Internet Drug
Pharmaceutical News & Information; Updated Daily

Medical Dictionary
Clinical Trials In Progress
Clinical Trial Results
SEARCH Medline
Medline Plus  by Topic
Gen Info;Site Dissection

Boiler Plate Patient Info
Advisory Documents
Database Of Ongoing Clinical Trials
New Drug
Dear Doctor Letter Database
Drugs@FDA [gateway]
Drug Approvals Report

Newly filed ANDA's
Product Data Database
Orange Book
Recently Approved Drugs (CenterWatch)
Upcoming Meetings

Medwatch Safety
NDC Code Directory

Postmarketing Safety Data

Warning Letters
Medwatch Top Pages
Site Map
Pharmaceutical Sales
Diabetes Drugs
Drug Information Databases
Pharmaceutical Sales

Search By Definition

This website is accredited by Health On the Net Foundation. Click to verify. We comply with the HONcode standard for trustworthy health information:
verify here

Worth a Click:
- PharmaGossip
- Viagra For Women; Investigative Report
- Patent Docs
- Medical Media & Marketing News
NEW - Farmazia.Net (Spain)
- Canada Pharmacy News
- Drug Wonks
- World Of DTC
ΏYour Link Here?
Let's Trade

Pharmaceutical News Harvest (TM)

10/28 Surprisingly Broad Support for Public Option
Drug Prices, Not The Health Law, Top Voters’ Health Priorities For 2017 .... Majorities of Democratic, Republican and independent voters all support making sure high-cost drugs for chronic conditions are affordable for patients who need them .... Kaiser Health News

10/28 Big Battle on Prescription Costs Coming in New Congress
In Washington's Drug Price Fight, Plenty of Blame to Go Around .... Whether Hillary Clinton or Donald Trump wins on Nov. 8, most of the players are betting that something will get done on the cost of prescription drugs. They’re laying defensive and offensive groundwork for when new laws are drawn up .... Bloomberg

10/28 Durvalumab and Tremelimumab Trials on Hold
AstraZeneca pauses two cancer drug trials' enrolment due to bleeding .... AstraZeneca's high hopes for cancer immunotherapy were dented as the recruitment of new patients with head and neck cancer into two clinical studies was put on hold, following instances of bleeding .... Reuters

10/28 GSK Brings You the Technology to Experience a Splitting Headache Whenever You Want
How Excedrin brought VR to drug marketing with The Migraine Experience .... Sufferers picked out the symptoms of their migraine then handed the VR headset over to their non-migraine-sufferer partner to experience a migraine first-hand, albeit without the pain .... MM&M

10/28 Overview of Twitter Use by Drug Companies
How pharma is using Twitter to connect with patients .... According to a list maintained by industry blog Eye on FDA, there were nearly 335 company Twitter accounts as of June 2016. These accounts represent some 69 companies, with several companies having multiple accounts, and 201 are active on a daily basis .... BioPharma Dive

10/28 Humana Will Require Prior Auth for DMD Drug; Will End Coverage if Mobility Lost
Humana spells out its conditional Exondys 51 coverage policy — strings attached .... Humana says that it will only provide coverage for the $300,000-plus therapy provided patients are still ambulatory, continue to prove that they remain able to walk and meet the criteria for patients who may benefit from an Exon 51-skipping drug .... Endpoints News

10/28 A Picture is Worth 1,000 Words
New research reveals pictograms help seniors understand medication instructions .... The researchers chose to focus on seniors as they form the largest group of medication users and are more likely to suffer from multiple chronic diseases, therefore taking multiple drug therapies. Physicians explain to their patients how to take medication, but when faced with an array of pills, older patients only remember about 20-60 percent of the instructions they've heard .... Medical Xpress

10/28 Better Adherence with E-Prescriptions
Electronic prescriptions associated with less nonadherence to dermatologic Rx .... The risk of primary nonadherence was 16 percentage points lower among patients given electronic prescriptions (15.2 percent) than patients given paper prescriptions (31.5 percent). .... Medical Xpress

