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Fast Takes
Newest Drug Shortage: Sodium Bicarbonate Injection, USP
Doc Gets 30 Years For Running Pill Mill Linked To 12 Deaths
A bankrupt KaloBios may still buy Chagas drug that Shkreli wanted to acquire-and-hike prices anyway
Biopharma Dive
FDA Rejects Expanded Use of Vertex Cystic Fibrosis Drug
India's Pharmaceutical Market to Skyrocket from $20B to $55B by 2020
Sun Pharma rolls out first U.S. copycat to $4.5B cancer drug copycat Gleevec (imatinib)
Tracy Stanton, Fierce Pharma

2/8 Shire Takes 2nd Bite At Dry Eye Apple
Resubmits lifitegrast application to FDA
Shire's self-described blockbuster eye drug lines up for FDA do-overFDA rejected Shire's first application in October, unmoved by a Phase III trial in which the treatment succeeded on only one of its two primary endpoints …[Fierce Pharma]

Real Shkreli Back Story: Rube Goldberg Drug Pricing System Is Broken
- Lack of transparency at every level makes for Gordian Knot; too easy to game the system
The Real Lesson of the Shkreli Circus … beyond the theatrics, the hearing highlighted what an opaque and broken mess drug pricing is in the United States … targeted old drugs with small patient populations in the hope payers, physicians, and patient groups wouldn't notice…[Bloomberg Gadfly]

Patient In Suspended Muscular Dystrophy Trial Dies
A patient in Akashi's suspended Duchenne MD trial dies … ittle more than a week after Cambridge, MA-based Akashi Therapeutics suspended its study of a new drug for Duchenne muscular dystrophy (DMD) after a patient was sent to the hospital, the biotech reports that the trial subject has died …[Fierce Biotech]

:::::::: Worth A Click:::::::::::::::::
Pharma Blogger Pioneer Launches Curated Online Newspaper
Pharma Marketing Pundit, Publisher & Chief Pharmaguy at
launches new online 'zine.  We think it's a winner.  See for yourself!

FDA Approval Of Pfizer, Celltrion Remicade (infliximab) Knockoff Looks Likely
FDA Staff Supports Remicade Biosimilar…  analyst said the broad interpretation of Remsima's potential effectiveness might signal its approval for treating all diseases in which Remicade can be marketed.… Pfizer and Celltrion want to market Remsima in the U.S. as a cut rate copy of infliximab or Remicade … Some medical analysts expect the drug to sell for at least 25% less …

Biosims: Interchangeability On The Table, Bureaucratic Overload Predicted
Woodcock expects surge of biosimilar applications … plans to release long-awaited guidance on interchangeability and labeling of biosimilars this year.  … "What I'm concerned about is that this program is going to explode," said Woodcock. "I'm concerned that we will not have the staff because we're always waiting to catch up … [BioCentury]
Related: Liability: The big biosim legal scuffle the industry should be anticipating … Are biosimilars going to be exposed to a higher degree of risk of product liability lawsuits than generic drugs? And how does that weigh into the overall economics of biosimilars? …[Biopharma Dive]

Remember Pain Creams? FBI Investigates Poss $500 Million Web Of Fraud
-Tricare paid $1.75 Billion for pain creams in 2015 alone
U.S. Probes Possible Fraud Linked to Compounding Creams … more than $10,000 for a single tube … allegations that some of the products provide little to no medicinal value … pitched on the Internet or by telemarketers as a safe way to help athletes heal quickly or alleviate types of pain or cramping,…[WSJ]
Related: Pharmacies push pricier drugs to Tricare users … compound pharmacy marketers have been cold-calling military families and retirees to persuade them to apply for specialty prescriptions like pain creams, wound ointments and erectile dysfunction medications …[Military Times]
See Also: Café Pharma threads regarding pain creams and selling of pain creams (sales compensation, etc),

Japan: Radical Changes Coming To Planet's #2 Pharmaceutical Market
Japan Takes Aim at Ballooning Drug Prices as Costs Strain Budget … For years, price was not a big factor in the Japanese pharma market as the national health-care system absorbed costs, one reason why the penetration of generics was much lower than other economies … [Japanese government] would like to see generics make up about 80 percent of prescriptions in Japan from about 50 percent now … Bloomberg]

