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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
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

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
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
Novo Nordisk's Victoza fails type 1 diabetes trial
FDA grants Tocagen's glioblastoma treatment orphan drug status
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
Pfizer says Hospira purchase will close in early September
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

Fast Takes
Factbox: Top 10 makers of prescription cancer drugs
Corporate America Saves $3 Trillion by Putting Retirees on Obamacare
The Street 
China to Speed Up New Drug Approvals in Boost For Multinationals
Gilead Sciences: Hep-C Prescriptions Still Slowing

8/24 Diabetes Big Dogs Stock Prices Soar
Lilly, Sanofi, Novo among many pharma players to throw off big price gains in H1 … Lilly enjoyed a 21% price rise in the first half of the year …  Sanofi, it also was anticipation that played the biggest part in its 17% stock gain … [Fierce Pharma]

Januvia Under Threat Again.  This Time SGLT2 Jardiance (empagliflozin) 
Merck's Diabetes Dominance at Risk as Rival Drug Helps Out Heart … two months after the company celebrated a study showing that its best-selling diabetes drug Januvia didn't harm the heart, new research shows a rival pill [Jardiance (empagliflozin)  ] significantly reduces the risk of cardiac events -- a first for any diabetes drug.

Novartis Buys License To Sell Version Of Arzerra (ofatumumab) For M.S.
- They paid $1 Bln for the rights
Novartis to Buy Multiple Sclerosis Drug From Glaxo … gives Novartis all remaining rights to ofatumumab, which is being developed to treat relapsing, remitting multiple sclerosis and other autoimmune conditions … $300 million upfront to Glaxo and another $200 million once late-stage clinical trials …[NY Times]

Google Developing Bloodless Glucometer That Reports To Your Smart Phone
How Google Wants to Help Change Diabetes Forever … small, band-aid sized blood glucose monitor that can measure and load blood sugar levels to the wearer's smartphone … continuous glucose monitor (CGM) monitors blood sugar levels through the skin without a blood sample, or skin prick …[The Street]

Onion Skewers Pink Viagra Sex Pill
What You Need To Know About 'Female Viagra' … Q: What are the possible side effects?  A: Trial participants reported feelings of being duped, ripped off, and lied to … Q: How does Flibanserin work?  A: Women simply take the pill daily for four to eight weeks, feel no increase in happiness or desire, and then discontinue using it …[The Onion]

Certain Harvoni Patients Need 24 Months Of Therapy At $1,125 Per Pill
Bad News for Hepatitis C Patients: Your Treatment Costs May Be Higher Than Expected … genotype 1 patients who have been previously treated and present with liver cirrhosis need to undergo a more rigorous 24-week treatment course if they're on Gilead's Harvoni. At $1,125 per pill, that works out to an additional expense of $94,500 …[Motley Fool]

Fast Takes
Poll: Majority in US wants gov't to curb prescription costs

SGLT2 Blocker JARDIANCE® (empagliflozin) 
Appears To Have Cardioprotective Effect
- Data suggests that Jardiance is 1st diabetic drug to prevent stroke, heart attack
- Data gives Lilly/Boehringer product leg up on the competition
Sweet Victory: Eli Lilly's Jardiance Is First Diabetes Drug To Reduce Heart Attacks And Strokes … Other diabetes drugs, like Merck's Januvia and AstraZeneca's Onglyza, have tried for this result and failed…. positive findings will highly likely represent an SGLT2 "class effect", technically speaking it will only be LLY/BI who could market the findings for their drug specifically …[Forbes]
Diabetes drug shows 1st protection from heart complications … For the first time, there's evidence that a diabetes medication, Jardiance, reduces risk of the complications that are the top killer of diabetics: heart attacks, strokes and other cardiovascular damage …[AP]
Lilly, Boehringer diabetes drug cuts heart attack, stroke risk in trial …[Reuters]

The FDA Is Basically Approving Everything. Here's The Data To Prove It
The FDA Is Basically Approving Everything. Here's The Data To Prove It … As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as "new molecular entities," faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%. …[Forbes]

