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Pharmaceutical News Harvest ™

10/31 Xigduo XR = Farxiga + Metformin Combo Pill; Gets FDA OK
FDA approves Xigduo XR to treat adults with type 2 diabetes .... The combination of dapagliflozin (Farxiga, Bristol-Myers Squibb/Astrazeneca) and metformin hydrochloride extended release (Xigduo XR, AstraZeneca) is designed for use with diet and exercise to improve glycemic control. .... [Healio]

10/31 Panel Supports Edoxaban 9–1
FDA panel backs Daiichi's blood thinner .... A panel of advisers to the U.S. Food and Drug Administration voted 9-1 in favor of approving Japanese drugmaker Daiichi Sankyo Co's blood clot and stroke preventer for use in some patients with atrial fibrillation .... [Reuters]

10/31 DMD Parents Want Eteplirsen Now
Moms, Regulators, Biotech Startups, and the Battle Over a Potentially Life-Saving Drug .... The FDA seems flummoxed over how to evaluate the experimental drugs, especially given a lack of large, clearly successful randomized studies. That’s left [families] confused and increasingly desperate .... [Business Week]

10/31 ED Advertisers Turn Up the Heat
Viagra's Come-Hither Ad Campaign .... Advertising expert: "It's skewed younger and infers a recreational, rather than medicinal, purpose." .... [Business Week]

10/31 Did CMS Staffers Tip Off Investors on Provenge Policy?
Insider-Trading Probe Focuses on Medicare Agency .... The SEC is investigating whether officials at the Center for Medicare and Medicaid Services tipped off a policy research group about the agency's review of Dendreon's cancer vaccine .... [$$WSJ]

10/31 Programmatic Still a Single Digit Percentage of Media Buying in Health Care, But Growth Expected
Programmatic buying stands to disrupt healthcare marketing .... While the media often associated with programmatic transactions is cheap, remnant inventory, "in the healthcare space, it's the opposite," — Nicole Woodland-De Van, Compas .... [MM&M]

10/31 Nuedexta's Promise for Dementia-Related Agitation Key to Expanded Market
Avanir Inroads in Alzheimer's Justify Offers .... The market for agitation caused by Alzheimer's is much larger than for Nuedexta's currently approved indication. PBA can affect 200,000 to 300,000 Americans by some estimates, while agitation can affect 25 to 40 percent of the country's 5 million Alzheimer's patients .... [Bloomberg]

10/31 Novo Expects Strong Sales Growth Next Year Despite Payer Limits
Novo Nordisk quells diabetes pricing fears with 2015 growth forecast .... Victoza grew by 20% in North America so far this year, the company said, despite some loss of coverage by "a large pharmacy benefits manager," a.k.a. Express Scripts .... [Fierce Pharma]

10/31 Sanofi Ouster Rocks Many Boats
Will foundering Sanofi spell trouble for Regeneron and other partners? .... Sanofi and Regeneron face what could be a fierce battle with Amgen over high cholesterol drug alirocumab. Amgen is seeking an injunction to block the manufacture and sale of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor over alleged infringement on patents .... [BioWorld]

10/31 Malpractice Awards and Costs Down
Fewer Malpractice Claims Paid in the United States .... The number of medical malpractice payments in the United States has dropped sharply since 2002, according to a new study .... [HealthDay]

10/31 What If They Made an App, and Nobody Came?
Big Pharma has apps up for grabs, but not many users are biting .... Leading pharma companies each have 65 apps in the Apple and Google Play app stores on average, compared to 1 to 2 apps from the average health app publisher .... [Fierce Pharma Marketing]

10/31 Internet Drug News Fast Takes:
Insurers have big plans for 2015 Obamacare enrollment
Can Lots of Sex Protect the Prostate?