10/28 The PBM Squeeze on Prices Will Spread from Diabetes to Asthma and Beyond
Eli Lilly's Diabetes Misery Will Have Company .... As insulins in particular get older -- Humalog was initially approved 20 years ago -- companies are increasingly competing on price and rebates to keep market share. PBMs and insurers are happy to help out .... Bloomberg Gadfly

10/28 Cancer Survivors Use Depression and Anxiety Drugs at Twice the Rate of Those with No Cancer History
Cancer Survivors Have Higher Rate of Antidepressant Use .... Among 3,184 adult cancer survivors, 19.1 percent reported taking medication for anxiety, depression, or both. Among the 44,997 adults with no history of cancer, 10.4 percent reported use of these medications .... Health Day

10/28 Internet Drug News Fast Takes:
Anti-Aging Startup Backed by Fidelity, Bezos Raises $116 Million
Antidepressants in pregnancy tied to health risks for kids
The Woman At The Center Of The Biggest Biotech IPO Of The Year
Sanofi will accept epilepsy drug blame if court rules that way
GSK expands meningitis B vaccine production in Germany

10/27 STAT Discovers That Pharma Companies Use Rebates to Get Better Formulary Placement
Drug maker thwarted plan to limit OxyContin prescriptions at dawn of opioid epidemic .... The strategy to pay Merck Medco extended to other big pharmacy benefit managers and to many other states, according to a former Purdue official.... The payments were in the form of "rebates" paid by Purdue to the companies. In return, the pharmacy benefit managers agreed to make the drug available without prior authorization and with low copayments .... Stat

10/27 Cigna Eases Access to Suboxone
Cigna drops prior authorization requirement for opioid-misuse treatment buprenorphine .... Cigna previously required physicians to answer various questions about an individual's treatment and medication history before it would approve coverage for buprenorphine .... Advisory Board Daily Briefing

10/27 Long Treatise on "March-in" Rights from Pharma Critic
Just the Medicine .... In the thirty-six-year history of Bayh-Dole, there had only been five attempts (petitions from patients, advocacy groups, or corporations) to get the government to invoke march-in or royalty-free rights--together referred to as "retained rights"--against a pharmaceutical company. All five petitions had been rejected by the National Institutes of Health (NIH), an agency of the Department of Health and Human Services .... Washington Monthly

10/27 Auvi-Q Coming Back to Market in 2017
An Alternative To The EpiPen Is Coming Back To Drugstores .... Eric Edwards, who was an inventor of the Auvi-Q and founder of Kaleo, says the company has fully automated the production of the devices and has a 100-point quality control inspection to ensure they deliver consistent doses of epinephrine to those who use them. .... NPR

* * * Earnings Roundup * * *

10/27 Gardasil and Cubicin Drive Merck Profits
Merck Beats Estimates as Sales of Gardasil Vaccine Surge .... A broader label is expected to more double Keytruda sales to about $3.3 billion in 2017.... Sales of top drug Januvia and related Janumet missed estimates .... Bloomberg

10/27 Interview with Outgoing GSK CEO Andrew Witty; Gives 3rd Quarter Rundown
Glaxo Sticks to 2016 Forecast as U.S. Pricing Pressure Continues .... Sales also surpassed estimates, climbing to $9.2 billion after one-time gains from seasonal flu vaccine demand and rebates on Advair, Glaxo's best-selling respiratory drug .... Bloomberg (autoplay audio)

* * *

10/27 Alternatives to EpiPen Get a Toe Hold
EpiPen prescriptions continue to climb, but market share dropped .... EpiPen's share of prescriptions fell from nearly 96 percent to 92 percent from August to September as more patients apparently pushed their doctors for an affordable option .... Stat/Pharmalot

10/27 Mylan's Concerta Copy Expected to Top $200 Million in Sales
Mylan cuts short J&J's Concerta generics reprieve with new FDA nod .... The generics behemoth has won FDA approval for its knockoff for all Concerta strengths. And unlike the two versions the FDA just booted, from Mallinckrodt and Lannett's Kremers Urban, Mylan's copy is substitutable for the original .... Fierce Pharma

