The report from the Generic Pharmaceutical Association said REMS have been used to prevent generic drugmakers from getting branded medicine to test their own versions, which is required to win FDA approval .... [Reuters]

7/24 Sovaldi Blows Through Another Record
Gilead hepatitis C drug Sovaldi racks up $3.5 bln in quarter .... In its first two industry record shattering full quarters on the market, Sovaldi has racked up about $5.8 billion in sales despite reports that thousands of patients are still waiting in the wings for Gilead's two drugs in one pill, once a day combination treatment expected to gain U.S. approval this year .... [Reuters]
See also: Health insurer group asks Gilead to cut hepatitis C drug price [Reuters]

7/24 Payers Cutting Access to New Hep C Treatment
Who Gets Saved? Hepatitis Cure at $84,000 Makes Doctors Choose .... Constrained by limited budgets, health insurers and government programs are forced to make hard choices about which patients will get the cure. Many are opting to treat only the sickest. .... [Bloomberg]

7/24 Idealisib Approved; Gets Black Box and REMS
FDA approves Gilead blood cancer drug Zydelig .... FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia (CLL) .... [Reuters]

7/24 BI Hid Benefits of Dose Control for Dabigatran
Monitoring, Dose Adjustment for Pradaxa? .... Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce major bleeding risk by 40% compared with well-controlled warfarin, according to company documents allegedly hidden from physicians and regulators .... [MedPage Today]

7/24 Rep: Celgene Pushed Thalidomide Derivative for Off-Label Use
A Legal Test for a Drugmaker's Off-Label Cancer Treatment .... Former saleswoman Beverly Brown alleged that "Celgene's initial marketing efforts for Thalomid were tantamount to ongoing human experimentation." She claimed that her ex-employer marketed Thalomid and Revlimid for purposes unapproved by the FDA, leading to unlawful claims for reimbursement .... [Businessweek via Pharmalot]

7/24 From the People Who Brought You, Now Here's the Open Payments Website
Error: You Have No Payments from Pharma .... Doctors checking a soon-to-be-unveiled federal website that will publicly list drug company payments are encountering error messages if they have not accepted industry money .... [ProPublica]

7/24 Glaxo Still Tumbling Down Patent Cliff
Another major drop in sales for GSK .... GSK's investors are worried that the firm is relying too heavily on its inhaled lung drug Advair, which makes up nearly a fifth of sales. It brought in £1.1 billion for the quarter, down 12 per cent. .... [Pharmafile]

7/24 Novartis in a Nutshell
5 Novartis Drugs You Need To Know About .... Novartis' most important drugs and the threats and opportunities that lie ahead for them .... [Motley Fool]

7/24 Lab Report Saves Owner's Life
Daisy, the dog who's sniffed out over 500 cases of cancer: She even saved the woman whose research revealed her uncanny skill .... 'The dogs can detect cancer in the urine of patients with prostate cancer more reliably than the PSA test', says Professor David Billington, referring to the blood test typically used to detect levels of prostate specific antigen, a protein linked to the disease. 'A positive PSA test is followed up by a multi-needle biopsy, which is unpleasant and invasive. .... [Daily Mail]

7/24 Internet Drug News Fast Takes:
Sanofi Pasteur starts shipping 2014 flu vaccine
Drug Store News
FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs
Regulatory Focus
FDA Warns of Compounded Drug Recall by Texas Firm
ABC News
Merck taps music industry for US HIV campaign
Life expectancy gains threatened as more older Americans suffer from multiple conditions
Johns Hopkins University Bloomberg School of Public Health

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