10/30 Sanofi Board Tried to Hire Away AstraZeneca CEO
Sanofi Said to Have Contacted AstraZeneca's Soriot .... Soriot, who successfully fought off Pfizer Inc.'s $117 billion hostile takeover this year, said he wasn't interested.... The approach was made earlier this year .... [Bloomberg]

10/30 Herper Blasts Viehbacher Firing
Dear Sanofi: Firing CEO Chris Viehbacher Is A Huge Mistake .... One of the world's largest drug companies just fired its boss over a bad quarter, a worse relationship with the board, and the company's own wrong-headed resistance to change. It looks like a huge mistake .... [Forbes/Matthew Herper]

10/30 Inside the Diabetes Market Share Wars
Who's the diabetes price-cutting culprit: Lilly, Sanofi or Novo? .... Lilly's out to win payers over. The company's Humalog pushed NovoLog off the Express Scripts formulary, which, despite the lower prices involved, has helped with sales .... [Fierce Pharma Marketing]

10/30 Google's Nanoparticles Will Scour Your Body for Disease
"We're Hoping to Build the Tricorder" .... Google X's Andrew Conrad is developing an early disease detection system that could reinvent health care .... [Medium]

10/30 Trumenba Approved
Pfizer meningitis vaccine wins U.S. approval .... Vaccine is used to counter meningitis B, a potentially deadly bacterial disease that has recently caused outbreaks on college campuses .... [Reuters]

10/30 PBM Begs for a Deal on New Hep C from AbbVie
Express Scripts says AbbVie drug could displace Sovaldi on formulary .... Pharmacy benefit manager Express Scripts may quickly change its preferred drug formulary to favor an expected new hepatitis C drug from AbbVie if it is clinically equivalent and less costly than Gilead Science Inc's $84,000 Sovaldi and $94,500 Harvoni treatments .... [Reuters]

10/30 Find an Ebola Treatment? Win a Valuable Bonus Voucher
Lawmakers Want to Give Pharma FDA Vouchers for Developing Ebola Drugs .... Two U.S. Senators have introduced a bill that would award a drug maker who comes up with an effective Ebola treatment a special voucher, which can be redeemed for speedier FDA review of another product or can be sold to other drug makers .... [WSJ/Pharmalot]

10/30 Switch to Specialty Distributors for Avastin, Herceptin and Rituxan Will Cost U.S. $300 Million
Hospitals Furious at Cancer-Drug Price Hikes .... Genentech—owned by Roche, which had $50 billion in sales last year—says the switch to specialty wholesalers will improve the efficiency and security of the supply chain. The company says its newer cancer drugs, such as Perjeta, Kadcyla and Gazyva, are already supplied this way, which allowed it to reduce the number of distribution centers from 80 to five. .... [Time]

10/30 Only One Quarter of T2 Diabetes Started on Metformin Need to Add Another Drug
Metformin Beats Other T2DM Meds for Initial Treatment .... Around 40 percent of people taking a sulfonylurea, a thiazolidinedione, or a DPP-4 inhibitor added a second drug to their diabetes treatment regimen during the study. Just 25 percent of those on metformin added an additional oral medication during the study period .... [HealthDay]

10/30 FDA Devotes Two Days to Female Sexual Dysfunction
Female Libido: Should There Be a Drug for That? .... Agency officials at the first day's session heard a lot from women who said their lack of interest in sex -- or who said they still wanted it but couldn't get physically aroused or found it painful -- had caused them substantial distress .... [MedPage Today]

10/30 Internet Drug News Fast Takes:
People with celiac disease more likely to fracture bones
Obamacare's Success Has Small Business Dropping Coverage
U.S. agency sues Honeywell over employee wellness testing
Make all Rx contraceptives OTC, lawyer urges FDA
Less Competition Among Docs = Higher Medical Costs

