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3/26 Fast Takes
FDA OK's first novel treatment for Parkinson's in ten years
Pharma Times
Five Questions to Ask When Selling Your Pharmacy
Drug Channels
AZN's lung cancer treatment Tagrisso (osimertinib) gets approval from China's FDA.
Stock News
Bristol-Myers and Pfizer's Eliquis outperforms rival Xa inhibitors versus warfarin
BioPharma Dive
Abbott dumps $1.7 Bln in Mylan stock
MassDevice
FDA approves Pfizer, German Merck immunotherapy for rare skin cancer
Reuters
Judge dismisses two Express Scripts claims in Anthem drug pricing lawsuit
Reuters

3/27 EU: Amgen Scores Biosim Home Run In Humira Nod
- Copycat version of Humira could disrupt $5 Bln Of AbbVie sales
$5B in Humira sales at stake with Amgen EU approval … AbbVie's blockbuster Humira (adalimumab). It got the ok for all nine Humira indications--a wide variety of inflammatory disease … launch has been held up in the U.S. by patent litigation, and a U.S. launch in 2017 still doesn't look particularly likely …[BioPharma Dive]
Related: Amgen targets Roche in Europe with Herceptin biosimilar submission … Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU …[Biopharma Reporter]

3/27
Lawsuit: Drug Rep Mis-info Blamed For Back Pain Woman's Overdose Death
Wrongful Death Suit Targets Drug Prescribing Practices … "For a doctor to allow a drug rep to dictate how to treat her patient--that's just irresponsible, … Subsys is approved only for treatment of pain in cancer patients, but Fuller did not have cancer … [NJ Law Journal]
Lawsuit blames improper marketing of potent opioid for woman's death … in the room was an Insys saleswoman, who was there to convince Fuller that Subsys would help treat her neck and back pain …[Pharmalot]

3/27
Valeant In Toilet But CEO Has $63 Million Payday
- Not bad pay for 7 months to lead failed company*
Troubled drug company pays CEO $63 million … Valeant Pharmaceuticals remains under several investigations, its biggest Wall Street backer just jumped ship, and shareholders lost nearly 90% in 2016 …[CNN Money]
*Editor's Note: Papa started in May, 2016

3/27
Eli Lilly to Invest $850M in U.S. Capital Projects This Year
Eli Lilly to spend $85M on Indy manufacturing facility … did not envision the company slowing down. The company is currently on track to introduce 20 new drugs in 10 years by 2023 …[Indy Star]

3/27
Divi Labs: US FDA Bans Another India Drug Factory
Divi's Labs' Vizag plant banned from shipping to US … not operating in conformity with current good manufacturing practices  … banned from shipping drug ingredients made at its Vizag plant to the US …[In-Pharma]


3/24 Really, Really Targeted Advertising
Drug Companies Are Buying Ads on Shows They Know Donald Trump Watches .... The top trade association for U.S. drugmakers is spending more on television advertising than any other special-interest group, part of a multi-year campaign to repair the industry's reputation and counter President Donald Trump's claims that it's "getting away with murder" on pricing .... Bloomberg (autoplay video)

3/24 Bavencio Approved for Metastatic Merkel Cell Carcinoma, a Rare Skin Cancer; $13,000 Per Month
FDA approves Pfizer, German Merck immunotherapy for skin cancer .... Bavencio belongs to a new class of oncology drugs called PD-L1 inhibitors that block a mechanism tumors use to evade detection from the immune system. It marks the first immunotherapy approval for the collaboration of Pfizer and Germany-based Merck .... Reuters

3/24 Who Are the 1% of Doctors Prescribing a Half Billion Dollars Worth of Acthar Gel?
Something weird's going on with the doctors prescribing one of pharma's most controversial blockbuster drugs .... In 2015 the US government spent over half a billion dollars on a $38,000 non-lifesaving drug with a wide range of cheaper alternatives, making it one of the top 20 expenses for Medicare Part D, a prescription drug program .... Business Insider

3/24 CVS and ExpressScripts Offer Discounted Insulins, Direct to Consumer
New PBM programs bypass insurers to offer drug discounts directly to consumers .... Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators .... Modern Healthcare

3/24 Big Pharma Decides Youtube Isn't Brand-Safe
J&J, GSK pull ads from YouTube amid display concerns .... Major drugmaker Johnson & Johnson has halted all global advertising on the video-sharing site YouTube in response to concerns product marketing appeared next to offensive content such as hate speech. .... BioPharma Dive

3/24 Fevipiprant is Promising Once-Daily Oral for Severe Asthma; May Enter Market in 2019
Novartis aims to bring first oral asthma drug to market in two decades .... Fevipiprant is the first asthma treatment to use a dual pathway approach by inhibiting eosinophils while stopping inflammation in the airway lining and repairing any damage .... MM&M

3/24 Dupixent and Ocrevus Poised for Approval
Crunch week looms for Sanofi, Roche and GSK at U.S. drugs agency .... The two FDA decisions, due by March 28 and 29 respectively, mark important landmarks for both firms, since Dupixent and Ocrevus are expected to be the biggest new drug launches from the global pharmaceuticals industry in 2017 .... Reuters

