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9/4 'No-Sees' Now the Majority
In a bad-news first for pharma reps, more than half of doctors now restrict access .... A major factor these days is consolidation among healthcare providers, which often puts physician practices under the control of big health systems. As part of that consolidation, doctors' practices cede control of policy-related decisions--such as access to reps--to their new owners .... Fierce Pharma

9/4 Xarxio, Biosimilar for Neupogen, Offered at 15% Discount
First Biosimilar Goes on Sale in U.S., Challenging Amgen .... Novartis is also working on biosimilars of AbbVie Inc.'s $12.5 billion-a-year medicine Humira and Amgen's Enbrel .... Bloomberg

9/4 Brilinta Now Approved for Use >1 Year After MI
FDA approves expanded indication for AstraZeneca's blood thinner .... The health regulator approved Brilinta tablets at a new 60 mg dose .... Reuters

9/4 Study of Arthritis Patients without Cardiovascular Disease Clears Celebrex of CV and Gastric Event Risk
UK Study Indicates That The Cardiovascular Risk Of Celebrex No Different From Other Pain Drugs .... "In patients with arthritis, without known cardiovascular disease, CV event rates were low and serious ulcer-related complication rates very low, and neither outcome differed significantly between NSAIDs and celecoxib...." (SCOT study authors) .... Forbes/John LaMattina

9/4 Zecuity Delivers Sumatriptan in an More Tolerable Way
Teva rolls out first migraine patch in US .... The new Zecuity product is a disposable patch system worn for four-hours - on the upper arm or thigh - that delivers the widely-used migraine drug sumatriptan through the skin. Sumatriptan is a serotonin 5-HT1 agonist that has been used for years in oral and injectable migraine formulations .... PM LiVE

9/4 No Evidence that Zetia Causes Diabetes
No Diabetes Increase With Ezetimibe in IMPROVE-IT .... A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe (Zetia, Vytorin with simvastatin). .... Cardiobrief/MedpageToday

9/4 Docs Find Wellness Visits are a Square Peg
Medicare's 'Wellness Visit' Money Goes Unclaimed .... Despite this potential largess for primary care, physicians have been slow to submit claims. For the third year of the new codes, only 12% of eligible beneficiaries had Medicare billings for these services, according to 2013 data from the Centers for Medicare and Medicaid Services .... MedpageToday

9/4 Microneedles, Hydrogels, and Tiny Tubes: Drug Delivery Systems of the Future
In for the long haul .... Medical technology: New devices that regulate the steady delivery of drugs within the body are on the way .... Economist

9/4 One Third of ADHD Diagnoses Made Before Age Six
More Parents Catching Early Signs of ADHD in Children .... The number of diagnosed cases of the disorder have shot up in recent years, rising 42 percent from 2003-2004 to 2011-2012, according to the study .... ABC News (autoplay audio)

9/4 Essential Tremor Effect Not Strong, But SAGE-547 May Have Other Uses
Sage Psychiatric Drug Shows Activity Hint in Small Muscle Tremor Study .... An injection of the experimental psychiatric drug SAGE-547 was more effective than a placebo in treating patients with essential tremors .... The Street/Adam Feuerstein

9/4 Hearing Loss Drugs Expected Within Next Decade
Hearing Help .... For decades, the only remedies for hearing loss were devices such as hearing aids or cochlear implants. Now, the first pharmaceutical treatments may be on the way. .... The Scientist

9/4 Internet Drug News Fast Takes:
The FDA May Add a Life-Saving Vitamin to Tortillas
Wired
Novartis' Revolade wins EU nod for rare blood disorder
Pharma Times
Insurers Can't Deny Gender Transition Treatment Under U.S. Plan
Bloomberg
FDA Issues Warning About Skin Lighteners
WebMD
CDC Finds Fewer in US Skip Healthcare Over Cost Since ACA
AJMC

9/3 Varubi (Rolapitant), New Treatment for CINV, Gets OK
FDA approves Tesaro's drug for chemotherapy-induced nausea .... The drug, known chemically as rolapitant, was approved in combination with other agents to prevent delayed nausea and vomiting associated with some forms of chemotherapy .... Reuters