Sanofi CEO Fired
Drugmaker Sanofi Fired Its CEO For Being Insufficiently French, And The Stock Is Tanking … since Viehbacher was brought in from the outside world  the ups have generally exceeded the downs, and our perception is that Viehbacher has had the support of the investment community more often than not …[Business Insider]
Sanofi board ousts chief executive Chris Viehbacher … would not put a timeframe on finding a replacement. "We are looking for the best CEO for this company … understood that Mr Viehbacher's decisive character and quick decision-making has irritated some board members …[]
French drug maker Sanofi sacks CEO Viehbacher … board said Sanofi would continue the strategy of international expansion pursued under Chris Viehbacher, blaming his dismissal on poor relations between the CEO and the board …[Globe & Mail]
Christopher Viehbacher, Sanofi Chief, Is Ousted by Board … The fall, when it came, was rapid. On Tuesday, the board put out a statement saying that discussions of his succession were not on its agenda that day. On Wednesday morning, the directors gathered early and applied the coup de grβce … [ NY Times]

Fast Takes
Divorce battle claims Agerion CEO, Seattle Genetics CEO did fornication, coke snorting
Amgen CEO: We're not splitting up
Price Drop for $57,000 Snakebite Drug May Arrive in 2018
Prescription Painkiller Deaths Decreased 5 Percent While Heroin Deaths Increased 200 Percent
Rehab Clinic Press Release

10/29 Novartis Boasts: We Have A Blockbuster - Nah Nah, Nah Nah Nah
Novartis sees new heart failure drug as 'multi-blockbuster' …  data for LCZ696 in August, which found the drug cut the risk of both cardiovascular death and admissions to hospital by a fifth … analysts have suggested the medicine could notch up sales of $8-$10 billion …[Reuters]

Pfizer: We Ain't Afraid Of Obama Tax Collectors
New Tax Rules Won't Stop Pfizer From Bidding U.S. Goodbye … attempt to block companies from leaving the country for tax reasons wouldn't stop Pfizer Inc. (PFE) from moving America's biggest drugmaker overseas if it finds an attractive deal, Chief Executive Officer Ian Read said …[Bloomberg]

Sanofi Shares Implode 10.6% After CEO Briefs Wall Street
- Questions regarding Lantus, Toujeo rebates dominate discussion
- CEO Viebacher skating on thin icea
Sanofi's (SNY) CEO Chris Viehbacher on Q3 2014 Results - Earnings Call Transcript … I think over time we're going to see this basal insulin market being a competition again between two players. It will be Toujeo against Tresiba and the benefit is to Toujeo; A) gets to market first and B) now we have a bigger base of prescriptions to build Toujeo off of …[Seeking Alpha; Free registration required]
Sanofi Board Said to Meet Amid Split on CEO's Future … complicating matters, Sanofi's shares yesterday plunged the most in almost 16 years after the company surprised investors with a disappointing forecast for diabetes sales … Sales of diabetes therapies probably won't grow in 2015 because of mounting price competition … [Bloomberg]

Sanofi Sneezes, Novo, Lilly Catch Cold
- PBM hardball tactic s ignited price war, race to bottom
Novo, Lilly Decline After Sanofi Warns About Diabetes Price War … Novo Nordisk A/S (NOVOB), Eli Lilly & Co. and other makers of diabetes therapies plunged after Sanofi (SAN) Chief Executive Officer Chris Viehbacher said competition on prices in the U.S. will hurt sales next year … diabetes is one of the areas where competitors are "prepared to start bidding on price …[Bloomberg]
Editor's Note: Toujeo is the proposed name for the experimental basal insulin product that Sanofi  plans on rolling out in anticipation of  Lantus' patent expiration.

How Many? Amgen Rejects a Break Up, But Will Slash Another 1,100 Jobs
How Many? Amgen Rejects a Break Up, But Will Slash Another 1,100 Jobs … moves came amid growing criticism that the biotech was not doing enough to generate growth and that a split would create more shareholder value … [Pharmalot]

Government Helpless To Shut Down Rogue Pharmacy Sites
Icann or I Can't? Internet Agency Clashes with FDA Over Online Sites … Consumers, meanwhile, increasingly turn to online sites due to the rising cost of their drugs. In Maine, for instance, the state passed a first-of-its-kind law in the country that permits residents to purchase medicines from pharmacies that are licensed in Canada, the U.K., New Zealand and Australia …[Pharmalot]

