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Pharmaceutical News Harvest ™
3/2 Fast Takes
U.S. judge denies Ranbaxy bid to reinstate approvals for Valcyte, Nexium copies
Actavis 3-Year IUD birth control device wins FDA approval
Novartis treatment for vision loss meets goals in study
Afrezza Will Succeed But Initial Sales Likely To Disappoint

Lantus Replacement Toujeo Approved But American Label Disappoints
- No verbiage regarding reduced hypogylcemia IN USA; differentiation questioned
- EU label has verbiage regarding less hypoglycemia
Sanofi's diabetes drug Toujeo gets U.S. approval, label disappoints … lower rates of hypoglycemia, a potentially dangerous drop in blood sugar, seen in clinical trials comparing Toujeo to Lantus, was not mentioned … Toujeo label is probably going to be viewed as more undifferentiated than investors have been expecting …[Reuters]
Sanofi diabetes drug Toujeo wins EU green light, pricing in focus … EMA highlighted the benefits of Toujeo in reducing the risk of hypoglycaemia … In Type 2 diabetes patients, the incidence of confirmed hypoglycaemia was lower with Toujeo, in particular at night, as compared to insulin glargine 100 U/ml (Lantus), …[Reuters]
See Also: Toujeo (insulin glargine) Package Insert

Lilly Plans EU Launch Of Biosimilar Lantus
Lilly to introduce Lantus copy in Europe after patent expires … start commercializing a cheaper version of Sanofi's Lantus insulin for diabetes in Europe at some point  … Sanofi has sued Lilly to block the biosimilar version …[Indy Star]

AZN Plans Stand-Alone Antibiotic Organization
AstraZeneca to carve out antibiotic R&D into separate firm … Antibiotics have fallen out of favour in the past decade among many Big Pharma companies, because of their typically low margins …  recently some companies have started coming back to the space, given the demand for novel medicines that can fight drug-resistant superbugs …[AP]

3/2 Scientists Worry That Much Hyped CHF Wonder Drug May Have Alzheimer Link
Novartis Amends Heart-Drug Trial … But some doctors question whether LCZ696's ability to inhibit an enzyme that fights sticky plaques in the brain could lead the drug to increase the risk of developing Alzheimer's, if taken on a long-term basis … [WSJ]

Gardasil Gets Boost From CDC
Merck & Co., Inc. Gardasil 9 Gets Green Signal From CDC Committee … announced Thursday that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has included its Gardasil 9 vaccine in the list of recommended HPV vaccines….[ BidnessETC]

That Flushing Sound: San Francisco Moves Closer to a Take-Back Program
That Flushing Sound: San Francisco Moves Closer to a Take-Back Program … Last month, however, three industry trade groups asked the U.S. Supreme Court to review that decision  … "we are concerned that this program not only off-loads costs of a local program to out-of-state consumers and businesses, but there is no evidence that it will address the issue of diversion or environmental concerns raised by the program's proponents….[Pharmalot]

Bristol hep C drug helps cure 97 pct of HIV coinfected patients-study
Bristol hep C drug helps cure 97 pct of HIV coinfected patients-study …  Ninety-seven percent of hepatitis C patients also infected with HIV were cured of the liver-destroying virus after 12 weeks of treatment with Bristol-Myers Squibb's daclatasvir and Gilead Sciences' Sovaldi …[Reuters]

2/27 Sovaldi Profits Are All Booked Overseas; Gilead Pays About 5% Foreign Taxes
Gilead Avoids Billions in U.S. Tax on Its $1,000-a-Pill Drug .... The company reported foreign income before taxes of $8.2 billion for 2014, earning more in non-U.S. profits than it recorded in non-U.S. sales .... Bloomberg

2/27 Daclatasvir Combines with Sovaldi to Clear Coinfected in 12 Weeks
Bristol hep C drug helps cure 97 pct of HIV coinfected patients .... Ninety-seven percent of hepatitis C patients also infected with HIV were cured of the liver-destroying virus after 12 weeks of treatment with Bristol-Myers Squibb's daclatasvir and Gilead Sciences' Sovaldi .... Reuters

2/27 Upcoming HBO Special Report on Cancer Reveals Basis for Optimism
What You Should Know Before Watching Vice's Special About Curing Cancer .... There are reasons to be wildly optimistic about the state of cancer research .... Reuters

2/27 Heart Failure Drug Needs to Answer Alzheimer's Fears
Novartis Amends Heart-Drug Trial .... Some doctors question whether LCZ696's ability to inhibit an enzyme that fights sticky plaques in the brain could lead the drug to increase the risk of developing Alzheimer's, if taken on a long-term basis .... $$WSJ

