Legal

Five things for pharma marketers to know: Tuesday, November 25

Five things for pharma marketers to know: Tuesday, November 25

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AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.

Vancouver tests prescription heroin

The north-of-the-border solution comes amid climbing heroin abuse in the US.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

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CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.

Unsealed court documents shed light on opioid marketing

Drug makers favor big spending on speakers' events and doctor outreach.

Five things for pharma marketers to know: Wednesday, November 19

Five things for pharma marketers to know: Wednesday, November 19

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Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.

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.

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.

Novo sued over generic Prandin claim

Three drug purchasing companies have taken the Denmark drugmaker to court in the US. The charge: wrongfully keeping generics off the market.

Teva, Pfizer settle on Viagra generic date

Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.

Novartis sued for alleged speaker-program abuse

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The Swiss drug maker is defending itself against two civil fraud lawsuits filed within a week of each other.

Myriad decision could be a drag on personalized medicine R&D

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After a skeptical Supreme Court hearing, diagnostics and biopharma patent lawyers are sweating the outcome of Association for Molecular Pathology vs. Myriad Genetics, in which the Court could decide whether or not swatches of genes are patentable.

Court could punt "Pay for Delay" back to Congress

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Eight members of the Supreme Court heard testimony in the case of FTC v. Actavis this morning, and the fate of so-called "pay for delay" settlements hangs in the balance.

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.

FDA regulatory policy chief to take on compounding question

FDA regulatory policy chief to take on compounding question

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FDA's Jane Axelrad is leaving the Office of Regulatory Policy to head the agency's compounding policy rethink.

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.

For Forest, one Bystolic test down, six to go

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Forest Labs may have settled a patent challenge from generics maker Hetero, but the drugmaker has yet to come to terms with six others.

Pharma execs: MLR teams are friendlier on digital

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Pharma's med/legal/regulatory (MLR) teams, managers of risk and so often the scapegoats for creating roadblocks to digital innovation, were discussed in a much friendlier light by digital marketers at last week's ExL Digital Pharma East conference in Philadelphia.

Hologic, seeking rights to Makena, trades barbs with KV

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Hologic alleges KV has botched the marketing and wants rights to the drug. KV disagrees.

Judge puts freeze on Merz bid to challenge Botox

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US District Court Judge Andrew Guilford slammed the breaks on Merz's foray into a market dominated by Botox, siding with Allergan in a case about stealing intellectual property and poaching sales reps.

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

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Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.

Merck v. Merck Facebook fracas a "tempest in a teapot" says US firm

Merck v. Merck Facebook fracas a "tempest in a teapot" says US firm

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Facebook shut down Facebook.com/Merck after Merck KGaA announced plans to take legal action "based on the apparent takeover of its Facebook page" by its US cousin, Merck & Co.

Amylin, parting ways with Lilly, plans for extra sales reps

Amylin, parting ways with Lilly, plans for extra sales reps

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Amylin said it will hire 365 sales reps to make up for Eli Lilly's departure from commercial activities, once the firm takes full control of the exenatide diabetes franchise in the US this month.

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.

Feds subpoena Merck on marketing of hepatitis, cancer drugs

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Merck said it received a subpoena related to marketing and selling activities with respect to three drugs: Temodar, PegIntron and Intron A.

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.

Supremes strike down Vermont data law

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The Supreme Court came down on the side of data firms, overturning a Vermont law banning the sale of prescription data to pharmas because it violates First Amendment speech protections.

Data firms get a little help from their friends in Supreme Court case

Data firms get a little help from their friends in Supreme Court case

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The data mining firms fighting for their right to sell physician data got an assist as a host of big names, including a pair of former Health and Human Services secretaries, filed 16 supportive amicus briefs with the Supreme Court.

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.

Supreme Court to weigh prescriber data ban

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After shrugging at a similar plea for a hearing in July of 2009, the Supreme Court has decided to weigh in on the legality of selling prescriber data - or information that details the prescribing habits of physicians - to drug marketers.

The Women's Health landscape is ripe with opportunity for pharma marketers. This seven-page eBook offers product managers a guide to capitalizing on the trends, growth areas and unmet needs. Includes alternative channels to engage OB/GYNs and oncologists, and plenty of tips. Click here to access it.

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