PhRMA Launches Ad Blitz Aimed At Lawmakers
- Using Facebook to pinpoint target people who make the decisions
Drug Industry Launches Ad Campaign Aimed at Lawmakers …  Websites like Facebook promise to deliver ads to specific audiences based on characteristics including their location, occupation and keyword search history. … ads are running on social-media sites like Facebook, LinkedIn and Twitter, because PhRMA wants to target federal and state lawmakers, policy analysts and other political "influencers …[WSJ]

2/5 Senators' Holds on Califf Finally Get FDA to Revisit Opioid Policy
FDA Will Act on Pain Pill Abuse After Senate Blocks Nominee .... Opioid addiction has become a major issue in the presidential race, at the White House and in Congress, where Robert Califf, President Barack Obama's nominee to head the FDA, has been held up in the Senate because of concerns about how the epidemic is being handled .... Bloomberg

2/5 Stem Cell Treatment Cures Diabetes in Animals; Now in Human Tests
Johnson & Johnson, ViaCyte testing possible diabetes cure .... The therapy involves inducing embryonic stem cells in a lab dish to turn into insulin-producing cells, then putting them inside a small capsule that is implanted under the skin. The capsule protects the cells from the immune system .... AP

2/5 Cognitive Dysfunction in Major Depressive Disorder is Now a Thing
FDA Advisors Support New Indication for Brintellix .... Panelists who voted to approve the indication said the data presented by drugmaker Takeda from two clinical trials showed a small effect on cognition, but this was at least a step toward mitigating an unmet need in depression .... Medpage Today

2/5 Trulicity Pulling Share from Victoza
Novo Nordisk Quarterly Profit Misses Estimates on Victoza .... Victoza, injected daily to mimic the activity of a hormone called GLP-1 that stimulates insulin production, showed the first signs of suffering from the introduction of a rival product called Trulicity by Eli Lilly that only requires a weekly injection .... Bloomberg

2/5 Updated Adult Immunization Schedule
ACIP Approves 2016 Adult Immunization Schedule .... The major changes to the schedule relate to human papillomavirus (HPV), pneumococcal, and serogroup B meningococcal (MenB) vaccines .... HealthDay News

2/5 More than Lip Service: Drug Companies Making Serious Investment in Adherence
Big Pharma's big push to get patients to take their meds .... GlaxoSmithKline has enrolled 3,000 of its employees, retirees, and their family members in North Carolina in a pilot program to better coordinate their health care. Among other things, it uses sophisticated analytics to determine who's not sticking with their medication .... Stat

2/5 New Valeant CEO Wants to Bring Copay Coupons to Medicare
Valeant chief calls on Medicare to allow controversial copay help from pharma .... Copay coupons for patients in Medicare and other government-funded healthcare programs are currently considered an illegal kickback under federal law, forcing drugmakers to limit their assistance to those with commercial insurance .... Fierce Pharma

2/5 Shkreli/Pharma Congressional Hearing Was Amusing Til You Remember These People are Making Life and Death Decisions
Valeant, Turing Slammed as Shkreli Calls Congress 'Imbeciles' .... The hearing in Washington was heated and at times a puzzling spectacle, with controversial pharma executive Martin Shkreli smirking throughout but refusing to testify after invoking the Fifth Amendment, his lawyer being asked at one point to stay seated, and Shkreli later taking to Twitter to insult lawmakers .... Bloomberg (link includes autoplay video highlights)

2/5 Benzodiazepines Off the Hook
Anxiety Meds Valium, Xanax And Ativan May Not Lead To Dementia .... The highest doses of benzodiazepines--use of the drugs daily for a year--were not linked to any increased risk for dementia. Oddly, low and moderate doses (up to one month, or four months, respectively) were linked to a slightly increased risk .... Forbes/Alice G. Walton

2/5 Pfizer Has Vaccinated About a Third of Those Eligible for Prevnar in US
Prevnar's 2015 sales surged to $6B-plus on new CDC nod in adults .... Though prices in Europe are much lower than they are in the U.S., there's a much larger group of eligible adults to draw from, and Pfizer is working to snag favorable reimbursement recommendations from authorities across the continent .... Fierce Pharma Marketing