Edoxaban: FDA Panel Recommends Daiichi Blood Thinner With Limitations
FDA staff recommends limited use of Daiichi's blood thinner … reviewers recommended approval of a 60 mg dose of Daiichi Sankyo Co's blood thinner for certain atrial fibrillation patients, but suggested limiting its use in those with abnormal kidney function …[Reuters]

Sales of Gilead's Pricey Hepatitis Drug Slow
- Apparently docs are warehousing patients in anticipation of son-of-Solvaldi
Sovaldi, Seen as the Biggest Drug Launch Ever, Saw Sales Fall 20% Between Quarters … drop that was expected as physicians and patients waited for the arrival of the company's newest drug Harvoni … Harvoni removes the need for injections and other pills and has been anticipated by doctors and patients …[WSJ]
Gilead stock falls on Sovaldi sales miss …  117,000 patients have been treated with Sovaldi and with the introduction of Harvoni--a single tablet regimen for the treatment of HCV-infected individuals which does not require either interferon or ribavirin …[CNBC]

Ranbaxy CEO:  Generic Nexium Monopoly Still Ours
Indian drugmaker Ranbaxy still has exclusive rights for Nexium generic -CEO … We believe we have the (Nexium) exclusivity and we will launch the product upon approval … in talks with at least two other companies on sourcing the drug ingredient …[Reuters]
A generic Nexium, at long last? … [MMM]

Fast Takes
Baxter's blood disorder orphan rug gets FDA approval
Akebia says experimental anemia specialty drug shows higher safety issues, shares plunge
Mylan Found to Have Infringed Medicines Co.'s Angiomax Patent

Sanofi CEO To Board: Don't Fire Me, I made You Money
Is he French enough?
Sanofi's Viehbacher Under Pressure Amid Board Tensions … Viehbacher's direct ways and open criticism of past research failures at the company, as well as his shifting of Sanofi's emphasis to the U.S., caused resentment among employees and some managers in France, even as investors applauded …[Bloomberg]
Don't fire me, Sanofi CEO tells board, amid tussle over strategy … All three raise one question: Is Sanofi still French enough? … "Sanofi is turning its back on its home country," a regional economic official, Jean-Louis Chazy, said at the time. "We cannot accept this pillage." …[Fierce Pharma]

Judge Reduces Actos Lawsuit Award 99%
Plaintiff Goes From Billionaire To Millionaire 
- Plaintiff lawyers have "ouch moment" after judge removes 3 zeros from plaintiff payday
Takeda, Lilly Win 99.6% Cut in Actos Punitive Damages …  panel's decision to order Takeda to pay $6 billion and Lilly $3 billion [was excessive] … panel's punitive-damages verdicts violated constitutional protections against excessive awards by assessing Takeda a punishment of more than 5,400 times the compensatory damage award and Lilly a punishment that was more than 8,100  …[Bloomberg]

Pfizer Yanks Plug On Remoxy Pain Pill, Investors Walk
- FDA rejection in 2011, follow up studies didn't pan  out?
Pfizer Stock Falls After Dropping Pain Drug … decision to end the agreement followed an internal review of data from five recently completed studies to address the June 2011 rejection by the FDA …[The Street]

Merck Having Tough Time -  Key Product Sales Shrink.
Merck Cuts Sales Forecast as Sales of Top Drugs Fall … second-biggest U.S. drugmaker, saw sales of two top drugs fall  … Gardasil, a vaccine for human papillomavirus, declined 11 percent on lower use from the U.S. public sector. Cholesterol drugs Zetia and Vytorin fell 3 percent in the quarter on weaker U.S. sales …[Bloomberg]
Cancer darling can't save Merck, as sales slip for quarter …[ MMM]

Xarelto #1 HCP Website, Traffic & Usability
Five things for pharma marketers to know … physicians also rated Xarelto's website highest in terms of usability. Xarelto was named the top site in terms of mobile traffic, too. Victoza, Invokana and Spiriva rounded out the rest of the top  …[MMM]

