Life Sciences

  • October 22, 2014

    Biotech IPO Market Hits Turbulence As Several Price Low

    After a year of flying high, biotechs are running into trouble this week, as several have priced below their range or pulled the plug on the float entirely, with satiated investor appetites and overall market volatility the likely culprits for the lull, experts say.

  • October 22, 2014

    Deals Rumor Mill: Apollo Global, Advent, Sterigenics

    Apollo Global Management LLC is looking to raise between $2 billion and $3 billion for a second natural resources private equity fund, while Advent International Corp. and Avista Capital Partners are nearing a deal to buy Kremers Urban Pharmaceuticals Inc. from Belgium's UCB SA for as much as $2 billion.

  • October 22, 2014

    Drugmaker Accuses Ropes & Gray Of Patent Filing Blunder

    The Medicines Co. has slapped Fish & Neave LLP and Ropes & Gray LLP with a legal malpractice suit in New Jersey claiming Fish & Neave blew the deadline for a critical patent filing associated with the company's anticoagulant drug Angiomax.

  • October 22, 2014

    Effexor Buyers Want Another Chance In Antitrust Suit

    Drug buyers on Tuesday urged a New Jersey federal judge to allow them to amend their complaint against Wyeth Inc. and Teva Pharmaceuticals USA Inc. over a no-authorized-generic deal for antidepressant Effexor XR, saying the court’s new pleading standard is novel and was only introduced after they filed their suit.

  • October 22, 2014

    Glaxo Eyes IPO For HIV Unit As Part Of Restructuring Plan

    GlaxoSmithKline PLC said Wednesday that it is considering launching an initial public offering for part of its HIV joint venture ViiV Healthcare as it embarks on an ambitious recovery plan to boost earnings that have been recently hit by declining U.S. drug sales.

  • October 22, 2014

    Nexium Jury Hears From Walgreens Exec On Generics

    A Walgreen Co. executive testified Wednesday at a pay-for-delay trial over AstraZeneca PLC’s Nexium that the heartburn treatment did face competition for prescriptions from several other similar drugs, but emphasized that cheaper generic versions were only available for a few lower dosages.

  • October 22, 2014

    ITC Agrees To Review Construction Of Sleep-Aid Patents

    The U.S. International Trade Commission has agreed to review a pair of claim constructions made in a case alleging sleep disorder devices imported by BMC Medical Co. violated patents held by ResMed Corp., according to a notice published in Wednesday's Federal Register.

  • October 22, 2014

    Mylan Signals $5.3B Abbott Inversion On Track After Tweaks

    Mylan Inc. and Abbott Laboratories said Wednesday that new limitations imposed by the Obama administration on tax-motivated M&A wouldn't derail their planned $5.3 billion inversion deal, though they did modify the terms of the transaction.

  • October 21, 2014

    Actavis Wins Bid To Keep Parts Of Antitrust Suit Under Seal

    A New York federal judge, citing concerns of competitive disadvantage, on Tuesday ordered that profit projections and other financial information remain confidential in the New York attorney general's suit accusing Actavis PLC and Forest Laboratories LLC of product-hopping antitrust claims over dementia drug Namenda.

  • October 21, 2014

    DePuy Hip Implant Bellwether Trial Heads To Jurors In Texas

    Bringing an eight-week bellwether trial to a close in Dallas federal court, a hip implant patient on Tuesday accused Johnson & Johnson's DePuy Orthopaedics Inc. unit of putting marketing and sales before safety in its allegedly defective Pinnacle line of metal-on-metal implants.

  • October 21, 2014

    OIG Finds Flaws In FDA's Cybersecurity Protections

    The U.S. Food and Drug Administration’s website recently contained vulnerabilities that could have let hackers hijack systems and precisely target their attacks, according to a report Tuesday from the Office of Inspector General at the U.S. Department of Health and Human Services.

  • October 21, 2014

    Pfizer Fights 'Do-Over' Of Plaintiff Experts In Zoloft MDL

    Pfizer Inc. on Tuesday fought what it called the plaintiffs' bid for a "do-over" on a Pennsylvania federal court's Daubert rulings in multidistrict litigation over its antidepressant Zoloft's alleged risk of birth defects, arguing that the plaintiffs should not be allowed to name a new expert after the deadline has passed.

  • October 21, 2014

    Viamet Gets $60M In Private Financing After Nixing IPO

    Antifungal drugmaker Viamet Pharmaceuticals on Monday scrapped its plans for a $75 million initial public offering and instead opted to raise $60 million in private venture financing and spin off its prostate cancer unit.

  • October 21, 2014

    Deals Rumor Mill: Actavis, Siemens, Yahoo

    Actavis is one of multiple companies interested in buying Omega Pharma, which would be worth up to $5.1 billion, while Siemens is on the verge of divesting its hearing-aid business in a deal that could net the German engineering titan upwards of $2.6 billion.

  • October 21, 2014

    Senate Shake-Up Would Breathe New Life Into ACA Battles

    An increasingly likely Republican takeover of the U.S. Senate in next month's midterm elections would almost certainly lead to new showdowns over controversial Affordable Care Act provisions, such as the employer mandate and the medical device tax, as incoming senators try to turn campaign rhetoric into reality.

  • October 21, 2014

    Nexium Jury Told Drug Cos. Wheeled-And-Dealed With Patent

    Nexium buyers pursuing a pay-for-delay case against AstraZeneca PLC and two generic-drug makers told a Boston federal jury on Tuesday that the pharmaceutical companies were trying to game the patent system to overcharge consumers by billions of dollars for the heartburn treatment.