9/3 CAR T Cell Treatment Eradicated Advanced Leukemia in 4 of 14 Subjects
Some leukemia patients see durable results from Novartis therapy .... Some leukemia patients who had exhausted other treatment options have no trace of the disease more than four years after being treated with an experimental type of therapy called CAR T cells in a small pilot study at the University of Pennsylvania .... Reuters

9/3 First U.S. Biosimilar on Sale Now
Amgen cannot stop imminent sale of Neupogen copycat: appeals court .... A U.S. appeals court has cleared the way for Novartis AG to launch the first biosimilar drug in the United States as it declined on Wednesday to stop the sale of the company's copycat version of Amgen Inc's blockbuster cancer drug Neupogen .... Reuters

9/3 PrEP Works
Insurer Says Clients on Daily Pill Have Stayed H.I.V.-Free .... San Francisco's largest private health insurer announced Wednesday that not one of its 657 clients receiving the drug had become infected over a period of more than two years. .... NY Times

9/3 Romosozumab Successful in Phase 3
Amgen and UCB's Osteoporosis Drug Bests Lilly's Forteo in Study .... In the study, about 436 post-menopausal women deemed at high risk of fractures were moved from a family of drugs called bisphosphonates that include Merck's Fosamax and given either romosozumab or Forteo for a year. The ones on romosozumab fared better, the companies said, without giving more details .... Bloomberg

9/3 Another Merger in Generics
Lannett Buys UCB's U.S. Generics Division for $1.23 Billion .... Lannett said it will acquire Kremers Urban Pharmaceuticals, adding products for attention-deficit hyperactivity disorder and gastroesophageal reflux .... Bloomberg

9/3 DTC TV Ads Pay Off Big
Pharma TV ads are good for the business bottom line, study says .... The companies that socked more money into TV averaged revenue gains of 12% and earnings per share gains of 2%, and saw stock price gains of 113% versus the S&P 500 index. The decreasing spenders averaged revenue losses of 12%, were down 15% in earnings per share and underindexed the S&P 500 by 48% .... Fierce Pharma Marketing

9/3 Xantus Study Supports Xarelto Safety
Bayer backs safety of Xarelto after real-world data study .... Around 96 in every 100 people treated with Bayer's anticoagulant Xarelto do not experience any major bleeding, related side effects or death, according to the results of a major study into the use of the drug in clinical practice .... PharmaFile

9/3 Blincyto Treatment Expected to Cost About $71,000 Because Not All Patients Will Get Full 56 Days
Real-world Blincyto spending likely to fall far short of Amgen's $178K list price .... In clinical trials, the average time on therapy was 21 days for the first cycle and 10 days for the second--and many patients may not need more than one cycle .... Fierce Pharma

9/3 Internet Drug News Fast Takes:
Skydeck-backed startup's digital stethoscope green-lighted by FDA
Berkeley News
Today's seniors are smarter but in poorer health
Medical News Today
Study Compares Hospitalized Infection Risk for Biologics in RA
HealthDay News
Pharma sales forces should act more like 'outcomes advocates'
MMM Online
CVS says its cigarette move affected other stores' retail sales as well
Washington Post

9/2 How About a Sliding Scale of Risk Thresholds for Drug Approval, Depending on the Disease?
Should riskier drugs be approved for lethal diseases? .... The new study suggests that for many devastating diseases, the current FDA standards are too risk-averse, erring on the side of keeping drugs off the market even when patients, facing a dire prognosis, would accept higher risks that the drug doesn't work or comes with toxic side effects .... Washington Post

9/2 Repatha U.S. Price: $14,100/year. U.K Price $6,780/year (converted)
Europe gets Amgen cholesterol drug for 50-60 percent of U.S. price .... U.S.-based Amgen has announced it would charge 340.20 pounds ($521.70) in Britain for a 28-day supply of Repatha, or roughly $6,780 a year, against a list price of $14,100 in the United States, where the drug is also being launched this week. .... Reuters/Yahoo

9/2 AstraZeneca Sells Off Brodalumab
Valeant to Work on Psoriasis With Astra After Amgen Bows Out .... Valeant agreed to pay $100 million upfront for the drug, as well as another $170 million in milestones before the product's launch .... Bloomberg

