Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

NIH: HPV test beats Pap for cancer assessment

HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.

Monday Moves—July 21, 2014

Hires and promotions for Manufacturers, Agencies and Media

Miss Idaho shows off diabetes pump

NPR reports that the move has made Sierra Sandison a type 1 diabetes hero and that users have given the Facebook photo over 4,000 "likes."

Roche is hungry, not starving for M&A

CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.

AbbVie nabs Shire for $54B

AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.

Leading AIDS researcher aboard downed flight MH17

Dr. Joep Lange was en route to the International AIDS Conference in Melbourne, Australia.

Digital sage Richman returns to healthcare

He started the Dose of Digital blog in 2008, then left healthcare. Now, after more than two years away, Jonathan Richman says he's back in the business.

Haymarket launches psychiatry news, CME site

Haymarket Media launched the site PsychiatryAdvisor.com today.

Treasury urges tax inversion action

Treasury Secretary Jacob Lew is urging lawmakers to prevent companies from "effectively renouncing their citizenship to get out of paying taxes," while also benefitting from the US-funded infrastructure.

Metric system boosts Rx accuracy

Researchers found that patients were more accurate when doling out medication measured in milliliters as opposed to teaspoons or tablespoons.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

Industry trims support for CME

Industry reined in commercial support for CME in 2013—the sixth consecutive annual decrease—data released today by the ACCME show.

Advocacy group alleges Sanofi-Shire conspiracy

An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.

Alzheimer's study to use healthy patients

Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.

Abbott pairs generics with tax benefit

Abbott and Mylan are setting up a generics business. The all-stock deal will give some branded generics a new home and offer Abbott a tax benefit that will increase over time.

Lilly's Cyramza misses liver-cancer target

Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.

Study links Actos with delayed dementia

German healthcare data from 2004 through 2010 across a data set that included 146,000 patients shows dementia surfaced later among Actos patients.

Committee votes on two health bills today

The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.

FDA quicker on approval trigger than EU: study

The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.

Allergan trims fat to halt takeover

Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.

Generics trigger wallet shock

Prices for some generics are rising, thanks to limited competition.

Experiment cuts cancer costs, ups drug spend

UnitedHealthcare finds drug costs more than doubled.

EU fines six for pay-for-delay

Servier and Teva have been fined for keeping a generic heart medication off the market.

Lilly, Yabao collaborate on diabetes

The companies will develop Lilly's glucokinase activator LY2608204.

CVS joins West Virginia pseudoephedrine fight

The drugstore chain will no longer sell Sudafed in West Virginia.

Sun recalls cancer drug

It's the generics maker's second recall of 2014.

Study unlinks testosterone and heart attacks

The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.

Healthcare organization makes big data bigger

Credit card and loyalty program purchases will help Carolinas HealthCare System flag potential patient behavior issues.

Merck stifles ezetimibe criticism

The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.

Study links DPP-IV medication to heart failure, hospitalization

Editorial says risk is small, researchers say it could be clinically relevant.

Zohydro's second act

Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.

EC cracks down on fraudulent drugs

The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.

France ponders off-label Avastin

French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.

Insurers put in bid for biosimilar naming

Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

India's generics makers hire Beltway help

The Indian Pharmaceutical Alliance makes a bid for legislators' attention.

ACP says no need for pelvic exams

The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.

Merck rolls out MedEd website in India

The website is a joint effort between Merck and The Lancet.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Facebook's clinical trial

The networking site's emotion experiment rankles some in the science and political communities.

Diovan competition is coming

Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.

Takeda releases internal probe over bad ad

An internal probe for a controversial ad for hypertension drug Blopress was released by Takeda, but the report is in Japanese.

Auxilium merges with Canadian biotech in tax-inversion effort

Pennsylvania drugmaker Auxilium will merge with Vancouver-based biotech QLT to lower its corporate tax rate.

BI's Pradaxa antidote gets Breakthrough label

FDA says it will fast track the blood-thinner antidote, designed to thwart runaway bleeding.

Vyvanse patent win bolsters Shire as AbbVie circles

Certain claims of the patents protecting the ADHD drug were both infringed and valid, a court ruled, giving Shire a boost as it contends with a takeover bid by AbbVie.

Novo issues bullish sales forecast

The firm said it expects to more than double its revenue within the decade, as the surging incidence of diabetes expands demand for its products.

FDA Guidance expands environmental perspective

The regulator is issuing draft guidance to address gene therapies.

Expanding weightloss drug doesn't wow

An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.

Shire rebuffs AbbVie

Dublin-based Shire is urging shareholders to back independence and ignore AbbVie's $46.4 billion bid.

BI calls it quits in hep. C

BI says there is no unmet need for faldaprevir.

Marketing tone sinks GSK recruiter

GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.

Triglycerides, not HDL, may be cardio bad guys

Gene mutations lead researchers to rethink ways to protect the heart.

