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12/18 Fast Takes
Drug Name Development: Regulatory Changes You Need to Know
Fierce Pharma
Eli Lilly predicts $23B-plus sales forecast on diabetes, cancer launches
Fierce Pharma
The top 10 prospective blockbuster drug launches slated for 2018 -- Evaluate
Endpoints News
Strike Over Teva Firings Shuts Israel Stock Exchasge, Banks, Airport
Mylan Announces IPR Proceedings for Sanofi's Lantus Patents

12/18 Sanofi Evades Questions On Compensation for Dengvaxia Victims
Sanofi official declined to say whether the company will compensate people who got sick due to its dengue vaccine … too early to discuss compensation since a Department of Health task force is still investigating the purchase of the controversial vaccine, which can cause severe cases of dengue in those who were never previously infected …[DZRH News]
Drug Company Under Fire After Revealing Dengue Vaccine May Harm Some … people who never had dengue are vaccinated and later become infected, the vaccine may provoke a much more severe form of the illness …[NY Times]

Billionaire Dude Who Founded Apotex Found Dead Along With Wife
- Police unsure if foul play involved; murder suicide scenario hinted
Canadian billionaire couple die in suspicious way, bodies found 'hanging side by side next to pool' …  police are not treating the case as homicide. The detective added that the police were still trying to "determine if there is foul play involved or not … [RT]
Billionaire philanthropists found dead in basement under suspicious circumstances, police say … Barry Sherman and his wife, Honey …  estimated net worth of $4.6 billion … built Apotex from a two-employee company into a global pharmaceutical organization that employs more than 11,000 people  … [Toronto Star]

Biosims May Get To Market Faster Thanks To This Court Decision:
Biosimilars may get to market still faster, thanks to another court ruling … appeals court ruled drug makers cannot use state laws to punish their biosimilar rivals from withholding information about their medicines … At issue was whether a biologics company can sue a biosimilar maker in state court in order to obtain certain marketing and manufacturing information within 20 days after the FDA accepts a biosimilar application … [Pharmalot]

Impax Charges Americans $400 For a Pill That Costs 4 Cents In Africa
Why A Pill That's 4 Cents In Tanzania Costs Up To $400 In The U.S. … "[Impax] fits into a category of companies that have taken drugs that have been around for many years, acquired the rights and jacked up the price [for the Western market] … company that holds the monopoly, we often see companies taking advantage of their market position." … [NPR]

German Merck Wants To Resubmit Pill For Severe Multiple Sclerosis; Cladribine (Mavenclad)
- Safety concerns derailed U.S. launch ambitions seven years ago.
Germany's Merck in fresh bid to enter U.S. MS pill market … targeted patient group is characterized by highly active relapsing MS. Among the relapsing-remitting type of MS, they account for the roughly 60 percent of patients most severely affected by neurological damage and disability …[Reuters]

Teva Rolls Out Viread Authorized Generic (tenofovir disoproxil fumarate 300 mg)
Teva rolls out exclusive generic of Gilead's Viread at the end of an awful week …  launching an exclusive generic to Gilead Sciences' hepatitis B and HIV antiviral Viread, a product the company says pulled in about $750 million over the last year …[Fierce Pharma]
See Also: Teva Press Release

12/15 Black Thursday at Teva; 25% Staff Cut; "Double-Digit" Number of Factories to Close
Teva axing 14,000 workers, putting R&D and manufacturing facilities on the block in massive restructuring .... Teva is melding together its generics and specialty drug business, integrating two research groups for branded and generic drugs and looking for “synergies” that allow the company to cut deep into R&D .... Endpoints News

12/15 Ten to Watch in 2018
The top 10 prospective blockbuster drug launches slated for 2018 .... There are new advances in HIV and diabetes, and it’s not the least bit unexpected to find that 6 of the 10 are either new cancer therapies or drugs for rare diseases — two fields where the FDA is now squarely behind rapid launches .... Endpoints News

12/15 Pfizer Has an 'Extra' Biosimilar; Deciding What to Do
Pfizer weighs 'strategic options' for newly FDA-approved Remicade biosim, its second .... When Pfizer bought Hospira back in 2015, the drugmaker already had one Remicade biosim in the works; Hospira brought along a second, which is now approved as Inflectra. On 12/14, the FDA blessed Pfizer's internally developed candidate .... Fierce Pharma

12/15 200 Waiting for Yescarta; Patients Dying Waiting for Insurance Clearance
Months After Approval, Breakthrough Cancer Drug Given to Just Five Patients .... Doctors at the cancer centers blame holdups in getting the treatment paid for by Medicare and Medicaid, the two giant U.S. government health programs, as well as some of the U.S.’s largest insurers .... Bloomberg

