A Delaware federal bankruptcy judge on Friday approved a settlement between drug developer KaloBios Pharmaceuticals Inc. and former CEO Martin Shkreli, who was arrested on securities fraud charges, that severely limits his future involvement with the company.
The U.S. Supreme Court has been urged to resolve a circuit split on whether a doctor's writing a prescription breaks the chain of causation between drugmakers like Sanofi Aventis US LLP and injured parties under the Racketeer Influenced and Corrupt Organizations Act.
Looking to end claims that its cholesterol drug Lipitor causes Type 2 diabetes, Pfizer on Friday told a South Carolina federal judge overseeing the multidistrict litigation that all the consumers lack admissible expert testimony proving that the drug specifically caused the disease.
A pharmaceutical sales representative who claims his former employer conspired with the government to set him up as a fall guy for criminal drug misbranding has taken his suit against the alleged conspirators to the U.S. Supreme Court after the Second Circuit refused to resurrect his claims in March.
The onetime leader of a drug company whose sole product was derived from goat’s blood on Thursday asked an Illinois federal judge to deny the U.S. Securities and Exchange Commission’s request that he be barred from serving on the board of any other public company following a verdict that went in the SEC’s favor.
The U.S. Food and Drug Administration should clear up how real-world evidence can be used in clinical trials and post-market surveillance for drugs and medical devices and consider expanded uses of such evidence in the agency's regulatory decision-making, according to a report released Thursday.
Actavis PLC on Thursday asked a Pennsylvania federal court to deny a motion for it to hand over documents in response to a third-party subpoena, saying that it has already produced the information requested by direct purchasers of Suboxone in multidistrict litigation accusing manufacturer Indivior PLC of engaging in a product-hopping scheme.
A Massachusetts federal judge has dismissed a shareholder suit alleging Biogen Inc. misled investors, finding the shareholders couldn't prove Biogen executives intentionally played down the impact of a safety issue with its main drug in rosy growth forecasts.
A North Carolina company accused General Electric’s health care and biosciences unit of stealing its customers and ruining its profits while also lying about the makeup of its own fetal bovine serum, a product used in laboratories to promote cell growth, in a complaint filed Thursday in federal court.
Watson Laboratories Inc. and its owner Allergan PLC on Thursday asked a Pennsylvania federal court to sever the Federal Trade Commission's case claiming that it delayed generic competition for Lidoderm from another similar case over Opana ER, saying the agency was trying to merge two unrelated cases.
Johnson & Johnson’s DePuy Orthopaedics Inc. unit told the Fifth Circuit Thursday that the Texas federal court overseeing multidistrict litigation over allegedly defective Pinnacle hip prosthetics has been abusing the bellwether process and asked for a halt to a trial scheduled for early fall.
The director of the U.S. Patent and Trademark Office on Wednesday told the Federal Circuit that America Invents Act patent reviews are constitutional and that the Patent Trial and Appeal Board didn’t err when it invalidated the asserted claims of its patent for extended-release drug technology.
CDx Holdings Inc. on Tuesday said it has agreed to pay $24 million to option holders of CDx’s predecessor company, Caris Life Sciences, to end a long-running merger class action that wound its way to the Delaware Supreme Court last week but still could have been revived over an alleged clerical error.
Norton Rose Fulbright has bolstered its New York office with a new partner from Sheppard Mullin Richter & Hampton LLP experienced in handling employment matters for clients that include financial services, technology, retail, entertainment and medical device companies.
The maker of the Mirena IUD, which is facing 1,200 lawsuits over uterine-wall punctures, renewed its fight for a quick win Wednesday, telling a judge the plaintiffs have no case without the expert witnesses who were recently barred.
Teva Pharmaceutical Industries Ltd. will be able to market a generic version of AstraZeneca’s diabetes drug Byetta by October 2017, according to a patent infringement settlement filed Thursday in Delaware federal court.
Medicare Part A will run out of money in 2028, about two years sooner than the Obama administration previously projected, Medicare’s board of trustees said Wednesday in its 51st annual report, calling on legislators to quickly take action to combat the shortfall.
Lehigh Valley Technologies Inc. and Endo Global Ventures sued generic-drug manufacturer Sandoz Inc. in New Jersey federal court on Wednesday over a potassium supplement that they say was never approved by drug regulators.
Eye drop manufacturer Altaire Pharmaceuticals Inc. can’t evade accusations that its general counsel committed fraud with a letter knowingly overstating the company's chemical supply to eye care firm Paragon BioTeck Inc. during a manufacturing and distribution deal, a New York federal judge ruled Tuesday.
The Ohio high court on Tuesday dropped a scathing opinion on a county judge who it said improperly “injected” himself into a multimillion-dollar judgment in Kentucky against disbarred fen-phen lawyer Stanley Chesley.
Although the recently proposed CREATES Act leaves some competitive concerns unanswered, and raises some additional questions, it provides a starting point to address some of the issues affecting consumer access to cheaper generic and biosimilar drug products in the United States, say Gregory Asciolla and Matthew Perez at Labaton Sucharow LLP.
It’s important to first decide what your personal brand is. Are you a crusader? A wry observer? A compassionate witness? Your social media presence doesn’t have to reflect the deepest aspects of your identity — it’s merely an image that you project, says Monica Zent, founder and CEO of Foxwordy Inc.
The Tennessee federal court decision in Fleming v. Janssen Pharmaceuticals serves as a good overview of the various grounds defendants use for dismissal of drug product liability claims, and the intersection of preemption and design defect claims, says Eric Alexander at Reed Smith LLP.
One of the most prevalent complaints by associates and recent law school graduates is the lack of meaningful mentoring by more seasoned attorneys. Gary Gansle, leader of Squire Patton Boggs LLP's Northern California employment law practice, offers several tips as a light that can help junior attorneys start down the right path in their career development.
The delay, for the third time, of the U.S. Food and Drug Administration's new prescription drug labeling rule means that plaintiffs injured by generic drugs are essentially prohibited from seeking or receiving compensation for their injuries, say Stefanie Colella-Walsh and Martin Schrama at Stark & Stark.
A defining feature of the U.S. Supreme Court's Alice decision, borrowed from Mayo, is reliance on “implicit exceptions” to the patent laws, under which the court regards patent claims too closely related to a law of nature, natural phenomenon or abstract idea as ineligible for patenting. It has fallen on the Federal Circuit to determine what scope should be given to these “implicit exceptions,” says Bruce Sunstein of Sunstein Kann ... (continued)
LeBron James has established his worth by tangible metrics. He cashed in on a free agent bonanza fueled by the NBA’s economic model that supports his regal compensation. But such is not the case when it comes to first-year associate salaries of $180,000 at certain law firms and $2,000 an hour billing rates for certain partners, says Mark A. Cohen, founder of Legal Mosaic LLC.
No one understands the concept and obligations of “fiduciary duty” better than legal professionals — and yet, many law firm partners and principals may be overlooking a significant source of liability in their practices, says Tom Zgainer, CEO and founder of America’s Best 401k.
As the concurring opinion in Warsaw v. NuVasive discusses, the Federal Circuit's majority opinion is a bit difficult to harmonize with Commil and Global-Tech, the U.S. Supreme Court’s most recent decisions on indirect infringement, say David Loewenstein and Clyde Shuman of Pearl Cohen Zedek Latzer & Baratz LLP.
While this acquittal is a notable loss for the government, and not its first against individual pharmaceutical defendants, history has shown the DOJ will continue to prosecute cases of individual wrongdoing, especially in this post-Yates era. But the question may now become whether the government will demand even more breadth and depth of cooperation from companies, say attorneys with Paul Hastings LLP.