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2/19 Gottlieb 'Most Bothered' by Brand Tactics to Block Generics and Biosimilars
FDA Head Vows To Tackle High Drug Prices And Drugmakers 'Gaming The System' .... Gottlieb said it's not his job to help insurance companies or government programs decide which drugs to cover. Health systems and insurers "have a difficult time saying no," Gottlieb said, "so they want to put the regulator in the position of saying no." .... Kaiser Health News

2/19 Imfinzi Approved for Stage III NSCLC; $2 Billion Opportunity
AstraZeneca's immunotherapy drug wins key lung cancer approval .... FDA has granted approval for expanded use of Imfinzi to treat non-small cell lung cancer (NSCLC) patients with inoperable mid-stage disease that has not spread widely around the body .... Reuters

2/19 Strike Two for Vitaros, a Rub-on ED Cream
Shares of Apricus tank after FDA declines to OK erectile dysfunction cream .... Alprostadil, the active ingredient in Vitaros, belongs to a class of medicines that work by dilating blood vessels and is presently only available in the U.S. as an injection or a suppository that must be inserted into the urethra. Vitaros is applied to the skin with a disposable applicator. .... Reuters

2/19 Meet Vasant Narasimhan, 41-Year-Old New CEO of Novartis
Novartis CEO Steers Drug Maker Back to R&D .... Narasimhan wants to introduce artificial-intelligence to find new biomarkers, molecules that can help identify patients most likely to respond to a specific treatment and speed up clinical trials. Novartis also is working on devices including wearable sensors to capture real-time data during drug trials .... WSJ $$

2/19 Bavencio Fails to Improve OS in Phase 3 Trial for NSCLC
Pfizer, Merck KGaA lung cancer drug fails .... JAVELIN tested the checkpoint inhibitor against docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after chemo .... BioPharma Dive

2/19 FDA Panel Votes to Send Exparel Back for More Studies
FDA Advisory Panel Spurns Pacira's Request for Expanded Use of Pain Drug Exparel .... In a six to four vote, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee questioned the efficacy and safety of Exparel, (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia .... BioSpace

2/19 Litigation Holding Up Approved Biosimilars from Reaching Market
Top-Selling Drugs in 2018: Biosimilar Competition is FDA Approved but Not Marketed .... FDA has already approved two biosimilar competitors to Humira — Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and Amgen's Amjevita (adalimumab-atto) — both of which would already be marketed in the US if all the companies needed was FDA approval. Instead, neither are likely to hit the US market anytime soon, and Amgen has agreed to delay its biosimilar's launch in the US until 31 January 2023. .... Regulatory Focus

Tweet of the Day


2/19 Merck Leader was First CEO to Criticize Trump's Remarks on Charlottesville
The C.E.O. Who Stood Up to President Trump: Ken Frazier Speaks Out .... Kenneth C. Frazier, the chief executive of the pharmaceuticals company Merck, served on one of Mr. Trump's business advisory councils in the early days of the administration. But after Mr. Trump equivocated in his response to an outburst of white nationalist violence last August in Charlottesville, Va., the advisory groups swiftly unraveled. .... NY Times

2/19 Largest Patent Verdict Overturned; Merck vs. Gilead Battle Over Hep C Treatments
A reversal of fortunes: Judge voids order Gilead must pay $2.5B to Merck over a patent dispute .... U.S. District Court Judge Leonard Stark has ruled that a Merck patent at issue was invalid, because the inventions did not meet a requirement for disclosing how to make and use the treatment it covered without undue experimentation .... Stat

2/19 Internet Drug News Fast Takes:
Lab to forfeit $1M for unnecessary urine drug screens
Boston Herald
Bioverativ taps new manufacturer as it steps out of Biogen's shadow
BioPharma Dive
Russia Allegedly Behind Merck's Cyberattack Last Year
BioSpace
Like Walgreens, CDC data suggests flu season has passed its peak
Drug Store News
Azar signals openness to easing physician-owned hospital restrictions
Advisory Board
Common blood pressure drug may prevent type 1 diabetes
Medical News Today


2/16 FDA Proposes to Approve Alzheimer's Drugs Based on Biomarkers
FDA Opens New Path for Alzheimer's Treatments .... In the proposal, the FDA said it could quickly approve a drug for people who haven't shown outward signs of Alzheimer's, if the therapy affects a biological marker of the disease.... Nothing like that currently exists for the disorder .... Bloomberg

2/16 Roche Buys Digital Cancer Management Startup
Alphabet-backed Flatiron Health is being acquired by Roche .... Flatiron has an electronic medical record system used by doctors who are treating patients with cancer. It then uses this data to help researchers and life sciences companies figure out better treatments for cancer -- for instance, by making sure that the right patients are being recruited for clinical trials .... CNBC