Ranbaxy Might Lose Nexium Exclusivity On Quality Control Issues
Ranbaxy might lose Nexium exclusivity … speculation over the delay of launch of the low-cost Nexium generic started in January when the FDA banned the Toansa unit in Punjab. Earlier, the FDA had banned the company's manufacturing units in Himachal Pradesh, Madhya Pradesh and Mohali in Punjab …[Economic Times]

10/27 Many $10,000/Month Cancer Drugs Don't Improve Overall Survival
Some drugs approved despite minimal benefits, severe side effects .... A Milwaukee Journal Sentinel/MedPage Today investigation found that the FDA has been approving dozens of cancer drugs based on what are known as surrogate measures — such as the shrinking of a tumor — rather than based on proof the treatment extends life. And they are often approved despite toxic side effects. .... [Milwaukee Journal-Sentinel]

10/27 Drug Chains Cut Off Apple Pay
Apple Pay Faces Challenge as CVS, Rite Aid Reject System .... The drug retailers, which are part of a consortium developing a competing payment system, stopped Apple Pay last week .... [Bloomberg]

10/27 Two Overdoses in One Day from Stolen Pain Meds at University of Michigan Hospital
Drug thefts at U-M hospital: A nurse's death, a doctor's overdose and 16,000 missing pills .... The drugs that went missing at the hospital in the past three years range from a single missing pain pill to a theft of 15,000 hydrocodone pills, a generic form of Vicodin .... [Michigan Live]

10/27 Eliquis Sales Show Signs of Life
Bristol-Myers Beats Q3 Views As Eliquis Revives .... especially robust sales for Eliquis, a stroke-prevention drug that is gaining a second wind after its initial launch flopped last year. Its quarterly sales of $216 million were about $18 million ahead of consensus and up from just $41 million in Q3 2013 .... []

10/27 CSL Expands
Australia's CSL buys Novartis influenza vaccine unit for $275 mln .... Combining the Novartis unit with CSL subsidiary bioCSL would create the No.2 player in the $4 billion global influenza vaccine industry .... [Reuters]

10/27 Baxter's Treatment for Rare Form of Hemophilia Approved
FDA approves Obizur for acquired hemophilia A .... Obizur is the first treatment of its kind and enables researchers to measure Factor VIII activity levels in patients with the disease .... [Reuters]

10/27 Sovaldi (at $85,000) Doesn't Make This List
The top 10 most expensive drugs of 2013 .... Among the 20 most expensive drugs, only hep C fighter Sovaldi, Roche's breast cancer drug Kadcyla and Bristol-Myers Squibb's colon cancer drug Erbitux are not orphans .... [Fierce Pharma]

10/27 Consumers Still Buying a Pig in a Poke When Shopping on Health Exchanges
Insurers' Consumer Data Isn't Ready for Enrollees .... A health maintenance organization offered by Blue Cross and Blue Shield of Florida illustrates the complexity. The plan has seven tiers of prescription drug coverage, including three just for generic drugs. .... [NY Times]

10/27 Long-term Stroke Costs Underestimated
Medical costs for stroke survivors stay high 10 years on .... Healthcare and personal expenses associated with a stroke continue to be substantial over time. The greatest ongoing costs are for aged care facilities and informal care .... [Monash University]

10/27 Germany's Quality and Efficiency Group Finds No Support for Entyvio Benefit
Added benefit of vedolizumab is not proven .... Crohn disease and ulcerative colitis are chronic inflammatory bowel diseases. Vedolizumab is an option when conventional therapy is not tolerated or does not provide sufficient release of symptoms .... [Medical Xpress]

10/27 Internet Drug News Fast Takes:
AstraZeneca Ovarian-Cancer Drug Wins EU Agency's Backing
Physicians rank their favorite insurance companies
Advisory Board
Drinking soda ages you as much as smoking cigarettes
Advisory Board
Pennsylvania curbs physician prescription drug dispensing and repackaging
Business Insurance
Gene Scan Helps Diagnose Mystery Disorders in Children
HealthDay News

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