9/2 When Scores of B-List Celebrities Have Millions of Social Media Followers, Expect More Misleading Drug Claims
Kim Kardashian's FDA run-in shows the challenge of policing drug ads in the Instagram age .... But other similarly misleading claims on social media may go unnoticed or untouched. This is not only because the FDA is overwhelmed with the volume of health claims on the internet, as Thomas Abrams, the FDA's director of the Office of Prescription Drug Promotion, explained in a Q&A, but also because the agency only has authority to respond to claims that are made by companies or people who are acting on behalf of a company .... Vox

9/2 Big Bet on BACE Inhibitors
Novartis, Amgen join forces to fight Alzheimer's and migraine .... Novartis's work with Amgen on Alzheimer's will focus on finding a medicine that can be given orally, rather than as an injection, through the development of so-called BACE inhibitor drugs. .... Reuters

9/2 Protonix Litigation Won't Go Away
Pfizer's Effort to Toss Medicaid Lawsuit Seemingly Unsuccessful .... The Justice Department filed a lawsuit against Wyeth in April 2009, accusing it of failing to provide to state Medicaid programs the same price discounts for Protonix that Wyeth was providing to certain nongovernment customers, as required by law, between 2001 and 2006 .... WSJ$$

9/2 Not the Bears' Fault: Grizzly Study Spoiled by Altered Results
Amgen Finds Data Falsified in Obesity-Diabetes Study Featuring Grizzly Bears .... The paper discussed how grizzly bears' metabolisms adjust to hibernation, and the key role of a certain fat protein, which offered a clue to a new kind of treatment for diabetes. Biotech Amgen Inc. was working on the bear research to get a better grip on the biology behind diseases like obesity and diabetes .... WSJ

9/2 27% of Those Prescribed Statins Metabolize the Drug Poorly; A Gene Test Can Find Them
Are Statins Bad For Me? Personalized Medicine Can't Yet Say .... Boston Heart has so far tested over 250,000 patients for statin intolerance but can't yet comment on its prevalence in specific ethnic groups. While this test is not approved by the Food and Drug Administration, it is reimbursed by some insurance .... NPR

9/2 AZN's Goal for Brilinta: $3.5 Billion Sales/Year
AstraZeneca gets more backing for long-term Brilinta use .... The drugmaker has won support from the European Society of Cardiology, which tweaked its guidelines to endorse potential use of P2Y12 blood thinners such as Brilinta--alongside aspirin--beyond 12 months .... Fierce Pharma

9/2 Empliciti, (elotuzumab) to Get Quicker Decision
FDA Grants Elotuzumab Priority Review in Multiple Myeloma .... At a median follow-up of 2 years, PFS with the elotuzumab regimen was 19.4 months (95% CI, 16.6-22.2) versus 14.9 months (95% CI, 12.1-17.2) with lenalidomide and dexamethasone alone (hazard ratio [HR], 0.70; 95% CI, 0.57-0.85; P <.001) .... OncLive

9/2 Internet Drug News Fast Takes:
Alexion gets EU approval for drug acquired in Synageva deal
Reuters
Most adults' 'heart age' exceeds their actual age: U.S. CDC
Reuters
Bristol-Myers Makes $150M Bet on Promedior, Fibrosis Drug
xconomy
Overweight in midlife may speed up Alzheimer's
AFP
FDA Warns on Powdered Caffeine: You're Selling Deadly Doses
NBC News

9/1
Fast Takes
Sanofi, Google team up to improve diabetes care
Reuters
Pfizer Unveils Single Packs For Viagra In Move To Refresh Aging Brand
International Business Times
FDA Reviewer who blocked thalidomide dies at age 101
LA Times
It's confirmed: 'No signal' of heart failure risk with Merck's Januvia
Fierce Pharma


9/1
Ed Silverman Reemerges: Partners With Boston Globe To Launch New Pharma News Website
- Pharmalot Blogger is Energizer Bunny of drug News
Examining drug issues in depth … You can have sex or you can drink, but you can't do both … Drug makers have free speech rights, too. Seriously, they do. …  You're dying, but getting access to experimental medicine may be nearly impossible ///[Boston Globe]
Editor's Note:  Ed Silverman can be reached at ed.silverman@statnews.com. Follow him on Twitter @Pharmalot. Follow Stat on Twitter @statnews.

