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7/26 False-Claims Action May Bring Former Celgene Rep $84 Million
Celgene Settles Whistle-Blower Fraud Suit for $280 Million .... Saleswoman Beverly Brown alleged that Celgene paid doctors and hired ghostwriters to tout uses for Thalomid beyond the product's approval, including treating blood cancer, years before it was authorized by regulators .... Bloomberg

7/26 Valuable Backgrounder on Orphan Drugs
Pricing Orphan Drugs .... Orphan drug status applies to diverse products with different pricing dynamics, complicating efforts to craft policies to address costs. In contrast to expedited pathways such as Accelerated Approval or Breakthrough Therapy Designation, orphan drug status is not tied to the severity of the disease or the perceived effects of the therapy; instead, it is simply a matter of counting potential patients .... Health Affairs Health Policy Brief

7/26 Lilly Thinning the Herd
Lilly puts two-thirds of midphase cancer pipeline up for sale in major shake-up of R&D priorities .... The company wants to offload six phase 2 candidates to focus its R&D dollars on a clutch of early to midstage assets it thinks can become the new standard of care .... Fierce Biotech

7/26 "Non-synergies" between Rite Aid and EnvisionRx
What Will Happen to Rite Aid's Struggling EnvisionRx PBM? .... It's been two years since Rite Aid completed its acquisition of EnvisionRx—and so far the results don't look promising.... revenues have been essentially flat and declined in 2017 .... Drug Channels

7/26 Spinraza Sales Almost Triple Estimates Despite $750,000 First Year Price Tag
Biogen, Opening Bottlenecks, Sees Spine Drug Sales, Shares Rise .... Biogen reported $203 million in quarterly nusinersen (Spinraza) sales this morning, well past consensus analyst estimates of about $70 million .... xconomy

7/26 POTUS Executive Order Coming, But Anyone's Guess What Will Be In It
Eli Lilly CEO expects a Trump executive order on drug pricing this year .... Reports have indicated that a measure may be weeks away, perhaps after the Senate votes on health care reform .... CNBC

7/26 Makers Evaluating Option on RA Drug
Lilly, Incyte likely won't resubmit baricitinib until 2019 .... FDA regulators, after delaying their approval decision three months, delivered a surprise rejection back in April.... [They] requested more data on dosing and the drug's safety profile .... Biopharma Dive

7/26 14-Part Article on Pfizer Outlook
Who's Eying Pfizer Now—And Why .... Pfizer estimated that its total revenues in fiscal 2017 could be in the range of $52.0 billion–$54.0 billion. Pfizer also expects diluted EPS (earnings per share) to be in the range of $2.50–$2.60 .... Market Realist

7/26 Datamonitor Report: US Drug Pricing a Hot-Button Issue Since the '90s
Drug spending in U.S. tops the world. Translation: No pricing-headache relief soon .... Annual per capita spending on prescription drugs in the U.S. is $1,112, about one-third higher than neighboring Canada, which ranked second in the world at $772 spent per person every year. Germany ($741), France ($646) and Spain ($547) rounded out the top five in per capita drug spending .... Fierce Pharma

7/26 Nice Primer on Biologics If You Need One
Biologics: The pricey drugs transforming medicine .... Cancer treatments dominate the list of targeted therapies, but since 2011 the U.S. Food and Drug Administration has approved new protein-based biologics for the treatment of Lupus, Crohn's disease, rheumatoid arthritis, multiple sclerosis, kidney failure, asthma and high cholesterol .... The Conversation

Tweet of the Day

7/26 Internet Drug News Fast Takes:
Sperm count falling sharply in developed world, researchers say
Reuters
GSK Hires Ex-Wal-Mart Executive to Transform Tech Operations
Reuters/NY Times
UnitedHealth Group Launches $240 Million Media Agency Review Amid Chaos in Congress
Adweek
275,000 calls to poison control centers for dietary supplement exposures, study finds
Science Daily
15 percent of men regret prostate cancer treatment choices years later, study finds
Stat News




7/25 EmCare Makes a Business Out of Out-of-Network Bills
The Company Behind Many Surprise Emergency Room Bills .... Nationwide, more than one in five visits to an in-network emergency room results in an out-of-network doctor's bill....[but] those bills aren't randomly sprinkled throughout the nation's hospitals. They come mostly from a select group of E.R. doctors at particular hospitals .... NY Times

