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5/26 Accelerated Approval: Issues and Suggested Reforms
Accelerated Approval and Expensive Drugs — A Challenging Combination .... Accelerated approval can lead to situations in which private payers may choose not to cover a drug because of high cost and lack of evidence of clinical efficacy, thereby thwarting the pathway's goal of getting potentially important therapies to patients earlier, while major government payers are forced to cover the product, directing substantial tax dollars to drugs not yet shown to have clinical benefit .... NEJM

5/26 CVS Specialty Out, Maxor In for CF Therapies Orkambi and Kalydeco
Is Vertex's Shift From CVS to Maxor the Sign of More Disruption? .... Vertex Pharmaceuticals Inc. is adding Maxor National Pharmacy Services, LLC to its specialty pharmacy network on Aug. 1.... What might be a surprise is that Vertex, maker of cystic fibrosis therapies Orkambi and Kalydeco, is removing CVS Specialty in the manufacturer's network at the same time .... AIS Health

5/26 New Drug Pipeline Unclogged, QuintilesIMS Says
Drug approvals bounce back as R&D labs churn out new winners .... According to QuintilesIMS, which compiles data for the pharmaceutical sector, the robust state of the industry's late-phase R&D pipeline means it is well placed to yield an average of 40 to 45 new launches annually through to 2021 .... Reuters

5/26 Dr. Gottlieb Prescribes Competition for Drug Market
FDA Chief Proposes Rules Changes to Fight High Drug Prices .... The new commissioner of the Food and Drug Administration plans a multifaceted effort to restrain high prescription-drug prices, centered on speeding cheaper generic medicines onto the U.S. market .... WSJ $$

5/26 CRO Mergers Allow Broader Range of Offerings to Pharma Clients
Consolidation in the CRO space a plus for biopharma .... For most pharmaceutical companies, CRO pricing is not a driving factor in choosing which companies to choose for outsourcing research and services. So, changes in costs for CRO services produced by consolidation won't have as large an impact as might be expected .... Biopharma Dive

5/26 First New Drug for Sickle Cell in 20 Years Now Before FDA
Mystery biotech Emmaus grabs groundbreaking FDA panel backing for sickle cell drug — after quietly scrapping $225M deal .... Emmaus Life Sciences won an FDA panel vote favoring an approval by 10-3, setting it on a course for an odds-on approval by the PDUFA date of July 7 .... Endpoints

5/26 No Shortage of Opinions on Biosimilar Rules
FDA Guidance on Biosimilar Substitution Needs Work, Commenters Say .... The FDA needs to clarify its standards for showing a biosimilar drug is interchangeable with the original biologic and how the biosimilar should be named and labeled, commenters said in response to an agency draft guidance .... Bloomberg BNA

5/26 Ibrance Joins Opdivo and Keytruda on DTC TV
Pfizer bows first Ibrance TV spot as Novartis revs up with rival breast cancer med Kisqali .... Pfizer developed the "new normal" ad concept with information gathered from 300 metastatic and early breast cancer patients and caregivers, 200 healthcare providers and 400 general consumers as well as several metastatic breast cancer advocacy groups .... Fierce Pharma

5/26 1 in 2 Women Over the Age of 50 Will Have an Osteoporosis-Related Fracture, and Radius Wants to Be Sure You Know That
Following Tymlos approval, Radius uses Facebook to educate about osteoporosis .... The company launched an unbranded Facebook effort, Fractured Truth, to educate and raise awareness among women in the 50-to-70 age range.... Since its launch the Facebook page has generated 4,400 likes and has had a reach of over 350,000 Facebook users .... MM&M

5/26 New Buzzword to Learn: Outcomes-Based Risk Sharing Agreement
UnitedHealth and Merck strike a deal to explore linking payments to drug performance .... "There's a lot of focus on high-cost specialty areas like oncology, but also in chronic conditions that affect a broad set of the population like diabetes." (Curt Medeiros, president of Optum Life Sciences) .... CNBC