3/24 Teva Cutting Staff; Company Says Rumored 11% Trim Not True
Teva to Cut Undisclosed Number of Jobs as It Seeks to Pare Costs .... The Israeli drugmaker is looking for a new chief executive to turn around the business after its $40.5 billion acquisition of Allergan Plc's generic business saddled the drugmaker with debt. The transaction came just as prices of cheap copycat drugs began to fall .... Bloomberg

3/24 "Right-to-Try" Laws in Place in 33 States
With patients demanding experimental drugs, 'right to try' is becoming the law of the land .... The new state laws, built on model legislation from the Goldwater Institute, seek to remove the FDA from the equation, allowing doctors, patients, and drug makers to strike their own deals for drugs that have cleared the safety phase of FDA testing .... Stat

3/24 "Social Media Market Intelligence Company" Tracks Drug Company Efforts, Reports What's Working
Big Pharma finds a hit with disease awareness social media posts in 2016 .... "all pharma companies saw the highest engagement when talking about the things that matter to their customers -- most importantly the disease or condition they're dealing with" (Lakshmanan Narayan, co-founder and CEO at Unmetric) .... Fierce Pharma

3/24 Internet Drug News Fast Takes:
Uncertain fate of Obamacare causes some hospitals to halt projects, hiring
Reuters
Cancer Is Partly Caused By Bad Luck, Study Finds
NPR Shots
Facebook exec: Purpose-driven marketing here to stay
Drug Store News
CANA/PHEN Aids Weight Loss in Obese Without Type 2 Diabetes
HealthDay News
Ex-FDA Commissioner Califf Returns to Duke, Chairs New PCORI-Funded Foundation
Genetic Engineering & Biotechnology News

3/23 340B Rule Enforcement Date Moved to May 22; Could Move to Oct. 1
Trump admin delays enforcement of 340B drug discount program rule .... Under the delayed rule, which HHS issued under former President Barack Obama, drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense .... Advisory Board Daily Briefing

3/23 Serelaxin Not Effective Against Heart Failure
Novartis Heart Medicine Fails in Late-Stage Clinical Trial .... The compound, serelaxin, didn't lower cardiovascular deaths or reduce worsening heart failure as expected .... Bloomberg

3/23 Adverse Events Reports Skyrocketing; Electronic Filing Prompted 300,000 New Reports
Reports of drug side effects increase fivefold in 12 years .... Researchers found that among the 10 drugs that accounted for the most reports, seven carry "black box" warnings, the FDA's most stringent alert for serious or potentially life-threatening side effects.... Those 10 drugs account for one out of every five reports filed since 2013 .... Milwaukee Journal Sentinel

3/23 A Browse Through Gottlieb's Industry Ties
Trump's FDA Pick Has Friends in Big Pharma. But Who Doesn't? .... The companies on Gottlieb's list have a strong track record in public health. "It's not an exaggeration to say that literally hundreds of millions of people owe their lives to these companies," says ex-FDA official David Gortler .... Wired

3/23 Norepinephrine Shortage Killed Hundreds
Drug shortage in 2011 tied to increased deaths .... The likelihood that hospitalized patients in septic shock would die was nearly 4 percentage points higher during the 2011 shortage of norepinephrine, compared to when hospitals had an adequate supply .... Reuters

3/23 Sanofi Has Aubagio and Lemtrada; Wants to Do More in MS
Note for those in MS: Ocrevus Approval Expected 3/28

Sanofi to be a leader in MS, but not yet .... The company currently has a Phase 1 molecule dubbed GLD52, a next-gen anti-CD52 antibody, which it is developing for relapsing MS .... Biopharma Dive

3/23 Cosentyx Shows Permanent Effect for Some
Novartis boasts a big new advantage for Cosentyx as data indicate the blockbuster can modify psoriasis .... New data show that in a full year following the end of treatment, 21% of patients retained clear skin. After two years, 10% were able to remain symptom free .... Endpoints

3/23 More Biologics on the Way for Asthma
Drugmakers target severe asthma patients with biologics, but payers raise pricing issue .... It'd be wise to keep an eye on expanded indications for Xolair as well as late-stage market challengers from AstraZeneca, Sanofi/Regeneron, and Novartis. While small molecules currently account for 98% of the products available in the asthma space, GBI Research found the pipeline consists of 12% mAbs and 17% non-mAb biologics .... MM&M
See also: Top 25 respiratory brands, by sales [MM&M]

3/23 Compounder Faces Long Stretch
Pharmacist guilty of fraud, not murder, in U.S. meningitis outbreak .... The co-founder of a now-defunct Massachusetts compounding pharmacy was found guilty of racketeering and fraud but cleared of murder for his role in a 2012 meningitis outbreak that killed 64 people .... Bloomberg