7/25 Q&A with Scott Gottlieb
Trump's FDA Commissioner on Drug Prices, Regulations, Science .... "What we're talking about [in regards to efficiency] is the clinical development process and how long does it take to actually go through the clinical trial requirements that FDA either imposes, or sort of steers toward, in order to demonstrate safety and efficacy" .... Bloomberg

7/25 New Remicade Biosimilar Launched at 35% Discount
Merck, Samsung Accelerate a Biosimilar Price War .... Pfizer will likely be forced to match Merck and Samsung price cut. And then J&J will have a harder time getting people to pick its more-expensive original .... Bloomberg Gadfly
See also: How Blockbuster Drugs Fight Off Cheaper Competition [WSJ]

7/25 Purdue, J&J, Teva, Allergan, and Endo in Crosshairs of Painkiller Lawsuits
Lawyers Hope to Do to Opioid Makers What They Did to Big Tobacco .... Mike Moore, a pioneer of cigarette litigation, is encouraging states to sue drug companies over the painkiller epidemic .... WSJ $$

7/25 Benlysta Getting Traction; Up 21% Y/Y; New Sub-Q Will Help
GlaxoSmithKline lupus med Benlysta aims for growth injection with new subcutaneous approval .... Many lupus patients are women of childbearing age with an active lifestyle, and it can be tough for them to carve out time to receive their monthly infusions.... The new subcutaneous option will allow them to inject themselves .... Fierce Pharma

7/25 WebMD Sold for $2.8 Billion
WebMD Goes Under the Knife of KKR's Turnaround Docs .... WebMD, where users can try to self-diagnose ailments, has been forecasting a 1 percent to 4 percent increase in revenue this year, one of its worst growth rates.... The turnaround doctors at the buyout firm will likely take a scalpel to WebMD's costs to maximize profits and cash flow .... Bloomberg Gadfly

7/25 AbbVie Loses AndroGel Heart Attack Case
U.S. jury finds AbbVie liable for misrepresentation in AndroGel verdict .... A federal jury in Chicago has found AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug AndroGel and ordered the drugmaker to pay $150 million in punitive damages .... Reuters

7/25 Keytruda Fails OS in Head and Neck Ca
Merck hit with another late-stage setback on checkpoint star Keytruda .... The pivotal KEYNOTE-040 failed to meet the primary endpoint on overall survival in comparing the blockbuster checkpoint against standard therapies for recurrent or metastatic head and neck squamous cell carcinoma .... Endpoints News

7/25 Alzheimer's Treatment Landscape: Need is Staggering, Successes Minimal
Alzheimer's disease: What you need to know .... The Alzheimer's Association estimates that the costs of the disease on the healthcare system could reach an astronomical $1.1 trillion by 2050 .... BioPharma Dive

7/25 Updates on HIV from Paris Meeting
HIV fight advances with new drug cocktails, fresh vaccine hopes .... For GSK, two-drug cocktails represent the future of HIV treatment, especially for the growing number of older patients who are more vulnerable to side effects from taking multiple medicines. It hopes to win approval for its first dual therapy — a tablet containing dolutegravir — later this year .... Reuters

7/25 Internet Drug News Fast Takes:
CSL Behring receives orphan-drug exclusivity for Haegarda
Reuters
The sky-high pay of health care CEOs
Axios
Blood Test Could Detect Early Sign of Alzheimer's
Futurity
GE Healthcare, Jefferson Health kick off work targeting $1 billion in efficiencies
Healthcare IT News
New Tool Aims to Link Patients to Life-Saving Investigational Treatments
PTCommunity
Molina Healthcare plans to lay off 1,400
Press Enterprise


7/24 Drug Companies' Promotions: Less Social, More Video
7 Trends On How Big Pharma Uses Social Media .... There are four major silos of effort that allow firms to use social media and still comply with regulatory requirements. .... Forbes
Direct link to report 7 Social Media Trends in the Pharmaceutical Industry

7/24 Changing Market for MS Therapies — New Products, Generic Competitors
Biotechs Find Strength In Numbers In Treating Multiple Sclerosis .... Analysts say Roche's drug puts Biogen's Tysabri and Tecfidera at the greatest risk of market share loss. Some Wall Street estimates see Ocrevus taking away 40%-50% of Tysabri sales and 30%-40% of Tecfidera revenue over three to four years .... Investors Business Daily (autoplay audio)

7/24 ASCO Statement on Cancer Drugs
ASCO Outlines Position on Cancer Drug Pricing .... ASCO supports testing various strategies, including value-based pathways, indication-based pricing and outcomes-based pricing.... The organization opposes to payment bundles .... Biocentury

