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Pharmaceutical News Harvest (TM)

2/21 Fast Takes
Mylan ordered by Tax Court judge to release documents to IRS
Endo Issues Recall for One Lot of Edex® (alprostadil for injection)
Endo Press Release
Former Valeant and Philidor executives plead not guilty in $40 Million fraud scheme
Merck drug prevents serious infection after marrow transplant: study

2/27 Pfizer Joins Long List Of Drugmakers Investigated For Patient Assistance Charity
Pfizer Subpoenaed in DOJ Investigation of Drugmaker Charity Connections …Patient Access Network Foundation and other organizations  … charities that help Medicare patients afford co-payments for drugs … … [Bloomberg]

Group: Pharma Uses Influential Thinkers To Secretly Promote Narratives
Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs … As it readies for battle with President Trump , the pharmaceutical industry is deploying economists and health care experts from the nation's top universities. … they lend their prestige to the lobbying blitz, without always disclosing their corporate ties … [ProPublica]

As World Runs Out Of Hep C Patients, Merck Takes $3 Billion Hit
- Nobody will ever match Gilead anyway
With hep C franchises languishing, Merck's MK-3682 goes from blockbuster to bomb … [Endpoints News]
Merck swallows $2.9B write-down of experimental hep C drug as market plummets … population of treatable patients has been diminishing rapidly since the market leader, Gilead, turned what was once a chronic disease into a curable …[Fierce Pharma]

Kids' Liquid Drugs Are Crazy More Expensive Than Tablet Version Of Same Med
Newer liquid versions of children's meds greatly exceed costs of older tablets …  used for treating pediatric hypertension in children six years of age and older, costs 775 times more than a 10-mg generic tablet …[Pharmalot]

New Questions Regarding Roche Hemophilia Drug
Patient death in phase 3 raises doubts about safety of Roche's potential hemophilia blockbuster emicizumab …  investigator ruled the death was unrelated to emicizumab, but, with the event following on from other reports of similar serious adverse reactions … [Fierce Pharma]

Pradaxa Superior to Warfarin in "Real World" Study
Pradaxa Superior to Warfarin in "Real World" Study … Compared with warfarin, dabigatran was associated with a 26% reduced risk of stroke (hazard ratio [HR], 0.74) and a 20% reduced risk of major bleeding  … [Managed Care Mag]

Gilead Gets A Great Deal A Fast Pass Priority Voucher
- Remember the company with the notorious $90K Corticosteroid pill?  They're  $125 Million Richer Today
Gilead buys Priority Review Voucher from Sarepta … Sanofi bought the first available PRV in 2014 for $67 million and later bought another one for $245 million. In 2015 AbbVie paid $350 million for its own fast-forward card … [Chemical & Engineering News]

Allergan CEO Wants To Deal Directly With The Donald Regarding Price Negations
- 47 year-old exec Brent Saunders (not related to Bernie) has bloggable ideas
Allergan CEO Pushes for Trump to Lead Drug Price Discussions … Voluntary agreements that restrain prices are "a very practical solution that doesn't, in my view, do anything to impede innovation … Asked about a targeted amount under restraint agreements, he said low single digits …[Bloomberg]

Patent Expiry Of One Means DTC Dies For The Entire Class
The Demise Of The Erectile Dysfunction TV Ads … Why promote a brand name drug in the face of generics? You would just help drive sales of the cheaper generic forms …[Forbes]

2/23 Zykadia Advances for ALK-Positive Lung Cancer; May Get First-Line
Novartis cancer drug Zykadia gets FDA priority review .... Novartis had said in December that Zykadia was twice as effective as chemotherapy in slowing the progression of the rare form of lung cancer in a late-stage study .... Reuters

2/23 Once Established, Ineffective Treatments Are Difficult to Root Out
When Evidence Says No, but Doctors Say Yes .... Long after research contradicts common medical practices, patients continue to demand them and physicians continue to deliver. The result is an epidemic of unnecessary and unhelpful treatments .... The Atlantic

