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Pharmaceutical News Harvest ™

1/26 Fast Takes
Paper clip-size device called a coupler helps control high blood pressure without medication
These 3 Pharmaceutical Companies Control Roughly Half of All Cancer Drug Sales
Motley Fool
Novartis: FDA approves 2nd vaccine against meningitis strain
GlaxoSmithKline to cut about 1000 staff in China: report
First Word

In His Own Words: Express' Dr Steve Miller Explains How Disgust With Drug Coupons Lead To NDC Lockouts
VIDEO: The Drug Price War Pitting Insurers Against Big Pharma … the only reason a company puts a coupon out is because there is a clinical equivalent or better drug out there and they are trying to maintain market share. … chief medical officer at Express Scripts, explains why Express Scripts isn't paying for some drugs and why he's making pharma companies compete on price. He speaks with Bloomberg's Pimm Fox on "Taking Stock. … [Bloomberg]

Ex-Sanofi chief Viehbacher makes a $5M-plus severance deal
Ex-Sanofi chief Viehbacher makes a $5M-plus severance deal … amounts to a year's compensation, duplicating the fixed and incentive pay Viehbacher earned in 2013 … agreed not to hire away any previous Sanofi employees for 18 months, and he's signed a two-year confidentiality agreement….[ Fierce Pharma]

US Pharma Industry Jobs Shrank 20% In 2014
JobWatch: Pace of Layoffs Slows Down .,.. total 17,636 announced jobs cuts--down 20% from 22,161 in 2013, according to the December Job Cut Report of Challenger, Gray & Christmas … ranged from consolidation and layoffs by pharma giants, to the overhauls of the nation's patent laws and healthcare system …[]

FDA Panel Green Lights Astellas Orphan Drug For Rare Fungal Ailments
FDA panel backs Astellas drug for invasive fungal infections … Invasive aspergillosis is a rare, life-threatening fungal infection seen predominantly in patients with compromised immune systems, such as those with leukemia. Mucormycosis is a very rare, rapidly progressing invasive fungal infection also …[Reuters]

FDA Green Lights Shire Parathyroid Hormone
- Drug comes stable of  recently acquired specialty drug maker NPS Pharma
U.S. FDA approves NPS drug, in move validating Shire takeover deal … Analysts expect the drug to generate peak annual sales of $542 million … designed to treat hypoparathyroidism, a condition in which the body's parathyroid gland does not secrete enough parathyroid hormone (PTH) …[Reuters]
Related: Shire's $5.2 Billion Gamble Pays Off as NPS Drug Wins Approval …[Bloomberg]

Basilea CEO: Triazole Antifungal Isavuconazole Has Blockbuster Potential
- Aims to compete with Pfizer's VFend
Basilea CEO Sees Blockbuster Potential for Antifungal Drug … advisory committee to the Food and Drug Administration recommended the treatment for approval to treat two fungal infections -- aspergillosis and mucormycosis -- that predominately occur in patients with a weak immunsystem. A final decision will be made in March …[Bloomberg]

Source: Pfizer Tried To Buy Teva Last Year, Teva Blew Them Off
Pfizer's Hunt Said to Have Included Rebuffed Teva Approach … While a full-blown takeover of Teva would've faced significant hurdles, Teva's $9.2 billion-a-year generic drugs business offers Pfizer a way to beef up its portfolio of off-patent medicine and give it infrastructure to eventually spin off into a separate company …[Bloomberg]

Mass Senator Wants Special Punishment For Companies Who Do Fraud
Senator Wants Big Drug Makers That Break the Law to Fund NIH … Drug makers that reach settlements with the federal government for paying kickbacks to doctors, defrauding Medicare or Medicaid or illegally marketing medicines would have to pay 1% of their annual profits for each blockbuster medicine that can be traced to public sector research. Such a penalty would run for five years …[Pharmalot]

1/23 Express Scripts' Miller Painting a Bullseye on Oncology Treatments
Skyrocketing Cancer Drug Prices Are Next Target for Cost-Cutter .... Express Scripts has set its sights on $37 billion in U.S. spending on cancer medications. Its goal is to start influencing the drugs' costs as soon as next year .... Bloomberg

1/23 Panel Recommends Cresemba, As Effective as Vfend
FDA panel backs Astellas drug for invasive fungal infections .... The advisory committee panel voted 11-0 that the Japanese drugmaker had demonstrated sufficient safety and efficacy to support approval of the drug, isavuconazonium to treat invasive aspergillosis .... Reuters