5/26 Internet Drug News Fast Takes:
Copaxone Generics: Who Will Win First Filer Exclusivity?
Regulatory Focus
The FDA cites risk info in letter over Contrave DTC ad
Novel ADHD Med May Make Mornings Easier
Medpage Today
Cannabis Jobs That Require a Life Science Background Are Booming
The lap band for weight loss is a tale of medicine gone wrong

5/25 Alexion's Aggressive Tactics Needed to Sell a $540,000/Year Drug
When the Patient Is a Gold Mine: The Trouble With Rare-Disease Drugs .... With Soliris accounting for almost all its revenue, Alexion has created enormous wealth out of an estimated 11,000 customers. It generated $3 billion in sales in 2016 .... Bloomberg

5/25 Neratinib Gets Panel OK
FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug .... In a big clinical trial, neratinib reduced the rate of breast cancer recurrence within two years by a third--but means that it reduced the absolute number of cases by only about 2 per 100 women. Meanwhile, the drug has side effects: 95% of patients had diarrhea .... Forbes/Matthew Herper

5/25 PML Case: Ocrevus AE or Carry-over from Tysabri?
Deadly brain infection in German MS patient prompts Roche investigation .... A person in Germany treated with Roche's new multiple sclerosis drug Ocrevus has been diagnosed with an often-deadly brain infection after switching from another medication earlier this year .... Reuters

5/25 Good Rundown on How Different Sectors for Pharma Will Be Affected by Gottlieb's Policies
Trump's Quiet on Drug Pricing, But His FDA Isn't .... Trump might just be off the drug pricing warpath temporarily because he has a few other things on his mind. But until he comes back, it makes more sense to watch Gottlieb to gauge the administration's temperature on drug pricing. .... Bloomberg Gadfly

5/25 Ocrevus, Dupixent, Durvalumab, and More: Projected Top Sales Performers for 2021
Top 8 New Drugs to Watch for 2021 .... The top eight drugs that bear watching this year--the ones that are expected to achieve blockbuster sales of more than $1 billion each by 2021--include a medicine for multiple sclerosis and one for eczema .... Drug Topics

5/25 NEJM Report: Epidiolex Cut Seizures in Half for 43% of Severe Childhood Epilepsy Patients
GW to file cannabis drug as journal confirms epilepsy success .... GW is seeking regulatory approval to sell Epidiolex as a treatment for both Dravet and Lennox-Gastaut syndrome, another severe form of epilepsy .... Reuters

5/25 New Twitter Ad Unit
Twitter launches DM cards for brands .... Brands can disseminate the cards via Promoted Tweets or organic sharing. The card can be embedded with image or video creatives and include up to four call-to-action buttons .... MM&M

5/25 Staff Workup on Retacrit is Positive
Pfizer's Epogen biosim scores solid backing from FDA staff ahead of panel review .... If approved, Retacrit would be Pfizer's second biosimilar to win U.S. approval, after Inflectra, a copycat to J&J's immunology med Remicade. And it would be the second biosimilar threat to Amgen, which faces Sandoz' Zarxio .... Fierce Pharma

5/25 J&J Settles 2009 Recall Case
Drugmaker Paying $33M Over Recalled Nonprescription Meds .... The products were recalled for issues including unpleasant smells that nauseated some consumers, tiny metal shards in liquid medicines and wrong ingredient levels. Many products weren't available in stores for several years, and Johnson & Johnson had to raze and rebuild a huge consumer-medicine factory in Fort Washington, Pennsylvania .... NY Times

5/25 Prescription Painkillers Go-To Choice for Docs Seeing Back Pain Patients
Poll: Doctors Are Still Prescribing Lots Of Opioids For Low Back Pain .... When people with back pain do go to a doctor, the treatment most commonly recommended to survey participants was prescription painkillers, at 40 percent .... NPR Health Blog

