Life Sciences

  • February 10, 2016

    3rd Circ. Ruling Backs RICO Claims Against Glaxo, Court Told

    Insurers suing GlaxoSmithKline over adulterated drugs from a now-defunct Puerto Rican factory said Tuesday a recent Third Circuit case that gave union health funds the ability to sue the drugmaker under the Racketeer Influenced and Corrupt Organizations Act supports their ability to bring similar claims.

  • February 10, 2016

    Bankrupt KaloBios Faces Fire For Employee Bonus Plan

    Investors suing KaloBios, which hit Chapter 11 weeks after its ousted CEO Martin Shkreli was charged with securities fraud, have taken aim at the embattled and bankrupt drug developer’s employee bonus plan, arguing it’s unnecessary for a company with uncertain prospects for any future revenues.

  • February 10, 2016

    NJ Shareholder Suit Over Nymox's Prostate Drug Trials Tossed

    A New Jersey federal judge on Wednesday released Nymox Pharmaceutical Corp. and its founder from a class action securities suit, concluding that shareholders failed to demonstrate a purposeful scheme to misrepresent the prospects of a prostate drug when trials showed the medication was doomed to fail.

  • February 10, 2016

    Cravath Reps Mylan In $9.9B Deal For Swedish Drugmaker

    Mylan announced on Wednesday that it has agreed to acquire Swedish drug company Meda AB in a $9.9 billion cash-and-stock deal guided by Cravath Swaine & Moore LLP, three months after it ditched a hostile takeover attempt of fellow generic-drug maker Perrigo.

  • February 10, 2016

    Steptoe Adds IP Partner From Ropes & Gray

    Steptoe & Johnson LLP said Wednesday it has strengthened its national intellectual property group and life sciences capabilities with the hire of an intellectual property partner in New York who comes from Ropes & Gray LLP.

  • February 10, 2016

    Smartphone, Pharma Giants Dominate List Of Top IP Targets

    Smartphone makers remain irresistible targets for patent litigation plaintiffs, with Samsung and Apple topping Law360's list of frequently named defendants in patent lawsuits filed in 2015. But increasingly ferocious intellectual property battles over generic drugs mean industry giants like Mylan Pharmaceuticals are starting to give smartphone makers some competition for that dubious honor.

  • February 10, 2016

    Hikma Chops $2.7B Boehringer Generics Offer By 20%

    U.K. drugmaker Hikma said Wednesday it has slashed nearly 20 percent from its $2.7 billion offer to buy Boehringer’s U.S. generics business, after discovering the unit's 2015 revenue would be lower than expected.

  • February 10, 2016

    Mylan Pushes 3rd Circ. To Revive Doryx Product-Hopping Suit

    Generic-drug maker Mylan Pharmaceuticals Inc. has urged the Third Circuit to resurrect its suit against Warner Chilcott PLC for allegedly tweaking the formula of its acne medication Doryx in order to block generic competition, saying Warner's defenses "amount to a call to abandon all antitrust review of product changes."

  • February 10, 2016

    PE-Backed US Foods Leads Trio Of New IPO Filings

    Private equity-backed food distributor US Foods and two life sciences companies are planning to go public in the U.S., venturing into a volatile market that has recently seen some companies nix their initial public offering plans, according to regulatory documents filed Tuesday and Wednesday.

  • February 10, 2016

    FDA Warning Can't Bar Fresenius Dialysis Suits, Court Told

    Hundreds of Massachusetts and Mississippi cases are eligible to join multidistrict litigation against Fresenius over GranuFlo's and NaturaLyte's alleged side effects, because there was no proof patients or their physicians knew about a 2012 FDA warning about the dialysis drugs, a court was told Wednesday.

  • February 10, 2016

    J&J Hit With $13.5M Verdict In 2nd Philly Pelvic Mesh Trial

    A Philadelphia jury returned a $13.5 million verdict against a Johnson & Johnson unit on Wednesday in a case over allegations that the company’s faulty pelvic mesh implants left a woman with near constant pain and discomfort and an inability to have sex.

  • February 9, 2016

    Corin Hip Implant Defect Suit Nixed For Lack Of Evidence

    An Oklahoma federal judge has ended a man’s lawsuit accusing medical device maker Corin of skirting federal regulations and defectively designing a metal-on-metal hip implant system that led directly to his injuries, finding that he simply lacked any proof to support his negligence claims.

  • February 9, 2016

    FDA Seeks $5.1B Budget, Including Funds For Food Safety

    The U.S. Food and Drug Administration on Tuesday said that it is seeking a $5.1 billion budget for 2017, including $211 million to fund the implementation of sweeping new food safety laws and $41.2 million to improve medical product safety.