2/16 FTC Direction Under Trump Hard to Predict
Trump FTC Pick Suggests Task Force to Monitor Drug Prices .... Joe Simons, a Washington antitrust lawyer, suggested creating the task force during his nomination hearing Wednesday before the Senate Committee on Commerce, Science and Transportation .... Bloomberg

2/16 TV Ad Sales (Whole US Market) Down 7.8% in 2017. Will Pharma DTC Follow Trend?
Oh no! TV advertising is declining! .... Research that showed that people, exposed to pharma DTC ads, were not likely to go online right away to learn about advertised drugs, but later and, since drug names today are so hard to remember, they start with Google where they are often hijacked by competing products .... World of DTC Marketing

2/16 NIH-funded Research Underlays Most New Drugs
$100B over six years led to 210 new FDA-approved medications .... The study team analyzed more than 2 million published research reports directly linked to the 210 new medicines approved by the FDA between 2010 and 2016, or to their biological targets. Of those reports, 600,000 were connected with NIH-funded research projects that involved more than 200,000 fiscal years of research funding and more than $100 billion in total cost .... UPI

2/16 What If You Were Worth Billions, But That Money Came From a Product Linked to Thousands of Deaths?
Meet the Sacklers: the family feuding over blame for the opioid crisis .... Philanthropic heirs to OxyContin fortune have a 'moral duty to help make this right' says the widow of one of Purdue Pharma's founders .... The Guardian

2/16 Health Savings Accounts for People on Medicare: Not Allowed Now, But Could Change
Trump's budget could let those on Medicare use this tax-favored account .... The White House calls for a new option that would permit Medicare beneficiaries to make tax-deductible contributions to health savings accounts .... UPI

2/16 Horizon Hikes Vimovo (naproxen + esomeprazole) Price to $3000/Month
Painkiller that once cost $138 is now $2,979 .... It's the latest in a series of about a dozen price hikes for Vimovo, which was listed at just $138 per 60-pill bottle in November 2013. That's when Horizon acquired the drug from AstraZeneca and began raising prices. Today, the painkiller accounts for just over 10% of Horizon's annual sales .... CNN (autoplay video)

2/16 Company Adds Subjects in Aducanumab Trial
Biogen's key Alzheimer's disease drug is facing potential signs of trouble .... Because the company saw "more variability on the primary endpoint than assumed," Biogen decided to increase the sample size of two ongoing trials by about 255 patients each .... Marketwatch

2/16 Portrait of a Patient Being Treated with Aducanumab
Inside One Couple's Experimental Treatment to Battle Alzheimer's Disease .... [Peter Wooding] agreed to receive injections of either the drug or a placebo once a month for a year and a half. After that, he is guaranteed to receive the drug for two more years. It won't be until 2020, when all the people in the study have completed their injections, that the Woodings and their doctor, Stephen Salloway, who is leading the study at Butler, will learn whether he received the drug or a dummy solution .... Time

2/16 Internet Drug News Fast Takes:
Azar defends Trump drug pricing proposals, pushing back against criticism
Stat
Northwell can now detect flu hotspots 7 days earlier. Here's how.
Advisory Board
Heart Stents Are Useless for Most Stable Patients. They're Still Widely Used.
NY Times
Why Warren Buffett's Berkshire Hathaway loves loathed Israeli drug stock Teva
CNBC (autoplay video)
Cells and their genes continue to function after death, study proves
UPI


2/15 Erleade (apalutamide) Approved for Nonmetastatic Prostate Cancer
J&J wins snap approval of apalutamide, the first drug OK'd for nonmetastatic prostate cancer .... The drug will now be sold as Erleade, handily beating a rival supplemental application from Pfizer on its cancer drug Xtandi. This approval came through just two months after the agency offered to give it a priority review .... Endpoints

2/15 Annual Health Spending Growth Projected at 5.5% Per Year Through 2026
U.S. healthcare tab to keep rising, led by higher costs for drugs and services, government report says .... The annual growth rate over the next decade is expected to average one percentage point more than overall economic growth. That means that healthcare will expand from about 17.9% of the economy in 2016 to 19.7% of the economy in 2026 .... LA Times

2/15 Surprising Claim for Invega Sustenna — This Drug Will Keep You Out of Jail
A Drug Company Says This Shot Will Keep You Out of Prison .... Last month, Johnson & Johnson announced it got the green light from the FDA to promote an unusual benefit of Invega Sustenna, an antipsychotic medication administered to patients as an injection once a month: The medication, the FDA concluded, could potentially keep people with schizophrenia out of prison or jail .... The Marshall Project