7/24 Make it Rain on Capital Hill
A Drug Maker Spends Big in Washington to Make Itself Heard .... Congressional donations from pharmaceutical PACs rose 11 percent in this year's first quarter, compared with the first three months of 2015 (the comparable point in the previous election cycle) .... NY Times

7/24 Blockbuster Cosentyx Faces New Competitors; Hits DTC Airwaves
Cyndi Lauper showcases backstage psoriasis woes in Novartis' new Cosentyx spot .... The commercial weaves Lauper's story with those of two other patients, shown struggling with unwanted attention as people around them stare at the red, flaky skin patches caused by the disease. .... Fierce Pharma

7/24 Cardiovascular Drugs Hitting Payer Wall
Drugmakers face challenges marketing new heart drugs .... Entresto, too, has been beset by restricted formulary access....Novartis has told investors that adoption of Entresto among cardiologists has been slow because these physicians don't traditionally advocate for new drugs to insurers, compared to other specialists, like oncologists .... MM&M

7/24 Factoids on Pfizer
5 Things You Probably Didn't Know About Pfizer .... The company launched its first pharmaceutical sold in the U.S. under the Pfizer label in 1950. That drug was an antibiotic marketed as Terramycin. The launch of Terramycin also led Pfizer to establish its first pharmaceutical sales force .... Motley Fool

7/24 Top Dem Promises to Go After Drug Companies
Schumer: Democrats were 'namby-pamby' .... Democrats have searched for a new message since their loss to President Donald Trump in November, with public polling showing that most people don't know what Democrats stand for .... Politico

7/24 Lawyer Threatens "Thousands" More Zostavax Liability Cases
Merck’s Zostavax draws new litigation from patients alleging they contracted shingles .... Instead of preventing shingles, Zostavax caused the plaintiffs to "contract a persistent strain of herpes zoster," according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases .... Fierce Pharma

7/24 Cash Doubles Colonoscopy Uptake
Offer of $100 boosts rates of colon cancer screenings .... Only 1.6 percent of the control group and 1.5 percent of the simple active choice group ended up receiving a screening colonoscopy within three months, compared to 3.7 percent of the group that was offered the $100 inducement .... University of Pennsylvania School of Medicine

Tweet of the Day:

7/24 Internet Drug News Fast Takes:
EU medicines agency recommends approval of Novartis leukaemia drug Rydapt
Reuters
USC moves to terminate former dean, citing evidence of drug activity
USA Today
Teva Pharm to Reduce Workforce in Israel, Mainly in Production
Reuters/NY Times
About one-third of dementia cases could be prevented by actions that begin in childhood
LA Times
DEA clarifies guidance on forwarding unfilled e-prescribed controlled substances
Drug Store News

7/21 Vertex is Now a Prize Acquisition Target; Here's Why
Vertex Becomes an Overnight Biotech M&A Darling .... Vertex expects to generate as much as $1.3 billion in sales this year, and analysts now expect the company to grow sales to nearly $5 billion by 2021. Vertex may be able to continue growing sales for years beyond that .... BusinessWeek

7/21 Trump Can't Crush New Valor Vial
Trump unveils companies' $500 million U.S. drug packaging project .... President Donald Trump has announced a $500 million investment that Corning is making with pharmaceutical giants Merck and Pfizer to manufacture a new kind of glass for injectable drug vials .... Reuters

7/21 Roche and Novo Add Diabetes Apps to Their Treatment Portfolios
Diabetes drugmakers partner with mobile startups to boost patient engagement .... Roche's acquisition of mySugr on June 30 netted the Swiss drugmaker a mobile app that specializes in diabetes. Similar to the Novo app, mySugr lets users capture information about their meals, activity, and blood sugar levels and also provides an overview of their recent activity .... MM&M

7/21 Keytruda's Market Share Up to 32%, +4% in June
Merck's Keytruda speeds its I-O market-share grab as Bristol-Myers' Opdivo declines .... Now approved for a half-dozen cancer types, Opdivo jumped to an early I-O lead after leapfrogging first-to-market Keytruda with its quick lung cancer approval, and it still leads with 46% of the market. But Keytruda has blown past it in the all-important lung cancer space .... Fierce Pharma

7/21 Aimovig, First of New Type of Migraine Drug, Filed with FDA
Amgen and Novartis ID the finish line in a wicked scramble for first CGRP migraine drug OK .... The FDA has accepted the partners' application for erenumab, the furthest advanced CGRP therapy which is now navigating toward a May 17 PDUFA date .... Endpoints