2/23 Letermovir Reduces All-Cause Mortality After Bone Marrow Transplant; 16% —> 10%
Merck drug prevents serious infection after marrow transplant .... In the study of 495 patients aged 18 and older who underwent bone marrow transplants, 37.5 percent who received either oral or intravenous letermovir developed clinically significant CMV infections by 24 weeks after the procedure. That compared with 60.6 percent of those who received a placebo .... Reuters

2/23 A Date With BMY Turns Sour Once the Check Arrives
Is anyone really shopping for Bristol-Myers? .... Even after the company's market cap took a $30 billion hit due to the failed trial results in first-line lung cancer last summer, the pharma is still worth upwards of $90 billion. Acquiring Bristol-Myers would mean paying a hefty pricetag, which is why only the largest pharmas were suggested as possibly being interested .... BioPharma Dive

2/23 Wild West Prevails in Programmatic Ad Market, Any Ol' Thing Gets Sent Down the Wire
Almost one-third of programmatic ads violate IAB guidelines .... The report identifies four major issues of the 28% that were found to abuse IAB's standards: they are oversized, over-requested, processor-intensive, and are not SSL encrypted .... MM&M

2/23 Who's Who in Specialty Pharmacy
The Top 15 Specialty Pharmacies of 2016 .... The two largest PBMs — Express Scripts and CVS Health — remain the largest participants in the specialty pharmacy market. The top five companies account for about two-thirds of prescription revenues from pharmacy-dispensed specialty drugs .... Drug Channels/Adam Fein

2/23 Up to a Third of Antidepressants Used for Pain, Insomnia, or Migraine
Off-Label Antidepressant Use Common, but Evidence Lacking .... Trazodone for insomnia was the most common off-label use for antidepressants.... As a class, tricyclic antidepressants like amitriptyline were the most likely to be prescribed off-label .... HealthDay News

2/23 VRX Team Makes Smooth Move to Synergy
Mass rep exodus at Valeant could seriously thwart its GI plans .... Rumors are swirling that more than 50 GI reps have left the embattled pharma "en masse" to join Synergy Pharmaceuticals, which won FDA approval last month for constipation med Trulance .... Fierce Pharma

2/23 Oral Ozanimod for MS Hyped as Future Blockuster
Here's Why Celgene's Latest Drug Is So Exciting .... Gilenya is a non-selective S1P drug, but ozanimod specifically interacts only with S1P1 and S1P5. That increased selectivity is important, because its appears to make ozanimod safer than Gilenya .... Motley Fool
See also: Oral Ozanimod Shows Efficacy, Safety in Phase 3 Relapsing MS Trial [PTCommunity]

2/24 Internet Drug News Fast Takes:
New FDA "Intended Use" Labeling Rule Causes Industry Convulsions
Orthopedics This Week
Drugs vanish at some VA hospitals
Physician-rating websites don't provide meaningful information
Fierce Healthcare
Medford's Seventh Sense wins narrow FDA approval for blood-collection device
Boston Business Journal
FDA urged to let abortion pill be sold at pharmacies
Minneapolis Star-Tribune
Walgreens designates more than 50 specialty pharmacies as cancer-specialized centers
Drug Store News
People who sleep longer twice as likely to develop dementia
Medical News Today

2/23 New Pay-for-Performance Deals for Forteo and Enbrel
Harvard Pilgrim expands use of novel drug purchasing deals .... The two-year Enbrel contract is based on an algorithm that includes six criteria, including how well patients comply with their prescription instructions.... The insurer will pay less for Forteo over time if patients take it for the required two years .... Boston Globe