2/15 $1 Billion in Cash Upfront for New Cancer Drug
Bristol-Myers to pay $1.85 billion in cancer deal with Nektar .... The partnership is built around the Nektar drug, NKTR-214, which will be tested with Bristol's immuno-oncology (IO) drugs Opdivo and Opdivo and Yervoy in 20 cancer indications across nine different tumor types, including melanoma, kidney and lung cancers .... Reuters

2/15 Listening to Sovaldi
What Gilead taught pharma about pricing a cure .... The uproar has died down a bit and there's now much less debate about whether Sovaldi was actually cost effective. It has since been shown the drug could save the health system millions by helping to prevent hepatitis C patients from progressing .... Biopharma Dive

2/15 Taking PrEP = Denials of Life, Disability, and LTC Insurance
He Took a Drug to Prevent AIDS. Then He Couldn't Get Disability Insurance. .... When Dr. Cheng applied for disability insurance — which many young doctors do to protect a lifetime's worth of income should they be hurt — he was told that, because he was taking Truvada, he could have only a five-year policy .... NY Times

2/15 PhRMA Wants to Undo Donut Hole Change
Drug industry scrambles after rare loss in budget deal .... A provision included in the budget deal approved last week raised the share of costs that drug companies have to pick up as part of closing the "donut hole," a gap in drug coverage for Medicare Part D beneficiaries .... The Hill

2/15 Brain Trauma Indicator Blood Test Approved
FDA approves first blood test to help diagnose concussions .... The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures the levels of two proteins — called UCH-L1 and GFAP — whose elevated presence suggests a certain type of brain damage normally only visible on a CT scan .... STAT

2/15 Academic Paper Looks at Pharma Tradeoffs in Developing More Innovative Drugs vs. Making Lower Risk Bets
Developing Novel Drugs .... On the margin, firms perceive novel drugs to be more valuable ex-ante investments but that financial frictions may hinder their willingness to invest in these riskier candidates .... Harvard Business School Working Knowledge (full PDF available free)

2/15 Lilly Partners with Digital Health Tech Startup
Lilly, Livongo team up for real-world diabetes research, aiming for better results in an outcomes-oriented market .... Livongo offers a cloud-based, Livongo-branded glucose meter and adjunct digital support program .... Fierce Pharma


2/15 Internet Drug News Fast Takes:
Minnesota renews push for tax on prescription opioids
Reuters
FDA Declares Pfizer's Atopic Dermatitis Drug a Breakthrough
Company news release
The Training Of Dr. Robot: Data Wave Hits Medical Care
Kaiser Health News
Researchers successfully reverse Alzheimer's disease in mouse model
Journal of Experimental Medicine
Merck Chemist Arrested for Stealing Deadly Chemical
Biospace


2/14 Walgreens Already Owns 26% of AmerisourceBergen; May Buy the Rest
Walgreens Has Made Takeover Approach to AmerisourceBergen .... Based in Valley Forge, Penn., Amerisource is one of the largest drug distributors in the U.S., turning a profit of $364.5 million on $153.1 billion in revenue in its fiscal year ended Sept. 30. In addition to supplying retail pharmacies, Amerisource has a large specialty-drug business .... WSJ$$
See also: Amerisource Deal May Not Keep Walgreens Competitive: Analysts [Reuters/NY Times]

2/14 Channel "Friction" (Fees, Shipping, Marketing, etc) Takes Up 20–30% of Health Care Supply Costs — Amazon Sees an Opportunity
Amazon's Latest Ambition: To Be a Major Hospital Supplier .... The online retailer is pushing hard to expand its foothold in medical supplies, creating a marketplace where hospitals could shop to stock emergency rooms, operating suites and outpatient facilities .... WSJ$$

2/14 Glatopa, a Generic for Copaxone, Gets OK After Manufacturing Issues
Novartis gains U.S. approval for delayed MS drug .... Sandoz began selling a 20 mg/ml Glatopa dosage to U.S. patients with relapsing MS in 2015 but missed out on millions of dollars in sales after the double-dosage version was pushed back last year after contamination problems at the Pfizer fill-and-finish plant being used by Sandoz .... Reuters

2/14 Verubecestat, an Alzheimer's Drug, Fails in Phase III
Merck just dashed the last remaining hopes for its industry-leading BACE drug for Alzheimer's .... Merck has scrapped the last remaining Phase III study of its leading BACE therapy verubecestat, the second of two collapsed studies, after independent monitors concluded that the drug wasn't working for early-stage, prodromal patients .... Endpoints News