  • February 9, 2016

    Hagens Berman Loses Sanctions Appeal In Thalidomide Row

    The Third Circuit on Tuesday dismissed Hagens Berman Sobol Shapiro LLP’s appeal of sanctions imposed on it by a district court judge for litigating three time-barred thalidomide birth-defect suits against Grunenthal GmbH, saying it lacked jurisdiction to hear the matter because related claims are still pending in the lower court.

  • February 9, 2016

    FDA Warning Wire: Cannabis Therapy, Cattle Feed, Frozen Fish

    The U.S. Food and Drug Administration set its sights on companies selling cannabis products that claim they relieve medical symptoms such as nausea and inflammation and can treat serious conditions including diabetes and schizophrenia. The agency also targeted an animal feed manufacturer in Florida and a seafood company in Queens, New York, whose frozen fish imports were allegedly contaminated. 

  • February 9, 2016

    FDA Panel OKs Celltrion Biosimilar Of Janssen's Remicade

    After a grueling debate, an independent panel on Tuesday advised the U.S. Food and Drug Administration to approve Celltrion’s copy of Janssen Biotech’s blockbuster immunosuppressant Remicade, the latest step forward for the emerging biosimilars industry.

  • February 9, 2016

    Bid For Info On Suboxone Resales Is Premature, Judge Says

    A Pennsylvania federal judge Monday ruled that direct purchasers of Suboxone who accuse manufacturer Indivior of engaging in a product-hopping scheme to stifle generic competition of the opiate addiction treatment need not turn over information about resales of the drug until a decision on the issue is reached.

  • February 9, 2016

    Jury Ready To Decide 2nd Philly Pelvic Mesh Case

    A Philadelphia jury will begin deliberating Wednesday whether a Johnson & Johnson unit could be held liable for a New Jersey woman's pain and inability to have sexual intercourse, in the second case to be tried in the jurisdiction's mass tort program for pelvic mesh implants.

  • February 9, 2016

    Biotechs Pull Offerings Totaling $155M Amid Weak Markets

    Two biotechs nixed stock offerings totaling $155 million on Monday, including an estimated $86 million initial public offering by rare-disease treatment developer Apellis Pharmaceuticals Inc., providing fresh evidence that issuers are skittish to tap volatile public markets.

  • February 9, 2016

    7 Bills Promoting Medical Innovation Pass Senate Committee

    The U.S. Senate Committee on Health Education, Labor and Pensions on Tuesday approved seven medical innovation bills, the first step in its piecemeal approach to its version of the 21st Century Cures Act, but most debate focused on whether or not the approach was appropriate.

Expert Analysis

  • Investing In The Marijuana Industry: Where We Stand

    John Bessonette

    Companies — and their investors — continue to face a myriad of risks associated with uncertainty over future regulatory developments concerning the marijuana industry. As large states like California and Ohio prepare for legalization initiatives, however, the trend toward increasing liberalization and associated comfort levels of investors seems likely to continue, say John Bessonette and Tai Aliya of Kramer Levin Naftalis & Frankel LLP.

  • How Does Skadden Stay No. 1?

    Elizabeth Duffy

    Analyzing the reasons why clients choose certain firms reveals a great deal about what is important and valued in the marketplace. Based on interviews with a random sample of over 600 heads of legal in the largest U.S. organizations, Elizabeth Duffy, vice president of Acritas US Inc., identifies the core brand drivers of Skadden Arps Slate Meagher & Flom LLP.

  • OPINION: The Road To Partnership Must Keep Evolving

    Daniel L. Butcher

    In a recent Law360 article it was suggested that promotion to partner was a competition between associates and that taking maternity, paternity or family medical leave could impact an associate's chances at promotion. But this sort of ethos — which may have contributed to law firms’ success in the past — is not the best way to secure the industry's future, says Daniel Butcher, managing partner of Strasburger & Price LLP.

  • How Pharma Cos. Can Lessen The Risk Of Gov't Action

    Charles Andres jpg.jpg

    Certain actions, like off-label promotion, and violations of broad health care laws, like the Sunshine Act, can make life sciences companies and individuals targets of government enforcement action — but there are steps companies can take to minimize this risk, say attorneys at Wilson Sonsini Goodrich & Rosati PC.

  • Has Gene By Gene Unzipped TCPA Insurance Exclusions?

    Joshua A. Mooney

    Evanston Insurance v. Gene By Gene Ltd. in Texas district court addresses a new twist on an insurer's Telephone Consumer Protection Act exclusion, in effect limiting it to underlying marketing claims involving junk faxes or spam email. Some might herald this decision as a judicial scaling back of the exclusion, but such proclamations would be premature, says Joshua Mooney at White and Williams LLP.

  • 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.