7/21 Ironwood GERD Treatment Successful in Phase 2b; 1500 mg Dose (6 Pills a Day) Raising Concerns
Ironwood touts positive data, but investors aren't sold .... All participants with persistent GERD stayed on PPI therapy during the study, but those who received a 1,500 mg regimen of Ironwood's IW-3718 demonstrated a 58% reduction in heartburn severity, the study's primary endpoint, versus a 46% reduction for those in a placebo arm .... BioPharma Dive

7/21 Handy List of Top Pharmacy Chains
2016's Top Retail Pharmacy Chains, According to Drug Store News .... CVS Health tops the DSN list, with $60.8 billion in retail prescription sales .... Drug Channels

7/21 Profile of First CAR T Patient
This Man's Immune System Got a Cancer-killing Update .... Scientists could code a homing device into Ludwig's T-cells and have a small population of these act as a sort of contract security force, added to aid the national security forces of his immune system. It was a gene designed on a computer and then cobbled together into disabled HIV, incorporating bits of genetic code from mice, cows, and woodchucks .... Nautilus

7/21 Lusduna Nexvue, Follow-on Biologic Insulin, Approved But Held Back by Legal Challenge
Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge Lantus .... Like Basaglar, Lusduna isn't a biosimilar, but a "follow-on biologic," though the general effect is the same. Also like Basaglar, it can be substituted for Lantus—not at the pharmacy, but on a doctor's prescription pad .... Fierce Pharma

7/21 UnitedHealth's Medicare Business Up 17% in Q2; Company Bullish on Market and Share Growth
UnitedHealth Group Predicts 50% Of Seniors Will Choose Medicare Advantage .... As of May, 58 million Americans are enrolled in Medicare. Of that, "Original Medicare" enrollment is 37.9 million with current MA enrollment at about 20.1 million .... Forbes/Bruce Japsen

7/21 Internet Drug News Fast Takes:
White House developing comprehensive biosecurity strategy
Reuters
Old antibiotic could form new depression treatment
Medical Xpress
NeuroVia Raises $14M to Test Drug for Rare, Fatal Metabolic Disease
xconomy
Expanding his medical empire is good for Patrick Soon-Shiong. But is it good for patients?
Stat News
BIO lobbies lawmakers for new rules that expose biotech short sellers
Endpoints News


7/20 Alzheimer's Etiology Remains Unclear
PET scans show many Alzheimer's patients may not actually have the disease .... Among 4,000 people tested so far in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, researchers from the Memory and Aging Center at the University of California at San Francisco found that just 54.3 percent of mild cognitive impairment patients and 70.5 percent of dementia patients had amyloid plaques .... Washington Post

7/20 PhRMA Report: 731 Cell and Gene Therapy Projects in the Works
King cancer: The top 10 therapeutic areas in biopharma R&D .... Cancer accounted for 8,651 of the total number of pipeline projects counted by the Analysis Group, crunching the numbers in a new report commissioned by PhRMA. That's more than a third of the 24,389 preclinical through Phase III programs .... Endpoints

7/20 Finalists for Merck's Alexa Diabetes Management Challenge
'Alexa, help manage my diabetes.' That's what Merck and its contest finalists envision for the Amazon platform .... The first finalist is a mood-sensing virtual voice assistant called DiaBetty, submitted by a group at the University of Illinois. It can give advice attuned to patients' moods and deliver educational information to help them better manage their condition .... Fierce Pharma

7/20 Monthly Copay for Specialist Mental Health Treatment Drove Sickest into Hospitals
New study suggests that reduced insurance coverage for mental health treatment increases costs for the seriously ill .... In the first year after the new out-of-pocket fee was established, the total cost of mental health care declined by an estimated €13 million (US$15 million), but the total cost for treating the most serious disorders — psychotic disorder and bipolar disorder — increased by an estimated €25 million (US$28 million) .... Medical Xpress

7/20 Almost a Third of US Population Has Diabetes or Prediabetes
Diabetes or its precursor affects 100 million Americans .... A total of 30.3 million people in the United States have diabetes, accounting for 9.4 percent of the population. Another 84.1 million — about one in three people — have prediabetes .... Medical Xpress

