Mylan and Ranbaxy said Thursday that purchasers bringing pay-for-delay claims over the narcolepsy drug Provigil have failed to give the Third Circuit any good reason to uphold a class certification order, which the drugmakers have attacked as unsupported by the buyers’ damages theory.
The U.S. Food and Drug Administration will soon consider whether to make opioid education for prescribers mandatory — it’s currently voluntary — amid other possible modifications to the agency's plan for evaluating and mitigating the risks associated with prescribing opioid painkillers.
Alere Inc. said Thursday that its board of directors rejected a request by Abbott Laboratories, which expressed concerns about the diagnostic services provider’s pending foreign bribery probe and delays with its annual report, to terminate their proposed $5.8 billion tie-up.
The Federal Circuit's holding that America Invents Act decisions must be reviewed with deference on appeal could inspire the U.S. Supreme Court to consider requiring greater scrutiny of the Patent Trial and Appeal Board, which could make AIA decisions easier to overturn, attorneys say.
Attorneys for the CEO of a pharmaceutical company admonished the U.S. Securities and Exchange Commission’s “harsh and hurtful words” Thursday, saying the agency couldn’t prove their client was lying to investors while promoting an experimental medication made from goat’s blood.
Abbott Laboratories has touted its proposed $25 billion acquisition of medical device maker St. Jude Medical as a chance to combine the companies’ cardiovascular device offerings, but any overlap in that area could become a target for a divestiture order from the Federal Trade Commission, attorneys say.
Express Scripts’ bid to escape an antitrust suit brought by compounding pharmacies who say it conspired with other pharmacy benefit managers to push them out of the market was little more than “self-serving fiction,” the compounders said in Missouri federal court Wednesday.
Bankrupt drug developer KaloBios Pharmaceuticals received final approval Thursday for a $3 million debtor-in-possession package that will convert to equity for lenders Black Horse Capital and Nomis Bay once the company successfully reorganizes.
The U.S. Food and Drug Administration is flouting a recent court ruling and federal law by refusing to grant orphan drug exclusivity for chemotherapy infusion Bendeka, according to a complaint filed Wednesday in D.C. federal court.
Health care M&A activity got off to a relatively quiet start this year as volatility took hold of the market following a record year for megamergers, but deal-making roared back to life on Thursday when three companies unveiled separate multibillion-dollar plays together worth $40.1 billion.
A man who claims he developed rashes and open sores after using Old Spice deodorant filed a putative class action in California federal court on Wednesday, saying Procter & Gamble knows the product can harm users' skin and has done nothing about it.
Merck on Wednesday escalated a war of words with Gilead over accusations that a Merck attorney lied during a deposition over accessing confidential information, saying its biopharmaceutical rival wants to “exploit” the allegation as a “get-out-of-jail-free card” after a California’s federal jury’s recent $200 million damages award in the patent infringement case.
French drugmaker Sanofi S.A. went public Thursday with an all-cash $9.3 billion offer in its hard-driving buyout bid for biopharmaceutical firm Medivation Inc., which responded that its board is already aware of Sanofi’s interest and is taking its time to review the proposal.
AbbVie Inc. will buy drug maker Stemcentrx and its potential breakthrough lung cancer treatment in a deal worth at least $5.8 billion in cash and stock, with the potential for another $4 billion should the tie-up lead to certain milestones, the global biopharmaceutical company said Thursday.
Abbott Laboratories, led by Wachtell, unveiled on Thursday a $25 billion cash-and-stock acquisition of medical device maker St. Jude Medical, strengthening its position in the cardiovascular market with products that can treat medical issues like atrial fibrillation, structural heart disease and heart failure.
Twenty-two law firms are the cream of the crop when it comes to delivering alternative fee arrangements, according to a new report. Here’s what clients say sets them apart and how the firms say they make it work.
22nd Century, a genetic engineering company specializing in low-nicotine tobacco, was hit with a $250 million contract suit in New York federal court Tuesday by its largest investor, private equity fund Crede CG, which alleges 22nd Century cut it out of a lucrative Chinese joint venture.