12/15 Biotechs Getting Better Return on Investment than Traditional Pharma
Bumper crop of new drugs fails to lift big pharma R&D returns .... This decade has seen shrinking profitability in big pharma research labs, with the average internal rate of return (IRR) down sharply from 10.1 percent in 2010 to 3.2 percent this year.... A separate group of four large biotech companies are projected to enjoy an IRR nearly four times higher at 11.9 percent .... Reuters

12/15 If You Like to Curl Up by the Fire with a Stack of Legal Briefs, This Article's Got You Covered
The 2018 biosimilar litigation landscape: A primer .... This year saw numerous new complaints about the law, five new FDA approvals, another biosimilar launch, the first U.S. Supreme Court decision concerning on the topic, and the first jury trial and damages award in a biosimilar case .... BioPharma Dive

12/15 Merck KGaA Pushing Mavenclad (Which Has EU Approval) for US MS Market
Germany's Merck to make new bid to enter U.S. MS pill market .... In early 2011 the U.S. regulator’s concerns put an end to Merck’s development plans for the cladribine pill, now branded as Mavenclad, but Merck later revived efforts by focusing on the most severely affected patients and won approval in Europe in August this year. .... Reuters

12/15 Battle Report from 340B Fight in Congress
Lawmakers battle Trump, PhRMA on discount drug rule .... Lawmakers in both parties are seeking to block the Trump administration’s changes to a Medicare drug discount program, arguing it would have a negative impact on hospitals that serve low-income people .... The Hill

12/15 Gottlieb Posts Policy Goals for 2018; Nicotine Addiction Leads List
Looking ahead: Some of FDA’s major policy goals for 2018 .... FDA serves Americans by delivering on the critical mission of protecting and promoting the public health. The more than 70 actions we have identified, as part of the Fall 2017 Unified Agenda, will help us even better deliver on this mission .... FDA

12/15 Lilly Challenges: Diabetes Competition, Cialis Dropoff
Eli Lilly builds $23B-plus sales forecast on diabetes, cancer launches .... Lilly's 2018 growth will be driven by its newest diabetes drugs—Trulicity, Basaglar and Jardiance—plus plaque psoriasis treatment Taltz and cancer offerings Verzenio, Cyramza, and Lartruvo .... Fierce Pharma

12/15 Internet Drug News Fast Takes:
Vertex licenses its first drug from CRISPR collaboration
BioPharma Dive
Families of dementia patients see positive effect of social robot seal
FDA to Pharma Firms: Update or Certify Drug Listings by End of Month
Regulatory Focus
Xepi Receives FDA Approval to Treat Impetigo
CoolSculpting Was Just FDA-Cleared for Use on Double Chins

12/14 Hemlibra Will Shake Up the Hemophilia Market, But Shire Expects to Keep Leadership
Shire CEO: Hemophilia will remain a core business .... Sales of hemophilia products make up about a quarter of Shire's global revenues, annualizing to about $3.6 billion per year. Only $800 million or so of those revenues are attributable to sales of the biotech's inhibitor therapies, such as Feiba .... BioPharma Dive

12/14 New Indication for Nucala
First drug approved for rare condition that inflames blood vessels .... Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first remedy to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to inflammation of the blood vessels .... Medical Xpress

12/14 Biosimilar for Remicade Approved
FDA Approves New Pfizer Biosimilar .... The FDA has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product .... Company news release

12/14 Yard Sale at Sandoz
Novartis generics arm says may sell or end some products .... Swiss drugmaker Novartis's Sandoz generics business is in the process of selling or closing some products in the United States .... Reuters

12/14 Fibroids Drug Developer Picked Up at Fire Sale Price
Allergan picks up Repros to boost women's health offerings .... Repros has been developing both an oral and vaginal version of a drug meant to treat uterine fibroids. The oral version has been on clinical hold from the Food and Drug Administration since August 2009 due to safety concerns about elevated levels of liver enzymes .... BioPharma Dive

12/14 Senolytic Medicines (Drugs that Counteract Aging) Raise a Lot of Questions
Why a drug for aging would challenge Washington .... Metformin may not be the strongest potential drug in the anti-aging arsenal, but Barzilai and fellow aging researchers see it as a good stepping stone. It's cheap, available and has been used by humans for decades with a reasonably clean safety record. All that should make it easier for the FDA to say yes to approval as an anti-aging treatment .... Politico

12/14 Stereotactic Radiation, Guided by Detailed Electrocardiography, Eliminates Tachycardia in Trial
A 'Game Changer' for Patients With Irregular Heart Rhythm .... In the three months before they tried the experimental treatment, the five patients together suffered more than 6,500 bouts of tachycardia. It took a month for their hearts to recover from treatment, but in the year afterward the patients collectively had just four episodes of tachycardia, and two did not have any at all .... NY Times