10/27 Generic Approval Overhaul
FDA Approval Changes Could Affect Drug Prices .... In the next user fee agreement, the FDA is committing to a 10-month review and an accelerated 8-month timeline for completing applications that would have an important impact on public health, remedy drug shortages or be the first generic competitor. .... Roll Call

10/26 Internet Drug News Fast Takes:
Humana CEO: We are using retail consumer behavior analytics to personalize care
MedCity News
Bypass surgery may be better than stents for patients who skip meds
Medicare subsidies may help more women stick with breast cancer drugs
Statins Offset Insulin-Related Cancer Risk in T2DM
HealthDay News
How to build a better care team, according to Google
Advisory Board Daily Briefing
Pollution particles damage blood vessels, may lead to heart disease

10/26 Drug Companies Spending $100 Million to Fight California Prop 61; Public Favors Measure to Force Down Prescription Spending
Big Pharma Fights 'Tooth and Nail' Against California Drug Vote .... Known as Proposition 61, the initiative intends to bring down the cost of prescription drugs by prohibiting California state agencies, such as Medi-Cal and state prisons, from paying more than the price paid by the U.S. Department of Veteran Affairs.... VA rates may be about 20 percent lower than Medicaid's .... Bloomberg

10/26 Addyi Was a Bust, But FDA Has a Guideline for New Female Desire Drugs
Female-Desire Drug Development Gets Boost From U.S. Regulator .... The Food and Drug Administration has released a draft guidance to inform drugmakers about its current thinking on the design of late-stage trials for such drugs .... Bloomberg

10/26 Express Scripts in the Crosshairs of DOJ Investigation
The Feds are starting to dig in at the biggest middle-man in the pharmaceutical game .... Both the US Attorney's Office for the Southern District of New York and the Department of Justice and US Attorney's Office for the District of Massachusetts want to know more about the company's client payment plans, pricing structures, and its patient assistance programs .... Business Insider

10/26 Walgreens Will Take Lead Share in Many Markets with RiteAid Acquisition
Trade classes battle in changing pharmacy market .... Fitch Ratings said Walgreens commands one-fifth of the U.S. prescription market, while Rite Aid has a 6% share. Besides bringing procurement and cost structure benefits from larger scale, the merger would significantly expand WBA's market reach .... Chain Drug Review

* * * Earnings Roundup * * *

10/26 Novartis: Profits Down for Seventh Straight Quarter
Novartis Profit Falls as Generics Hurt Sales of Gleevec Drug .... Novartis repeated a yearly forecast of $200 million in sales of Entresto, which brought in $53 million in the quarter, compared with an estimate of $57 million. Cosentyx revenue also fell short of estimates at $301 million .... Bloomberg

10/26 Disappointing Sales (Cialis, Talz, Diabetes Treatments) Across Lilly Line
Lilly Profit Falls Short as Humalog Insulin Sales Disappoint .... The biggest miss was Humalog, whose revenue fell 9 percent to $641 million, short of the $738 million estimate by analysts... Sales of Jardiance, a product Lilly is relying on to help drive future growth, tripled to $48 million, but were below expectations .... Bloomberg

* * *

10/26 Viagra Sales Down in 2016; Generic Expected in Late 2017
Viagra May Witness a Decline in Revenues in 2016 .... Analysts estimate that Viagra's sales in 2016 will reach approximately $1.6 billion, which would be a year-over-year decline of about 7.7%. This is mainly due to the increasing amount of rebates paid by Pfizer to the pharmacy benefit managers .... Market Realist

10/26 Insider Trades on Pfizer M&A Deals Lead to Fine and Possible Sentence
Ex-Oppenheimer adviser pleads guilty to U.S. insider trading charges .... A former investment adviser at an Oppenheimer Holdings unit has pleaded guilty to charges that he engaged in an insider trading scheme based on information supplied by a childhood friend working at Pfizer .... Reuters/Yahoo

10/26 FDA Revises Labels for Testosterone and Anabolic Steroids
FDA Adds New Warnings to All Testosterone Product Labels .... The new warning will alert prescribers to the abuse potential of testosterone and the serious health risks, especially those related to heart and mental health .... Medscape

