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Pharmaceutical News Harvest (TM)

Samsung Bioepis receives final European approval for its Remicade copy
FDA issues complete response letter for AstraZeneca's filing of ZS-9 for hyperkalaemia
First Word
Intercept Wins FDA Approval for  Ocaliva, (obeticholic acid) Drug to Treat Liver Disease
Feds Subpoena Sun Pharma Over Doxycycline Pricing

5/31 AZN Has Largest Late Stage Pipeline with 35; JNJ in 2nd Place With 31
- Find out which Big Pharmas have large late-stage pipelines
Bet You Can't Guess Which of These 10 Big Pharma Names Has the Largest Late-Stage Pipeline … Phase 3 data is the bread and butter of all drugmaker catalysts … If you're looking for a Big Pharma stock that could potentially surprise in the coming quarters, then AstraZeneca might be a name you'll want to consider. …[Motley Fool]

FDA Approves Once-Monthly Injection Zinbryta To Treat Multiple Sclerosis
Biogen, AbbVie once-monthly MS injection wins U.S. approval  … used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions … [FDA]

Medivation: Sanofi's Poor Track Record In Oncology Means It's Clueless Regarding Value
- Statement mocks Sanofi's  ability to run an oncology business
Medivation Fires Back Following Sanofi's Board Proposal … Sanofi's track record in oncology raises serious concerns about its understanding of the value of Medivation's business … "Sanofi's lack of recent success in oncology, and the significant deterioration of its oncology franchise, suggest that it is not well-suited to evaluate or realize the significant opportunities associated with Medivation's  …[The Street]

Bacteria Resistant To Antibiotic Of Last Resort: Medical Establishment Concerned
U.S. sees first case of bacteria resistant to last-resort antibiotic … end of the road for antibiotics unless we act urgently … This heralds the emergence of truly pan-drug resistant bacteria … superbug could pose serious danger for routine infections if it spreads …[Reuters]

Feds Probe Pharma Relationship With Copay Assistance Charities
Does participation violate anti-kickback statutes?
Feds ask Gilead, Biogen, Jazz for info on ties to charities …  their support means patients continue to take expensive drugs instead of less expensive alternatives … not allowed to give direct copay help to patients who get treatments paid for by Medicare because that would be deemed a kickback … [Fierce Pharma]

Experts Predict Insulin + GLP1 Combo Shots To Have Slow Uptake
- Predict Novo product will have better label
Upcoming Novo, Sanofi combo meds eye $6B-plus market, but launches could be slow …  both drugs will face marketing challenges … expects Novo to price the combo product at $25 to $30 per day …  Payers have been more reluctant to give combination products favorable spots on recent formularies …[Fierce Pharma]

Lawmakers Accuse Obama Administration Of Delaying Off Label Guidelines
Lawmakers accuse HHS of delaying FDA guidelines for off-label marketing …unless the FDA acts, we'll have federal judges making these decisions for us. That's not good for the FDA or the public health." …  "perplexed" the FDA has not yet issued new guidelines covering off-label marketing or held a promised meeting …[Pharmalot]

5/27 FDA Approves Probuphine Implant; Expected Cost About $6000
First Implant to Treat Opioid Addiction Gets FDA Approval .... Titan and Braeburn's implant is limited to patients who are stable taking 8 milligrams or less per day of buprenorphine (about 47% of users).... Doctors who want to prescribe the Probuphine implant to patients must take a four-hour training program that includes practice implanting the device .... Bloomberg
See also: FDA Approves New Arm Implant to Treat Opioid Dependence [WSJ]

5/27 Megalodon Bug Sighted
U.S. sees first case of bacteria resistant to all antibiotics .... The superbug itself had first been infected with a tiny piece of DNA called a plasmid, which passed along a gene called mcr-1 that confers resistance to colistin .... Reuters

5/27 Pharma TV Ad Spending Up 20% in 2015, And is Up 20% YTD in 2016
Pharmaceuticals are the hottest thing in TV ads .... There's growing evidence that digital spending is shifting back to TV.... national TV ad growth accelerated to about 5% in the fourth quarter of 2015 and the first quarter of 2016, driven in particular by the strengthening economy .... Yahoo Finance

5/27 Cigna Focus on Opioids
How One Insurer Plans to Cut Customers' Opioid Use By 25% in 3 Years .... The company will be screening for patients who are on particularly high-dose opioid regimens that last more than 21 days, or those who are prescribed a combination of drugs that might make them more vulnerable to addiction .... Fortune

5/27 FDA and Flatiron Getting Big Picture Overview of Immunotherapy
FDA and Flatiron Health collaborate on cancer research .... The new initiative will focus on gleaning insights into the care and treatment of patients with advanced non-small cell lung cancer .... Healthcare IT News

5/27 Two Out of Three Non-Depression Prescriptions for an Off-Label Purpose
Many Antidepressant Scripts Written for Off-Label Purpose .... Other illnesses treated with antidepressants included: anxiety disorders (18.5 percent); insomnia (10.2 percent); chronic pain (6.1 percent); and panic disorders (4.1 percent) .... HealthDay News

5/27 Some of These Execs Earned More in Two Days than You Did All Year
Paycheck envy? Check out how much pharma and health care CEOs made last year .... Here are the top 20 earners in the health care field, from the AP and Equilar, which analyzed CEO pay at hundreds of companies on the S&P 500 .... Stat News

5/27 "Use Two of Our $100,000 Cancer Drugs, Get the Third for $50,000" ... or Something Like That, According to Pfizer Exec
Pfizer Offers Hope For Lower-Priced Cancer Drug Combos .... Will healthcare systems truly be able to afford paying drug expenses on the order of $300,000 or more annually for all of their cancer patients who survive for decades? Earlier this week, one drug company signaled that they are considering a much more conservative and responsible position. .... Forbes/John LaMattina