5/25 Internet Drug News Fast Takes:
Estimated 23 mln would lose health insurance under Republican bill: CBO
Two NEJM Papers Spotlight Promising But Early New Cardio Drugs
Novartis to sever 250 U.S. workers days after announcing 500 cuts in Switzerland
Fierce Pharma
26 patients have died after replacing controller for Abbott blood pump at home
Minneapolis Star-Tribune
Silicon Valley VCs Quietly Hiring Biotech Experts

5/24 Kevzara Approved for RA; 30% Discount to Humira and Enbrel
Sanofi, Regeneron set Kevzara up for tough RA turf battle with $39K list price .... Kevzara (sarilumab) is Sanofi and Regeneron's second entry into the immunology field, after the approval of Dupixent, a treatment for severe eczema.... The two meds--with sales estimates of $1 billion-plus and up to $4 billion, respectively--are key to both companies' top-line futures .... Fierce Pharma

5/24 FDA First: Keytruda Approved for Biomarker Indication, Not Tied to Site of Cancer
FDA clears Merck's Keytruda for cancers with certain genetic traits .... The accelerated approval was for solid tumor cancers not eligible for surgery or that have spread in patients identified as having a biomarker called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) .... Reuters

5/24 Pharma Escapes Meat-Ax in Trump Budget; Medicaid Cut in Half by 2027
Trump Budget Contains Little on Drug Prices Despite Tough Talk .... The budget proposal calls for the FDA to "speed the availability of innovative, safe, and effective medical products in the market," and calls for reducing reporting burdens for drugmakers. Trump would also clear the way for drugmakers to talk to insurers and other payers about treatments before FDA approval, so that they're not caught off guard by any high prices .... Bloomberg (autoplay video)

5/24 Bioverativ Goal: "The Leading Rare Disease Company Focused on Blood Disorders"
Not Resting on Hemophilia Biz, Bioverativ Pays $400M For True North .... Biogen spinoff Bioverativ has acquired True North Therapeutics, a privately held South San Francisco, CA, biotech.... True North's drug is an antibody that blocks a protein called C1s, part of the complement system, a family of proteins in the innate immune system that help antibodies kill bacteria .... Xconomy

5/24 A Look at PBM Contracting Trends
Aetna Sees Evolving Relationship, 'Fundamentally Rethinks' PBM Role .... The number of clients mulling early renewals is increasing and PBMs including Express Scripts and CVS are becoming more aggressive with early contract renewals, sometimes offering new financial terms effective this year versus 2018.... Rebates also have notably increased for the 2018 selling season (Ross Muken, senior managing director and partner at Evercore ISI) .... Health Business Daily

5/24 Amazon as PBM: What Their Playbook Might Look Like
A Reality Check on Amazon's Pharmacy Ambitions .... I would never underestimate Amazon. However, I believe that Amazon has limited feasible options for disrupting pharmacy and PBM markets. (Adam Fein) .... Drug Channels

5/24 Ingrezza Not Effective Against Tourette's in Phase 2
Hard charging Neurocrine hit with a sudden setback as Tourette study flops .... Investigators for the company immediately pinned the blame on what they called ineffective dosing of the drug, vowing to plow ahead with a better design. And they pulled some subset data out of the batch to illustrate their case .... Endpoints

5/24 Pravastatin Questionable for Primary Prevention for Adults 65+
Statin Therapy Found to Be of Little Benefit in Older Adults .... The researchers found no significant difference in coronary heart disease event rates among the two treated and untreated groups of adults 65 and older with hypertension, but without baseline atherosclerotic cardiovascular disease. The hazard ratios for all-cause mortality trended higher in the pravastatin group versus the usual care group .... HealthDay News