Valeant to Buy Maker of Women's Libido Drug for $1 Billion
Valeant to Buy Maker of Women's Libido Drug for $1 Billion … Sprout will become a unit of Valeant, keeping its headquarters in Raleigh, N.C. … will take Valeant into the market for women's health products. Because it is the first drug of its kind to win approval, Addyi, known generically as flibanserin, will avoid the kind of competition that can diminish commercial prospects …[WSJ]

Takeda's Velcade Patent Overturned in Win for Generics
Takeda's Velcade Patent Overturned in Win for Generics … patent on the medicine that expires in 2022 is invalid … generic version of the medicine could enter the market when another patent expires in May 2017 … [Bloomberg]

Female Libido Pill and Five Other Drugs That Can Be Defeated by Their Own Side Effects
The Female Libido Pill and Five Other Drugs That Can Be Defeated by Their Own Side Effects … sex-drive enhancer that can cause drowsiness or nausea? It's not the only drug that sometimes backfires … drug labels are pages long and filled with small print about the possible downsides. Sometimes those side effects actually exacerbate the problem the drug is intended to treat …[Bloomberg]
Editor's Note: Mentions Advair, antidepressants, osteoporosis drugs and Epogen as drugs that can exacerbate the ailments they are used to treat.  Includes 3 minute video.

8/21  Mylan hit with FDA warning, Janssen lawsuit
Mylan rapped over manufacturing violations … Three facilities in India owned by Mylan failed to follow procedures intended to ensure that injectable products were sterile, the FDA said in a warning letter. Separately, Mylan confirmed that Janssen is suing it after Mylan filed an application for a generic version of the prostate cancer treatment Zytiga …[Pharma Times]

Merck recalls 276K Bottles Of Temodar and Temozolomide
Merck recalls cancer drugs with cracked bottle caps … voluntarily pulling certain bottles of the oncology drug Temodar and the generic temozolomide because about 276,000 of them may have cracked caps that are no longer child-resistant. The capsules were sold between July 2013 and August 2015 …[Consumer Affairs]

8/20 More Hype for Special K
Is ketamine the best hope for curing major depression? .... The U.S. Food and Drug Administration hasn't approved ketamine for the treatment of mood disorders, but dozens of medical studies show that it can quickly alleviate severe depression. There's no regulation to stop doctors like Brooks from administering ketamine for nonapproved uses—a practice known as "off-label" treatment—but insurers typically don't cover it. .... Bloomberg

8/20 Addyi Already on Anthem Formulary; on Tier 3
Libido Pill's Risks Have Insurers Weighing Whether to Cover It .... Anthem, the third-largest health insurer in the country, will cover Sprout's Addyi in many cases. Insurer Cigna Corp. and drug benefits managers including Express Scripts Holding Co. and CVS Health Corp. said they'll evaluate what to do over the next few weeks .... Bloomberg

8/20 No Promotion Allowed for 'Pink Viagra' But Demand is Building
FDA to Sprout: Forget advertising your sex-drive med till 2017 .... Eighty percent of women surveyed recently by Treato said they would take a daily pill to improve a low sex drive. Another 73% said they were likely to discuss low sex drive with a physician .... Fierce Pharma Marketing

8/20 Lundbeck Will Cut 17% of Workers
Lundbeck Surges as New CEO Cuts 1,000 Jobs to Fight Generics .... "Unsatisfactory profitability" and a 7 percent decline in underlying revenue caused by generic competition for the antidepressant Cipralex and Alzheimer's treatment Ebixa necessitates firings, [CEO] Schultz said .... Bloomberg

8/20 Record New Price for Priority Review Voucher
AbbVie buys special review voucher for $350 mln .... The voucher, which offers a plethora of incentives, makes its holder eligible to have one of its drugs reviewed in six months, compared to the standard 10 months .... Reuters

8/20 When There Aren't Enough Patients to Go Around
For a Rare Disease, Drug Trials Scramble for Patients .... The pharmaceutical companies need to enroll enough patients to demonstrate results. The pool of eligible patients in a rare disease like Niemann-Pick Type C is small, though. Doctors say there aren't yet reliable counts of diagnosed cases, but current estimates put the number at around 500 world-wide. .... WSJ