2/5 Internet Drug News Fast Takes:
CDC: Women who don't use birth control shouldn't drink
Advisory Board Daily Briefing
Hospitals can be 'urban' and 'rural' at same time: U.S. appeals court
Scientists Use Infrared Light to Measure Blood Glucose
FDA Approves Merck's Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)
Company news release
Depomed Wants to Block FDA Approval of Nucynta Generics
Bloomberg BNA

2/4 Here are 2016's Blockbusters
Seven $1 billion-plus drugs seen reaching market in 2016 .... The two top hits of 2016 are tipped to be Intercept Pharmaceuticals' chronic liver disease drug obeticholic acid, with a consensus sales forecast of $2.6 billion in 2020, and Gilead Sciences' new fixed dose HIV drug emtricitabine plus tenofovir alafenamide, on $2.0 billion .... Reuters

2/4 How Valuable Can This Doc Be for Your Brand? Zephyr Says it Knows
The Startup Tracking 'Valuable' Doctors for Big Pharma .... Gathering various strands of information, Zephyr generates profiles that score each doctor's influence and ability to drive sales on a scale of 1 to 10. The software's slick, mobile-friendly interface lets a drug company search in broad or specialized disciplines (from "oncology" to "non-Hodgkin lymphoma") and ranks each person's influence in the chosen field .... Bloomberg

2/4 The 'Foot in the Door' Gets Harder and Harder
4 industry vets sound off on the state of physician-rep access .... Although access has improved, it has done so at the expense of additional restrictions.... the percentage of physicians requiring appointments or restricting access to certain hours has increased more rapidly and is at a three-year high .... MM&M

2/4 Januvia Off Target; Keytruda and Zetia Save Merck's 4Q
Merck's Top-Selling Diabetes Drugs Miss Sales Estimates .... The diabetes pill Januvia is Merck's top-selling product, and sales of $1.44 billion for that drug and another formulation, Janumet, fell short of estimates for $1.67 billion .... Bloomberg

2/4 Nobody Wants to Hear About Your Disease at a Superbowl Party
NFL games are magnets for drug ads. But the Super Bowl isn't. Here's why .... In the lighthearted atmosphere of the Super Bowl, it's an uphill battle to produce a successful ad about a serious health condition .... Stat

2/4 ACCORD Trial Long-term Follow-up
Neutral Long-Term Effect for Intensive Glycemic Control .... The researchers found that a mean of 3.7 years of intensive glucose lowering had a neutral long-term effect on the primary composite outcome (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular disease), death from any cause, and an expanded composite outcome that included all-cause death .... HealthDay News

2/4 Eliquis Sales Doubled Since Last Year; BMS Wants #1 Position
BMS expects fast-growing Eliquis to take the lead over Xarelto, Pradaxa .... Bristol isn't planning to let up on any of the increased spending that helped Eliquis make big gains last year. The company began its DTC efforts in September of 2013, a year in which Q4 Eliquis revenues tallied just $48 million .... Fierce Pharma Marketing

2/4 Ruckus Over Flooding Living Room Heart Failure Ad
Entresto Maker In Deep Water Over Terrifying TV Advertisement .... The ad depicts a middle-aged man in an easy chair reading the newspaper, oblivious to a rising flood that threatens to drown him, though his dog, climbing onto a couch for safety, expresses considerable anxiety .... Cardiobrief

2/4 TrusTED Wants to Put FDA Approvals Up to a Congressional Vote
Sen. Ted Cruz Wants To Change The Way The FDA Approves Drugs .... The RESULT Act would allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in European countries, as well as from Japan, Canada, Australia and Israel. In addition, the bill would allow Congress to overrule FDA rejections of life-saving drugs with a majority vote via joint resolution .... Forbes/John LaMattina

2/4 Viewability Pow-Wow Feb. 4
Pharma, ad agencies press publishers for higher ad viewability standards .... The Internet Advertising Bureau now recommends that 70% of the ad be visible for one second, while individual brands and agencies are pushing for even more, usually 100%. .... Fierce Pharma Marketing