3/23 Overhaul the Anti-kickback Laws
Penn researchers call for better laws covering patient incentives to improve care .... Anti-kickback laws prevent hospitals from offering services that could potentially benefit patients, such as free rides to elderly or disabled patients to help them get to their appointments .... University of Pennsylvania School of Medicine

3/23 Internet Drug News Fast Takes:
Mylan recalls 81,000 EpiPens outside U.S. after reports of failure
Reuters
Ultragenyx seizure drug fails mid-stage study
Reuters
A boom in medical tourism to Mexico predicted if Obamacare ends
Yahoo News
Sanofi's Xyzal Allergy 24HR hits store shelves
Chain Drug News
Vitamin E, Selenium Don't Prevent Dementia in Older Men
HealthDay News

3/22 Newron's Xadago for Parkinson's
FDA approves drug to treat Parkinson’s disease .... The FDA has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing "off' episodes. .... FDA News Release

3/22 Application of Real-World Evidence: Eliquis Tops Warfarin in Efficacy and Cost
Bristol-Myers and Pfizer's Eliquis outperforms rivals versus warfarin .... Bristol-Myers and Pfizer's study relied on what's known as real-world evidence, in this case claims data from over 186,000 non-valvular atrial fibrillation patients age 65 and older in Medicare's database .... BioPharma Dive

3/22 83% of Initial PCSK9 Inhibitor Prescriptions Are Rejected
Data Show It's Hard to Fill PCSK9 Prescriptions, Confirming Cardiologists' Complaints .... Patients in Medicare have an easier time getting approved than those with commercial insurance; Medicare approved PCSK9 inhibitors 57% of the time, compared with a 30% approval rate for commercial payers .... AJMC

3/22 Head-to-Head Comparison of PBMs, Conducted by Drug Channels Guru Adam Fein
Which PBM Best Managed Drug Spending in 2016: CVS Health, Express Scripts, MedImpact, or Prime? .... All four PBMs reported that their drug trend percentages for 2016 were in low single digits. The unweighted average among them was a mere 3.5% .... Drug Channels

3/22 Valeant Has $30 Billion in Debt to Pay Down; Stock Price is Sinking
With Ackman Out, Valeant Confronts Rocky Road to Revival .... While CEO Joe Papa has talked up Xifaxan, the gastrointestinal drug that is the company's bestseller, the other big hope, the psoriasis drug, comes with a "black box warning" that suicidal thoughts have occurred in patients taking the drug .... Bloomberg (autoplay video)

3/22 DTC Works; Testosterone Supplement Ads Associated with 283,000 New Prescriptions
'Low T' television ads linked to surge in testosterone use .... Each additional ad men saw was associated with a 0.6 percent increase in testing as well as a 0.7 percent climb in new prescriptions for testosterone. There was also a 0.8 percent increase in new prescriptions that were not preceded by testing .... Reuters

3/22 House Leadership Tweaks Reform Bill
The 7 Big Revisions Republicans Made to Their Health Care Bill, and Why They Made Them .... Most of the changes will appeal to the party's right flank, including the Freedom Caucus -- which has voiced concern that the bill does not go far enough to undo Obamacare -- but there are also concessions to more moderate Republicans .... Axios

3/22 Ketamine Getting Larger Trials; Sparking New Research on Glutamate Neurotransmitter
Ketamine For Severe Depression: 'How Do You Not Offer This Drug to People?' .... A number of small studies have found that ketamine can do something no other drug can: it often relieves even suicidal depression in a matter of hours in patients who have not responded to other treatments .... NPR Health Blog

3/22 Nine Deaths Linked to Breast Implants, FDA Warns; Risk Linked Especially to Textured Shells
Breast Implants Can Cause Rare Form of Cancer, FDA Says .... The cancer is called anaplastic large cell lymphoma and the FDA is checking into more than 350 reports linking it with both silicone and saline breast implants .... NBC News

3/22 Sanofi/Regeneron Go to the Mattresses on Dupixent
Sanofi, Regeneron sue Amgen to protect eczema drug from patent claims .... The lawsuit, filed in federal court in Boston, was intended to preempt one expected to be brought by Amgen, which has previously sued Sanofi and Regeneron over their rival cholesterol drug Praluent .... Reuters

3/22 Auditors Will Study Orphan Drug Program, But Don't Hold Your Breath
GAO To Launch Investigation Of FDA's Orphan Drug Program .... Grassley's office said they expected the GAO to begin its work in about nine months. The delay is typical as the agency has a queue of requests it is pursuing. .... Kaiser Health News

3/22 Internet Drug News Fast Takes:
Esperion Therapeutics Sees Clear FDA Path For Its Heart Drug
Forbes/Matthew Herper
Popular Prostate Cancer Therapy Is Short, Intense and Unproven
NY Times
Health Insurance Lobby Backs Key Trumpcare Revisions
Forbes/Bruce Japsen
Could OTC medicines be the answer to alcoholism?
University of Miami Miller School of Medicine
How Sickweather Can Forecast OTC Sales
Linkedin Pulse

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