1/23 About 30% of Women of Child-Bearing Age Get Opioid Prescriptions Each Year
Wide use of prescription painkillers found in U.S. women of childbearing age .... Of women aged 15-44, more than a third on Medicaid and a fourth on private insurance filled prescriptions for so-called opioid pain medications each year between 2008-2012 .... Reuters

1/23 Headaches Cost U.S. $31 Billion a Year
Costly, complex headache treatment on the rise .... The researchers discovered that use of advanced imaging procedures such as CT scans and MRIs rose from less than 7 percent of visits in 1999-2000 to almost 14 percent in 2009-2010. Referrals to other physicians increased from about 7 percent to 13 percent .... Reuters

1/23 Josh Hardy, Chimerix, and Brincidofovir: Where Are They Now
The CEO Who Saved a Life and Lost His Job .... While the question of whether to give Josh the drug seemed like a no-brainer to his family and supporters, it presented Chimerix with tricky issues to sort out. .... Business Week

1/23 Banner Year for FDA Approvals
FDA Approval of 'Novel' New Drugs Up Sharply in 2014 .... The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) approved 41 novel new drugs in 2014, 14 more than in 2013 and the highest number in nearly 20 years .... Medscape

1/23 Who Do You Believe on Flu Medicine?
Why The CDC And FDA Are Telling You Two Different Things About Flu Drugs .... The discrepancy between the CDC's assertion that the flu drugs can prevent complications, hospitalizations and perhaps deaths, and the FDA's insistence that the drugs have only been shown to cut the amount of time that symptoms persist comes down to how they weigh the evidence ....

1/23 How Valeant Lost Allergan
Valeant CEO admits 'major miscalculation' in failed quest to nab Allergan .... "So when Actavis came in, I was naive and thought we had a better fit strategically--more synergies and a lower tax rate. But whenever there's an auction we are likely to lose, because we are so strict on price, so that was a major miscalculation." (Valeant CEO Michael Pearson) .... Fierce Pharma

1/23 PBM Head Claims Price War Has Saved $25,000 per Hep C Patient
Express Scripts' Miller says hepatitis C price war to save billions .... Express Scripts was able to secure a discount that has brought the AbbVie price down to Western European levels for Gilead's hepatitis C treatment, Chief Medical Officer Steven Miller told Reuters. Such prices overseas range from about $51,000 to $66,000 .... Reuters

1/23 Open Sunshine Database Filled with Typos, Mispellings, Inconsistencies
Data on Payments From Drugmakers to Doctors Is Marred by Error .... As we tried to get accurate tallies of all payments associated with each drug and device, we encountered widespread problems with companies' submissions. We also learned that the Centers for Medicare and Medicaid Services, which administers the Open Payments database, doesn't double-check what companies submit. .... NY Times

1/23 Internet Drug News Fast Takes:
Obamacare Pays for Insurers Who Fought It as Stocks Rise
Ventana Seeks FDA Premarket Approval for Lung Cancer CDx
Genome Web
Which of FDA's Drug Advisory Committees Were Most Active in 2014?
Regulatory Focus
Long-term use of hormonal contraceptives is associated with an increased risk of brain tumors
Medical Xpress
HealthMine Survey Reveals Wellness Plans Are Not Sustaining Consumer Engagement
HealthMine news release
AstraZeneca's $1.3B gout drug comes under EU scrutiny
Fierce Biotech

1/22 Editor's Recommended Link: Profile of Actavis CEO Brent Saunders
This Giant Drug Firm Won't Invent Medicines. Investors Are Cheering .... Actavis-Allergan will have the scale in marketing and clinical trials of a global powerhouse like Eli Lilly or Bristol-Myers Squibb, but it will eschew the core mission of most drug companies—inventing drugs—preferring to buy them from universities or biotechs all the time .... Forbes/Matthew Herper

1/22 FDA Approves Cosentyx, New Mechanism for Psoriasis, Sub-Q, Claims Better Than Enbrel and Stelara
Novartis Wins U.S. Approval for First of New Psoriasis Drugs .... The medicine, also known as secukinumab, is predicted to top $1 billion in sales by 2020 and will compete with other biologic drugs including AbbVie's No. 1 seller, Humira, and Amgen's best-selling Enbrel. .... Bloomberg

1/22 Lilly Just Wants Access, Not Trying to Push Other Drugs Off Formulary
Lilly snares formulary spots for diabetes meds, no pricing war necessary .... The narrow formulary idea, tested by industry leaders Express Scripts and CVS Health, is catching on, with more insurance plans cutting down their drug coverage to exclusive brands .... Fierce Pharma Marketing