2/27 Declining Sales Brought to CEO's Attention in a Forceful Way
Glaxo Chief Witty's Compensation Cut 46% as Profit Declined .... The pay cut reflects Witty's struggle to halt a slide in U.S. market share for Advair, its top-selling asthma medication, and failure to win over doctors and insurers for products designed to replace it .... Bloomberg

2/27 After Prolonged Efforts, AZN Launches Spinoff
AstraZeneca spinning out its anti-infectives R&D unit in Waltham .... The new company, which hasn't been named yet, will take over the antibiotic pipeline, including the novel gyrase inhibitor AZD0914, currently in Phase II for gonorrhea.... AstraZeneca expects that some of the current employees in the group will run it .... Fierce Biotech

2/27 Drug Coverage at a Breaking Point
The Drug Pipeline Flows Again .... In cancer, "it wasn't that long ago" that the FDA was being asked to approve drugs that shrank tumors in only 10 percent to 15 percent of patients, the FDA's Jenkins says. "Now we are seeing drugs with a 50 to 60 to 70 percent response rate." .... Bloomberg

2/27 Selling to Hospitals and Health Networks
Drugmaker shifts sales model to keep pace with formulary decision making .... Daiichi Sankyo is one of several pharmaceutical companies to employ key account managers who target sales pitches to executives at large hospital systems and independent delivery networks rather than to individual prescribers .... MM&M

2/27 42% of FDA Funding Comes From User Fees
Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts .... The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration .... Regulatory Focus

2/27 "For single patient use only" Label to Appear on Diabetes Pens
FDA requires warning to prohibit sharing of multi-dose diabetes pens .... The FDA is requiring additional label warnings on multi-dose diabetes pen devices prohibiting the sharing of the injectable medicines to reduce the risk of infections being spread .... Healio

2/27 Internet Drug News Fast Takes:
Why health centers are urging patients out of high-deductible plans
Advisory Board
Major insurers are finally revealing one of health-care's greatest mysteries
Washington Post Wonkblog
PCORI explains how it will release comparative-effectiveness findings
Half a million C. diff infections and 15,000 deaths in 1 year
Medical News Today
Boehringer puts BACE inhibitor trial on hold
Pharma Times

2/26 WebMD Sends Your Health Searches to 34 Other Companies
Looking Up Symptoms Online? These Companies Are Tracking You .... An astonishing number of the pages we visit to learn about private health concerns—confidentially, we assume—are tracking our queries, sending the sensitive data to third party corporations, even shipping the information directly to the same brokers who monitor our credit scores .... Vice

2/26 Avycaz Approved
Actavis' superbug antibiotic gets U.S. approval .... The drug can be used in combination with generic antibiotic metronidazole to treat adults with complicated intra-abdominal infections. As a standalone medication, it is used to treat urinary tract infections .... Reuters

2/26 FDA OKs Toujeo
Sanofi Gains U.S. Approval for Successor to Top-Selling Lantus .... Studies have shown that patients taking Toujeo have fewer drops in blood sugar while asleep than those taking Lantus, an advantage that Paris-based Sanofi is banking on to convince patients and doctors to switch to the new drug .... Bloomberg

2/26 Imbruvica's Launch Trajectory Rivals Avastin's
Cancer Drug Once Bought for $7 Million May Now Fetch $18 Billion .... Imbruvica is an easy-to-use pill that costs around $100,000 a year, avoids certain serious side effects of chemotherapy, and patients can stay on it for long periods of time .... Bloomberg

2/26 GSK's 'Go Heavy' Strategy
GSK to be No. 1 vaccine producer when it completes $25B asset swap with Novartis next week .... As pricing pressures, patent expirations and fewer blockbuster new drugs affect their bottom lines, drug companies have looked to focus more closely on certain therapeutic areas. That's exactly what happened in this asset swap .... Triangle Business Journal

2/26 No 'Reimportation' for Maine
Federal Judge Overturns Maine Prescription Drug Law .... Judge Nancy Torresen of the U.S. District Court, Portland, Maine,, ruled that the law is pre-empted, or superseded, by federal legislation. This means the state didn't have the right to enact such a measure because the federal government has jurisdiction over importation .... WSJ

2/26 Valeant Plans to Cut $500 Million in Costs from Salix
Valeant to keep specialty Salix reps, but it's eyeing primary care for potential cuts .... The FDA is expected to hand down a decision on a new indication for the North Carolina drugmaker's lead product, Xifaxan, in irritable bowel syndrome associated with diarrhea, and ... the success of the Valeant buyout depends on the rollout in that market. .... Fierce Pharma Marketing

2/26 'Doctor-Shopping' Seems to Apply to Antibiotics Also
Competition among physicians and retail clinics drive up antibiotic prescribing rate .... The presence of retail medical clinics, like those found in chain drug and "super" stores, and of urgent care centers increases the prescribing rate, but the effect was different in wealthy versus poor areas .... Johns Hopkins Medicine