12/14 Walgreens is Keeping Track of How Many Steps You Took Today
Walgreens app makes health tracking easy .... The retailer, which is marketing Striiv, its own branded activity tracker, allows members of the company's Balance Rewards program to also connect through 40 different devices and 27 apps .... Drug Store News

12/14 Promising Advanced Cutaneous Squamous Cell Carcinoma Results
Regeneron, Sanofi Report Positive Top Line Skin Cancer Data .... Cemiplimab is a checkpoint inhibitor targeting PD-1 (programmed death protein 1). The cemiplimab monotherapy study showed an overall response rate (ORR) of 46.3%. .... Zacks

12/14 Botox Chain Gaining Traction; $482 Average Spend per Visit
Woman-Led 'Drybar For Botox' Chain Alchemy 43 Grows -- With Drybar Founders' Backing .... It feels very much like the "beauty lab" Levy bills it as: a physician's assistant, your "alchemist," offers complimentary 3D imaging, showing on a large screen in a private room what your face could look like after a boost from Botox, Dysport, or any of the other fillers on offer. Alchemy 43, like Drybar, offers a membership program to encourage loyalty and frequency. Its $99 monthly subscription has proved a big hit with a younger clientele. .... Zacks

12/14 Internet Drug News Fast Takes:
Ironwood strengthens leadership with two new hires
Fears of Israeli Job Cuts at Teva Sparks Call for General Strike
NY Times
Older women should not take hormones to prevent chronic diseases
Parkinson's disease progression can be slowed with vigorous exercise, study shows
Chicago Tribune
Medtronic Settles Deceptive Advertising Lawsuit for $12M
Regulatory Focus

12/13 Ascension and Providence St. Joseph Health Hospital Groups Working on Merger; Would Create 191-Hospital Behemoth
Hospital Giants in Talks to Merge to Create Nation's Largest Operator .... A deal would create an entity of unprecedented reach, with 191 hospitals in 27 states and annual revenue of $44.8 billion .... WSJ $$

12/13 "White Coat Marketing" Scheme
Three more drug makers allegedly used nurses to promote medicines .... The documents describe how Gilead Sciences, Amgen, and Bayer Pharmaceuticals hired nurses to talk up treatments to doctors and their patients, an arrangement that purportedly violated federal kickback laws .... Stat $$$$

12/13 Incentive Programs Take Hold in Medicaid
Medical plans dangle gift cards and cash to get patients to take healthy steps .... Medicaid patients who agree to be screened for cancer, attend health-related classes or complete health risk surveys can get gift cards, cash, gym memberships, pedometers or other rewards. They may also get discounts on their out-of-pocket health care costs .... LA Times

12/13 Chemo for Early Breast Cancer Declined from 34.5% to 21.3% Between 2013 and 2015
Fewer women getting chemotherapy for early stage breast cancer .... The latest data suggests physicians are increasingly opting for genomic testing of tumors when a patient's treatment preferences don't align with a doctor's treatment recommendation .... UPI

12/13 "Big Box Pharmacy is a Pressure Cooker" — Results from a National Survey of Pharmacists
The Drug Topics 2017 Pharmacist Salary Survey .... The good news is that the majority of pharmacists got a pay raise in 2017, but it came with a downside: a rise in stress levels .... Drug Topics

12/13 Darzalex Pushing Its Way to the Front of the Line
ASH: Johnson & Johnson scores big Darzalex win in first-line myeloma, slashing risks in half .... At a median follow-up of 16.5 months, Darzalex, in combination with Takeda's Velcade, melphalan and prednisone, cut the risk of disease progression or death by 50% in newly diagnosed myeloma patients .... Fierce Pharma

12/13 Eight Proposals to Lower Drug Spending: What Are the Chances of Enactment?
Experts Tell Congress How To Cut Drug Prices. We Give You Some Odds. .... The report from the National Academies of Sciences, Engineering and Medicine's committee on drug pricing identifies eight steps to cut drug prices.... It also provides a list of specific "implementation actions" for various federal agencies .... Kaiser Health News

12/13 No Cure for Nonadherence
People Don't Take Their Pills. Only One Thing Seems to Help. .... High-tech approaches and "reminder" packaging don't work well. Reducing prices does. .... NY Times

12/13 Only 4% of Those Who Should Be on PrEP Take the Pill
Many young U.S. men at high risk for HIV do not take anti-HIV pill .... Those at high risk for HIV should ideally take a daily pill to lower their likelihood of infection. So-called pre-exposure prophylaxis cuts the risk of getting HIV from sex by more than 90% .... Reuters