1/22 Sovaldi and Company Knock Out Another Older Hep C Med
Merck Will No Longer Sell its Victrelis Hepatitis C Drug in the U.S. .... Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug .... WSJ/Pharmalot

1/22 Depomed Tosses Out Old Playbook, Finding Success with Digital Marketing
Depomed drawing on digital savvy--and 250 reps--to relaunch Nucynta franchise .... Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug .... Fierce Pharma

1/22 NPs Become New Focus
Nurse practitioner workforce has just about doubled .... The US now has around 205,000 nurse practitioners .... MM&M

1/22 Brivaracetam for Epilepsy
UCB submits brivaracetam for use in epilepsy .... Both the US FDA and the European Medicines Agency have accepted brivaracetam for review as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients over 16 years of age .... PM Live

1/22 Lawmakers Want to Ease DEA Bottleneck
DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals .... DEA can take more than a year to schedule a product under the Controlled Substances Act, even when FDA has made specific recommendations regarding the drugs' scheduling. At present, even if a drug manufacturer has obtained approval from FDA to market a drug, it cannot do so without first obtaining approval from DEA as well .... Regulatory Focus

1/22 HELP WANTED: CEO, Major Pharma Company
Takeda's Weber was approached for Sanofi CEO job but not interested .... Christophe Weber, chief operating officer of Takeda Pharmaceutical has been approached in connection with the vacant chief executive post at French drugs group Sanofi but decided to stay put .... Reuters

1/22 Internet Drug News Fast Takes:
High levels of Formaldehyde Hidden in E-Cigs
NBC News
Study Suggests Drug Coverage Alone Not an Easy Solution to Closing Treatment Gap in Depression
Weill Cornell Medical College news release
Drugs' Path to China Slows as Regulatory Delays Add Up, J&J Says
Two-in-three Americans are willing to have doctor visits via video telehealth
Drug Store News
Only about half of teenage girls receive HPV vaccine at the CDC's recommended age
Medical Xpress

1/21 Giovanni Caforio, New CEO $BMY
Bristol-Myers Names New CEO as Andreotti Becomes Chairman .... Under Andreotti, Bristol-Myers has been one of the U.S. drug industry's brightest stars. The shares have almost tripled during his tenure .... Bloomberg

1/21 Zarxio Sales Strategy, Potential First U.S. Biosimilar
Sandoz gets ready to make the biosimilar case with oncologists .... Helping to make the case with doctors, Sandoz detailers will be equipped with post-marketing data derived from [Zarxio]'s use in over 40 countries, leading to 7.5 million patient exposure days of experience .... MM&M

1/21 Decision Hinging on Power of Appellate Judges Benefits Teva
Teva Wins U.S. High Court Ruling to Delay Copaxone Rivals .... The ruling gives Teva more time to shift patients to a longer-acting version that won't face generic competition until 2030 .... Bloomberg

1/21 Contrave Leading Obesity Race; Belviq Maker Throwing Long Pass
Eisai's copay offer on Belviq has unintended consequences for Arena .... The new card will allow eligible patients without commercial coverage for Belviq to snag the med for no more than $75 for each monthly prescription. Those who do have commercial coverage can use the new card to secure additional savings if their copay is higher than $50 per monthly prescription. .... Fierce Pharma Marketing

1/21 Salix May Put Self on Market
Salix hires Centerview Partners to explore sale .... Speculation about the fate of Raleigh's largest home-grown drug company, Salix Pharmaceuticals, has revolved around whether the company would be able to stay independent, especially since the multibillion-dollar drug company does not have a CEO .... Triangle Business Journal

1/21 PCSK9 Inhibitor Maker Not Happy with Express Scripts Focus
Benefits firms shouldn't play drug favorites: CEO .... Express Scripts wants to make "exclusive choices and say, 'Give us a huge discount and we'll take your drug and we won't take the other drug'" .... CNBC [autostart video]

1/21 FDA Guidance on Wearables
The FDA will regulate wearables making health claims .... If you see a product that promises to treat your obesity, autism, muscle dystrophy or erectile dysfunction -- plus anything that's physically invasive or prosthetic -- then the gear will have to jump through the FDA's numerous hoops .... Endgadget

