Legal

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

Judge puts freeze on Merz bid to challenge Botox

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

Supreme Court to weigh prescriber data ban

By

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.

FTC actions in Watson case come under Senate scrutiny

By

Two senators grilled the chairman of the Federal Trade Commission (FTC) yesterday over allegations made by Watson Pharmaceuticals that the agency used its subpoena power and access to confidential information to force the company into a business deal with a rival generics firm.

Watson: FTC abused power in trying to 'engineer' entry of generic Provigil

Watson: FTC abused power in trying to 'engineer' entry of generic Provigil

By

The FTC, which opposes reverse-payment patent settlements but has failed to muffle them via the courts or healthcare reform legislation, is now trying some new tactics: harassment, use of privileged information and attempting to force a pharma company to partner with another firm against its will.

AstraZeneca settles Seroquel off-label suit for $520m, CIA

AstraZeneca settles Seroquel off-label suit for $520m, CIA

By

AstraZeneca agreed to pay $520 million and enter a five-year Corporate Integrity Agreement to settle a federal case against the company for off-label marketing of Seroquel, the Departments of Justice and Health and Human Services' Healthcare Enforcement Action Team announced.

New Jersey's tough new conflict regs face uncertain future

New Jersey's tough new conflict regs face uncertain future

By

Conflict-of-interest rules announced by New Jersey's Division of Consumer Affairs last week would seem to have mixed prospects under an incoming Republican administration.

Senate health bill pharma-friendly on biologics, price controls

By

The Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity period for biologics.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.