AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
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.
Drug makers favor big spending on speakers' events and doctor outreach.
Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.
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.
Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.
Three drug purchasing companies have taken the Denmark drugmaker to court in the US. The charge: wrongfully keeping generics off the market.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
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.
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