10/26 Inflectra Launch Breaks Ground for Other Biosims
Could Pfizer's at-risk Inflectra launch set a biosimilars precedent for Amgen, Novartis? .... With U.S. biosimilars law taking shape in real time, the legal back-and-forth between the New York drugmaker and Remicade manufacturer Johnson & Johnson could set precedents for future cases .... Fierce Pharma

10/26 Zinplava Gets OK
FDA approves Merck's Zinplava to reduce recurrence of Clostridium difficile infection .... Bezlotoxumab is a selective, fully-human monoclonal antibody designed to neutralize C. difficile toxin B. Toxin B can damage the gut wall and cause inflammation .... Medical Xpress

10/26 Internet Drug News Fast Takes:
New Vascepa Capsule Strength Available
N.J. doctor accused of improperly prescribing addictive drug agrees to suspension
Merck Consumer Health CMO on who makes healthcare decisions
Newt Gingrich is the new face of a controversial opioid addiction therapy
Washington Post

Fast Takes
FDA Green Lights Keytruda As 1st Line For Lung Cancer
Merck Press Release
Price-hiking Concordia CEO heads for the exit, drawing parallels with Valeant
Fierce Pharma
Teva's: drug factory that makes hard to get bleomycin gets US FDA warning letter
In-Pharma Technologist
Clostridium Difficile (C. diff): FDA Green Lights Merck's bezlotoxumab Treatment

Seeking Alpha
Average premiums for popular Obamacare plans rising 25 percent
Washington Post

GSK Shingles Vaccine Could Be A Real Contender
- Potency, staying power appear to be differentiating feature
GSK files potential $1 bln shingles vaccine for U.S. approval … GSK's Shingrix has outperformed Merck's Zostavax in trials …  90 percent effective in people over age 70, even four years after injections. Zostavax efficacy, by contrast, varies between 18 and 70 percent, and it declines noticeably in older people … [Reuters]

Benefits, Schmenefits Sick People Are Going Broke
Employer Pharmacy Benefits in 2016: More Specialty Drug Cost-Shifting Means More Problems for Patients … cancer, rheumatoid arthritis, multiple sclerosis, and HIV.  … Patients taking specialty drugs face economically-debilitating coinsurance--in some cases with no limit on out-of-pocket expenses …[Drug Channels]

Heard On The Street: Novo Lay Off
The much anticipated Novo Nordisk layoff went down Monday morning.  Exact numbers are not known but this morning at 8:00 AM, more that 500 people were on the Cafι Pharma Novo Nordisk  anonymous message board.   To all those laid off - sorry for your loss hang in there.

Live Listeria Bugs Detected In Another Patient
Treated With Cancer Vaccine Derived From Attenuated Listeria Bugs
- Trial placed on hold, stock hammered 22%
FDA places Aduro studies on partial hold after Listeria report … based on live, attenuated, double-deleted Listeria monocytogenes. That gene deletion process is intended to destroy the natural virulence of the Listeria bacteria … [Fierce Pharma]
New Listeria fears spotlighted as Aduro's CRS-207 is slapped with partial hold … isn't the first time that Aduro has had to deal with Listeria fears … second Listeria case seen in 350 treated patients …[ENDPOINTS NEWS]

Lannett, Mallinckrodt Not Ready To Capitulate On Generic Concerta Hopes
- FDA questions proposed knockoff's bioequivalence
Generic drug makers challenge FDA plan to withdraw their ADHD pills… confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA … [Pharmalot]

Japanese Women Lawsuit:  HPV Vaccines Damaged Them
- Seek  ₯15 million each ($144K)
Lawsuit over cervical cancer vaccines to drag on as health ministry fights on … inexplicable pains and cramps throughout their bodies … Few are now opting to undergo the vaccinations in Japan … Cervical cancer is the second-largest cause of cancer deaths in women up to 40 … [Japan Times]

Fast Takes
Merck's Keytruda succeeds in key bladder cancer trial
Inside big pharma's fight to block recreational marijuana
The Guardian
Merck lays groundwork for biosimilar push
Bio Pharma Dive
Congressman calls for probe into Valeant's pricing of lead poisoning drug
The Pharma C.E.O. Who Wants to Lower Drug Prices
NY Times