5/24 Benralizumab (Asthma) Succeeds, but Bydureon (Diabetes) Does Not Show Heart Benefit
AstraZeneca asthma shot hits goal but diabetes drug lags rival .... AstraZeneca's experimental injection for severe asthma cut substantially the need for patients to take problematic oral steroid drugs in a late-stage study.... [But] Bydureon medicine for diabetes failed to show a hoped-for benefit in reducing heart risks .... Reuters

5/24 Coughs Dropped on Experimental Medicine
New Drug Eases Chronic Cough .... "This drug blocks the neuronal activation, and blocks the cough," investigator Dr Jacky Smith explained. Studies have shown that current drugs, such as dextromethorphan, only reduce cough by about 12%. "We're showing 30% or more." .... Medscape (reg reqd)

5/24 Internet Drug News Fast Takes:
How 3 hospitals are partnering with Google to predict patients' futures
Advisory Board Daily Briefing
Rite Aid's ecommerce platform breached, personal info stolen
Healthcare IT News
Actemra approved for certain blood vessel inflammation
The Next Generation of Episode-Based Payments
Study: DIR fees, MACs are biggest concerns for rural pharmacists
Drug Store News

Legal marijuana sales top revenues for Viagra and Cialis
Palm Beach Post
PhRMA doubles down on R&D but falls short in bid to rein in bad actors
Pharmalot Free Trial
District court decides Eli Lilly must pay $20m over Cialis
Life Sciences Intellectual Property
Merck Seeks OK For $60M Settlement In K-Dur Pay-For-Delay Row
360 Law Free Trial
Nevada Senate Passes Bill to Force Diabetes Drug Manufacturers to Disclose Pricing Practices
The Street
Smart money dumping Teva, Allergan, Valeant
Motley Fool

5/23 Sodium Bicarbonate For Injection Has Hospitals Scrambling
Pundits blame Hospira reorg
- Pfizer working hard to ameliorate bicarb situation; sodium acetate supplies dwindle
A Vital Drug Runs Low, Though Its Base Ingredient Is in Many Kitchens
…  problem had worsened just after Pfizer went from shipping its generic injectable products from five regional warehouses to one national distribution center, part of a reorganization after its acquisition of the drugmaker Hospira … [NY Times]

Amgen, UCB Experimental Bone Drug Linked To Cardiac Safety Problems
- Romosozumab approval unlikely anytime soon; analyst says 50:50 it will ever get approved
- Not a big deal for Amgen but UCB long term prospects in question as Cimzia (certolizumab) faces patent expiry
Amgen's Bone Drug Disappointment Shows Limits Of Genetics In Drug Discovery
… sclerostin, the protein of romosozumab targets, may be involved in the calcification of the arteries … Animal data didn't seem to indicate that romosozumab could lead to heart attacks …[Forbes]
Heart safety clouds hopes for Amgen, UCB bone drug approval … companies did not disclose the nature or severity of the heart-related side effects, but Leerink analyst Geoffrey Porges said he believed romosozumab now had only a 50/50 probability of coming to market … [Reuters]

Bipartisan Push For Medicare Drug Rebates Modeled After Medicaid Rebate Scheme
A Bipartisan Way to Lower Drug Prices … The White House and Democrats agree: The government should demand rebates for drugs sold to poor Medicare beneficiaries … [regarding Medicaid, drug companies] must rebate 23 percent of the average wholesale price of a drug, plus an extra percentage if the drug's price has risen faster than overall inflation …[Bloomberg]

Proposed California Bill: End Speaker Fees, $250 Annual Limit On Food
California may turn off speaking fees and ban pharma gifts … staple of pharma marketing, the slideshow over dinner … Per person, drugmakers could only spend $250 per year on free meals … speaking fees, meals and travel, were two to three times more likely to prescribe branded meds …[Fierce Pharma]
See Also: SB-790 Health care providers: gifts and benefits; California State Assembly Proposed Bill
Editor's Note: Adds information on Vermont, Minnesota and Maine's laws restricting pharma largess.