8/20 Reed v. Town of Gilbert Eyed for Impact on Drug Labeling
Court's Free-Speech Expansion Has Far-Reaching Consequences .... Justice Thomas took a different approach. Any law that singles out a topic for regulation, he said, discriminates based on content and is therefore presumptively unconstitutional. Securities regulation is a topic. Drug labeling is a topic. Consumer protection is a topic .... NY Times

8/20 Project Evo Working on Computer Game to Treat ADHD
'Play This Video Game And Call Me In The Morning' .... "If it says 'FDA approval needed' in the business plan, I myself scream in fear and run away," says Tim Chang, managing director at Mayfield Fund, a venture capital firm. He has never backed a company that wanted to go through the FDA. Most startups can bring a new video game to market in six months. Going through the FDA approval process for medical devices could take three or four years — and cost millions of dollars. .... NPR

8/20 'New Wave' Cancer Tactic Has Hits, Misses
First trial targeting mutation, not cancer type, gives mixed results .... Among 20 patients with non-small-cell lung cancer, the most common form of lung cancer, 42 percent of patients showed signs of responding to the drug and average progression-free survival time was 7.3 months .... Reuters

8/20 Internet Drug News Fast Takes:
Buyer beware: some generic eczema creams pricier than others
Why researchers are training dogs to help with cancer diagnosis
Daily Briefing
New FDA Guidance Addresses Common Issues in Orphan Drug Development
Regulatory Focus
Roche snaps up gene sequencing group Kapa
Pharma Times
Just one or two drinks a day could increase risk for certain cancers
Medical News Today
Lynparza Improves Overall Survival in High-Risk Gastric Cancer
Med Page Today

8/19 Pink Viagra (Addyi) Approved; Black Box and REMS; Approx: $400/Month
FDA Approves First Drug To Boost Women's Sexual Desire .... Some women faint when they take it. Others wake up so groggy the morning after it could be dangerous for them to drive to work. And there could be long-term risks from taking a psychoactive drug daily for years. Addyi works by altering the levels of three important neurotransmitters — norepinephrine, serotonin and dopamine .... NPR Health Shots blog
See also: FDA Approves Addyi (Flibanserin), 'A Milestone Moment' In Women's Health [Forbes/David Kroll]

8/19 Newly Insured Don't Need to Dip into Grocery Money to Pay for Prescriptions
Wal-Mart Margins Hurt by Affordable Care Act .... The Bentonville, Ark.-based retailer said its pharmacy business had reduced margins, which hurt earnings at the U.S. business. Much of that was due to fewer customers paying for drugs with cash, which has higher margins .... WSJ CFO Journal$$

8/19 Implantable Drug Pump Beats Januvia
Boston firm's diabetes treatment beats $6B Merck drug in head-to-head trial .... The trial showed patients who had Intarica's tiny ITCA 650 implanted under their skin saw double the reduction in a type of hemoglobin tied to the disease after one year than patients taking Januvia, by Merck. The company's device also brought about four times the weight loss in patients — about nine pounds in a year versus two pounds .... Boston Business Journal

8/19 Off-Label Marketing Settlement
Amgen pays $71 mln to settle Enbrel, Aranesp marketing case .... Authorities said Amgen violated state consumer protection laws by marketing both drugs for off-label uses, through its promotion of Enbrel to treat mild plaque psoriasis and Aranesp to treat anemia caused by cancer .... Reuters

8/19 Collusion Settlement
Concordia, Par Pharmaceutical settle anti-competition charges .... The FTC had alleged Concordia, a unit of Concordia Healthcare Corp, had agreed not to sell a generic version of the drug in exchange for a share of Par's revenues .... Reuters

8/19 Orencia Back on the Airwaves
BMS revives Orencia DTC advertising after two-year absence .... Orencia was approved by the FDA in 2005 and has been approved for a patent extension which is currently set to expire in the U.S. in 2019. The drug has been a steadily building blockbuster for BMS .... Fierce Pharma Marketing

8/19 Plan Says 'Go 90'
Anthem reminds Medicare members to ask for 90-day prescription fills .... One out of every 10 cases of missed medication is caused by a patient being too late to get a pharmacy refill. Missed prescriptions cost about $100 billion annually because patients are forced into the hospital for acute episodes that could have been avoided .... American Pharmacy News