9/1
Kim Kardashian Posts Corrective Information Morning Sickness Pill She Hyped
- Posting to Facebook, Instagram & Twitter highlight warnings
Kim Kardashian Posts Drug Side Effects After FDA Warning …  boilerplate risk information that voice actors speed through in the final seconds of TV drug ads: "Diclegis has not been studied in women with hyperemesis gravidarum," or extreme, persistent vomiting … also included warnings about interactions with other medications and alcohol, as well as side effects like drowsiness … [Bloomberg]

9/1
Bayer, CHF: Promising Data For Bayer Mineralocorticoid Receptor Antagonist
- Mid stage trial shows drugt cut deaths
Bayer to Forge Ahead With Finerenone Trials on Positive Data … Finerenone is the next generation of treatments to block the damaging effects caused by the hormone aldosterone in patients with chronic heart failure … will conduct final-stage tests on an experimental drug to treat chronic heart failure and diabetic kidney disease following successful mid-stage trials….[Bloomberg]
Bayer heart failure drug cuts deaths in mid-stage trial … [Reuters]

9/1
Afrezza Inhaled Insulin: Mannkind Hints Prosperity Just Around The Corner
- Chats up better formulary coverage, DTC advertising in face of disappointing sales results
5 Things MannKind Corporation's Management Team Wants You To Know … Sanofi's discussions with managed care organizations are ongoing, and we expect the insurance coverage and patient access to improve … While the excuses given about Afrezza's slow start appear to be valid, there's still a good chance patients and providers just aren't interested enough. Inhaled insulin was launched years ago and failed miserably … [Motley Fool]

8/31
Fast Takes
$415 Bln Dutch pension fund exits Mylan over concerns it supplies death penalty drug
Reuters
Billion$ in the Balance: 5 Big FDA Decision$ Expected in $eptember
247 Wall Street


8/31
Januvia, Onglyza, Nesinia Accused Of Causing Severe Arthralgia In Certain Patients
- Majority of the cases were Januvia Patients; FDA adds class warning
FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain … saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors …[FDA]
FDA warns of severe joint pain risk with DPP-4 diabetes drugs … FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors  … most frequent number of cases, 28, occurred with Januvia, five cases were reported with AstraZeneca Plc's Onglyza (saxagliptin) …[Reuters]

8/31
Majority Of Large Employers Offer Skype-Medicine To Employees
- Telehealth grows leaps and bounds
The doctor is online: Remote video medical exams gain popularity …  74% of large employers plan to offer telehealth services in 2016, up from about half in 2015 … A report last year by consulting firm Deloitte projected as many as 300 million e-visits within a few years, compared with just 800,000 the American Telemedicine Assn. expects in 2015 …  most frequent use of remote sessions with a doctor today is for common ailments like respiratory illness, fever, ear and urinary tract infections, concerns about a child's health, and skin or eye problems … [LA Times]

8/31
Alnylam, Medicines  Experimental Cholesterol Jab Could Give PCSK9s Stiff Competition
- Lasts much longer (140 Days)
Alnylam, Medicines cholesterol drug lasts months after one shot … single dose of 300 mg reduced LDL by just over 50 percent at 12 weeks, similar to the 50-60 percent seen with antibody drugs, … first-in-class treatment that stops synthesis of the protein which is linked to "bad" LDL cholesterol in the liver unlike rival antibody-based PCSK9 medicines that work in the blood … [Reuters]
Alnylam's New Drug May Prove Threat to Sanofi, Regeneron, Amgen … [Bloomberg]

8/31
Risperdal Accusation: Jannsen New Of Man-Boob Problem All Along
- Young boys grew ladylike breasts due to modulation of prolactin
Janssen Pharmaceuticals Accused of Hiding Risperdal's Breast Effects In Boys … accused of hiding evidence back in 2003 that would have alerted clinicians and regulatory authorities to the connection among risperidone, increased prolactin, and gynecomastia…. clinicians began prescribing it off-label for autistic children … [Forbes]