May 22nd Fast Takes
J&J Plans to Seek Approval for 10 New Drugs by 2021
DOJ sues UnitedHealth over $1B worth of alleged bogus Medicare claims
Beckers Hospital Review
FDA expands approval of Vertex cystic fibrosis drug without clinical trial
Boston Globe
FDA OKs Merck's Keytruda for two new uses in bladder cancer
Seeking Alpha
The top 15 generic drugmakers by 2016 revenue
Fierce Pharma
Diabetes drug metformin shows promise in treating one form of autism
Fierce Pharma

Another Humira Patent Falls, As Expected
- More patents remain; Humira expected to be bulletproof until 2020
- Humira did $16 Billion worldwide last year
Coherus wins Humira patent ruling, chipping away at AbbVie's defenses …  invalidated all claims tied to AbbVie's U.S. Patent 8,889,135 (commonly referred to as the '135 patent), which covered subcutaneous dosing of 40 mg of Humira every 13 to 15 days for treatment of rheumatoid arthritis. … [Biopharma Dive]

JNJ In Last Ditch Effort To Block Samsung Remicade Knockoff
Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy  … lawsuit comes about a month after Samsung said it got U.S. Food and Drug Administration approval to sell its biosimilar of Remicade, which is marketed as Renflexis in the United States …[Reuters]

Orphan Drug Makers Defend Astronomical Price Model
- Expensive but rarely used, not like Hep C pills
No scandal here, say rare disease drugmakers, as pricing scrutiny lands on their doorstep … Rare disease drugmakers, which have historically been better able to justify high prices than their peers, have recently ended up in the hot seat … Pricing focus on orphan disease is a bit out of place snce drug success rates are (much) higher than in non-orphan: …[Fierce Pharma]

HHS Boss: Drugmakers Should Finance FDA 100% With User Fees
HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees … "To ensure the FDA has the critical resources needed to keep pace with this field, the President's Budget Blueprint proposes to increase and restructure the medical product user fee programs at FDA to be 100 percent user fee supported programs… [Regulatory Affairs Professionals …[Regulatory Affairs Professionals]

Gleevec For Severe Asthma
Could Cancer Drug Gleevec Help With Severe Asthma? … Gleevec (imatinib) reduced the "twitchiness" of airways, making them less likely to reflexively constrict when exposed to an allergen or asthma trigger … blocking the signal that helps keep mast cells alive, we were hoping to reduce the number of these cells …[Lincoln Journal Star]

Amazon Beat CVS? Walgreens?  No So Fast; Harder Than You Think
- Analysts point out hurdles Amazon needs to overcome
Why It Would be Tough for Amazon to Beat CVS and Walgreens … Amazon "would face major infrastructure, payer and regulatory hurdles … hard for Amazon to get wider discounts on generic drugs than the current players … Mail order penetration has been flat to slightly down over the past five years. …[Barrons]

House Acts To Limit Single Source Price Gouging
House committee adds pharma 'bad actor' provision to FDA user fee bill … aiming to curb abusive drug pricing on pharmaceuticals without generic competition … six-month exclusive rights period generic manufacturers who choose to compete against an off-patent drug that currently has no competition …[Modern Healthcare]

5/19 WSJ Rehashes the Case Against Eteplirsen
How the FDA Approved a $300,000-a-Year Drug Its Own Experts Didn't Believe Worked .... After trial data for a new medicine proved inconclusive, Sarepta Therapeutics joined with the parents of sick boys to persuade officials it helped .... WSJ

5/19 NVS Overhauls Swiss R&D Unit
Novartis is sending 500 jobs to the scrap heap while adding 350 'high-tech' positions for growth .... You can file this latest round of cuts and growth to a decision the company made last year to improve operations and increase efficiency .... Endpoints

5/19 Price Blows Up User Fee Agreements
HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees .... Secretary of Health and Human Services Tom Price is continuing to push the Senate to further increase the industry fees paid to the US FDA, which would upend the agreed-to amounts negotiated by FDA and industry for the next five years .... Regulatory Focus