Drug Rep Figured Out How To Defraud Insurance Companies
Fentanyl drug rep masterminded insurance fraud, feds say … How do you make a ton of money selling a potent drug intended only for late-stage cancer patients? … pretend they were calling from a doctor's office seeking authorization for Subsys -- and not from the pharmaceutical company that made the drug …[Fusion]
Related: Feds Charge Sales Manager In Kickback Scheme For Fentanyl Prescriptions  … [Hartford Currant]

Critic: Chicago Plan To License Drug Reps Won't Impact Opiate Demand
Chicago's proposal to license pharma sales reps is "bad morality, bad economics," critic says … "The city is looking for money, if I had to guess," he said. … proposed ordinance would do little to reduce opioid abuse and would instead just put up barriers to entry for new pharma sales reps. …

Pfizer Launches Biosim Remicade ( Trade Name = Inflectra) Next Month
Pfizer readies Inflectra launch … Pfizer says its version of the blockbuster TNF-inhibitor will be sold at a 15% discount to Remicade instead of the 80% to 90% discount often seen with generics … cannot be switched out by a pharmacist and need to be specifically prescribed …[Biopharma Dive]
Want to see a pharm exec squirm? Tell him biosimilar and generic mean the same thing.
See Also: What is the difference between Biosimilars and Generics? … [ Mary Wahl, Ph.D; Quora]
See Also: Biosimilars Clarified … [Merck & Co]

EpiPen: Another Senator Comes Out Against Mylan Sweetheart Deal
Mylan Settlement With DOJ 'Shamefully Weak' … "This settlement is shockingly soft … because it lacks criminal penalties or any incentive to "prevent drug companies from engaging in abusive schemes to defraud Medicaid … [Bloomberg]

GSK Will No Longer Sell Cervarix In The USA
- Plug pulled due to poor demand; Gardasil outsells it 17:1
GSK exits U.S. market with its HPV vaccine Cervarix … $107 million worldwide total compared to Merck's global total of $1.9 billion for the Gardasil franchise … gives Merck complete control of the U.S. HPV vaccine market as public health officials push for higher HPV vaccination rates … [Fierce Pharma]
Related: Doctors Should Push HPV Vaccine for Cancer Prevention, Says CDC … [Xtalks]

Novartis Patent Woes Crater Sales, Share Price
Novartis May Be Too Generic … Novartis stock has fallen 14% in the last year. A wave of generic drugs has wrecked results … Gleevec, which is used to treat a type of blood cancer called myeloid leukemia, lost its patent protection … [The Street]

Alkermes Depression Drug Helped Refractive Patients
- Shares surge a stunning 47%
Alkermes depression drug succeeds in key trial; shares surge … demonstrated clear superiority over placebo on two different depression scales at the higher of two tested doses, the lower dose did not achieve significance compared with placebo …[Reuters]
Editor's Note:  ALKS-5461is a fixed combination of  Buprenorphine + samidorphan. It is also being investigated as treatment for cocaine addiction.

Some NSAIDS Linked To Increased Risk Of Heart Failure
- Certain NSAIDS more risky than others
Anti-inflammatory pills tied to heart failure risk … odds of a hospital admission for heart failure was 19 percent higher  … 16 percent [higher] for naproxen but 83 percent for ketorolac. Many NSAIDs, including celecoxib (Celebrex), were tied to little or no increased risk …[Reuters]

Fast Takes
Allergan recalls some Tazorac acne gel
Fierce Pharma
FDA panel backs Allergan's night-time urination nasal spray
Pharma Times
FDA faces an overflow of orphan drug applications

10/20 Chicago Politicians Seek License Drug Reps @ $750 Per
- Compel reps to gather, share intell on their docs, take ethics courses
Chicago may license pharma reps as part of battle against opioid abuse … track and provide to the city, if requested, the number of health care professionals they've contacted, information about drugs promoted, samples provided … [Chicago Tribune]
Card-carrying pharma reps? Chicago eyes licensing for painkiller promoters … reps would have to participate in training on drug abuse, ethics and proper marketing to earn their licenses, and pay a yearly fee of $750 … [Fierce Pharma]
Editor's Note: Holding pill-mill doctors, dirty pharmacists, drug dealers or drug addicts responsible for their behavior would never work in Chicago.   Drug reps are responsible for Chicago's opioid problem.  Next they need to go after waiters for promoting obesity.  In 20 years of curating drug news for this site, this has to be the wackiest statute I have ever heard.  It is however, a creative way to raise money. 