2/14 Drug Channels Takes a Deep Dive into Express Scripts Drug Trend Report
New Express Scripts Data: The Drug Spending Slowdown Is Real .... Express Scripts was kind enough to share the following data about total out-of-pocket expenses for prescription drugs in 2017: 78.2% of patients had total out-of-pocket expenses that were less than $250; 15.5% of patients had total out-of-pocket expenses that were between $250 and $1,000; 6.3% had total out-of-pocket expenses that were greater than $1,000 .... Drug Channels

2/14 Symdeko (tezacaftor/ivacaftor) Approved for CF; Could Be Used for 44,000 Patients
New approval helps Vertex's 'cleanest growth story in biotech' .... Vertex set Symdeko's annual list price at $292,000, sandwiching it between the $272,000 and $311,000 it respectively costs for a year's supply of the company's other marketed CF products, Orkambi and Kalydeco .... BioPharma Dive

2/14 FDA Gets $473 Million Boost in Proposed FY 2019 Budget; Generic Rules to be Tweaked
Trump pitches changes to 180-day generic exclusivity .... The idea is to maintain the current 180-day exclusivity for first filers, but to prevent them from "parking" their exclusivity by treating a second generic application as a trigger for the first applicant's exclusivity period. .... BioPharma Dive

2/14 Brexanolone Promising in Phase 2; Phase 3 Results to Come
The First Drug For Postpartum Depression Could Be On Its Way .... Conservative estimates say 11 percent of women become depressed at some point in their first year of motherhood; others put that figure at closer to 25 percent. And that's just the women who seek help.... Sage Therapeutics believes it has tapped into a novel way of treating the most severe cases of PPD by targeting the brain's GABAA receptors with an infusion of brexanolone .... HuffPost

2/14 Taltz for Ankylosing Spondylitis
Eli Lilly Builds Case to Expand Immune Drug's Use to Spinal Arthritis .... Preliminary results from its Phase 3 clinical trial show that its drug hit main and secondary goals, posting statistically significant improvements in the symptoms of AS .... xconomy

2/14 New Approval for Algorithm-Based Decision Support Device
FDA Establishes Precedent by Approving AI-Powered Stroke Triage Software .... The software is a clinical decision support tool that uses artificial intelligence (AI) to analyze CT imaging for indications of stroke. If a suspected large vessel blockage is identified, the algorithm will automatically send a text notification to a neurovascular specialist .... Healthcare Analytics News

Tweet of the Day

2/9 Internet Drug News Fast Takes:
Drug copies ready to take next bite out of Roche's cancer sales
Reuters
Pfizer Announces FDA Acceptance of NDA for NSCLC Candidate
Zacks
6 Tips for Managing a Drug Information Center
Pharmacy Times
Texas Woman Dies From Flu After Rejecting Expensive Tamiflu Medication
Newsweek
Is Social Security to blame for so many men dying at 62?
Fox News (autoplay video)


Corey Says:
Don't forget to get your wife a card! 

2/13 Fast Takes
Why Biotech Stocks Soared in Trump's First Year in Office
Motley Fool
Resume typos that will keep you unemployed
Twitter
Merck subsidiary StayWell acquires Portland digital health startup Provata Health
GeekWire
Patient Advocate Says Novartis' $475,000 Breakthrough Leukemia Med Should Cost Just $160,000
Forbes
Former Celgene Pharma Exec Running For Senate Seat
Pharmalot

2/13 Lilly To Novo: Trulicity (Dulaglutide) Ain't Afraid Of Ozempic (semaglutide)
- Once per day Glutides gear up for battle
Bring on Novo Nordisk's semaglutide, Eli Lilly says. We're ready … Semaglutide, though, has a couple points in its favor, including head-to-head data that showed it beat Trulicity at delivering reductions in blood sugar, as well as double the weight loss … [Fierce Pharma]
See Also: Ozempic (semaglutide) PI | Trulicity (dulaglutide)  PI
See Also: Ozempic literature search | Trulicity literature search
See Also: Ozempic retail price | Trulicity retail price
See Also: Ozempic coupon | Trulicity coupon
Editor's Note: This will be a formulary battle, not a  merit battle.  You can have the best glutide in the world but if you need a prior auth and the other guy doesn't, you lose every time.  Coupons don't help.