5/19 A Novel Way to Promote Your Drug — Get It Written into a Soap Opera Story Line
How a drug ad made its way into 'General Hospital' .... Incyte's move to bake a disease-awareness campaign into a TV show looks to be an industry first... [An industry expert thinks] it's a clever way to educate the public about a serious disease .... Stat

5/19 Growth of 340B Accelerating
The 340B Program Hits $16.2 Billion in 2016; Now 5% of U.S. Drug Market .... The compound average growth rate (CAGR) was below 11% from 2007 to 2013. Since then, however, the CAGR has been an amazing 31%! .... Drug Channels

5/19 Now Comes the Hard Part — Value-Based Deals Rely on Patient Adherence
Can value-based deals work if patients don't take the drug? .... Deals tying adherence to payment, though, have motivated some payers to develop more innovative approaches to identify which patients are most likely to be non-adherent.... Express Scripts was able to achieve a 92% adherence rate for patients receiving Viekira Pak through its Accredo Pharmacy using predictive modeling, and therefore paid out few of the guarantees .... Biopharma Dive

5/19 Biopharma Execs: Even More Pricing Pressure from Politicians than Payers
What keeps 88% of biopharma executives up at night? One guess, and it's pricing .... Executives appear to be expecting the biggest [price containment] moves in cancer drugs, with 28% of respondents pegging oncology as the field at highest risk — but 21% saw oncology as the lowest-risk field .... Fierce Pharma

5/19 Docs More Comfortable with Third-party HCP-facing Sites than Pharma Sites
One-third of docs trust pharma content on HCP sites .... Seventy percent of physicians said it's crucial for drugmakers to provide educational resources rooted in science to gain their trust, yet half of them agree that no drugmakers are providing quality scientific online .... MM&M

5/19 PPI:CKD Link?
Do Best-Selling Drugs That Calm Stomachs Damage Kidneys? The Answer's Unclear. .... Recent research has linked the proton pump inhibitors to serious side effects, including chronic kidney disease, and recently filed lawsuits allege that the manufacturers should have known of their potential harms. The risk of chronic kidney disease is as much as 50 percent higher in people who've taken the drug compared with those who've not .... Kaiser Health News

5/19 Audit Finds Medicare and Medicaid Improper Payment Rates Exceed 10%
Are CMS Improper Payment Rates Too High? .... The Medicare fee-for-service improper payment rate was above 10 percent in FY 2016, and the Medicare Advantage program failed to meet an improper payment rate target .... Bloomberg BNA

5/19 Internet Drug News Fast Takes:
Investor Jim Chanos slams Express Scripts and Mallinckrodt over high drug prices
What's your risk of developing an autoimmune disease? Your EHR might hold the answer
Advisory Board Daily Briefing
House May Be Forced to Vote Again on GOP's Obamacare Repeal Bill
Patients may fare worse when treated by older doctors
Fierce Healthcare
Pharma's Not So Stingy With R&D After All
Forbes/Frank David

5/18 Amazon Looking for a Piece of the $300 Billion Pharmacy Business
Amazon is hiring people to break into the multibillion-dollar pharmacy market .... The company hired Mark Lyons two months ago from Premera Blue Cross. Lyons is tasked with building an internal pharmacy benefits manager for Amazon employees, which might be later scaled out .... CNBC (autoplay video)
See also: Amazon's Long Shadow Falls on Pharmacies [Bloomberg]

5/18 Pols, Health Groups Furious Over Exclusive Deal for SNY on Vaccine
Sanofi rejects US Army request for 'fair' pricing for a Zika vaccine .... "American taxpayers have already spent more than $1 billion on Zika research and prevention efforts, including millions to develop this vaccine. Americans should not be forced to pay the highest prices in the world for a critical vaccine we paid to help develop." (Sen. Bernie Sanders) .... Stat