2/4 Internet Drug News Fast Takes:
18 cities in Pennsylvania reported higher levels of lead exposure than Flint
CVS Pharmacy makes Target debut
Chain Drug Review
Cancer drug testimonials tinged with financial interest
Milwaukee Journal-Sentinel
Smart Band-Aid on the Horizon
NY Times
Old Novartis cancer flagship Gleevec heads to pharmacies as lower-cost generic

2/3 Cleveland Clinic Has a Full-Time Pharmacist Dealing with Drug Shortages
Drug Shortages Forcing Hard Decisions on Rationing Treatments .... Such shortages are the new normal in American medicine. But the rationing that results has been largely hidden from patients and the public .... NY Times

2/3 Drug Price Boosts Most Common at End and Beginning of the Year
Shkreli Was Right: Everyone's Hiking Drug Prices .... A survey of about 3,000 brand-name prescription drugs found that prices more than doubled for 60 and at least quadrupled for 20 since December 2014 .... Bloomberg

2/3 Internal E-mails Show Turing Execs Cackling Over $7.2 Million Purchase Orders for Daraprim
Martin Shkreli All but Gloated Over Huge Drug Price Increases, Memos Show .... Martin Shkreli anticipated huge profits from raising the price of Daraprim, belying any notion that helping patients was foremost in his minds .... NY Times

2/3 Baby Powder Link to Cancer?
J&J's Talcum Powder Goes on Trial in Ovarian Cancer Lawsuits .... The world's largest maker of health-care products faces accusations by the family of a woman who died that it knew decades ago that talc, the Earth's softest mineral, was linked to ovarian cancer .... Bloomberg

2/3 Brintellix Tries for New Indication: Confused Thinking Tied to Depression
This antidepressant may be no better than cheaper alternatives. But demand could soon soar .... The drug makers behind Brintellix are betting they can give it a boost by marketing it to treat a whole new category of depression symptoms -- namely, cloudy thinking. .... Stat News

2/3 Ketamine Now Mainstream; Boasts 75% Success Rate
Onetime party drug hailed as miracle for treating severe depression .... A growing number of academic medical centers, including Yale University, the University of California at San Diego, the Mayo Clinic and the Cleveland Clinic, have begun offering ketamine treatments off-label for severe depression, as has Kaiser Permanente in Northern California .... Washington Post

2/3 His Life Mission: End Drug Patents
Big Pharma's worst nightmare .... Jamie Love has spent years battling global drug companies, unshakable in his belief that even the world's poorest people should have access to life-saving medicines .... The Guardian

2/3 "Three is the magic number for payers to get more aggressive": PBMs Holding Fire on PCSK9 Inhibitors
With PCSK9s, payers say, 'Let the market decide' .... Several months after introduction many payers haven't yet anointed one PCSK9 over the next. Nor have they publicly taken the makers to task over pricing, positioning or anything else .... MMM-Online

2/3 Pfizer Stops Trial; Wall Street Sells Off Related Drug
Pfizer Halts Drug Trial, Investors Flee Axovant .... Pfizer discontinued the PF-05212377 (also known as SAM-760) trial in October of 2015 but only updated the NIH's listing on February 2, making the futility discontinuation public knowledge .... Forbes/Jake King

2/3 Insulin Prices Up 20% in One Year
Patients shocked as insulin prices climb higher .... Express Scripts, the largest U.S. pharmacy-benefit manager, said the price of two prominent brand-name injectable insulins, Lantus and Humalog, rose 22.7 percent and 19.9 percent, respectively, from 2014 to 2015. .... Medical Xpress

2/3 Internet Drug News Fast Takes:
Sanofi launches hunt for Zika vaccine as disease fears grow
Abbott plunges deeper into diagnostics with $5.8bn Alere buy
Pharma Times
Andreessen Horowitz Wants To Bring Biology To The Cloud
Forbes/Steve Dickman
Empliciti on track for European approval in multiple myeloma
Researchers Say JNC8 Recs May Put Some Patients at Risk
HealthDay News

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