8/31
Eli Lilly's Diabetes Drug Synjardy Gets U.S. Approval
Eli Lilly's (LLY) Diabetes Drug Synjardy Gets U.S. Approval … Synjardy® combines empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), commonly prescribed for the treatment of T2D … third empagliflozin containing product to gain FDA approval, the other two being Jardiance and Glyxambi and the fifth product under the Lilly-Boehringer Ingelheim …[NASDAQ]


8/28 Second PCSK9 Inhibitor Repatha Approved; $14,100 Per Year ($500 Cheaper than Praluent)
Amgen gets a big win with FDA OK for PCSK9 cholesterol drug Repatha .... Amgen's approval came in looking remarkably similar to Praluent's OK, getting approved for patients who don't respond to maximally tolerated statins. .... Fierce Biotech

8/28 Long-Awaited Biosimilar Naming Rules
What to Call Biologic Copycats? FDA Plans Names And Suffixes .... Cheaper versions of biotechnology drugs in the U.S. will be distinguished from the expensive brand-name medicine they imitate by attaching a suffix to their generic name, the Food and Drug Administration proposed, a plan that may affect how doctors prescribe the treatments. .... Bloomberg

8/28 Synjardy Approved: Metformin + Jardiance
Become a pharmaceutical industry monster in this striking new simulation game .... It works in two ways: by removing excess glucose through the urine by blocking reabsorption in the kidney and by lowering glucose production by the liver and its absorption in the intestine. .... Indianapolis Star

8/28 Doc Groups Send Preemptive Shot at Necitumumab Pricing
Lilly Lung-Cancer Drug Stirs Price Debate .... An experimental Eli Lilly & Co. lung cancer drug hasn't reached the market, but some doctors are already weighing in on how much it should cost--arguing the price should be below average because the drug extended patient lives by only six to seven weeks in a clinical trial .... WSJ via Nasdaq

See also:
8/28 What's a QALY Worth? Oncology Treatments Stretch the Upper Limits
Cancer drugs aren't just really expensive; they're a bad value .... The price of the advanced colon cancer drug, regorafenib, assumes that the value of an additional year of life in perfect health is more than $700,000 -- more than three times what most economists suggest we should be paying. The price of bevacizumab for advanced colon cancer reflects a year of life valued somewhere between $350,000 and $500,000. .... Washington Post/Wonkblog

8/28 Volibris+Adcirca Improves Walking and Peptide Levels for PAH Patients
GSK/Lilly pulmonary hypertension combo continues to impress .... A primary endpoint event occurred in 18% of the combination participants, 34% of the Volibris (ambrisentan) participants, and 28% of the Adcirca (tadalafil) participants. .... Pharma Times

8/28 Lilly Study Finds Good News on Trulicity
Patient Satisfaction Up for Dulaglutide Treatment in T2DM .... Significantly greater improvement was seen for dulaglutide versus placebo (26 weeks) and exenatide (26 and 52 weeks) on the total Diabetes Treatment Satisfaction Questionnaire score .... HealthDay

8/28 A Look Ahead at the Duchenne Muscular Dystrophy Decisions
Predicting the Outcome of the Biomarin and Sarepta FDA Drug Reviews .... Approving both drugs is the most politically expedient decision FDA can make. The drisapersen and eteplirsen reviews are still nominally about the science, but in this case, equally about making good on promises (explicit and implied) to the families of kids with Duchenne muscular dystrophy .... The Street/Adam Feuerstein

8/28 Ibrance in Testing for Head&Neck, Pancreatic, and Earlier Stage Breast Cancer
Pfizer plots Ibrance expansion as early-stage breast cancer trial begins .... The pharma giant is testing the drug--the first in the new CD4/6 inhibitor class to hit the market--in early-stage patients with tumors that are estrogen-receptor-positive but HER2-negative .... Fierce Pharma