2/13
Pain Pill Companies Spent Millions Behind Scenes To Influence Public Opinion
- Funded groups opposed using opioids as last resort
Opioid makers gave millions to patient advocacy groups to sway prescribing … guidelines and policies "minimizing the risk of opioid addiction and promoting opioids for chronic pain, lobbied to change laws directed at curbing opioid use, and argued against accountability …[Ed Silverman; Pharmalot]

2/13
Drug Rep Who Bribed VA Docs Gets Probation
- Docs in scheme get off scot-free
Pharma exec who bribed VA docs: 'Greed is an ugly, ugly emotion' … Most of the others involved in the scheme of suffered no such pain; Assistant U.S. Attorney David Reese Jennings remarked that, two resignations aside, none of the VA doctors who received the bribes have left the VA, and many have found "new suitors." … [Seattle PI]

2/13
Critics: Trump Drug Price Strategy: Hefty Bluster, Wimpy Relief
- Big savings if Medicare had direct role in price setting
Trump's big promises on drug costs followed by modest steps … White House strategy largely sidesteps the question of whether drugmakers set their prices too high to start with. Rather, it recommends changes to policies that the administration believes unwittingly lead to higher prices …[AP]

2/13
Trump FDA Pick Walks Fine Line Between Rhetoric And Action
- Skeptics are newly hopeful
F.D.A. Chief Goes Against the Administration Stereotype …  nine months after he was confirmed, he has quieted some skeptics, while also managing to keep industry supporters content and the president on his side … day he was sworn in, he sold all of his health-related stock … [NY Times]

2/13
Raft Of New Drugs Set To Compete With Tamiflu
Flu relief is coming as successors to aging Tamiflu near market … raft of new options for treating and preventing a disease that kills as many as 650,000 people worldwide … [Tamiflu] reduces the duration of illness by only up to a day if it's taken within the first 48 hours of the onset of symptoms … [Seattle Business Times]
Editor's Note: Adds information on flu pipeline candidates from JNJ, Vertex, Daiichi Sankyo and Biocryst.

2/12
Fast Takes
Sanofi sounds taps on a half dozen drug programs in latest pipeline cleanup
Endpoints News
On drug costs, modest steps follow Trump's big promises
AP
Teva Migraine Drug Likely Delayed by Manufacturing Trouble
Xconomy
Will Allergan cannibalize Botox with ubrogepant?
Biopharma Dive
Regeneron's late to a group of drugs worth billions -- here's why the company thinks it can still compete
SF Gate
CVS Health CEO On Amazon-Berkshire Threat: We've Got This
Forbes

2/12
Internal JNJ Memo: Staffers Knew About Asbestos In Talc Products As Early As 1970
Johnson & Johnson says talc products have always been asbestos-free. Court documents suggest otherwise … documents filed in the ongoing legal saga, provided to FiercePharma, suggest some tests found asbestos and that the company debated internally about the issue … [Fierce Pharma]

2/12
Novartis Generic Version Of Advair Delayed
- How long will GSK's luck hold out?
Drugmaker GSK wins fresh Advair reprieve as Novartis copy delayed … Advair is particularly difficult for generic drugmakers to copy fact that Sandoz, one of the world's most experienced generics firms, has also stumbled highlights the challenges of making a generic that is acceptable to the FDA, although such Advair copies are already available in Europe … [Reuters]

2/12
Big Pharma Joins Cannabis Gold Rush; Epilepsy Drug Inches Forward
Big Pharma green lights cannabis-based drug for epilepsy … Unlike the CBD oil sold in legal marijuana states, most health insurance networks would cover Epidiolex. This is a good thing since the drug is expected to cost patients up to $60,000 per year … [Salon]

2/12
Amgen Cautiously Hungry For A Deal; $27 Bln On Table
-
Refuse to overpay despite overheated market
Amgen 'looking hard' at striking deals using $27bn cash pile ...cautioned it would be difficult "as long as people are willing to pay levels above what we deem we can make a return on" … product sales declined last year, while the launch of its new cholesterol drug Repatha has fallen short …[FT]

2/12
Canadian Reimportation Is Hot Issue Again
States Look to Lower Drug Costs, Consider Canadian Imports … Six states are considering bills that would allow drugs to be imported from Canada, where they cost an average 30 percent less than in the United States … hope is that importing drugs can put downward pressure on domestic costs for all …[NY Times]

2/12
Bill In Congress To End Medicaid D Donut Hole, Deepen Government Drug Discounts
- Trump admin sees passing on rebates to patients key to lowering retail drug prices
Lower Drug Prices: New Proposals Carry Lots of Promises … Consumers don't get discounts that drug manufacturers offer to health insurers … insurance company pockets hundreds of dollars every time she fills her prescription from Amgen, which makes Enbrel. Ms. Lopez will never see that money -- the rebates are instead applied across the board to keep premiums low for all of the people enrolled in Humana's Medicare plan …[NY Times]
Smorgasbord of health items in massive 2-year budget deal … accelerated close of the so-called Medicare Part D donut hole. The change would also increase the discount that pharmaceutical companies would pay to individuals who fall in a coverage gap from the current 50% cost of the applicable drug to 70% starting in 2019 instead of 2020 … [Biopharma Dive]