7/20 Yes, You Have 3 Boxes in Your Cupboard, But Your Hospital is Desperately Low
How a baking soda shortage became a health-care crisis .... A breakdown in the supply chain of sodium bicarbonate — the same basic compound as household baking soda — for use in medical procedures is expected to limit access to certain treatments in hospitals through the end of the year .... USA Today

7/20 GSK Streamlines
GSK puts old antibiotics and UK Horlicks business on the block .... The antibiotics business under strategic review covers the brands Zinnat/Ceftin, Zinacef and Fortum and has worldwide annual sales estimated at around 200 million pounds ($260 million) .... Reuters/Yahoo

7/20 J&J Quarterly Results
This Drug Bellwether's Sales Miss Actually Bodes Well For The Sector .... Sales of J&J's immunosuppressant Remicade declined 14% year over year. But rivalry from biosimilars contributed to just 5% of that decline .... Investors Business Daily

7/20 Cancer Doctors: Hospitals are Using 340B Money to Buy Up Their Practices
Hospitals oppose cuts to 340B drug program, but oncology group says they're abusing the discount program .... The Community Oncology Alliance said a 2016 study by the actuarial firm Milliman calculated that the shift of chemotherapy from community oncology practices to hospitals cost Medicare an extra $2 billion in 2014 alone .... Healthcare Finance

7/20 Stem Cell Scams
The stem cell therapies offered by this La Jolla clinic aren't FDA approved, may not work — and cost $15,000 .... Many clinics offering the treatments capitalize on the public’s impression that stem cells have become some sort of medical miracle .... LA Times

Tweet of the Day:

7/20 Internet Drug News Fast Takes:
Long work hours tied to irregular heart rhythm
Reuters Health
EU Watchdog Concerned Drug Agency EMA May Be Too Close to Companies
Reuters
There's An Amazing New Drug For Multiple Sclerosis. Should I Try It?
NPR/Shots
The flu vaccines are coming: GSK, Sanofi ship the first of more than 150M doses headed to U.S.
Fierce Pharma
FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings
Regulatory Focus

7/19 Three New Triple-Drug Regimens Highly Effective for CF
'Just What We Dreamed.' New Vertex Drugs Show Dramatic Benefit Against Cystic Fibrosis .... Right now, just 4,900 CF patients can take Kalydeco, a gene-targeted drug made by Vertex that has stunning benefits on patients' lung function. Another 25,000 can benefit from Orkambi, a Vertex drug combination that is far less effective than Kalydeco. Any of these three new drug treatments, it would appear, could get a benefit similar to Kalydeco's for 90% of cystic fibrosis patients .... Forbes/Matthew Herper

7/19 Vosevi Approved for Hep C
FDA Greenlights Vosevi to Treat Hepatitis C Virus .... Vosevi is a fixed-dose, combination tablet containing sofosbuvir and velpatasvir, as well as the new drug voxilaprevir.... Clinical trials showed that 96% to 97% of patients administered Vosevi had no viral detection 12 weeks after treatment, suggesting that the infection had been cured .... Specialty Pharmacy Times

7/19 Behind the Scenes at a Specialty Pharmacy
A health care business model that puts patients first? Dallas-based Senderra shows it's possible .... In just seven years, privately held Senderra has gone from an idea to $750 million in revenue projected for this year.... About 65 percent of Senderra's reimbursements come from medications treating chronic autoimmune diseases such as rheumatoid and psoriatic arthritis, Crohn's disease and plaque psoriasis .... Dallas News

7/19 Brighter Outlook at Alcon
Novartis Points to Early Signs of Rebound at Alcon Eye-Care Unit .... Alcon's revenue in 2017 will likely grow by a low "single-digit" percent .... Bloomberg (autoplay video; interview with CEO Joe Jimenez)

7/19 Specialty Pharmacies Sue Over Reimbursement Cuts; Half Will Go Out of Clotting Factor Business
Lawsuit: New TennCare Rates Endanger Hemophilia Patients .... Pharmacies in Tennessee are accusing the state of breaking federal law and endangering people with bleeding disorders such as hemophilia by reducing reimbursements for prescription blood-clotting drugs through its Medicaid program .... NY Times

7/19 Roche Judged to Have Best Pipeline Through 2022; AstraZeneca and Abbvie Follow
5 Big Pharma Stocks With the Best Drug Pipelines .... Market research firm EvaluatePharma recently released its report looking at the potential value creation from pipeline products between now and 2022 .... Motley Fool

7/19 $800 Million a Year in "Expired" Drugs Tossed; Most Are Still Effective
That Drug Expiration Date May Be More Myth Than Fact .... An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the shelf life extension program — which saved the department from replacing $2.1 billion in expired drugs .... Propublica/NPR