8/19 Temodar Packaging Recall
Merck Recalls Chemotherapy Drug Over Child-Proof Cap Cracks .... The recall covers bottles of the drug that were sold between July 2013 and August 2015. The problem affects bottles containing the drug under its brand name, Temodar, and its generic name, temozolomide .... NY Times

8/19 Overweight Diabetics Lose 6% of Body Weight in a Year on Saxenda
Liraglutide Linked to Weight Loss Over 56 Weeks in T2DM .... The researchers found that weight loss was 6.0, 4.7, and 2.0 percent, respectively, for liraglutide 3.0 mg, liraglutide 1.8 mg, and placebo (P = 0.001 for both) .... HealthDay News

8/19 FDA Will Evaluate First-Line Expansion for Keytruda for Melanoma
US priority review for first-line Keytruda .... One-year survival for Keytruda was 74% versus 58% for Yervoy, while the risk of death was cut by 37% .... Pharma Times

8/19 Mylan Can't Keep Its Own House Clean
Mylan, Critic of Indian Drugmakers, Warned by FDA on Quality .... Mylan, one of the generic drug industry's biggest critics of poor quality at Indian drugmakers, had "significant violations" of manufacturing-quality rules at three plants in India .... Bloomberg

8/19 Internet Drug News Fast Takes:
Frito-Lay Slammed by FDA for Dirty Plant That Leaks Cookie Dough
How Kentucky Embraced A Life-Saving Drug For Opioid Addicts
Huffington Post
Anxious? Depressed? Blame it on your middle-management position
Columbia University's Mailman School of Public Health
Liver damage in hepatitis C patients significantly underestimated
Henry Ford Health System

Top 100 Drugs Revealed
100 Best-selling, Most Prescribed Branded Drugs Through June …  Rosuvastatin had about 21 million prescriptions, followed by (Advair Diskus, GlaxoSmithKline), at about 13.6 million prescriptions;  (Nexium, AstraZeneca), at about 13.2 million prescriptions; the insulin glargine injection Lantus Solostar (sanofi-aventis), at about 11.2 million …[Medscape; Free Reg. Req..]
Comment: The top 100 meds generated $112 Bln in sales.  Fascinating article; good hip pocket data.  Includes gross US sales for all 100 products.  The top 3 dollar amount selling drugs are monoclonal antibodies; of the top 5 money makers , 4 are large molecules. 

Fallout From Kardashian's Unconventional Advertisement Continues
- FDA letter keeps Diclegis In The News; Experts Predict Duchesnay To See Bump In Sales.
Has Kim Kardashian ruined pharma marketing, too? Fallout from the infamous Instagram post … more than 460,000 likes and social media conversations about the drug skyrocketed--up more than 500% … Adweek's headline declared: "FDA rebukes Kim Kardashian for morning-sickness drug ad on Instagram but pharma marketer Duchesnay wins big anyway …[Fierce Pharma Marketing]
Note: If you Google "morning sickness pill". Diclegis comes up first.  Best pill for morning sickness - Diclegis comes up 5th.  If you google "Kardashian pill", of the top 10 results, articles regarding FDA's displeasure take 7 of the spots.  Will FDA will insist Duchesnay  put together an Adwords campaign regarding Diclegis side effects for the key words and phrases relating to morning sickness?  Like when you google "enbrel" and see ads for Otezla® (apremilast).

Experts: Pfizer To Sell Rights To Remicade Knockoff
- Picked up a similar product when they bought Hospira
Analyst: Pfizer may favor Hospira's Remsima over in-house Remicade biosim … Hospira has a partnership with South Korea-based Celltrion--and that duo is already selling biosimilar Remicade in Europe … recent accounts suggest that the Celltrion-Hospira partnership is grabbing some significant market share with their biosim, sold under the brand names Remsima (Celltrion) and Inflectra (Hospira) …[Fierce Related: Will Novartis AG (ADR) Buy Pfizer Inc. Biosimilar Remicade? … Five of these 11 candidates overlap with the ones being developed by Pfizer, so upon the completion of the deal, Hospira would add six new biosimilar candidates to Pfizer's biosimilar pipeline …[BidnessEtc 8/6/15]

