The company is seeking a diabetic retinopathy indication.
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'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.
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.
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.
Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.
The company will shell out $2.2 billion over allegations of marketing misconduct for Risperdal, Invega and Natrecor.
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.
Pfizer settles Rapamune lawsuits; Moody's downgrades GSK; Astrazeneca pursues anemia medication; Mallinckrodt drugs gets priority review
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.
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.
Endo gets a new president, Allergan settles a Botox case
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.
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 "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.
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.
Elsevier launches new drug class overviews, a whistleblower accuses Abbott and Genzyme clears the way for Lemtrada.
The proposed changes center around non-cancer related pain and seek to alter how drug companies can talk about these pain meds.
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.
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 removed records from its website that had detailed payments made to doctors from the middle of 2010 through first-half 2011.
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.
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.
Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.
Elan Pharmaceuticals pleaded guilty today to a misdemeanor violation for illegally promoting epilepsy drug Zonegran.
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.
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 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.
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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