5/18 Bills in 30 State Legislatures to Regulate/Influence Drug Prices
As States Wage Battles on High Drug Prices, Drugmakers Fight Back .... The industry fought hard against state drug-price bills in 2015 and 2016 — and was mostly victorious. Several states considered bills requiring drugmakers to disclose their research and other costs to justify price increases, but only Vermont enacted one last year .... WSJ

5/18 "Remyelination" — Repairing the Protective Sheath Around Nerve Cells — New Roche MS Push
Roche Seeks to Mend Damaged Nerves in Multiple Sclerosis Push .... In remyelination, Roche will have to catch up with Biogen, which is already conducting human tests on its drug candidate. .... Bloomberg

5/18 'Big Data' Prescription/Medical Record Integration Reveals Trends, Off-Label Uses, Errors
MedAware's script-error tool for docs could help marketers plenty, too .... The company has aggregated millions of prescriptions and full medical records — including blood tests, diagnoses, admissions, outpatient visits and more — to create mathematical models that describe which patients are likely to be prescribed which drugs, and at what point in their condition and treatment .... FiercePharma

5/18 J&J Business Review Meeting
J&J claims higher R&D productivity than peers .... J&J's Janssen unit is expected to submit or launch around 14 new drugs between now and 2021, with more than 10 having potential blockbuster status .... Biopharma Dive

5/18 FDA Inspectors Will Specialize by Product Area, Not Region
New FDA Commissioner Gottlieb Reorganizing Inspection Staff .... Workers in the FDA's Office of Regulatory Affairs will begin focusing on overseeing specific product areas -- such as pharmaceuticals or medical devices -- rather than activities in their U.S. geographic regions .... Bloomberg

ASCO Abstract Releases

5/18 36% of Advanced Bladder Cancer Patients Alive at 18 Months on Keytruda vs. 20.5% on Chemo
Merck says test shows Keytruda improves survival for bladder cancer patients .... Data from an open-label Phase 3 trial of 542 advanced bladder cancer patients showed median survival of 10.3 months for Keytruda patients and 7.4 months for patients given second-line chemotherapy .... Reuters

5/18 Combo of Two Immunotherapy Drugs Brings Significant Tumor Shrinkage
Merck, Incyte immunotherapy combination effective in lung cancer study .... Fourteen of 40, or 35 percent, of patients with advanced non-small cell lung cancer who received Keytruda and Incyte's epacadostat experienced tumor shrinkage of at least 30 percent. That is nearly double the overall response rate of about 18-20 percent seen with Keytruda alone .... Reuters

5/18 HPV-Vaccinated Have Next to Nil Chance of Getting Oral Infection
HPV vaccine may reduce oral infections by as much as 88 percent .... At the time of the study, about 18.3 percent of young adults in the U.S. reported receiving one or more vaccine dose by age 26, with vaccination more common in women than men, 29.2 percent versus 6.9 percent, respectively .... MD Anderson

5/18 Internet Drug News Fast Takes:
Obamacare Helped Americans Detect Cancer Earlier
FDA shoves Bayer's lymphoma drug copanlisib into the spotlight with its promise of a speedy review
Bluebird, Kite and Juno Delivering CAR-T Cancer Study Updates to ASCO '17 Meeting
The Street
FDA expands approval of Vertex cystic fibrosis drug
Boston Globe
Express Scripts to acquire myMatrixx
Drug Store News

5/17 Deep Dive in CRLs; Special Focus on Manufacturing Issues
The complete response letter: The mail no one wants to receive .... Responding to and fixing manufacturing problems cited in a CRL and underlying warning letter can take time, and FDA may spend up to six months reviewing a resubmitted application.... The average resolution took 17 months .... Chemical & Engineering News

5/17 Invokana Gets Black Box on Amputation Risk
FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label .... FDA noted final results from two clinical trials – CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo .... Regulatory Focus