2/12
Crushing Formulary Exclusions Take a Billion Dollar Bite Out of Sanofi's Diabetes Business
- Sanofi's diabetes franchise has awful  year; Q4 down nearly 30%
Want numbers on formulary pain? Sanofi's diabetes sales are Exhibit A .... Sanofi reported a U.S. diabetes sales decline of 29.5% in the fourth quarter and 22.8% for the year....Lantus and Toujeo sales were hit by CVS Health and UnitedHealthcare formulary exclusions .... [Fierce Pharma ]

2/12
Purdue Exits Opiate Pain Pill Business
OxyContin maker will stop promoting opioids to doctors … eliminated more than half its sales staff and will no longer send sales representatives to doctors' offices to discuss opioid drugs … remaining sales staff of about 200 will focus on other medications … [AP]
OxyContin Drugmaker Vows To Stop Promoting Opioids To Doctors … sales representatives will now focus on Symproic, a drug for treating opioid-induced constipation, and other potential non-opioid products …[Reuters]

2/12
Yet Another Alzheimer's Med Lays An Egg
Scientists toss another Alzheimer's program into the scrap heap as PhII fails … Today, Boehringer Ingelheim threw in the towel on an Alzheimer's program … Boehringer hasn't given up on the drug. It has plans to test it in schizophrenia … [Endpoints News]


2/9 Real World Evidence in the Real World
How Bristol-Myers and Pfizer are using real-world data to unseat warfarin .... An analysis presented at the European Society of Cardiology Congress pooled data from four U.S. insurance databases, comparing Eliquis to warfarin in patients with non-valvular atrial fibrillation.... The study found Eliquis was associated — though not causatively linked — with lower risk of stroke and fewer incidents of major bleeds across a number of high-risk patient groups (such as patients aged 75 or older) .... BioPharma Dive

2/9 Shift to Hospital Sites Hurts Specialty Distributor Profits
Specialty Distributors' Customer Mix Changes As Physician Buy-and-Bill Fades .... Hospital outpatient sites now constitute more than one-third of Medicare spending and have been crowding out physician offices. Part B payments to physician practices are growing much more slowly than are payments to hospitals .... Drug Channels

2/9 Merlo Says They're Many Steps Ahead of Amazon's New Health Partnership
CVS Health CEO On Amazon-Berkshire Threat: We've Got This .... Merlo seemed to indicate CVS Health's acquisition of Aetna for $69 billion would put them well ahead of anything Amazon and Berkshire may launch .... Forbes/Bruce Japsen

2/9 Access to Samples Law Smothered in the Back Cloakroom
Senate Republicans Kept Provision To Fight High Drug Prices Out Of Spending Bill, Democrats Say .... The Creating and Restoring Equal Access to Equivalent Samples Act, known as the CREATES Act and co-sponsored by members of both parties, was rumored to be a part of budget negotiations until the final days .... The Intercept

2/9 Spending for Obesity-Related Illnesses Up 29% Since 2001
Obesity-Related Illnesses Consume 7.9% US Health Care Spending .... In 2015, states such as Arizona, California, Florida, New York and Pennsylvania devoted five to six percent of their total medical expenditures to treating obesity-related illness, whereas North Carolina, Ohio and Wisconsin spent more than twice that — over 12 percent .... Cornell University

2/9 Teva Sales Could Drop 18% in 2018
Teva Says 2018 Profit Will Keep Falling as Generic Drug Slump Persists .... CEO Kare Schultz blamed sweeping changes in the U.S. pharmaceutical industry for Teva's mounting woes, ranging from accelerated Food and Drug Administration approval of competing medicines to government regulation that limits drug prices. Even the new tax law hurt the company .... Bloomberg

2/9 The Guys at the Dealer Who Calculated the Value of My Trade-in Run the Numbers on Kymriah
Novartis could cut its Kymriah price to $160,000 and keep its profit margins: study .... The Health Affairs team incorporated Novartis' stated development costs of $1 billion and Kymriah's $475,000 sticker. They estimated manufacturing expenses of $20,000 per treatment and considered that Novartis plans to refund the costs if certain patients don't respond, ending up with an 84% profit margin for the drug on average over 10 years .... Fierce Pharma

2/9 FDA Arranges Domestic Supply for Crucial Tc-99m
Isotope manufacturing headed back to US following new FDA approval .... Through a collaboration with industry leaders and other regulatory bodies, the FDA approved the RadioGenix System, a technology makes the isotope, known as Technetium-99m or Tc-99m. More than 80% of nuclear medicine imaging that takes place in the U.S. uses Tc-99m .... BioPharma Dive