Docs Don't Understand Biosilimar; Biosim Not Slam Dunk For Success
Most docs are in the dark about biosimilars: survey … only 38% could name a biosimilar that's under consideration for FDA approval … Only 17% of that segment said they are "very likely" that they would prescribe biosimilars and 70% said they either aren't sure or are "somewhat likely'" to prescribe a biosimilar.  …[MMM]
Comment: The biosim war will not be fought in the doctor office.  This is a payor market.  Expect PBMs to extract ginormous discounts that will shrink the financial benefits of prescribing biosims. The docs may be in the dark now, but they will learn awful fast once the phone "that's not coveredf" phone calls start to roll.

Why drug companies are betting big on 'pharmerging' countries
Why drug companies are betting big on 'pharmerging' countries … developing countries where use of pharmaceuticals is growing rapidly-are expected to see the fastest growth in total drug spending over the next three years, making them attractive targets … [Fortune]
Comment: Interesting article; describes benefits and pitfalls.  Adds that Novartris, AZN and Sanofi are at the head of the pack.

FDA: Esperion Cholesterol Pill Will NOT Require Cardio Outcome Trials
Esperion Cholesterol Drug Can Forgo Heart Trial, Aiding Approval …  developing ETC-1002 as a cholesterol-lowering therapy for patients who can't be helped just by statins like Pfizer Inc.'s Lipitor … Esperion said it's planning to run a trial anyway…[Bloomberg]
Related: According to the Esperion website, "ETC-1002 is converted to a derivative coenzyme, or ETC-1002-CoA, which directly inhibits ACL, a key enzyme that supplies substrate for cholesterol and fatty acid synthesis in the liver"  More ackground information on ETC-1002.

Tsunami Of Truthful Off Label Discussion From Gun-shy Drug Companies? Not Yet
What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma … It's one ruling and one case in New York… The smoke hasn't cleared yet … "Industry is warned not to change its off-label policies based only on this decision," Kamp wrote. "However, it is clear that the era of bans on truthful off-label marketing is coming to an end …[MMM]

Fast Takes
Did Merck and NewLink Genetics Just Cure Ebola?
Motley Fool
Roche Wins Reversal of $25M Accutane Verdict
NJ Law Journal
FDA approves OxyContin for children 11 and older
Kim Kardashian, Dr. Oz And TV Drug Ads
Novo Nordisk updates on Ryzodeg, Tresiba and Xultophy
The Pharma Letter - Free Trial
Sales rep's non-compete clause trumped pregnancy-bias claim

The 5 Most Expensive Drugs in the World in 2015
- Drugs priced in the $300,000-$360,000 annual cost range didn't make the list!
The 5 Most Expensive Drugs in the World in 2015 …  Glybera: $1.21 million wholesale cost per year … Soliris: $700,000 wholesale cost per year … With little standing in the way of higher prescription drug prices, annual costs in the high six-digit range could soon become a norm in the orphan disease space….[Motley Fool]

Endo Prevails: No Generic Opana ER Till 2023
- Actavis has 60 days to pull it's knockoff
Endo Wins Order Blocking Generic of Opana ER Until 2023 … Actavis's generic version of Opana ER -- which isn't crush resistant -- accounts for about 13 percent of prescriptions … Impax struck a deal with Endo in 2010 to make its generic version …[Bloomberg]

Probing Lawmakers Grill Valeant On Gigantic Price Hikes
For Nitropress (nitroprusside), Isuprel  (isoprenaline)
Probing lawmakers grill Valeant on price hikes …  company jacked up list prices for the meds by 525% and 212%: Abnormal heart rhythm treatment Isuprel jumped to $1,346.62 per vial from $215.46, while blood pressure therapy Nitropress shot up to $805.61 from $257.80 … Horizon Pharma ($HZNP), for one, sent the price of Vimovo pain tablets soaring by 597% after buying the rights from AstraZeneca …[Fierce Pharma]

Execs Behind So-Called Pink Viagra Have Poor Reputation With FDA
Drug execs behind female libido pill have run afoul of FDA … critics, who see a troubling pattern in the aggressive tactics it has used to urge the FDA to approve the women's desire drug, which was previously rejected two times …  marketing push ran afoul of federal rules, making misleading, unsupported statements about the benefits of testosterone therapy while downplaying risks ...[AP]