2/23 Cancer Cost Burden Worst for Pre Medicare-Age Patients
Many U.S. cancer patients struggle to afford life-saving medications .... 32 percent of the patients recently diagnosed with cancer and 28 percent of people with any past history of cancer reported a change in their prescription drug use due to financial concerns. Among people with no history of cancer, 21 percent changed their medications because of money considerations .... Reuters

2/23 Facebook Campaign Generates 271,000 Downloads and 98,000 Website Visitors
How VAYA Pharma used Facebook ads for its ADHD campaign .... The campaign used a two-fold approach: Facebook link ads and Facebook Audience Network. The Facebook link ads were designed to optimize towards link clicks. The Facebook Audience Network, on the other hand, was an ad placement to boost scale against a niche targeting group and optimize towards download actions .... MM&M

2/23 Testosterone: May Help with Bone Strength and Anemia, But Not Memory
Testosterone Gel Shows No Benefit for Older Men's Memories .... Testosterone had no effect on memory or mental function, based on tests given before, halfway and at the end of treatment to nearly 500 men with age-related memory decline .... NY Times

2/23 Pfizer Cancer Treatment Gets Priority Review
FDA grants priority review to inotuzumab ozogamicin for ALL .... Inotuzumab ozogamicin (CMC-544, Pfizer) is an investigational antibody–drug conjugate comprised of a monoclonal antibody that targets CD22 — a cell surface antigen expressed on approximately 90% of B-cell malignancies — linked to the cytotoxic agent calicheamicin .... Healio

2/23 Tau Protein Might Reveal Football Players' Chronic Traumatic Encephalopathy
A biomarker could tackle one of worst diseases in sports .... Data published in 2016 from Boston University's DETECT study, a preclinical trial of 78 former NFL players, found those players had higher levels of plasma exosomal tau than a control group, and that the higher levels also correlated with poorer performances on memory tests .... BioPharma Dive

2/23 Crowd-Source Compiles Patient Ratings and Experiences with Different Meds
'Iodine' Pools Thousands of Reviews To Help End The Pain Of Finding Medication .... Based on thousands of real-life reviews covering hundreds of drugs, the tool offers insights on what patients may expect and look for when exploring their treatment options .... Forbes/Janet Burns

Sample Iodine screen:

Screen Shot 2017-02-22 at 5.40.56 PM

2/23 Gilead, Straight From the Top
3 Things Gilead Sciences' CEO Just Said That You'll Want to Know .... Gilead Sciences' CEO talks about HCV challenges, HIV rivals, and the possibility of acquisitions .... Motley Fool

2/23 Medicare Out-of-Pocket Cost for Revlimid: $11,538/Year.
Celgene Key Executive Compensation 2014–2015: $100+ Million

New patient group focuses on drug prices amid bipartisan concern .... The organization Patients for Affordable Drugs launched a campaign to share the stories of Americans who struggle to cover the cost of their prescriptions and who are hoping to find a solution to lower drug prices .... USA Today

2/23 Patient-Reported Outcomes Tools to be Used for Data Collection on Phones and Tablets
Icon to validate PROs as measurement of clinical endpoints for the FDA .... The PRO instruments the CRO will help validate this time are used in trials of drugs treating acute bacterial skin and skin structure infections (ABSSSI), and bacterial pneumonia acquired either in community or healthcare settings .... Fierce Biotech

2/23 Internet Drug News Fast Takes:
Online treatment reduces chronic knee pain from arthritis
Bayer Hints at Delay on Monsanto as Regulators Seek Details
Dentists are feeling a sharp pain, thanks to Delta Dental
Boston Globe
Just say 'No'—it's how your most successful colleagues get ahead
Advisory Board Daily Briefing
North Korean Biotech Institute Allegedly Involved in the Killing of Leader Kim Jong-Un's Half Brother

2/22 No New FDA Commish Pick Yet, But a Look at Reforms that Are Needed and Likely
An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months? .... Even if he doesn't get the tap, Gottlieb has laid out agency reforms that will likely figure prominently at the FDA over the next four years; a middle way between anarchy and a brittle, bureaucratic status quo, revising but not dismantling the agency's insistence that any new drug that hits the markets has a clear risk/benefit profile for physicians and patients .... Endpoints