1/21 FDA Archives Pre-2005 Correspondence; Brouhaha Ensues
What Did the FDA do With Some of Those Old Warning Letters? .... The FDA recently removed access to an untold number of letters issued prior to 2005 — notably, those concerning manufacturing problems — after reviewing traffic on the page and found it was extremely low .... WSJ/Pharmalot

1/21 Salt Back on the Table
Salt Intake Not Associated with Mortality or Risk of Cardiovascular Disease, Heart Failure in Older Adults .... Salt intake was not associated with mortality or risk for cardiovascular disease (CVD) and health failure (HF) in older adults based on self-reported estimated sodium intake, according to a study published online by JAMA Internal Medicine .... JAMA news release

1/21 J&J Has a Deep Bench But a Tough Schedule
J&J's pharma unit 'fastest-growing' in the drug business, CEO Gorsky says .... Thanks to treatments from psoriasis-fighter Stelara to antipsychotic Invega Sustenna, the company's pharma sales were up a whopping 25% in the U.S. for 2014, and 15% worldwide, to $32.4 billion. .... Fierce Pharma

1/21 Internet Drug News Fast Takes:
Put this patch on your kid, and monitor their temperature on your smartphone
FDA Approves Phoxillum Renal Replacement Solution
Renal and Urology News
FDA lifts hold on trial of CytRx' aldoxorubicin
Pharma Times
Hospira closing US manufacturing plant
8 Biotech Stock Controversies Emerging From 'JPM15' Conference
The Street/Adam Feuerstein

1/20 FirstWord Pharma's Picks for Most Important Drugs in 2015
The drugs that will shape 2015 .... Which pharmaceutical products — both marketed and in the pipeline — will dictate industry news flow over the next 12 months? .... FirstWord Pharma

1/20 Viekira Pak Wins Deal with State AIDS Directors
AbbVie Strikes Hepatitis C Discount Deal With AIDS Drug Programs .... AbbVie has agreed to provide its breakthrough, $1,000-a-day hepatitis C treatment to state-based HIV drug programs at a substantial discount, according to a group that negotiates drug pricing for the programs. .... Bloomberg

1/20 Biotech: Boom or Bubble?
Riding High, Biotech Firms Remain Wary .... Biotechnology stocks have outperformed the overall market for several years. Last year the Nasdaq Biotechnology Index rose 35 percent compared with 11 percent for the Standard & Poor's 500-stock index .... NY Times

1/20 Anti-Vaxers Stick Together, Share Their Germs
Underimmunized, unvaccinated families cluster together .... About 18 percent to 23 percent of children in those clusters were underimmunized, compared to about 11 percent of children outside those clusters .... Reuters

1/20 FDA Urges People with Overactive Bladder to Seek Help
Overactive Bladder a Common Problem, FDA Says .... More than 33 million Americans suffer from overactive bladder, including 40 percent of women and 30 percent of men .... HealthDay News

1/20 Viewpoint: F.D.A. Should Support Vaping as a Safer Alternative to Smoking
Will the F.D.A. Kill Off E-Cigs? .... Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor .... NY Times

1/20 FDA Staffs Up Office of Generic Drugs
On a Hiring Spree, FDA Hires Almost 1,000 New Generic Drug Regulators .... Traditionally, hiring at FDA has been somewhat of a challenge. FDA typically pays less than industry for comparable positions, and it can be especially difficult for the agency to recruit high-level leadership for its divisions .... Regulatory Focus

1/20 Fewer Problems with Medical Bills Since ACA
More Americans Getting Needed Health Care .... The number of working-age adults who said they didn't get the care they needed because of the cost dropped to 66 million in 2014 from 80 million in 2012 -- the first decline since 2003 .... Health Day

1/20 Factors for Adherence to Diabetes Regimen
Rx Adherence Lower for Patients New to Diabetes Therapy .... Independent correlations were seen for adherence with older age, male gender, higher education, higher income, use of mail order versus retail pharmacies, primary care versus nonendocrinology specialist prescribers, higher daily pill burden, and lower out-of-pocket costs. The likelihood of adherence was significantly lower for patients who were new to diabetes therapy. .... Health Day

1/20 Internet Drug News Fast Takes:
Merck funds tests of lower Zilmax doses as seen seeking way to resume sales
Novartis to close manufacturing plant in Puerto Rico by 2019
Medical Xpress
European green light for Novartis' Cosentyx in psoriasis
Pharma Times
Neurocrine's Drug for Rare Adrenal Disease Gets FDA Help
Times of San Diego
Many Americans Taking Meds Not to Be Mixed With Alcohol
Health Day

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