Life Sciences

  • February 5, 2016

    4 Firms Set To Guide Billion-Dollar Slate Of IPOs

    Four firms plan to steer initial public offerings surpassing $1.1 billion the week of Feb. 8, edging a sluggish market forward in what attorneys said could be the last of a spate of offerings before a fast-approaching filing deadline requires companies to update their financial statements.

  • February 5, 2016

    PE-Backed Therapure Biopharma Delays $93M Canadian IPO

    Private equity-backed biopharmaceutical company Therapure Biopharma said Thursday that it has postponed plans for a CA$130 million ($93.5 million) initial public offering in Canada because of shaky markets in the country and in the U.S.

  • February 5, 2016

    2nd Circ. Urged To Revive Actos Pay For Delay Row

    Actos diabetes drug buyers told the Second Circuit on Thursday that a lower court wrongly dismissed their pay-for-delay suit against Takeda and five generics makers for not plausibly showing the companies' actions delayed generic Actos from hitting the market.

  • February 5, 2016

    McDermott Taps BioTech Markets Pro For NY Office

    McDermott Will & Emery LLP has added a wealth of deals experience to its New York office with the hiring of its newest partner, a biotech markets specialist with extensive experience working on initial public offerings and follow-on capital markets transactions in the U.S. and Israel.

  • February 5, 2016

    Fed. Circ. Affirms Validity Of Vascular Stent Patent

    The Federal Circuit on Friday determined that the Patent Trial and Appeal Board correctly found that a patent for vascular stent technology held by its inventor is not invalid because of obviousness.

  • February 5, 2016

    ScriptPro Asks Fed. Circ. To Save Pill-Dispenser Patent

    ScriptPro urged a Federal Circuit panel on Friday to revive a patent for automated pill-dispensing systems challenged by Innovation Associates, arguing a lower court misread the patent when it found the claims were overly broad and didn't line up with a description of the invention.

  • February 5, 2016

    Taxation With Representation: Kirkland, Sullivan, Norton

    In this week’s Taxation with Representation, a Utah-based natural gas utility is acquired with the assistance of Kirkland & Ellis LLP tax pros, a medical device manufacturer acquires a peer and Lowe’s buys a Canadian hardware retailer.

  • February 5, 2016

    6th Circ. Told Pliva Can't Dodge FDA's Stance On Warnings

    A woman accusing Pliva of failing to warn consumers of neurological problems associated with a generic anti-nausea drug told the Sixth Circuit on Thursday that a federal judge has gone against the U.S. Food and Drug Administration by throwing her suit out.

  • February 5, 2016

    FDA Staff Back Celltrion's Remicade Biosimilar

    U.S. Food and Drug Administration staff on Friday voiced support for Celltrion's proposed biosimilar of Janssen Biotech’s Remicade, keeping it on track to become the second and most complex U.S. biosimilar.

  • February 4, 2016

    Astellas To Pay $13.3M To Settle Prograf Antitrust Case

    Astellas Pharma agreed Thursday to pay indirect purchasers of its Prograf $13.25 million to settle claims that it delayed generic competition to the immunosuppressant drug amid an appeal of class certification in the antitrust case.

  • February 4, 2016

    Judge In Reed Smith Suicide Case Can't Beeline To Trial: GSK

    GlaxoSmithKline PLC told an Illinois federal judge Thursday he can't just skip ahead to trial in a suit by the widow of a Reed Smith LLP partner accusing the drugmaker of concealing data linking its drug Paxil to suicide, urging him to first rule on its pending motions to end the suit.

  • February 4, 2016

    Diet Pill Maker Can't Skirt Campbell-Ewald With Deposit

    A New York federal judge on Wednesday refused to allow Basic Research LLC and a "Jersey Shore" star to skirt the U.S. Supreme Court’s recent Campbell-Ewald ruling by depositing with the court their full offer of relief to the individual plaintiffs in a putative false advertising class action.

  • February 4, 2016

    AbbVie, Others Escape Some Testosterone Therapy Claims

    An Illinois federal judge on Thursday tossed most of a putative class action accusing AbbVie Inc. and other pharmaceutical companies of causing health insurers to pay for medically unnecessary uses of testosterone replacement therapy drugs via fraudulent marketing, but allowed the deficient claims to be amended.

  • February 4, 2016

    Medicare's Biosimilar Pay Policy Draws Congressional Fire

    Lawmakers on Thursday trained bipartisan fire on plans to cut Medicare’s costs for biosimilars, questioning whether it will discourage development of the copycat medicines.

  • February 4, 2016

    FDA Announces Review Of Opioid Policies

    With senators blocking Dr. Robert M. Califf’s appointment to lead the U.S. Food and Drug Administration over his ties to Big Pharma and the agency’s perceived lack of commitment to dealing with opioid painkillers, the FDA announced Thursday that it will be reassessing its approach to the class of drugs.

  • February 4, 2016

    Liberty Says MusclePharm's $3M Indemnity Suit Won't Fly

    A Liberty Insurance unit on Wednesday told a Colorado federal judge that sports nutrition company MusclePharm is rewriting the scope of its policy to try to obtain coverage for $3 million in costs of complying with a U.S. Securities and Exchange Commission investigation.

  • February 4, 2016

    KaloBios Can Keep Control Of Bankruptcy

    A Delaware bankruptcy judge let KaloBios' new management keep control Thursday of the drugmaker's Chapter 11, mounted two weeks after ousted CEO Martin Shkreli was charged with securities fraud, after hearing a potentially lucrative drug development deal, thought dead, was still on the table.