Looked Good On Paper But Sales Disappoint
- PBM regs effective at limiting scripts
Despite Promising Early Data, The New Cholesterol Lowering Drug - PCSK9si - Has Significant Hurdles …  combined sales of these drugs is merely $327 million, a pittance compared to peak statin sales. These relatively poor sales are due to payers putting heavy restrictions on these drugs … [Forbes]

Mylan: Senator Blasts DOJ Sweetheart Deal; Demands Reset
Senator blasts DOJ's 'unacceptable' deal with Mylan, urges AG to dig deeper … deal lacks "real accountability for Mylan's apparent lawbreaking." … misclassification lasted nearly a decade cost taxpayers more than $700 million … lacks any acknowledgment of responsibility and requires payment smaller than profits made illegally … [Fierce Pharma]
See Also: Actual letter cited above … proposed settlement has been reached - inexplicably -- without knowing the exact profit Mylan made through these overcharges and requiring Mylan to pay at least that amount in fines and restitution.  Moreover, Mylan also plans to include this $465 million as a "pre-tax charge" in its upcoming quarterly filings, thereby getting a tax break for repaying overcharges to federal and state taxpayers.   Taxpayers become losers several times over … [Letter From Senator Richard Bumenthal To Attorney General Loretta Lynch]

Biosim Remicade Beats Remicade; JNJ Not Worried
Remicade patients are OK to switch to Celltrion's biosim, study shows, as Pfizer gears up for U.S. rollout … In the Remicade arm, 26.2% of patients saw their disease worsen, while 29.6% of Remsima patients … no less safe or effective for patients who switched to the biosim from Remicade … [Fierce Pharma]

FDA Wonk Vows: Sarepta Scenario Won't Be Repeated
FDA official warns other drug makers not to copy Sarepta … personal attacks on FDA reviewers, which occurred at a meeting last spring to review the drug, are unacceptable … "use of (the) accelerated approval pathway should be prospectively planned, NOT (used) as a 'rescue' for a failed program … [Pharmalot]

Site Map | Privacy Policy | Contact Webmaster
Site Mission Statement, Intended Audience, Editorial Policy, Advertising Policy
This Page Last Updated 10/24/2016

If your intellectual property being infringed
e-mail the webmaster and we will fix it. 

The information on this site is not meant as medical advice.  If you have any medical questions please consult your medical doctor or similar medical practitioner. 

The information contained on this web site is for your information only.  You should never take a drug without a doctor's prescription - only an idiot does that.   
Do NOT give yourself any drug unless it has been prescribed for you by a doctor.

Do NOT start or stop taking a medicine based on information you read here or any other internet web site because this could cause you to become seriously ill or die or worse even.


Corey Namhman Licensed Pharmacist (State Of NY; Lic #035512)

We subscribe to The HONcode of  online conduct:

1.  Qualification of author(s)
This site is published and webmastered by Corey Nahman, Registered pharmacist in the Sate of New York.
2.  Complementarity
Let it be known that the information provided on this site is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.
3.  Privacy.
We respect the privacy of the users of this site.  Please see our plain English privacy policy.
4. Attribution
At all times, the information on this site shall be footnoted with the source(s) of published information, date and medical and health pages provided.
5.  Justifiability
This site shall at all times back up claims relating to benefits and performance.
6  Transparency
This site shall at all times use accessible presentation, you can e-mail the publisher of this site at his personal e-mail address at any time.
7.  Financial disclosure
This site is supported by click advertisements, banner advertisements and affiliate arrangements.  All ads are properly labeled as such.  If you have any questions regarding how we make money please e-mail the webmaster with your questions.  All advertisements shall be clearly distinguished from content.

Badea, Badea, Badea,
That's All Folks!