The U.S. Food and Drug Administration's increasingly docile enforcement posture toward pharmaceutical advertisements may be emboldening drugmakers to take promotional liberties, a potentially perilous move despite the laid-back oversight. Here, experts share eight promotional pitfalls that pharma compliance officers need to know in today's enforcement environment.
The U.S. Supreme Court’s decision not to revive a Helsinn patent on the nausea drug Aloxi has clarified the scope of the on-sale bar under the America Invents Act and underscored the need for inventors to file their patent applications as early as possible.
Walgreens Boots Alliance Inc. has inked settlements worth $269 million to end False Claims Act allegations of egregious overbilling for various drugs, the U.S. Department of Justice said Tuesday, marking some of the largest FCA payouts ever by a retail pharmacy.
An environmental health scientist pushed back Tuesday against Johnson & Johnson’s claims that multiple studies have shown no signs of asbestos in the talcum powder J&J used to make baby powder for decades, telling a California jury the FDA’s test methods in the 1970s were "dubious,” and others, inadequate.
A Johnson & Johnson unit will pay $120 million to end a wide-ranging investigation into whether it misled customers about the longevity and efficacy of its hip replacement devices, attorneys general in New York and Texas announced Tuesday.
A group of 71 organizations sent a letter Tuesday to members of Congress urging them to remove provisions in the revised version of the North American Free Trade Agreement that would allow pharmaceutical companies to keep charging high prices, saying that pushing the same policies onto Mexico and Canada is not the solution to the drug pricing problem.
The U.S. Food and Drug Administration on Tuesday released final guidance outlining an updated pathway for bringing medical devices to market that uses objective performance criteria to show that the devices are safe and effective.
The U.S. Supreme Court on Tuesday held the America Invents Act did not narrow the scope of the on-sale bar in patent cases, leaving unchanged a long-standing rule that confidential sales of an invention can be used to invalidate a patent.
Hologic Inc. is settling out of a Delaware federal court lawsuit from Fujifilm Corp. accusing the medical technology company of patent infringement and maintaining an illegal monopoly over the U.S. market for mammography systems used to diagnose breast cancer.
The Patent Trial and Appeal Board invalidated a patent covering Valeant Pharmaceuticals’ Jublia by expanding the definition of what the antifungal medication treated, the drugmaker told the Federal Circuit in a bid to revive the patent.
A German pharmaceutical company has urged the Federal Circuit not to rehear a panel decision that upheld a $20 million Eastern District of Texas jury verdict that Eli Lilly and Co.’s Cialis drug infringed its patent, saying that Lilly lost its chance to make validity and venue challenges by not raising them earlier.
A unit of Valeant Pharmaceuticals can keep its false drug marketing claims against a subsidiary of rival Virtus Pharmaceuticals in California federal court, a judge has ruled, finding the dispute didn’t have to go through the U.S. Food and Drug Administration first.
Drug wholesalers urged a New Jersey federal court Monday to nix a bid from GlaxoSmithKline PLC and Teva Pharmaceutical Industries Ltd. to pause an antitrust suit over the availability of generic alternatives to epilepsy drug Lamictal while the companies seek Third Circuit review of the direct buyers’ class certification.
Archer Daniels Midland Co. on Tuesday dodged much of a proposed class action brought by two horse owners who alleged contaminated feed products harmed their animals, when an Illinois federal judge said most of the owners' claims don't have a legal foundation.
Fawaz Alhokair Group has reportedly tapped Morgan Stanley and Moelis related to reignited plans to float its Arabian Centres malls unit, Saudi Aramco could invest billions in natural gas in the United States, and Colfax Corp. has tapped Goldman Sachs to help it sell its Howden unit.
2018 was full of important developments in international law, including a new North American trade treaty, significant litigation at the International Court of Justice, and rulings by various bodies related to environmental, human rights and criminal law, say Viren Mascarenhas and Douglass Cassel of King & Spalding LLP.
Earlier this month, a California federal court denied discovery into the identification of third-party funders with a financial interest in the outcome of an underlying patent infringement action. This decision in MLC v. Micron follows a long line of well-reasoned precedent across U.S. federal courts, say Matthew Harrison and Sarah Jacobson of Bentham IMF.
U.S. law firms are on track to achieve gender parity in partner promotions by 2032, and gender parity within the partner ranks at a time far beyond that, a reality some say necessitates drastic change if firms hope to alter the current trajectory.
The administrative agency of the federal court system said Tuesday that federal courts will have enough funding to continue operating until Jan. 31 despite the government shutdown, the third time the courts have extended the estimated date when they will have to start cutting staff.
A Russian company criminally charged with thwarting enforcement of the Foreign Agents Registration Act asked a judge on Tuesday to make prosecutors explain why Skadden Arps Slate Meagher & Flom LLP "was permitted to purchase a declination" in its own FARA case.
While there is general support in the legal field for policies geared toward reaching gender equity in the industry, a survey released on Tuesday reveals an “enthusiasm gap” by which women are more likely to champion these efforts than their male colleagues.
Law Finance Group LLC has hit the law firm Girardi Keese and trial attorney Thomas V. Girardi with a breach of contract suit in California state court claiming they have failed to make repayments on a debt of more than $15 million.
A former Weil Gotshal & Manges LLP bankruptcy partner has hit Metropolitan Life Insurance Co. with a lawsuit in New York federal court accusing the insurance carrier of wrongly denying him long-term disability benefits even though he suffers from a series of psychiatric problems.
Florida Gov. Ron DeSantis filled the final vacant seat on the Florida Supreme Court Tuesday with the appointment of Carlos Genaro Muñiz, who is serving as general counsel at the U.S. Department of Education and will be the first Nicaraguan-American on the state’s highest court.
To Planet Fitness World Headquarters General Counsel Justin Vartanian, the biggest challenge for his industry is to motivate others to incorporate fitness into their lives. Here, he explains the benefits lawyers can gain from healthy lifestyles as the legal industry strives to reduce stigmas that surround mental health, and offers advice on how to stick to wellness-related resolutions amid demanding workloads.