  • February 4, 2016

    Anda Pushes For W.Va. 'Pill Mill' Coverage In 11th Circ.

    Anda Inc. told the Eleventh Circuit on Thursday there is no doubt that a West Virginia lawsuit claiming the drugmaker contributed to an “epidemic” of prescription drug abuse stems at least partially from its citizens’ “bodily injuries,” thus coverage from its five insurers should have been triggered.

  • February 4, 2016

    Judge Takes 2nd Look At $174M 'Short And Distort' Damages

    A Delaware Chancery Court judge ordered a fresh look Thursday at a short-seller’s alleged online smearing of biotech company Organovo Holdings Inc., saying he needed a closer look at the offending statements before deciding on a damage bid that could reach $174 million.

  • February 4, 2016

    Deals Rumor Mill: Mattel, Sharp, Ardian

    Mattel and Hasbro are discussing a merger that would unite the world's two largest toy companies, Sharp has selected Hon Hai and its $5.9 billion takeover bid for the struggling tech company, and Ardian is offering to buy Novacap for $783 million.

Expert Analysis

  • Proportionality Ruling Raises Concerns About Rule 26 Change

    Henry J. Kelston

    During the drafting process leading to the recent Federal Rules amendments, some participants expressed concern that the relocation of the proportionality provisions might be interpreted as placing a burden on the requesting party to demonstrate the proportionality of the discovery it seeks. A California federal court's recent decision in Gilead v. Merck indicates that these concerns may indeed come to fruition, says Henry Kelston of Milberg LLP.

  • Health Care Deal Trends Emerge From JP Morgan 2016

    Amber McGraw Walsh

    After more than 50 structured conversations with health care private equity and investment banking professionals at the recent J.P. Morgan health care conference, we can conclude that there is a deep — almost ubiquitous — interest in finding and structuring the next provider services consolidation, say attorneys with McGuireWoods LLP.

  • FDA's Strategy For Interoperable Medical Device Regulation

    Mark Mansour

    In order to balance the competing priorities of developing new and innovative interoperable medical devices and protecting patient safety and privacy laid out in its recent guidance, the U.S. Food and Drug Administration should conduct a fact-based technical analysis to assess the costs and potential burdens for medical device manufacturers and others in the health information technology marketplace, say attorneys at Mayer Brown LLP.

  • Unexpected Uncertainty For The 340B Drug Pricing Program

    Alyce Katayama

    The Bipartisan Budget Act of 2015 poses an unexpected threat to the 340B Drug Pricing Program — even though it doesn't even mention the program — as it changes the way new off-campus hospital outpatient departments are paid, which could have a substantial impact on 340B Program child site eligibility. But covered entities shouldn't throw in the towel just yet, say Alyce Katayama and Elizabeth Gebarski at Quarles & Brady LLP.

  • Medical Device Cybersecurity: What Pharma Cos. Should Know

    Elaine H. Tseng

    The U.S. Food and Drug Administration’s most recent draft guidance on postmarket cybersecurity for medical devices may be "nonbinding" but it is clear that the FDA will at some point start policing and enforcing cybersecurity issues in marketed medical devices, so pharmaceutical companies should be on their guard, say Elaine Tseng and Alexander Haas at King & Spalding LLP.

  • What The Court Got Wrong About Hatch-Waxman In Alcon

    Brian D. Coggio

    The New Jersey federal court's recent decision in Alcon v. Akorn disregards the very purpose of the 30-month stay of U.S. Food and Drug Administration approval as apparent from the legislative history of the Hatch-Waxman Act, say Brian Coggio and Ron Vogel of Fish & Richardson PC.

  • A Cautionary Tale About 'Other Acts' And Insider Trading

    Daniel Wenner

    Former Major League Baseball star Douglas DeCinces' recent strikeout in the Ninth Circuit is noteworthy for the government’s application of Rule 404(b) in an insider trading case. Both this tactic — which appears like "guilt by association" — and outcome could have serious implications for other defendants in insider trading prosecutions, say Daniel Wenner and Kenton Atta-Krah of Day Pitney LLP.

  • The FDA's Priority List For 2016

    Erica Cribbs

    The U.S. Food and Drug Administration has big plans for 2016, including negotiating the sixth reauthorization for the Prescription Drug User Fee Act, continuing to implement its biosimilars program, integrating the Sentinel Network and potentially developing labeling rules specific to different types of drugs, say attorneys at Nixon Peabody LLP.

  • Expectation Damages Now A Real Possibility In Delaware

    Philip Richter

    The Delaware Supreme Court’s decision in SIGA Technologies v. PharmAthene — stemming from a bridge loan and merger agreement between the two when SIGA was in dire financial straits — changes the calculus for a party considering whether to breach an obligation to negotiate an agreement in good faith as there is now a potential for expectation damages, say attorneys with Fried Frank Harris Shriver & Jacobson LLP.

  • The Precision Medicine Initiative's 1st Annual Checkup

    Antoinette F. Konski

    One year has passed since President Obama announced a new “precision” medicine initiative to advance personalized, effective therapies for the American public. Since then, an extensive framework has been created, and associated funding and other support has been provided to move the president’s initiative forward, says Antoinette Konski at Foley & Lardner LLP.