7/19 Learn to Calm Yourself by Playing Video Games
When Children Can Benefit From Playing Videogames .... Children with anxiety and ADHD can learn to control their emotions by playing games connected to a heart-rate monitor .... WSJ $$

7/19 Gottlieb Targets REMS Abuse
FDA moves to increase generic competition .... One initiative takes aim at objections branded drugmakers raise to giving access to their medicines to generic drugmakers working on copies that would bring costs down .... CNBC

7/19 Dr. Fein Explains Proposed 340B Cuts
Understanding CMS's Surprising Reimbursement Cut for 340B Hospitals .... The proposal would reduce patients’ coinsurance obligations.... Manufacturers would not gain from this proposal. CMS designed the proposal to be budget neutral.... The proposal does not address contract pharmacies. .... Drug Channels

7/19 Internet Drug News Fast Takes:
Safeway to pay $3 million to resolve U.S. drug probe
Reuters
Independence Blue Cross cutting some pay rates for doctors
Philly.com
Blood sugar swings tied to depression in elderly with type 2 diabetes
Reuters
Octagam 10% Gains Orphan Drug Status for Rare Muscle, Skin Disorder
MPR
Takeda relocates hundreds of R&D, vaccine jobs and cuts 480 in sales
Fierce Pharma
A New Front in the War Over Reproductive Rights: 'Abortion-Pill Reversal'
NY Times

7/18 Family-Owned Boehringer Ingelheim Operates on a Different Time Scale from Public Companies
This Secretive Clan Wants to Beat the World's Biggest Drugmakers .... The family's attitude limits Boehringer Ingelheim's ability to take risks as it tries to compete with pharma giants in the high-stakes and costly business of developing new drugs.... The company has repeatedly ruled out selling shares in an initial public offering .... BusinessWeek

7/18 340B Proposal Pharma-Friendly; Will Hurt Hospitals
Trump's New Drug-Pricing Move Won't Cut Prices .... The 340B program has issues; it can create market distortions and is costly. But this particular reform won't help many consumers with high drug prices. And it leaves the pharma industry's unfettered pricing power intact .... Bloomberg Gadfly

7/18 Why Do Grocery Stores Have Pharmacies? Because Each New Script is Worth $43 in Other Sales in the Store
Big-Box Pharmacy on the Rise .... Big box retailers are adding more pharmacist jobs than traditional pharmacy chains. And mass merchandisers are paying the highest pharmacy salaries in the industry .... Drug Topics (h/t @DrugChannels)

7/18 Express Scripts Says Some Co.'s Starting to See the Light on Prices
Tough-and-vocal PBM executive Steve Miller says pharma may be coming around on pricing .... Miller said Dupixent/Tymlos/Ocrevus are all examples of drugmakers pricing new therapies lower than the market expected — and a "recognition by certain pharmaceutical manufacturers that they are in control of their price and can do something" about growing costs .... Fierce Pharma

7/18 FDA Application Filed for Luxturna, Gene Therapy for Rare Form of Blindness; Potentially Curative
First gene therapy could hit the market in January .... Spark submitted its Biologics Licensing Application earlier this year and announced the regulatory agency has accepted the approval, as well as granted accelerated approval. Luxturna is a potential one-time treatment — verging on a cure — for a rare genetic form of blindness .... BioPharma Dive

7/18 Neratinib Reduces Risk of HER2+ Breast Cancer Recurrence After Surgery and Herceptin
U.S. FDA approves Puma Biotech's breast cancer treatment .... After two years, 94.2 percent of patients treated with neratinib had not experienced cancer recurrence or death, compared with 91.9 percent of patients receiving a placebo .... Reuters

7/18 Live Online the Go-To CME Trend
Pharma spending on CME rose in 2016 .... The pharmaceutical industry spent more on accredited continuing medical education in 2016 than it did in 2015, with spending hitting $704 million last year, up from $693 million in 2015 — a 1.5% increase .... MM&M

7/18 FDA Head Promises Hiring Spree
FDA's Scott Gottlieb is fielding a new team of recruiters to start scouting top talent .... The FDA has been plagued by hundreds of positions long left open at the agency, making recruitment a key issue for Gottlieb as he navigated his recent confirmation hearing at the Senate .... Endpoints