2/9 New York City, Los Angeles, and San Francisco Provide Truvada for PrEP, But No Federal Support
Only a handful of countries are backing a life-saving HIV-prevention drug .... Norway, France, Belgium, Kenya, South Africa, and Brazil all have government programs lowering the cost of Truvada, and in some cases, making it free. Today (Feb. 7), New Zealand became the latest to join this group .... Quartz

2/9 Sanofi Genzyme Cuts Workers
Sanofi Genzyme to Lay Off 130 Employees at Boston Facility .... The company is laying off 130 people at a manufacturing facility in Boston. The facility is based at Allston Landing in Boston, and will remain a biomanufacturing site .... BioSpace


2/9 Internet Drug News Fast Takes:
Harvard genetics pioneer wants to monetize DNA with digital currency, and defeat 23andMe
CNBC
Free Lyft may not help poor people keep doctor appointments
Reuters
Study finds only one-third of patients diagnosed with depression start treatment
Kaiser Permanente
This drug has been used to treat PTSD symptoms. What happens when it fails a trial?
Stat
Ex-Pharmaceutical Firm Worker Headed to Prison in $1M Scheme
NYT/AP



2/8 Formulary Exclusions Take a Billion Dollar Bite Out of Sanofi's Diabetes Business
Want numbers on formulary pain? Sanofi's diabetes sales are Exhibit A .... Sanofi reported a U.S. diabetes sales decline of 29.5% in the fourth quarter and 22.8% for the year....Lantus and Toujeo sales were hit by CVS Health and UnitedHealthcare formulary exclusions .... Fierce Pharma

2/8 Rheumatology Workforce to Fall 25% — Who's Going to Write the Humira Scripts?
Rheumatologist shortage looms amid surging patient demand .... An estimated 6,013 clinicians in the U.S. specialized in rheumatology as of 2015, the equivalent of 5,415 full-time providers, according to one of the studies, published in Arthritis Care & Research. By 2030, that's projected to fall to 4,882 clinicians, or the equivalent of just 4,051 full-time providers .... Reuters

2/8 Biktarvy Approved, New Triple Combo for HIV; $36,000/Year
U.S. FDA approves Gilead triple HIV drug, rival files lawsuit .... Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide .... Reuters/Yahoo

2/8 Gilead Sees Soft 2018 on Hep C Drug Sales Falloff; No Help Yet from Kite
Gilead fourth-quarter hepatitis C drug sales plummet; company sees a further slowdown .... Quarterly sales of hepatitis C drugs totaled $1.5 billion, down from $3.2 billion a year earlier but in line with analysts' forecasts. Sales of antiviral and HIV drug rose to $3.7 billion from $3.4 billion .... CNBC/Reuters

2/8 Shoe-Leather Survey Finds a Lot of Suspect Insulin Vials
Insulin Quality Questions Have Diabetes Experts Scrambling .... The study author, a pharmacist, bought vials of insulin at a number of pharmacies and found that on average the vials had less than half of what was listed on the label and none met a minimum standard .... NY Times

2/8 One in 4 Drugs Approved in Past Four Years are Personalized
Personalized Medicine Approvals Continued to Surge in 2017 .... The FDA approved 16 new personalized treatments in 2017 alone compared with a decade ago when these drugs only accounted for less than 10% of approvals .... Specialty Pharmacy Times

2/8 Five Players in the Data Game: Veeva, Zephyr, DMD, Indegene, and IQVIA
High five: How these companies are leveraging data to engage A-list HCPs .... Engaging with physicians isn't as easy as serving them a Google ad. That's why a number of companies are trying to bridge the communication divide with data-driven tools that help pharma companies improve their connection with healthcare providers .... MM&M

2/8 Tysabri for Stroke Trial Flops
Biogen scuttles a Tysabri program after the drug fails stroke test, thinning the pipeline .... Investigators for Biogen say that the drug failed the primary and secondary endpoints in a Phase IIb trial, offering convincing data that the drug would not work for this indication .... Endpoints News

2/8 Big Investment in New IBD Drug
J&J Gambles $1B on Theravance and Its GI Pipeline .... The companies will work to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor. IBD includes Crohn's disease and ulcerative colitis (UC). .... Biospace

2/8 One Pill Makes You Larger, And One Pill Makes You Small
Pharma wades into the world of virtual reality marketing .... It looks as though VR has taken root across some of the biggest names in drugmaking. Pfizer Inc. and Novartis AG are deploying the technology in the lab; Amgen Inc. offers a virtual tour of its manufacturing facilities on its website; and Merck KGaA has experimented with its branding applications .... BioPharma Dive