A shareholder in StemCells Inc. launched a putative class action Wednesday in Delaware Chancery Court challenging the biopharmaceutical company’s fee-shifting bylaw enacted the day the state Senate voted to ban the practice, and a later-added rule that effectively prohibits stockholders from recovering legal costs in a lawsuit.
The Internal Revenue Service's recently proposed anti-inversion regulations, which led to the highly publicized death of the $160 billion Pfizer-Allergan merger, are only a bandage fix that fail to address why U.S. companies feel compelled to shift their headquarters to lower-tax jurisdictions, Rep. Kevin Brady said Wednesday.
The outgoing CEO of Valeant Pharmaceuticals International Inc. told a skeptical U.S. Senate panel Wednesday that he and the company were “too aggressive” when increasing drug prices, as hedge fund manager and Valeant board member Bill Ackman promised that “a lot’s going to change” at the company.
Human pharmaceutical companies tend to rely upon a "patent thicket" to obtain overlapping scope designed to deter competitors, and some animal pharmaceutical companies are following this model for their products. Close examination of the filing strategies and drafting considerations that lead to the creation of portfolios like Zoetis’ for Apoquel provides insight for other animal health companies looking to expand market share, say... (continued)
The 2015 amendments to the Federal Rules of Civil Procedure present a fertile opportunity for defendants to leverage the rules' renewed focus on reasonableness and proportionality to rein in rampant discovery abuse. Courts' application of the amended rules has already shown promise in this regard, say Martin Healy and Joseph Fanning of Sedgwick LLP.
The Ninth Circuit’s recent opinion in a case involving a dietary supplement manufacturer and its celebrity spokesperson, former NFL quarterback Joe Theismann, reaffirms a large body of case law suggesting that public figures who simply endorse a product have a viable defense against claims for false advertising, say Christina Guerola Sarchio and Emily Luken at Orrick Herrington & Sutcliffe LLP.
Dentons is two different law firm networks in one. So even if the Swiss verein structure should eventually fail and Dentons is forced to operate as a network of independent law firms, it could still be a significant market force, says Mark A. Cohen, a recovering civil trial lawyer and the founder of Legal Mosaic LLC.
The U.S. Food and Drug Administration recently approved its second-ever biosimilar product, Inflectra. Daniel Wittenberg at Snell & Wilmer LLP takes a look at the regulatory framework for biosimiliar approval in the U.S., various states’ responses to interchangeability substitution, and the litigation that may delay Inflectra’s U.S. launch.
As Saudi Arabia's market continues to expand and with its stock market becoming increasingly opening to foreign investors, many U.S. companies and banks are expanding operations in and to the kingdom. These expansions pose a great opportunity for many technology and life science companies — and the potential for the theft or misappropriation of a company’s trade secrets by an employee or business partner, say Paul Keller and Jihad ... (continued)
While the U.S. Department of Health and Human Services' new guidance on the use of its so-called permissive exclusion authority should provide more transparency and predictability, many of its provisions focus on the risk of future misconduct, which run counter to requests for positive incentives for the development and implementation of effective compliance programs, say attorneys at Skadden Arps Slate Meagher & Flom LLP.
The Federal Trade Commission's recent complaint against Endo Pharmaceuticals — the FTC's first lawsuit challenging a "no-authorized-generic" agreement — reflects a number of positions that the FTC has taken in litigation or in amicus briefs, but more broadly reflects two characteristics of commission legal actions against Hatch-Waxman settlements, say Robert Reznick and David Goldstein of Orrick Herrington & Sutcliffe LLP.
The directors and officers insurance marketplace is built around a basic premise that private companies generally do not have liability exposures under the securities laws. With the advent of the U.S. Securities and Exchange Commission's investigation into high-flying startup Theranos — and the possibility of similar probes into other private companies — a number of D&O policy terms and conditions may need to be reviewed, says Kevi... (continued)
The U.S. Food and Drug Administration's recently updated expedited review of abbreviated new drug applications for “sole-source” drug products is a positive development that will provide incentives for generic companies to develop generic versions of off-patent one-source drugs, with potential benefits of keeping the cost of generic drugs down and reducing drug shortage, say Jason Luo and Jordana Garellek at Duane Morris LLP.