8/28 Play Pharma Tycoon on Your Couch This Weekend for 20 Bucks
Become a pharmaceutical industry monster in this striking new simulation game .... Big Pharma, out today on PC, Mac and Linux, is a fascinating look at the complicated and often dark world of drug development .... BoingBoing

8/28 Internet Drug News Fast Takes:
FDA wants food companies to hand over their pathogens
Reuters
Jarring statistics prompt renewed concerns about doctors' mental health
Advisory Board Daily Briefing
Alzheimer's disease thought to be accelerated by an abnormal build-up of fat in the brain
University of Montreal
New blood test predicts breast cancer relapse
Pharma Times
Sunovion prepares for FDA decision on Aptiom
MM&M

8/27 Supermarket Pharmacies Get Top Rating from Consumers over Chains, Over Chains and Mail Order
Overall customer satisfaction up at U.S. pharmacies .... The J.D. Power 2015 U.S. Pharmacy Study, which was released on Monday, ranked Wegmans Pharmacy highest among supermarket pharmacies, with an overall satisfaction score of 887. .... American Pharmacy News

8/27 FDA Turns Blind Eye to Homeopathic Claims; FTC Wants Crack Down
The FDA Is Under More Pressure To Regulate Homeopathic Products .... The FTC filed official comments that said it is "concerned" that the FDA's policy on homeopathy conflicts with the FTC's requirement that medical advertising claims be supported by evidence .... Bloomberg

8/27 GSK Deals Away Autoimmune Drug
Glaxo in $1 Billion Ofatumumab Deal With Novartis .... The drug is used for the treatment of autoimmune diseases, most notably multiple sclerosis. .... Investopedia

8/27 Diabetes Drug Maker Plans to Manufacture New Treatment in North Carolina
Novo to spend $1.2B, hire 700 for its first major drug plant in U.S. .... Novo will build the facility in Clayton, NC, where it already has facilities to fill and package products and where it makes some of its prefilled insulin devices for the U.S. market .... Fierce Pharma

8/27 AZN Gets Movantik Moving with $10 Million in DTC
AstraZeneca uses snails and overstuffed luggage to push OIC awareness--and its branded solution .... Movantik became the first mu-opioid treatment approved specifically for OIC in September. It launched in March into a market that industry watchers expect to grow to $1.98 billion by 2017. Movantik's main competitor is Relistor, an injectable treatment also approved for OIC in the fall .... Fierce Pharma Marketing

8/27 Ambulance Chasers Get Ready Hand from Ambulance Bankers
U.S. business groups call for probe of medical funding industry .... Medical funders profit by purchasing bills for the medical treatment of injured plaintiffs at a deep discount from health care providers, then claiming the full amount of the bill as a lien against the patient's legal recovery through a settlement or verdict .... Reuters

8/27 Alimta, $2.7 Billion in Sales Last Year, Wins Protection Till 2022
Lilly wins again in Alimta patent row with Teva .... The new court ruling provides intellectual property protection for the drug until May 2022. This should technically provide Lilly market exclusivity until then, even though the compound patent expires in 2017. .... Pharma Times

8/27 2 mg of Fentanyl Can Be Fatal; Maine Seeing Overdose Deaths Daily
How The Prescription Painkiller Fentanyl Became A Street Drug .... "Patterns of abuse actually began with hospital workers, anesthesiologists and nurses.... There were a rash of [health specialists] dying from overdose. You'd hear of them getting it in the operating rooms by drawing out fentanyl from vials and putting saline in its place." .... NPR
See also: Illicit Version Of Painkiller Fentanyl Makes Heroin Deadlier [NPR]

8/27 New Tricks for Old Dogs
Brand Development Strategies: Golden Oldies .... Late-lifecycle marketing and the companies and brands that manage to flourish here .... MM&M

8/27 Phase 3 Trials Support Trumenba
Pfizer posts positive Trumenba vaccine data .... As it stands today nearly 15% of patients with menB ultimately die and many of those who survive are burdened with long-term and life-altering disabilities .... PM LiVE