Ex ONC chief heads ACO group

Farzad Mostashari is leading a startup to help primary care physicians create Accountable Care Organizations

Dr. Oz runs afoul of lawmakers

Lawmakers criticized Columbia University chairman and professor of surgery Dr. Mehmet Oz for calling weight-loss supplements miracles on his TV program, despite lacking scientific proof to support those claims.

PhRMA uneasy about "right-to-try" laws

Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

FDA releases new draft social media guidance

FDA issued two guidance documents today for industry and its representatives to communicate online about prescription drugs and devices.

CMS site guides patients through insurance coverage

The Centers for Medicare and Medicaid Services launched a new site Monday to help patients understand how to use their health coverage.

Takeda walks away from Omontys

The drugmaker is pulling its US marketing application for the anemia drug.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

Medtronic buys Covidien

The deal makes Medtronic the most recent company to seek out lower tax rates.

FDA labels AbbVie hep C drug Breakthrough

The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.

Novartis says it buried studies

The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.

Italy: Use Avastin off-label

The Italian Medicines Agency is guiding patients away from Roche's costlier AMD-indicated Lucentis.

Seniors are major painkiller users

A USA today analysis shows Medicare painkiller prescriptions rose 30% between 2007 and 2012.

Oregon seeks HCV Rx waiver

The Oregon Health Plan wants to keep hep. C medications Sovaldi and Olysio off its list of covered treatments.

Lilly drug misses Phase III target

Eli Lilly's gastric cancer drug Cryamza failed to hit its primary Phase III liver cancer target.

Pfizer says money killed AZ deal

CFO Frank D'Amelio told an investors conference AstraZeneca wanted more money.

Allergan turns down Valeant

CEO David Pyott told Modern Healthcare that acquisition fallout would have probably included a pinched R&D budget and higher product prices.

Dendreon CEO resigns

August 15 is John Johnson's last day as president and CEO.

Statins linked to less exercise, more diabetes

Two studies found two different facets of statin therapy—one found patients moved less a year after starting their regimens, and another that the drugs upped the diabetes risk for some.

Top opioid prescribers not pain specialists

Express Scripts said that family and internal medicine doctors were the top opioid prescribers between 2011 and 2012.

AMA names president-elect

Steven Stack will be the association's youngest president when he takes office in 2015.

Obesity cause of knee replacement increase

A study shows that total knee replacement is rising—and occurring in more youthful people. The uptick tracks with the rise in obesity.

Chicago sues painkiller companies

The Windy City seeks $9.5 million in damages in a lawsuit that accuses manufacturers of misleading consumers.

Pharma seeks to offload old drugs

The WSJ reports that Merck, Sanofi and GSK are looking to put older medications at arm's length.

Doctors get political

A study shows doctors have been giving more political donations—and leaning heavily Democrat—since 1991.

Sanofi's CEO moves to Boston

The company says the re-lo is for personal reasons. The move will put him in close proximity to Genzyme, as well as other members of the French firm's executive committee.

Medicare to cover some hep. C screening

Patients have to be high-risk or Baby Boomers for coverage.

Gwee moves to Digitas Health Lifebrands

Shwen Gwee, the social media guru, has joined Digitas Health Lifebrands as VP of social strategy.

Teva reorganizes

The company has created three new departments.

Roche builds strength in molecular diagnostics

The company is buying Genia Technologies for $125 million.

Genentech cancer med nabs Breakthrough status

The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.

Valeant ups the ante

In addition to raising its bid for Allergan, Valeant is lobbying for a shareholder meeting to oust six board members.

People Moves: June 2014

Promotions and hires for manufacturers, agencies and technology companies

Upward Move: Michael A. Griffith

Michael A. Griffith, Executive vice president, inVentiv Health

CDC: un-vaccinated behind measles outbreak

The CDC said Thursday that most of the 288 recent US measles cases were caused by un-vaccinated travelers who brought the virus home with them.

Italy fines Roche and Novartis

The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.

Insurers pay docs to stick to regimens

Companies including WellPoint and Highmark are deploying financial incentives for doctors to stick with recommended cancer treatments.

Valeant ups Allergan bid

The new offer is $49.4 billion.

Boehringer settles Pradaxa suits

The company is settling around 4,000 cases for around $162,500 apiece.

Fraud office looks at GSK

The company announced Tuesday that the UK fraud agency is giving the company a closer look.

BMS enters two immuno-oncology deals

The drugmaker has paired up with Incyte and CytomyX in two separate deals.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

App can estimate blood loss

The maker of an FDA-approved app says its algorithm can use images to assess surgery-related blood loss.

CA counties sue makers of painkillers

Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.

Purdue installs first commercial chief

Saeed Motahari, formerly AbbVie's VP of US sales and marketing, specialty brands, is Purdue Pharma's new SVP, chief commercial officer—a new position.

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