The Swiss drug maker is defending itself against two civil fraud lawsuits filed within a week of each other.
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.
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 "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's Jane Axelrad is leaving the Office of Regulatory Policy to head the agency's compounding policy rethink.
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.
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'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 alleges KV has botched the marketing and wants rights to the drug. KV disagrees.
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.
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.
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 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.
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 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.
Merck said it received a subpoena related to marketing and selling activities with respect to three drugs: Temodar, PegIntron and Intron A.
Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.
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.
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.
Elan Pharmaceuticals pleaded guilty today to a misdemeanor violation for illegally promoting epilepsy drug Zonegran.
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.
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.
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 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.
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.
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.
An ad hoc coalition, spearheaded by industry veteran Arnold Friede, is formulating a proposal to challenge recent DDMAC actions it considers misguided.
Iowa's state Senate passed a healthcare bill containing some of the toughest restrictions on drug company contacts with physicians yet.
The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
The Department of Justice is suing Forest Laboratories over the alleged promotion of Celexa and Lexapro off-label, for pediatric use. Forest also paid kickbacks to physicians, the DOJ said.