5/17 Gottlieb Expected to Streamline Approvals for Generics and Biosimilars
Taking office, Gottlieb keeps drug pricing front and center .... Gottlieb has been outspoken about his desire to see generic drugs approved more rapidly, and has written frequently on the topic prior to being appointed FDA Commissioner .... Biopharma Dive

5/17 County Government Lawsuit Claims Painkiller Makers Misled on Dangers
New York county sues Purdue, J&J over opioid marketing .... Orange County, which has a population of about 379,000, said it recorded 943 opioid-related emergency department admissions in 2014 and 44 deaths from overdoses involving opioid pain relievers in 2015 .... Reuters

5/17 If You Need an 11-page Manifesto Against PBMs, We Have You Covered
The Economic Costs of Pharmacy Benefit Managers .... Due to their government sponsored "near-monopoly" position, PBMs can charge fees that are high and retrospective. The retrospective fees, such as the direct and indirect remuneration fees (DIR), are particularly problematic as they "claw back" revenues from pharmacies based on sales that were made months earlier. .... Pacific Research Institute

5/17 Inside Inside Rx
Five Fun Facts About the New Express Scripts-GoodRx Drug Discount Partnership .... Inside Rx enables the eight participating manufacturers to offer the advantage of rebates to uninsured patients. Consequently, manufacturers gain new volume from prescriptions that otherwise would have been abandoned .... Drug Channels

5/17 Teva, Mylan, Novartis Top Generics Makers
The top 15 generic drugmakers by 2016 revenue .... Life science commercial intelligence firm Evaluate recently predicted that generics will continue on a steady growth path to $115 billion in 2022, up from $80 billion in 2016 .... Fierce Pharma

5/17 Former FDA Head Wants Agency to Set the Rules for Off-Label Promotion
Califf calls for marketers to develop off-label 'code of ethics' .... Califf doesn't necessarily agree that expanding the ability of drugmakers to engage in off-label promotion is a good thing. "I haven't seen a whole lot of good come from real off-label promotion.... you can look at 100 experiences and pick 5 that look good." .... MM&M

5/17 Maybe Worth a Click
A report on the changing dynamics affecting drugs over their lifetime .... This report tracks the changing dynamics affecting drugs throughout their lifetime during the past 15 years .... Stat/Quintiles (must give contact info to download)

5/17 Consumer Reports: 25% Pay More For Same Drug Compared to a Year Ago
Rx patients hit with higher out-of-pocket costs .... Of respondents reporting that they pay more out of pocket, 24% said they forked over $50 or more for a single prescription this year than for the same prescription a year earlier .... Chain Drug Review

5/17 Internet Drug News Fast Takes:
FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support
Health Affairs
With Latest Deal, Biogen Bets $120M on Remedy Pharma Stroke Drug
Hepatitis C infections nearly tripled between 2010 and 2015, CDC says
Advisory Board Daily Briefing
CVS's Omnicare to pay $8 million to settle U.S. probe
This cash-strapped hospital's last resort: GoFundMe
Advisory Board Daily Briefing

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This site is published and webmastered by Corey Nahman, Registered pharmacist in the Sate of New York.
2.  Complementarity
Let it be known that the information provided on this site is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.
3.  Privacy.
We respect the privacy of the users of this site.  Please see our plain English privacy policy.
4. Attribution
At all times, the information on this site shall be footnoted with the source(s) of published information, date and medical and health pages provided.
5.  Justifiability
This site shall at all times back up claims relating to benefits and performance.
6  Transparency
This site shall at all times use accessible presentation, you can e-mail the publisher of this site at his personal e-mail address at any time.
7.  Financial disclosure
This site is supported by click advertisements, banner advertisements and affiliate arrangements.  All ads are properly labeled as such.  If you have any questions regarding how we make money please e-mail the webmaster with your questions.  All advertisements shall be clearly distinguished from content.

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