8/17 Novo Hypes Oral GLP1 Pill, Possible American Factory Plans
Biggest Insulin Maker May Build Diabetes Drug Plant in U.S … considering building a factory overseas to make an oral version of a medicine for type 2 diabetes called semaglutide … If oral semaglutide, a so-called GLP-1 drug, is approved and primarily sold in the U.S. initially, there is an expectation from government and insurance payers that …[Bloomberg]

Too Few Actos 'Victims' Signing Up For Class Action Payout;

8/14 Compounded Drugs Blow $2 Billion Hole in Pentagon Budget
Rising Drug Costs the Real Stumbling Block for Defense Measure .... Amid continuing increases in the cost of prescription drugs, the budget hole was created in part by a surge in the use of compound medicines. Reimbursements for the specially formulated drugs rose to $1.7 billion in the first half of this year from $23 million in 2010 .... Bloomberg

8/14 Big Bet on Breo
GSK hopes big clinical trial can breath new life into lung drug .... Data from the so-called SUMMIT study, designed to show GSK's Breo can prolong lives of patients with chronic lung disease, are expected as early as next month, nine years after a similar study with GSK's older drug Advair failed by a whisker .... Reuters

8/14 Drug Sales and Scripts Leaderboard
100 Best-selling, Most Prescribed Branded Drugs Through June .... Through June of this year, the cholesterol-lowering drug rosuvastatin (Crestor, AstraZeneca) was the most prescribed branded drug in the United States, and the arthritis drug adalimumab (Humira, Abbott Laboratories) was the best-selling branded drug .... Medscape [reg. req'd]

8/14 Talking Tough on New Cholesterol Drugs; Plus Hep C Demand Flattening Out
Payers Set To Play Hardball On PCSK9 Pricing .... Analyst Michael Yee estimated that use of exclusive deals could drive pricing 10% below the consensus forecast, given the similarity of the two drugs. .... Investor's Business Daily

8/14 Anger and Agita at the Prescription Counter
Consumer Reports' poll shows one-third of Americans hit by high drug prices .... People said they paid an average of $39 above the usual cost for their prescription—and one in 10 said they paid a whopping $100 or more out-of-pocket .... Consumer Reports

8/14 "Pink Viagra" Decision Expected August 18
Women's sex drug gets political hard sell .... Many of the groups that signed on to Even the Score also acknowledge flibanserin is not perfect, but they say approval is necessary to get other companies to invest in the field. .... Politico

8/14 Amgen vs The Cancer Letter
Journalist fights Amgen subpoena in Aranesp class action suit .... Amgen is asking a federal judge to force a reporter to testify about an article he wrote that prompted a shareholder suit against the company and to spell out how he got information about an abandoned clinical trial .... Fierce Pharma

8/14 Multiple Myeloma Disease Trajectory Changing
Pharma should revamp marketing for life-extending blood cancer meds .... The study concluded that survival rates for patients with multiple myeloma would hit 6 years by 2022, up from about two and a half years in 2000 and three and a half years in 2008 .... Fierce Pharma Marketing

8/14 Kim K 1, FDA, 0. Diclegis Post Huge Success for Sponsor
Kim Kardashian, Dr. Oz And TV Drug Ads .... While few will pay attention to the warning letter, millions now know that there is a 'morning-sickness' pill that works for Kim Kardashian, and looking at how beautiful her baby turned out, it must be safe to take while pregnant .... Forbes/John LaMattina

8/14 Data Quality Issues Often Glossed Over in New Drug Applications
Eliquis claim about reduced deaths questioned by FDA reviewer .... FDA reviewer Thomas Marciniak concluded that if there was one more death among Eliquis patients or one less warfarin death, the benefit would no longer be considered statistically significant. In a December 2012 memo, Marciniak noted there were more than 300 Eliquis patients with missing data. .... Journal Sentinel

8/14 Internet Drug News Fast Takes:
Scientists use bioengineered yeast instead of poppies to make opioids
Women tend to stick with IUDs over long term
They Have Insurance, but a Third of Breast Cancer Patients in Appalachia Are Not Taking Their Prescribed Adjuvant Hormone Therapy
Oncology Times
Google's Alphabet inks first health pact
Healthcare IT News
Study shows that women's brains respond more to romantic cues on a full stomach
Drexel University