  • October 21, 2014

    Nexium Pay-For-Delay Jury Told Size Of Settlement Is Key

    As the first pay-for-delay jury trial kicked off Tuesday, a Boston federal judge told jurors that though patent settlements are usually good, a large and unexplained payment in the case over Nexium could spell trouble under antitrust law.

  • October 21, 2014

    Molecular Partners Hits Brakes On IPO In Shaky Market

    Swiss biotechnology company Molecular Partners AG has become the latest European company to postpone a planned initial public offering amid widespread market tumult driven by worry surrounding plummeting oil prices and stagnating regional growth.

  • October 21, 2014

    Avandia User's Warranty Violation Suit Flops In 3rd Circ.

    The Third Circuit on Tuesday refused to revive a putative class action accusing GlaxoSmithKline PLC of violating the warranty on its diabetes drug Avandia, ruling a label declaring the drug “safe and effective” was not enough to create a warranty under New Jersey law.

  • October 21, 2014

    FDA Finalizes Stance On Obstructed Pharma Inspections

    The U.S. Food and Drug Administration on Tuesday finalized new policies on oversight of drug manufacturing plants, adopting an aggressive stance on its photography powers while also describing situations in which it’s acceptable to inhibit inspections.

Expert Analysis

  • OIG Remains Focused On Pharmaceutical Copayment Coupons

    Eve M. Brunts

    A report and special advisory bulletin from the U.S. Department of Health and Human Services' Office of Inspector General are the latest examples of ongoing scrutiny and challenges involving copayment coupons offered by pharmaceutical manufacturers, say Eve Brunts and Smita Singh of Ropes & Gray LLP.

  • New Jurisdictional Issues When Moving To Quash A Subpoena

    Steven Luxton

    The Nevada federal court's recent ruling in Agincourt Gaming LLC v. Zynga Inc. is an important reminder that a nonparty wanting to challenge a civil subpoena should consider carefully the appropriate jurisdiction in which to file a motion to quash under recently enacted Rule 45, say Steven Luxton and Brad Nes of Morgan Lewis & Bockius LLP.

  • GSK Bribery Conviction Signals Increased Risks In China

    Jay Pomerantz

    China’s anti-corruption efforts have historically focused on the Chinese government officials who solicit or receive bribes, but GlaxoSmithKline PLC's recent bribery conviction demonstrates that companies doing business in China must be mindful of China’s own anti-corruption laws in addition to the Foreign Corrupt Practices Act, say Jay Pomerantz and Catherine Kevane of Fenwick & West LLP.

  • Random Selection Is Best For MDL Bellwether Trials

    Matthew A. Holian

    The inadequacies of party selection are particularly troubling when compared to random selection, which yields representative plaintiffs, is fair to both sides, and also produces valuable information for courts and litigants, say Loren Brown and Matthew Holian at DLA Piper LLP and Dov Rothman at Analysis Group Inc.

  • What Litigators Can Learn From Novelists

    Michael H. Rubin

    Many legal briefs are written in impenetrable jargon and begin with an introduction telling the court what it already knows, using words that stem from the 18th century, such as “hereinafter.” Instead, we should approach briefs the way novelists approach their writing, says Michael Rubin of McGlinchey Stafford PLLC.

  • The Learned Intermediary Doctrine: A Historical Review

    Keri L. Arnold

    In the last 15 years, a few courts have expressed greater resistance to the protection the learned intermediary doctrine provides pharmaceutical companies given the way medications are prescribed and advertised since the rule was originally developed, say Keri Arnold and Sarah Duncan of Arnold & Porter LLP.

  • If High Court Reverses Teva, Litigation Costs May Increase

    Irena Royzman

    The policy arguments presented to the U.S. Supreme Court in Teva Pharmaceuticals USA Inc. v. Sandoz Inc., which was argued Wednesday, are off-base. In fact, increased deference to lower court claim construction determinations is more likely to increase litigation costs than decrease them, say Irena Royzman and Aron Fischer of Patterson Belknap Webb & Tyler LLP and Maggie Wittlin, an associate-in-law at Columbia Law School.

  • Assessing FDA Powers After A Failed 510(k) Rescinding

    Lynn C. Tyler

    It may well be a good thing that the D.C. Circuit's Ivy Sports Medicine LLC v. Burwell decision does not apply to medical devices currently under review — if the U.S. Food and Drug Administration knew it could only rescind a 510(k) clearance through the cumbersome rulemaking process it might become even more conservative about granting clearances, says Lynn Tyler of Barnes & Thornburg LLP.

  • A Convergence Of Antitrust, Anti-Graft Enforcement In China

    Kareena Teh

    In their efforts to combat unfair competition, Chinese authorities have used both antitrust and anti-corruption laws, targeted specific industries, conducted swift investigations, executed dawn raids to obtain evidence, and shared information among different departments. It is highly likely that this will continue for the foreseeable future, impacting the operations of many multinationals, say Kareena Teh and Fabian Roday of Dechert LLP.

  • Information Governance: A Missed Opportunity For Lawyers

    Ann Snyder

    Today, information intersects every practice area, making all lawyers effectively information governance practitioners in one way or another. The issue is whether you will consciously embrace this emerging discipline — and capitalize on it to the benefit of your clients and your practice, says Ann Snyder of the Information Governance Initiative.