2/26 Other Obesity Drugs Have Peaked; Contrave Gaining Ground
Obesity Drugs: Orexigen Gains Market Share at Expense of Arena, Vivus .... Here's a chart depicting the most current obesity drug market share

.... The Street/Adam Feuerstein

2/26 alli Returns to the Shelves
Nonprescription diet pill alli back in stores after recall .... The British drugmaker voluntary recalled the product last March after finding some packages in stores didn't contain real alli, indicating tampering after shipment .... Medical Express

2/26 'Basket Studies' Target Mutations
A Faster Way to Try Many Drugs on Many Cancers .... The studies of this new method, called basket studies because they lump together different kinds of cancer, are revolutionary, much smaller than the usual studies, and without control groups of patients who for comparison’s sake receive standard treatment .... Johns Hopkins Medicine

2/26 Internet Drug News Fast Takes:
How Your Smartphone Will Radically Change Your Health Care
Huffington Post/Eric J. Topol, MD
Daily tasks predict hospitalization, death for heart failure patients
Sunovion begins late-stage trials of COPD drug to rival Spiriva
Boston Business Journal
FDA to review Teva's abuse deterrent opioid
Pharma Times
10X Genomics Unwraps Its 'Toaster Oven' For Better DNA Sequencing
Forbes/Luke Timmerman

2/25 Ibrance Off to Strong Start
Can Pfizer's new breast cancer med really cruise to $4B and beyond? .... Some physicians say the solid FDA backing, plus impressive progression-free survival stats--20 months, versus about 10 for the current standard of care--are enough to persuade them to pick up Ibrance immediately .... Fierce Pharma Marketing

2/25 $280 Per Year Not Enough to Change Behavior
Cash Payments Fail to Improve H.I.V. Drug Adherence .... Paying patients in the Bronx and in Washington — where infection rates are high among poor blacks and Hispanics — up to $280 a year to take their pills daily improved overall adherence rates very little .... NY Times

2/25 160 Cases of Meningitis B a Year; Pfizer Believes It Has Vaccine
Pfizer Meningitis B Vaccine Meets Safety, Tolerability Goals in Studies .... Meningitis, a life-threatening bacterial disease spread by respiratory secretions, affects about 500 mostly young Americans a year; vaccines already exist for the four other known strains, A, C, Y and W .... WSJ

2/25 Isentress, Sold for $1350/Month in U.S., Made Available Cheaply Overseas
Merck grants free license for pediatric HIV drug .... The deal lets any generic or brand name drug manufacturer make low-cost pediatric versions of Merck's raltegravir for sale in 92 low- and middle-income countries .... AP/Yahoo

2/25 Hep C Price Battle Largely Over, But What Battles Lie Ahead?
Formulary Fireworks .... "The PBMs are going to press us on price right up to the point where [a formulary decision] becomes a PR disaster for them. Nobody will come out of this looking good." (quote from unnamed pharma exec) .... MM&M

2/25 Long-Time Congressional Pharma Critic Ends Up a Lobbyist
Ex-Rep. Henry Waxman lands on K St. .... While Waxman is required by ethics laws not to lobby his colleagues for at least one year, he told Politico that he might consider advocacy once his "cooling off" period expires. .... The Hill

2/25 7% CAGR for Oncology Through This Decade
Global cancer drug market to grow to $111 billion by 2020 .... Researchers expect targeted therapies and immunotherapies to surge by "10% in market share collectively by 2020." .... MM&M

2/25 Depression Leads to Violence — But Take with a Grain of Salt (Scandinavian Observational Study)
Clinically depressed three times more likely to commit violent crime .... When they adjusted for other factors such as previous history of violence, self-harm, psychosis and substance misuse -- all of which increase the risk of violence -- they found a smaller but still increased risk of violent crime among depressed people .... Reuters

2/25 Scientists Get the Axe at Pfizer
Pfizer is once again cutting back R&D staff in reorganization .... The cutbacks at Pfizer follow one of the biggest restructurings in the industry, as the pharma giant carved billions of dollars out of its research budget .... Reuters

2/25 Shire Preparing the Battlefield
Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease .... The marketing strategy for Vyvanse, like that of Adderall, sheds light on how pharmaceutical companies seek to influence the diagnosis and treatment of a medical condition — in an effort to make billions of dollars in sales — even in the face of concerns about potential dangers of a drug .... NY Times

2/25 Internet Drug News Fast Takes:
State again faults Kaiser Permanente for mental health treatment delays
LA Times
Revel Casino Buyer to Mix Anti-Aging Agenda With Poker
Anthem says hack may affect more than 8.8 million other BCBS members
Centralized Reminder System Could Increase Vaccination Rates
HealthDay News
Watchdog group seeks US ban of antifungal tablets

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