8/13 Venetoclax Successful in Phase 2 for CLL Variant
AbbVie to seek approval for potential blockbuster leukemia drug .... The drug was tested in patients with chronic lymphocytic leukemia (CLL) who had a so-called 17p gene deletion that has been associated with aggressive cancer and survival of less than 2 to 3 years after diagnosis.... Venetoclax achieved its target overall response rate .... Reuters

8/13 Dean of Health Economists Looks at What We Pay for Specialty Drugs
Probing our Moral Values in Health Care: the Pricing of Specialty Drugs .... The health system's QALY supply curve confronts society with 2 vexing moral questions that physicians are not in a position to determine on their own. First, how much is society willing to pay for an additional QALY derived from a particular intervention? And second, should the maximum price to be paid per additional QALY be the same for everyone, or can it vary with the individual patient's ability to pay for it? .... news@JAMA

8/13 Rumor Mill: PfizerKline
Pfizer Is in Talks to Acquire GlaxoSmithKline .... Combining these two pharmaceutical giants would likely result in substantial savings for Pfizer, both in drug development and administratively, as the two drugmakers have a few overlapping development programs. .... Motley Fool

8/13 10 Minute Computer Game Will Serve as Dementia Early Warning
FDA approves tool for diagnosing dementia in a doctor's office .... Cognivue is a cognitive-assessment tool that functions somewhat like a video game.... The 10-minute, non­invasive examination can detect subtle lapses in the brain's perceptual ability that may signal the early stages of mental decline .... Washington Post

8/13 Bay State Flirts with Transparency and Price Controls for Pharma
Mass. bill seeks to rein in prices of some drugs .... An alliance of lawmakers, consumers, and health insurers is pushing for a law that would force biotechnology and pharmaceutical companies to justify their prices by disclosing how much they spend on research, production, and marketing. It also would allow the state's Health Policy Commission to limit the prices of especially costly drugs .... Boston Globe

8/13 Keep Your Launch on Track with Quick Polling
Real-time data can put slow drug launches into the fast lane .... Disconnects between doctors and pharma are common during launches. Advertising missteps and negative consumer perceptions can also trip up a new drug. .... Fierce Pharma Marketing

8/13 Everyday Health Strategy
Everyday Health expects growth from consolidated offerings and specialty brands .... Everyday Health CEO Ben Wolin said future growth for the company will likely come from its ability to combine its audience and CRM services into one offering and generate revenue from health insurers and hospital systems. .... MM&M

8/13 Opdivo Melanoma Decision Pushed Back
FDA Pushes Back Decision on Expanded Use of Bristol-Myers Squibb Drug Opdivo .... Bristol-Myers, which initially said a decision was expected by Aug. 27, said it had submitted additional clinical-trial data, which amounts to a “Major amendment” that requires additional time to review .... WSJ

8/13 Coverage Lines Being Drawn for PCSK9 Inhibitors
Battle Over Who Gets $15,000 Heart Drug Focuses on Guidelines .... Aetna will approve Praluent for heart disease patients whose bad cholesterol remains above 70 milligrams per deciliter despite trying two regimens containing both a statin and another type of cholesterol drug, according to a recent policy bulletin. The average American adult has an LDL of about 115, according to recent AHA statistics .... Bloomberg (autoplay audio and video)

8/13 Patent Raider Defends His Lawsuits and Short Sales
Kyle Bass Says So What If He Challenges Drug Patents for Profits .... The drug industry also is lobbying Congress to exclude drug patents from the review process that's been called a "death squad" for the high number of patents invalidated. .... Bloomberg

8/13 Internet Drug News Fast Takes:
Music boosts recovery from surgery, reduces pain
This tool could predict which of your patients will develop sepsis
Advisory Board
Is Google's Switch To Alphabet Good For Healthcare? Definitely Maybe
Forbes/Matthew Herper
Antidepressant drug trials criteria not generalizable
Rhode Island Hospital
Antidepressants During Pregnancy Have Benefits, Risks

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