2/22 Interchangeability Standard for Biosims Sets High Bar
From Similar To Same: Why Few Biosimilar Companies May Use FDA's Proposed Interchangeability Pathway .... Unless payers or physicians associate interchangeability with higher quality or safety, the interchangeability designation might not be valuable for drugs dispensed in hospitals and physicians' offices, where decisions by group purchasing organizations or PBMs and formulary committees will determine which biologics patients receive .... Biocentury

2/22 8 Baby Deaths, 370+ Reported Adverse Events from Homeopathic Teething Product
Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years .... A review of FDA records obtained by STAT under the Freedom of Information Act paints a far grimmer picture: Babies who were given Hyland's teething products turned blue and died. Babies had repeated seizures. Babies became delirious. .... Stat News

2/22 Post-marketing Studies Don't Seem to Find Problems
Company-funded studies of approved drugs may not catch safety issues .... Even if post-marketing studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients to learn about safety issues .... Reuters

2/22 Sarepta Promises Use PRV Sale for DMD Research; More Vouchers Coming Under 21stCC
Sarepta Sells Priority Review Voucher for $125M to Gilead .... This is the third PRV Gilead has purchased after buying PaxVax's PRV last summer for about $200 million and Knight Therapeutics' PRV in 2014 for $125 million, which Gilead used to gain approval for its HIV drug Odefsey .... Regulatory Focus

2/22 Intranasal Naloxone Gets 'No'
FDA rejects Amphastar's nasal opioid overdose treatment .... The FDA's complete response letter identifies issues with user human factors study - which is designed to evaluate the user interface of a product - among others .... Reuters

2/22 Sharks Circling BMY
Bristol-Myers Buys Back Shares, Shuffles Board .... Bristol-Myers Squibb on Tuesday added three new directors to its board and announced a $2 billion fast-tracked share buyback program .... The Street (Autoplay video)

2/22 WebMD Numbers Down, Looking for an Exit
WebMD considers sale or merger .... WebMD now expects a faster decline in the growth of pharma advertising in 2017 than it had originally anticipated. The WebMD network, which operates sites including WebMD, Medscape, MedicineNet, and eMedicine, reported that its biopharma advertising sales came in $20 million lower in the last few weeks of the fourth quarter of 2016 .... MM&M
See also: Why A Walgreens Bid For WebMD Makes Some Sense [Forbes/Bruce Japsen]

2/22 Copaxone 40 mg, Cialis, Viagra, and Velcade … $10 Billion+ in Sales Losing Exclusivity this Year
Top 10 U.S. patent losses of 2017 .... When generics make it to market, branded drugs lose up to 90% of their sales.... Drugs that face just one or two copycats at first under Hatch-Waxman Act first-to-file rules will have a six-month scrimmage before the real competition—and real pricing battle—begins against multiple generics. At that point, small-molecule meds typically face copycats that are 80% to 85% cheaper than the originals .... Fierce Pharma

2/22 Head-to-Head Matchup Looms for Inflectra vs. Remicade
Pfizer's new Inflectra biosim data puts J&J's Remicade on notice in Crohn's .... Inflectra made its stateside debut at a list price 15% lower than the brand, Pfizer said; negotiations with payers may have yielded further discounts .... Fierce Pharma

2/22 Internet Drug News Fast Takes:
Orphan drugs face criticism on prices — and from patients
If you need a primer on the drug approval process: Here's how drugs are approved today
Business Insider
Obamacare launched a new wave of startups. Now they're bracing for what's next.
St. Louis Post Dispatch
Can Craig Venter Cheat Death?
Forbes/Matthew Herper
Likelihood of dieting success lies within your tweets
Georgia Institute of Technology

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