2/8 DTC TV Booms in January; Up $30 Million vs. December
AbbVie, Pfizer in another close TV ad spending race to kick off 2018 .... Humira and Lyrica each spent more than $35 million on TV ads, almost double the next closest competitor, Novo Nordisk's diabetes treatment Victoza .... Fierce Pharma

Tweet of the Day

2/8 Internet Drug News Fast Takes:
LA Times Buyer Is a Basketball-Loving Biotech Billionaire
NY Times
IRI explores how hard the flu is hitting retail
Drug Store News
Another Day, Another Breakthrough Tag for GlaxoSmithKline's Bexsero
Biospace
After approving Medicaid work requirements, Trump's HHS aims for lifetime coverage limits
McClatchy DC



2/7 Express Scripts 2017 Drug Trends Report is Out; Claims 90% of Rebates Passed Through
Secret Discounts Kept Soaring Drug Bills Down, Says Middleman .... Express Scripts senior vice president Glen Stettin credited the slower growth in drug costs to aggressive steps Express Scripts has taken to secure greater discounts for high-cost drugs, including expensive injected anti-inflammatory drugs, a category that includes blockbuster arthritis treatment Humira .... Bloomberg

2/7 More on ESRX Drug Trends Report: Total Spend for Clients Up Only 1.5%
Express Scripts plans see lower gains in prescription drug spending .... Nearly half of all private insurance plans spent less per person year over year, including plans on the Obamacare exchange market, which saw drug spending fall more 3 percent. Overall drug spending for Medicare rose 2.3 percent, while the Medicaid safety net program saw a 3.7 percent spending increase .... CNBC
2/7 Apalutamide Delays Prostate Cancer Metastases 2+ Years; Slightly Longer than Xtandi
Strong data lift profile of J&J's cancer drug apalutamide .... Adding apalutamide to androgen deprivation therapy resulted in a median MFS of 40.5 months — widely outshining the 16.2 month mark record in the group receiving placebo plus ADT. The benefit corresponded to a 72% reduction in the risk of developing metastases or death .... BioPharma Dive

2/7 Oral Semaglutide Potentially on the Market in 2020
In diabetes war, Novo Nordisk aims to break mold with new pill .... Oral semaglutide is no simple tablet. This is a big, complex molecule, known as a peptide, which would normally be destroyed by stomach acid and it requires protection with a special compound to boost absorption. What's more, the drug must be in close contact with the stomach wall, which means patients cannot eat for 30 minutes after taking it and the pill can also cause nausea .... Reuters

2/7 Tax Reform Leads Amgen to Build New Plant in U.S.
Part of Amgen's tax savings to go into $300M U.S. biologics plant, 300 new jobs .... Amgen scientists tested new technology using modular 2,000-liter vessels that are portable and accommodate single-use bioreactor bags, but when lined up can produce as much protein as the massive conventional tanks. Such a plant's smaller size and new design would allow it to be constructed in about 18 months, not four or five years .... Fierce Pharma

2/7 Wholesalers Out of the Game as Market Moves to More and More Specialty Products
A Lesson from McKesson: How Specialty Pharmacy Growth Is Hurting Wholesalers .... Manufacturers' network strategies have concentrated market share for dispensing specialty drugs into the largest specialty pharmacies—which are also wholesalers' least profitable customers. Many of the largest U.S. pharmacies are now central-fill, mail pharmacies operated by large PBMs and health insurers .... Drug Channels

2/7 Noctiva to Launch Soon
Tired of waking up to pee? Missouri drug company may have answer, but there are risks .... Avadel has been doing market research, scaling up production, hiring a sales force and looking for urologists who might be interested in prescribing Noctiva. The company is planning a "soft launch" in the next couple of weeks and CEO Michael Anderson expects the drug to be widely available by April or May .... Kansas City Star (autoplay video)

2/7 New Melanoma Combo Doubles OS Times vs Zelboraf for BRAF Mutation Patients
Array melanoma drugs show significant survival versus Roche drug in study .... A combination of experimental drugs from Array BioPharma Inc kept patients with advanced melanoma associated with a common gene mutation alive for nearly three years and twice as long as Roche's Zelboraf .... Reuters

2/7 Digital PreDiabetes Program
Merck KGaA puts devices to work against diabetes in Blue Mesa digital program .... Blue Mesa's yearlong program uses remote health coaching, peer support and integrated smartphone activities such as connected bathroom scales and activity trackers .... Fierce Pharma

2/7 Zentiva Unit Sale Expected by End of 1Q
Two Drugmakers Compete for Sanofi's $2.4B Generics Biz .... Potential buyers have been winnowed down to two pharma companies, three private equity funds, and a consortium of buyers .... Biospace

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