7/18 Sanofi Sells Vaccine to Bioterrorism Defense Company
Emergent acquires Sanofi smallpox vaccine in deal worth up to $125 million .... Emergent will add the only smallpox vaccine licensed by the Food and Drug Administration to its existing portfolio of medical countermeasures to bioterrorism threats .... Washington Business Journal

7/18 Research Consortium Swears Off Secrecy, Patents to Speed Discovery
Big Pharma Buys Into Crowdsourcing for Drug Discovery .... Members of a nonprofit called the Structural Genomics Consortium are sharing everything with each other — drug wish lists, results in open access journals, and experimental samples — hoping to speed up the long, expensive drug design process for tough diseases .... Wired

7/18 Internet Drug News Fast Takes:
An overdose, a young companion, drug-fueled parties: The secret life of USC med school dean
LA Times
Controlling asthma in pregnancy may help keep disease from kids
Health Day
Artificial Sweeteners Don't Help People Lose Weight, Review Finds
NPR Shots Blog
California Supreme Court: Medical board can examine prescription records without a warrant or subpoena
LA Times
Online tool predicts heart risk in young adults
Reuters Health

7/17 CMS Proposed to Cut 340B Payments; Would Affect Half of US Hospitals
U.S. Proposes Deep Cuts to Some Drug Payments Under Medicare .... Currently, hospitals are reimbursed for 340B drugs at their average sales price, plus 6 percent. The proposed rule would pay average sales price, minus 22.5 percent .... Bloomberg
See also: OPPS Rule Proposes to Reduce Part B Reimbursement for 340B Drugs [John Shakow/King & Spalding] H/T @DrugChannels

7/17 Prior Auth, Step Therapy Killing Duplixent Uptake
Payer hurdles hit dispense rates on Sanofi and Regeneron's eczema blockbuster-to-be Dupixent .... Though early payer negotiations helped deliver a 50% prescription fill rate at first, that figure has since dropped to 40% .... Fierce Pharma

7/17 Novartis Has Biosimilars for Enbrel, Humira, and Remicade on Tap
Novartis stocks drug cabinet with "Big-3" arthritis blockbusters .... Novartis generics unit Sandoz contends having knock-offs of all three big "anti-TNF" drugs against disorders such as psoriasis, rheumatoid arthritis and ankylosing spondolitis will raise its portfolio's allure for cash-strapped health care systems .... Reuters

7/17 Setback for Osteoporois Drug Romosozumab
FDA rejects Amgen's osteoporosis drug romo — another big plus for rival Radius .... The agency wants Amgen to include the data from two late-stage studies — the ARCH study as well as a Phase III in men called the BRIDGE trial, significantly delaying a comeback .... Endpoints

7/17 Pharma Playing Vial Games to Increase Profits
Raising the Dose and Raising the Cost: The Case of Pembrolizumab in Lung Cancer .... Manufacturers have a subtler mechanism by which they can increase the revenue of their product: entering the market at one dose, establishing a per-milligram price, and then increasing the dose .... Journal of the National Cancer Institute

7/17 Namenda + Disease Management Yields Better Outcomes
Drug combined with care program better at reducing Alzheimer's symptoms than drug alone .... Combining a specific care management program with a commonly-prescribed drug for Alzheimer's disease multiplies the medication's ability to improve daily function by about 7.5 times, stalling some of the disease's most damaging effects. .... Medical Xpress

7/17 CAR-T, If Approved: Demand Will Be High; Supply Will Be Slow
Sophie's Choice for Oncologists: Who Gets New Life-Saving Drug .... Because it's a made-to-order treatment that involves re-engineering a patient's cells in a specialized lab, the logistics of getting CAR-T to the thousands of Americans who will be eligible as soon as this year are uniquely daunting. Some blood cancer patients who face imminent death won't get it in time .... Bloomberg

7/17 Kentucky-based US WorldMeds Will Market Xadago in US; 60 Reps to Promote
Parkinson's drug Xadago launches in US .... With the U.S. launch, Xadago is has now broken into the markets of 12 different countries. ....It's the first drug in more than 10 years to be approved stateside for treating Parkinson's disease patients with motor fluctuations .... Biopharma Dive

7/17 Long-term Success for RNAi Hemophilia Drug Fitusiran
Experimental gene-silencing drug from Alnylam and Sanofi shows strong results in hemophilia .... 48 percent of 33 patients in the study have not bled after a median observation period of 11 months.... Before starting the study, patients were reporting a median of 20 bleeding events per year. That number was reduced to 1 following the fitusiran injections .... Stat News