12/13 Only 11% of Golden State Pharmacists Getting into Prescribing Birth Control; Average Service Fee $40–45
Few California retailers offer pharmacist-prescribed birth control, despite law .... Just 11 percent of the state's more than 5,000 community-based retail pharmacies offer birth control. Among those that do, the vast majority (68 percent) charge a fee for the service .... University Of California - Berkeley

12/13 Internet Drug News Fast Takes:
27 Top Cardiologists, Picked By Big Data
Forbes/Matthew Herper
U.S. FDA accepts application for Indivior's new schizophrenia drug
FDA Proposal Would Make Clear There's No Gluten in Your Pills
SEC charges Provectus founding CEO Dees with looting millions for girlfriends' cosmetic surgeries, travel and more
265 Employees Affected as San Diego's Dart NeuroScience Decides to Close Its Doors

12/12 Admelog Approved; New Substitute for Humalog
FDA OKs Sanofi's follow-on biologic of Lilly's diabetes drug Humalog .... Admelog, generally taken just before meals, was approved for use in children older than three and adults with type 1 diabetes, as well as adults with type 2 diabetes .... Reuters

12/12 FDA's OTC Regulations Due for Overhaul
The way over-the-counter drugs are regulated is a mess — and Congress is ready to step in .... The current regulatory process for over-the-counter, or OTC, drugs dates back to 1972, and is based on a simple but flawed assumption that most such products already on the market wouldn't change much over time .... Stat

12/12 Fun Read: Insider Stories on the Discovery and Marketing of Viagra
The Little Blue Pill: An Oral History of Viagra .... [The subjects in one of the first studies] were fitted with what was called a Rigiscan—you can imagine what that does—and given the drug and shown blue movies. At the end of the week, we had to get the drugs back from them, anything that was unused. Some of them would not give the drug back .... Bloomberg

12/12 Antisense Drug Similar to Spinraza Successful in Huntington's disease
'Ground-breaking' new drug gives hope in Huntington's disease .... Scientists have for the first time fixed a protein defect that causes Huntington's disease by injecting a drug from Ionis Pharmaceuticals into the spine .... Reuters

12/12 Has the Price of Your Niacor Gone from $35 to $295? Blame Avondale Pharmaceuticals, a Ghost Company from Alabama
US drug company hikes price of everyday vitamin pills by 800% .... Avondale Pharmaceuticals bought the rights to Niacor from Upsher Smith, a division of Japan's Sawai Pharmaceutical, earlier this year. The company also bought the rights to a drug used to treat respiratory ailments, known as SSKI, and increased the price by 2,469 per cent .... The Independent

12/12 Key Day for Graphic Designers: FDA Releases Drug Name Placement Directives
FDA Finalizes Guidance on Promotional Drug Labeling and Ads .... The recommendations pertain to product names in print media promotional labeling and advertisements (e.g., journal ads, detail aids, brochures), audiovisual promotional labeling (e.g., videos shown in a health care provider's office), broadcast advertisements (e.g., television advertisements, radio advertisements) and electronic and computer-based promotions (e.g., internet, social media, emails, CD-ROMs and DVDs). .... Regulatory Focus

12/12 A Dozen New Treatments in the Works for Sickle Cell
Life-Shortening Blood Disease Gets Rush of Gene-Based Research .... Bluebird Bio hopes to cure patients with a single injection of its gene therapy one day. Farther down the road are even more potent and permanent experiments using the gene-editing technology Crispr .... Bloomberg

12/12 Gottlieb's Stepped Approval Idea (for Devices) Drawing Flak
FDA Plans New Medical-Device Approval Processes .... FDA commissioner Scott Gottlieb has called for "progressive," or stepped, approvals of certain devices that would allow them to go to market with initial approvals, with further evidence to assess performance coming later .... WSJ $$

12/12 Pfizer's Cancer Drug Talazoparib Expected to be Fourth PARP Inhibitor — How Will the Market Shake Out
A Cancer-Drug Pricing Experiment Just Got More Interesting .... The PARP inhibitor market is going to be split. The question is to what extent, and whether insurers, pharmacy benefit managers and other payers will use this crowding to lever down drug prices .... Bloomberg Gadfly

12/12 Just 3 FDA Warning Letters in 2017
FDA issues 'record low' number of warnings to drugmakers over misleading ads .... The sharp drop-off in FDA warning letters for lies and misleading statements in ads in recent years, comes amid a 62 percent increase in direct-to-consumer ad spending by pharmaceutical companies .... CNBC

12/12 Internet Drug News Fast Takes:
Medical lab trade group sues over U.S. reimbursement cuts
Hospitals are making a fortune on Wall Street
Lilly Nixes Expansion of Stomach Cancer Drug After Mixed Study Results
Amgen's Kyprolis improves overall survival in blood cancer patients
Lia Diagnostics gains FDA approval for flushable, biodegradable pregnancy test
Drug Store News

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