5/27 A Medical Decision-Making Expert Runs the Numbers on Lucentis and Avastin
An Easy (But Politically Complicated) Way To Save Billions Of Dollars On Medical Care .... The price of some macular degeneration treatments is staggeringly high, and both doctors and the pharmaceutical company making the treatments are motivated to keep it that way. If we as a country want to forestall blindness in people like my wife, without going bankrupt in the process, we need to pressure our government to do some hardball negotiating .... Forbes/Peter Ubel

5/27 No One is Checking if Surrogate Endpoints Are Really Meaningful
Surrogate endpoints poor proxy for survival in cancer drug approval process .... The authors could not find any formal analyses of the strength of the surrogate-survival correlation for 14 drugs (56 percent) that received accelerated approval and 11 drugs (37 percent), which received traditional approval .... Mayo Clinic

5/27 Only About One Third of Americans Would Be Likely to Participate in a Clinical Trial
Many Americans Have Reservations About Clinical Trials .... Many clinical trials are available to patients in the earliest phases of treatment, but 56 percent of doctors said they considered clinical trials for patients only late in treatment. Twenty-eight percent said they considered clinical trials "a treatment of last resort." .... HealthDay News

5/27 ZS-9 Gets CRL on Manufacturing Issues
AstraZeneca's $2.7B hyperkalemia drug ZS-9 rejected by FDA .... This is a major disappointment for AstraZeneca, which just last year paid out $2.7 billion for ZS Pharma to gain access to the drug .... Fierce Biotech

5/27 Internet Drug News Fast Takes:
Scientists zero in on microcephaly risk for babies born to Zika-infected mothers
Stat News
Lawsuits Over Baby Powder Raise Questions About Cancer Risk
NY Times
Could Alzheimer's Stem From Infections? It Makes Sense, Experts Say
NY Times
Experts Launch Antibiotic Stewardship Playbook
PT Community

5/26 FDA Calls Time Out on Eteplirsen
FDA delays decision on whether to approve Sarepta drug for Duchenne .... It's unclear when the agency will announce its decision. In premarket trading, Sarepta stock surged nearly 20 percent .... Stat/Pharmalot

5/26 Bidders Gathering for Medivation
Celgene, Gilead Said to Join Suitors Mulling Medivation Bids .... Top executives at Celgene and Gilead have said recently they would like to grow via acquisitions. Celgene President Jackie Fouse said in an interview earlier this month that the company has set an aggressive growth target of more than doubling sales by 2020 .... Bloomberg

5/26 Tanezumab, an Effective Alternative Pain Reliever, to be Filed for Approval in 2018
Lilly says new type of pain drug could lessen need for opioids .... Tanezumab has proven in large trials conducted by Pfizer more effective than oxycodone, a widely used opioid, and naproxen, the active ingredient of over-the-counter painkiller Aleve. .... Reuters

5/26 Lily's Pipeline Faces Entrenched Competitors
Lilly Tests Shark-Filled Launch Waters .... One reason for its improved R&D output has been a renewed focus on validated targets -- meaning research Lilly knew would produce successful medicines. This reflects Lilly's current belief that a "best-in-class" latecomer can be just as successful as a first-to-market drug.... but it also means a lot of Lilly's drugs are immediately running into competition .... Bloomberg View

5/26 Valeant, Turing Provided a Lot of Negative Headlines in 2015, But Public Opinion of Pharma is Remains Positive
Conflicting polls highlight uncertainty about the public's opinion of pharma .... Bayer was the top ranked pharma company with Abbott, Novo Nordisk, Roche, and Merck rounding out the top five for 2016. Novartis, Bristol-Myers Squibb, and Pfizer finished in the bottom three of all the 14 ranked manufacturers .... MM&M

5/26 Part B Battle Royal
Medicare's Drug-Pricing Experiment Stirs Opposition .... One of the approaches included in the proposal would allow Medicare to earmark "therapeutically similar" drugs and set a benchmark, or "reference price," that it would pay for all drugs in that category .... Kaiser Health News

5/26 Down the Primrose Path with Elizabeth Holmes
Craving Growth, Walgreens Dismissed Its Doubts About Theranos .... Drugstore chain made blood-testing deal without fully validating the startup's technology, worrying that Elizabeth Holmes might balk; 'a very strange situation' .... Wall Street Journal

5/26 iGlarLixi (Lantus + Lyxumia) Gets 12-2 Up Vote
FDA panel backs 2nd diabetes combo, endorses Sanofi's iGlarLixi .... Outside panelists were won over by the advantages patients could gain if they needed to up their therapeutic regimen for the disease .... Fierce Biotech

5/26 Jimenez Ready to Part with Roche Shares
Novartis willing to sell Roche stake without demanding premium - CEO .... It built up its one-third stake in Roche voting stock between 2001 and 2003 under former Chairman Daniel Vasella for a possible merger that never happened. .... Reuters

5/26 Decision Coming on Probuphine Implant
FDA Considering Pricey Implant As Treatment For Opioid Addiction .... One addiction treatment option now under consideration by the Food and Drug Administration is a system of implanted rods that offer controlled release of buprenorphine -- a drug already used in other forms to treat opioid addiction .... Kaiser Health News

5/26 Internet Drug News Fast Takes:
Lung cancer patients at bigger cancer centers may have better outcomes
Sophiris Streamlines Operations, Weighs Options on Prostate Drug
iBeat Watch Will Call 911 if Your Heart Stops While You Are Wearing It
AbbVie's Newly Licensed Drug Scores Against Crohn's Disease
Investor's Business Daily
Janssen's Stelara impresses in Crohn's maintenance trial
Pharma Times
Alnylam Soars as Drugmakers Circle Rival Biotechnology Company

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