8/27 Internet Drug News Fast Takes:
Alvogen bags four US drugs from Pfizer
Pharma Times
After two deaths, Verastem defends safety of experimental cancer drug
Boston Business Journal
Common 'heart attack' blood test may predict future hypertension
Johns Hopkins Medicine
Lilly and Boehringer launch Lantus biosimilar in UK
PM LiVE
Proportion of patients with diabetes undergoing CABG spikes 5-fold over 4 decades
American Association for Thoracic Surgery

8/26 Unexpected Effect of REMS Programs — FDA Approves Products It Might Otherwise Have Rejected
Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application .... But the agency also goes through cycles, sometimes approving too little, sometimes too much. If 96% of applications for brand new drugs are getting through, it's hard not to suspect that we're getting close to the "too much" end of the pendulum .... Forbes/Matthew Herper

8/26 Hayman Defeat on Ampyra May Blunt Future Attacks
Why This Small Victory Against Short Sellers Might Be a Big Deal for Biotech Companies .... The next skirmish is expected to come in about a month, when the Patent Trial and Appeal Board is to decide whether to institute reviews of patents related to two Shire drugs: one for ulcerative colitis and the second for short bowel syndrome .... Bloomberg

8/26 Cometriq to Get Quick Review for Renal Cell Carcinoma
Exelixis' Cancer Drug Gets Breakthrough Therapy Status .... Cometriq is already approved in the U.S. for the treatment of progressive, metastatic medullary thyroid cancer .... Zacks

8/26 No Lasting Effect for Steroid Injections
Steroid injections for lower back pain have limited benefits .... The team of researchers reviewed 30 studies involving radiculopathy and eight trials involving spinal stenosis, and observed that within weeks of receiving epidural corticosteroid treatment, pain subsided and function was restored by a fractional amount, but that those results were null within three months' time .... Fox News

8/26 Sarepta Priority Review Decision by Feb 26, 2016
Sarepta gains after-hours as FDA accepts application for Duchenne drug approval .... The Food and Drug Administration set a Feb. 26 deadline to make a decision regarding the drug by Sarepta, called eteplirsen, which is aimed at 13 percent of the patients with the rare disease with the most common gene mutation that causes it .... Boston Business Journal

8/26 Cost of Medicines Expected to Be 2016 Campaign Issue
Voters want candidates to address drug prices .... One poll found that 93 percent of Democrats, 83 percent of independents, and 74 percent of Republicans want the federal government to negotiate drug prices for Medicare — even though the Republicans in the survey were skeptical the approach would actually work .... Stat/Boston Globe

8/26 Whistleblower Blowing Spit
Bristol-Myers, Sanofi catch a break in Plavix marketing case .... U.S. District Judge Freda Wolfson partially dismissed claims from Elisa Dickson, a former Sanofi-Aventis sales rep, who alleged that the company told her to falsely promote Plavix to docs. Dickson said she was instructed to promote the drug as better than aspirin for stroke patients, for example, even though trial data showed the drug was not effective for that population ... Fierce Pharma

8/26 Informal ANDA Updates Are Back — For Now
Generic Drug Sponsors Will Get Status Reports — But Only For Old ANDAs .... FDA is ready to restore some informal communications for generic drugs, but only for applications not covered by the newly implemented user fee action dates. ... RPM Report/First Take

8/26 Obstacles to Afrezza
3 Reasons Why Afrezza's Launch Has Been So Disappointing .... The FDA is requiring patients to take a lung function test from a device called a spirometer before starting on Afrezza. This was called out as a major reason for slow adoption in the first quarter -- apparently only around 30% of doctors that specialize in diabetes had a device to perform the test ... Motley Fool

8/26 "If there were a cure for Alzheimer's or breast cancer that cost $40,000 or $50,000, we would not be having this conversation…" — Ryan D. Clary, advocate for broader use of new Hep C medicines
Wider Reach Is Sought for Costly New Hepatitis C Treatments .... The experts, from the Public Health Service and President Obama's Advisory Council on H.I.V./AIDS, said that restrictions on the drugs imposed by many states were inconsistent with sound medical practice, as reflected in treatment guidelines issued by health care professionals and the Department of Veterans Affairs ... NY Times