7/17 Internet Drug News Fast Takes:
Legislation in the Works to Loosen Restrictions on Drug, Device Promotions
Bloomberg BNA
Health-care fund manager with 20% gain this year sees good times ahead as FDA becomes 'more accommodating'
Market Watch
Mylan Shareholders Tilt at Executive-Pay Windmill
Bloomberg
Cancer may metastasize without lymph node involvement
National Foundation for Cancer Research
Big-Data Analysis Points Toward New Drug Discovery Method
Technology Networks

J&J's Tremfya approved, further crowding IL-inhibitor market
Biopharma Dive
Insurance giant Anthem takes Insys to court for 'creative, fraudulent, and illegal' opioid promotion scheme
Fierce Pharma
The top 15 highest-paid biopharma executives
Fierce Pharma
White House doubles down on call to fund FDA entirely with industry fees
Endpoints News
Health-care fund manager with 20% gain this year sees good times ahead as FDA becomes 'more accommodating'
MarketWatch

7/17 NY Times: Pharmacy Dispensed Wrong Pill, Pays Patient $2,500
- Rx was for omeprazole, they gave her Diclucan
I Got the Wrong Drug. And a $2,500 Band-Aid.
…  "Just bring it back, and we'll exchange it … After taking another "Omeprazole" to no avail the next day, it occurred to me to look at the container. I saw a female first name, someone else's last name and the name of a drug I'd never heard of … [NY Times]

7/17 Pundits: Trump Drug Price Plan Is A Dud
Trump's New Drug-Pricing Move Won't Cut Priceschange won't directly affect drugmakers. It will instead hit about half of U.S. hospitals. And it will weaken a program the pharma industry dislikes … [Bloomberg Gadfly]

7/17 AZN CEO Not Moving To Teva
- Soriot to remain At AZN, $20 Million signing bonus rumour was fake news
Pascal Soriot looks set to stay as AstraZeneca chief … rebuffing rumours that he was planning a move to rival Israeli drugs giant Teva Pharmaceuticals … Soriot was likely to receive a salary double that of the former chief and earn a bonus on joining of around $20m if he made the switch … [Telegraph UK]
Related: AstraZeneca's silence on CEO helps wipe out 3 billion pounds … [Reuters]
Related: AstraZeneca Stock Surges After Company Confirms Soriot Staying on as CEO … [The Street]
Editor's Note: AZN is silent.  We can only guess.  What happened?  Was Soriot all set to go but AZN offered him more money?  Was Soriot all set to go but AZN threatened him with a lawsuit?    Stay tuned.

7/17 Novartis Set To Displace Pfizer As Worlds #1 Pharma Co
Pfizer Is Set to Lose Its No. 1 Spot Among Drugmakers: Here's Why It Doesn't Matter … there will be a virtual tie five years from now among Pfizer, Novartis, and Roche for the mantle of world's largest drugmaker.  … Novartis should push Pfizer out of the top position by 2022 … [Motley Fool]

7/17 Lilly Squeezes Out A Few More Months Of Exclusivity For Cialis
- Cialis doomsday clock set to ring September 2018
Eleventh Hour Settlement in Cialis Patent Suit Clears Path for Generics … extends its exclusive right to market Cialis … four to 10 months longer than had been expected … In exchange, Lilly is giving up the last 19 months of coverage on a separate patent which had been set to run through April 2020 … [National Law Journal]

7/17 FDA Advisory Panel Supports Biosims For 2 Roche Products
- Herceptin, Avastin
ODAC gives its seal of approval to two more biosimilars … FDA support, coupled with the strong ODAC vote, doesn't guarantee a passing grade for the biosimilars by their BSUFA dates.  … committee voted 17-0 Thursday for Amgen and Allergan's ABP-215, referencing Avastin (bevacizumab) and 16-0 a few hours later for Mylan NV and Biocon Ltd.'s Herceptin (trastuzumab) biosimilar … [BioWorld]

7/17 JNJ Fights To Dismiss Talcum Powder Female Cancer Lawsuits
- Recent Supreme Court decision deriding venue-cherry picking cited
Battle Over Venue for 1,300 Mo. Talc Cases Flares in Wake of 'Bristol-Myers' … 95 percent of the women who've sued in Missouri haven't lived in Missouri, bought or used talcum powder in Missouri or gotten ovarian cancer while in Missouri. … 1,365 women with talcum powder suits because their lawyers have engaged in "blatant forum shopping on a grand scale … [National Law Journal]

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