Off-label

Roche seeks new Lucentis indication

Roche seeks new Lucentis indication

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The company is seeking a diabetic retinopathy indication.

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

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The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

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FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

Study: sales rep limits reduce off-label prescriptions

Study: sales rep limits reduce off-label prescriptions

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Researchers found that limiting sales rep access and interactions reduces off-label prescriptions for the previously detailed drugs, while also upping off-label prescriptions of the drugs that had not been promoted.

Off-label guidance may not be publishing boon

Off-label guidance may not be publishing boon

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The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.

Lidoderm reps inflated drug's uses

Lidoderm reps inflated drug's uses

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Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.

J&J marketing triggers $2.2B payout

J&J marketing triggers $2.2B payout

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The company will shell out $2.2 billion over allegations of marketing misconduct for Risperdal, Invega and Natrecor.

Business briefs: Abbott, IMS Health, Boehringer, plus healthcare reform

Abbott's Depakote lawsuits roll on; IMS buys mobile health firm's assets; BI shutters a chemical plant; and the healthcare reform back-and-forth continues.

Business briefs: Pfizer, GlaxoSmithKline, AstraZeneca, Mallinckrodt

Pfizer settles Rapamune lawsuits; Moody's downgrades GSK; Astrazeneca pursues anemia medication; Mallinckrodt drugs gets priority review

Business Briefs Merck, GSK, Novo, Walgreen, Epocrates, Doximity

HPV vaccine price cut; Merck files new allergy med with FDA; GSK pursues online transparency; Walgreens ready for greater nurse autonomy; Epocrates ranks high among docs with tablets.

Novartis: lawsuits, layoffs and, by the way, earnings

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It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year.

Business briefs: Endo; Allergan

Endo gets a new president, Allergan settles a Botox case

Business briefs: Gilead, Shire, The Medicines Co., HHS

HHS wants input for its TXT4Tots childhood advice program, Gilead releases some Hep. C clinical trial data, and Shire settles with the DOJ over disputed marketing practices.

Researcher takes aim at clashing drug data

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An expert witness in a 2008 lawsuit highlights holes in clinical data, and finds that corporate and published trial data do not necessarily correspond.

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

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Amgen "marketed the spread" between the price practices pay for Aranesp and that patients pay as a means of driving sales—to the point of having speakers tell docs that they could make a million more each year by prescribing the Amgen anemia drug over its competitor, Procrit.

Court says off-label decision against Jazz rep ran afoul of free speech protections

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A federal appeals court has overturned the conviction of a drug rep for detailing a drug off-label on First Amendment grounds, ordering the lower court to retry the case.

Company news: Elsevier, Abbott, Genzyme

Elsevier launches new drug class overviews, a whistleblower accuses Abbott and Genzyme clears the way for Lemtrada.

Petition asks FDA to set opioid marketing ground rules

Petition asks FDA to set opioid marketing ground rules

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The proposed changes center around non-cancer related pain and seek to alter how drug companies can talk about these pain meds.

GSK in biggest-ever $3b marketing fraud settlement

GSK in biggest-ever $3b marketing fraud settlement

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GlaxoSmithKline will pay $3 billion to settle state and federal charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.

Social media an outcomes listening post for pharma

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FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms, say pharma and device firms.

Allergan scrubs some doc-payment data, spares med-ed grants

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Allergan removed records from its website that had detailed payments made to doctors from the middle of 2010 through first-half 2011.

GSK hopes $3-bil. off-label settlement will end legal woes

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GlaxoSmithKline's deal to resolve multiple US investigations into its sales and marketing practices—one of the largest settlements by a pharma company—aims to patch up several long-running legal disputes.

Par Pharma suit could set up off-label court showdown

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Par Pharmaceutical last week asked a federal court to tell the FDA to back off and allow the company to detail docs about using its Megace ES to treat AIDS-related wasting.

Florida harasses dead doc for off-label months after suicide

Florida harasses dead doc for off-label months after suicide

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The Florida Department of Health is seeking to sanction a doctor who committed suicide in February, distraught over getting swept up in an off-label promotion sting.

Pharmas ask FDA for guidelines on off-label info

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Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.

Off-label marketing offenses cost Elan $203 million

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Elan Pharmaceuticals pleaded guilty today to a misdemeanor violation for illegally promoting epilepsy drug Zonegran.

Former Glaxo lawyer accused of marketing cover-up

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A federal grand jury has indicted a former GlaxoSmithKline attorney for allegedly failing to comply with an FDA request for documents in an off-label marketing probe.

CIAs pressure pharma to rethink sales rep compensation

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Novartis's recent off-label settlement with the Department of Justice -- to the tune of $422 million -- also included the signing of a Corporate Integrity Agreement (CIA) requiring the Swiss-based manufacturer to review incentive-based compensation for reps, and to examine "the extent to which compensation is based on product performance," according to the CIA.

Forest Labs to pay $313 million in DOJ settlement

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Forest Laboratories is the latest pharmaceutical company to settle unlawful marketing allegations with a multi-million dollar payout - over $313 million - to the Department of Justice (DOJ), just two weeks after Allergan agreed to pony up $600 million to settle illegal Botox marketing practices.

Allergan drops FDA lawsuit as part of off-label settlement

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Before Allergan could begin settlement negotiations with the Department of Justice (DOJ) -- which ended with an agreement to pay $600 million on Wednesday -- DOJ required the Botox manufacturer to first withdraw a First Amendment lawsuit against the FDA filed last October.

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