The U.S. Supreme Court said Monday it will not hear an appeal from an attorney convicted of fraudulently inflating a medical device company’s stock by drafting press releases about nonexistent purchase orders.
Monsanto Co. and its Pfizer Inc.-owned successor couldn’t have known polychlorinated biphenyls cause cancer in 1969, so they don’t have to face a $28 million lawsuit from a Massachusetts town over PCB contamination, the First Circuit said Friday.
The U.S. Food and Drug Administration on Monday released final guidance laying out its recommendations for how product names are displayed on advertising and promotional labeling for prescription drugs, and proposed to study how consumers and health care providers spot deceptive ads.
A California federal judge on Friday granted class certification to Puma Biotechnologies Inc. investors in a stock drop suit accusing the company of misrepresenting the effectiveness of a breast cancer treatment called neratinib.
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A shadowy investor has been hit with a $38 million default judgment for spearheading a “short and smear” campaign against a bioprinting company after he failed to respond to a suit in Delaware state court.
Trade group Pharmaceutical Research and Manufacturers of America on Friday sued California to block a newly approved drug pricing law, calling it a vast overreach that amounts to a “nationwide ban” on price increases.
Hoffmann-La Roche Ltd. has convinced the New Jersey Supreme Court to review two state appellate decisions related to the company's acne medication Accutane, with the justices agreeing to consider rulings over the adequacy of the drug's label and the admissibility of expert testimony.
A shareholder of drug developer Innoviva Inc. won a battle with the company over the makeup of its board of directors Friday when a Delaware Chancery Court judge determined that a deal among the parties to resolve the investor's proxy fight was valid and should be enforced, requiring two investor nominees to be added to the company's board.
A onetime colleague of former Katten Muchin corporate attorney and fraud defendant Evan Greebel who was retained to handle a U.S. Securities and Exchange Commission investigation into one of Martin Shkreli’s hedge funds told a Brooklyn federal jury on Friday that he never saw Greebel do anything illegal.
Pharmaceutical company Patheon Inc. has urged a New York federal judge to deny softgel maker Procaps SA’s request to vacate part of an arbitration award finding it can't recover $135 million in lost profits damages for a nixed product development agreement, telling the court the agreement doesn’t allow for such damages.
Shares of Denali Therapeutics Inc. soared Friday after the company raised $250 million in an upsized initial public offering that amounted to the largest biotechnology IPO of 2017, leading one of three newly public companies that raised $506 million combined.
Biopharmaceutical firm Gilead Sciences Inc. said Thursday it will acquire private equity-backed biotechnology company Cell Design Labs Inc. for $567 million in a deal that will see Gilead build up its cell therapy capabilities even more.
Three companies are set to raise about $762 million combined from initial public offerings during the week of Dec. 11, led by a commercial real estate broker, private equity-backed cable equipment maker and biotechnology company, a small lineup that marks the start of a year-end slowdown.
The European Commission is wary of Bayer’s blockbuster buyout of Monsanto, Toshiba and Western Digital have come to terms on a settlement that will end their dispute over the planned 2 trillion yen sale of Toshiba Memory Corp., and Elliott Management is pushing for changes at Alexion Pharmaceuticals.
An electrical contractor sued a slew of construction and insurance companies in Maryland federal court Wednesday, demanding $21 million for the contractor's extra work on a biological warfare research facility and alleging the project was mismanaged and inefficient even before a fire destroyed half the building.
The U.S. Food and Drug Administration on Thursday unveiled new oversight policies for digital health products, including increasingly popular software used to assist doctors in making treatment decisions.
Drugmaker Amgen asked the Federal Circuit on Wednesday for an en banc rehearing of a decision that revived a challenge to its patents for Repatha, an antibody-based cholesterol treatment, saying a panel abandoned precedent by rejecting a previously used test for patentability of such drugs and finding admissible evidence that post-dates the challenged patents.
The government urged a Massachusetts federal court Wednesday to not acquit a pharmacist convicted of 77 counts including racketeering and mail fraud for manufacturing deadly drugs in the 2012 fungal meningitis outbreak, saying the arguments presented to support acquittal have been rejected by the court or rely on facts dismissed by the jury.
Federal courts across the country are handing down important rulings interpreting the U.S. Supreme Court’s landmark decision on False Claims Act liability in Universal Health Services v. Escobar. As the rulings keep pouring in, stay up to speed on Law360’s latest coverage and analysis of Escobar’s impact.
There have been many articles on the corporate monitor selection process, but you will find little guidance about how to prepare yourself for a job that has few parallels. There are three key lessons I have learned over the course of a Foreign Corrupt Practices Act monitorship still in progress, says Gil Soffer of Katten Muchin Rosenman LLP.
Much has been written about the 2012 "Resource Guide to the U.S. Foreign Corrupt Practices Act," but no one has talked about the behind-the-scenes work that produced the guide — until now, say Charles Duross, former chief of the FCPA Unit at the U.S. Department of Justice, and Kara Novaco Brockmeyer, former chief of the FCPA Unit at the U.S. Securities and Exchange Commission.
The twist in the Lindsey Manufacturing Foreign Corrupt Practices Act case was the truncated time in which we prepared. Having refused to waive their rights to a speedy trial, our clients took control of the case — this, along with the compressed time frame, forced the government to make errors, say Janet Levine, Sima Namiri-Kalantari and Megan Weisgerber of Crowell & Moring LLP.
Having defended some of the most notorious defendants in 40 years of practice as a criminal defense lawyer, I thought I was prepared for everything. That was until jury selection commenced last summer in “pharma bro” Martin Shkreli’s trial, says Benjamin Brafman of Brafman & Associates PC.
Since its whopping $800 million Foreign Corrupt Practices Act settlement in 2008, Siemens cleaned up — and it has “cleaned up” in its long-standing competition with General Electric. How? As Secretary of State Rex Tillerson reportedly told President Donald Trump, you don’t need to pay bribes to succeed in international business, says Peter Y. Solmssen, former general counsel of Siemens.
The 2008 Siemens matter — then the largest sanction ever imposed in a Foreign Corrupt Practices Act enforcement action — set the stage for future cross-collaboration in global anti-corruption enforcement, say Cheryl Scarboro, former chief of the FCPA Unit at the U.S. Securities and Exchange Commission, and Diana Wielocha of Simpson Thacher & Bartlett LLP.
The U.S. Food and Drug Administration recently issued warning letters concerning violations of the Federal Food, Drug and Cosmetic Act to four companies that market products containing cannabidiol, a nonpsychotropic cannabinoid found in cannabis. These letters should serve as a reminder that the FDA is watching closely, say attorneys with Arent Fox LLP.
Given the high cost of litigation and what's at stake in loss of market share to generic drug manufacturers, brand drug companies should employ a multipronged drug development and pre-litigation strategy, coming to market well prepared for battle, say Laura Vogel and Bella Satra of Barclay Damon LLP.
The Foreign Corrupt Practices Act case of U.S. v. Harris Corp. was tried in March 1991 — so long ago that pretty much only the parties and counsel remember it. With a smile, I’ve just about given up correcting people who say their case is "the only FCPA case ever to be tried,” says Robert Feldman of Quinn Emanuel Urquhart & Sullivan LLP.
A federal judge in New Jersey recently granted summary judgment to drug manufacturers in a lawsuit alleging that Plavix caused gastrointestinal bleeding. The multidistrict litigation court, sitting in New Jersey, applied California's learned intermediary doctrine, but may not have reached the same conclusion had it applied New Jersey law, say Stefanie Colella-Walsh and Martin Schrama of Stark & Stark.