8/26 Internet Drug News Fast Takes:
Skipping blood pressure pills may raise heart failure risk
Reuters
Novo Nordisk's Victoza fails type 1 diabetes trial
PMLiVE
FDA grants Tocagen's glioblastoma treatment orphan drug status
PMLiVE
US filing for Amgen's secondary hyperparathyroidism drug
Pharma Times
Evidence Supports Flu Vaccine for Nursing Home Residents
HealthDay News

8/25 NCCN Will Rate Cancer Drugs for Costs, Benefits and Side Effects
Powerful cancer alliance joins cost-effectiveness drug crusade .... The tool will assign scores to each drug in 5 areas--price, effectiveness, safety, quality and consistency of clinical data.... The first drugs to be evaluated will be treatments for two blood cancers, multiple myeloma and chronic myeloid leukemia, with most other cancers to follow by the end of next year .... Fierce Pharma

8/25 AZN Picks a Cancer Expert for CMO
AstraZeneca Appoints Roche's Sean Bohen as Chief Medical Officer .... Bohen will oversee the development of drugs through late-stage testing to regulatory approval.... At Genentech, he oversaw early drug development across all therapy areas, including oncology, respiratory and autoimmune diseases .... Bloomberg

8/25 Patent Raider Thrown Off the Saddle
Hedge fund manager Kyle Bass loses challenges to pharma patents .... Prominent hedge fund manager Kyle Bass's campaign to wipe out certain drug patents hit a roadblock when the U.S. Patent and Trademark Office declined to formally review two patents on Acorda Therapeutics Inc's flagship multiple sclerosis drug, Ampyra .... Reuters

8/25 Healthcare's Heavy Hitters (And Why No Pharma Execs?)
100 Most Influential People in Healthcare — 2015 .... Modern Healthcare has released its 14th annual list of the "100 Most Influential People in Health Care," which includes a range of policy leaders, hospital executives, insurance giants, and more. .... Modern Healthcare

8/25 Promacta New Indication
FDA Grants Expanded Use of Promacta for Novartis .... FDA has approved an expanded use for the company's Promacta to include children who are 1 year of age and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy .... AP/Yahoo

8/25 Psoriasis Link to Depression
Psoriasis: A Mandate for Depression Screening? .... People with a history of psoriasis had a depression prevalence of 16.5% compared with 8.9% among individuals with a no history of psoriasis.... More people with psoriasis had a history of cardiovascular events .... Medpage Today

8/25 Non-selective Beta Blockers Lengthen OS in Ovarian Cancer by Almost Five Years
Beta-blockers could increase cancer survival .... The study analysed data from 1,425 women with the tough-to-treat cancer and found that median survival in patients taking beta blockers was 47.8 months — five months longer than the 42 months median for those not using the treatment .... Pharma Times

8/25 Most Pharma Apps Are Once and Done
Sure, there's an app for that, but few top pharma apps get most of the attention .... The top 5 apps were Sanofi's Go Meals, Bayer's Clarityn's Pollen Forecast UK, Johnson & Johnson's 7 Minute Workout App, Sanofi's PillReminder Denk an mich, and the Merck ($MRK) Manuals professional edition .... Fierce Pharma Marketing

8/25 Myeloma Outlook
Myeloma market set to be $9bn by 2021 .... Promising new drugs include Takeda's oral drug ixazomib, which is currently acing late-stage trials, and Array Biopharma's filanesib, as well as BMS/AbbVie's candidate elotuzumab and Janssen's daratumumab. .... PM LiVE

8/25 Joint Trial Proposed for "T" Drugs
FDA official encourages makers of Low T drugs to work together on a single risks trial .... While there has been a big increase in the use of the drugs to treat older men whose sex drive has waned, the benefits and risks of doing that have not been determined. In the piece, the authors encourage "companies to work together on a single trial." .... Fierce Pharma

8/25 Internet Drug News Fast Takes:
An aspirin a day — for years — may keep colon cancer away
Reuters
Pfizer says Hospira purchase will close in early September
AP/Yahoo
Survey: Over a third of U.S. adults miss life events due to flu
American Pharmacy News
Increasing Use of Statins for Primary Prevention in Elderly
HealthDay News
After A Divorce, What Happens To A Couple's Frozen Embryos?
NPR Health Blog


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