A New York federal judge asked Friday whether Sanofi's "very happy opinion" shared with investors about prospects for on-time approval of its potential blockbuster Lemtrada multiple sclerosis drug carried with it a duty to detail concerns among regulators about bias in the single-blind method by which the drug giant and its recently acquired Genzyme Corp. unit were conducting trials.
The Office of Inspector General at the U.S. Department of Health and Human Services on Friday detailed its investigative priorities for fiscal 2015, vowing to scrutinize Medicare and Medicaid billing by insurance plans, medical device makers and an array of health care providers.
A consumer group that was barred by the Federal Circuit from challenging a University of Wisconsin-Madison stem cell patent asked the U.S. Supreme Court Friday to review the ruling, saying the appeals court's finding that it lacks standing "violates fundamental fairness and plain common sense."
A Seventh Circuit panel on Friday grilled NBTY Inc. and plaintiffs’ attorneys about the $6.5 million settlement they struck in a glucosamine supplement false labeling class action, questioning how the class ended up with only $900,000 and a dubious label change.
The New York attorney general has urged a federal judge to block Actavis PLC from pulling its widely used dementia drug Namenda from the market until the office's antitrust suit concludes, while the drugmaker countered that the standards required for an injunction have not been met.
A Washington federal court on Friday dismissed a proposed class action alleging breast cancer detection device maker Atossa Genetics Inc. misled investors into buying $3.7 million worth of shares in an initial public offering, saying the plaintiffs failed to adequately prove the company had acted unlawfully.
Voters on Tuesday will decide the fate of myriad state and local initiatives that address issues as varied as fracking, medical marijuana and care for terminally ill patients. Here, Law360 looks at eight ballot initiatives that could have significant nationwide implications, should they pass or fail.
Takeda Pharmaceuticals International Inc. and Eli Lilly & Co. said Thursday they will appeal a $37 million punitive damages ruling against them in a suit that alleged the company hid the cancer risks of diabetes drug Actos to keep sales high.
A Delaware federal judge invalidated part of a DNA technology patent Genetic Technologies Ltd. accused Bristol-Myers Squibb Co. and a Sanofi-Aventis SA unit of infringing because it merely described a natural law, dooming the claim under the U.S. Supreme Court’s landmark Mayo v. Prometheus decision.
TIG Insurance Co. is liable for $7.6 million in excess coverage obligations for Stryker Corp.’s settlement of artificial knee defect lawsuits, a Michigan federal judge ruled Thursday, finding the insurer wasn’t required to consent to the deals for Stryker to secure coverage.
Merck KGaA unit EMD Millipore Corp. urged the Federal Circuit to reconsider its decision that rival AllPure Technologies Inc. didn't infringe a device patent for withdrawing fluid from a container, saying Wednesday that the panel’s decision was contrary to “well-settled law” on prosecution history estoppel.
The U.S. Securities and Exchange Commission on Thursday filed suit against a former director of pharmaceutical company InterMune Inc., alleging he and his friends made more than $1 million using insider information to trade on the news of European regulators’ approval of a lung disease drug.
Five drug manufacturing and health care organizations spoke out on Thursday against a proposed San Francisco ordinance requiring pharmaceutical companies to pay for the collection of unwanted drugs, saying it would have little positive health impact while forcing drug companies to bear the full burden of running the program.
The Ninth Circuit on Thursday revived a putative Employee Retirement Income Security Act class action against Amgen Inc. for a second time, after the U.S. Supreme Court vacated its first ruling, saying the high court's ruling doesn't shield Amgen from liability for a dip in the company's stock price.
Anemia treatment developer FibroGen. Inc. fine-tuned its initial public offering plans Thursday, setting the stage to raise about $124 million and become the largest biotech by diluted market capitalization in a decade.
Rhythm Pharmaceuticals Inc. on Wednesday pulled its planned $86 million initial public offering after the company reached a deal last week with Actavis PLC for an exclusive option to purchase one of its gastrointestinal drug subsidiaries.
A former Pfizer Inc. sales manager who was convicted in 2009 for illegal drug marketing can’t be forced to testify in a class action suit alleging the pharmaceutical giant concealed a broader fraud scheme from investors, a New York federal judge ruled Thursday.
The Eleventh Circuit on Thursday sent to arbitration a dispute brought by U.S. Nutraceuticals LLC alleging that microalgae products maker Cyanotech Corp. breached an agreement by stealing confidential information.
Jones Day has strengthened its business and tort litigation practice by adding to its Atlanta office a former federal prosecutor and Womble Carlyle Sandridge & Rice PLLC partner who has extensive experience in tobacco and pharmaceutical litigation.
A Nevada federal judge on Wednesday tossed a private clinic’s suit accusing GlaxoSmithKline LLC, nonprofit Apexus Inc. and a public health agency of abusing a federal drug-discount program, ruling the agency’s purchase of vaccines was exempted from an antitrust law.
A significant departure in the U.S. Food and Drug Administration's final guidance on distinguishing medical device recalls from enhancements involves changes to references of nonviolative devices and nonviolative labels — the addition of a new warning now will not be considered a recall, say attorneys at King & Spalding LLP.
While many of the changes in the latest European Patent Office guidelines reflect the current practice of the EPO’s boards of appeal, they also suggest that the first-instance departments of the EPO may be moving toward a less rigid and formalistic approach to some issues, say Philip Cupitt and Hazel Ford of Finnegan Henderson Farabow Garrett & Dunner LLP.
For companies with an interest in assisting the government in its Ebola prevention and treatment efforts, a strong working understanding of a broad agency announcement originally issued by the U.S. Department of Health and Human Services in 2009 is vital, say Jennifer Plitsch and Michael Wagner of Covington & Burling LLP.
It is obvious that there is a segment of the investment marketplace convinced there is money to be made out of the Ebola outbreak by trying to pick the winners on the Ebola drug derby. Among the companies that got caught up in the frenzy was iBio Inc., says Kevin LaCroix of RT ProExec.
Not surprisingly, it took a while before the first petitions for post-grant review were filed, but LaRose Industries LLC and Toys “R” Us-Delaware Inc. filed in August, and Accord Healthcare Inc. filed in September. If one or both petitions are granted, one question will be whether the Patent Trial and Appeal Board will be able to issue a decision within the mandatory 12-18 months, says Lisa Mueller of Michael Best & Friedrich LLP.
A California district court's ruling in JHP Pharmaceuticals LLC v. Hospira Inc. may persuade other courts to either extend the U.S. Supreme Court's generally permissive view of Lanham Act claims to drugs and cosmetics or find some claims that previously required U.S. Food and Drug Administration expertise may now be precluded after Pom Wonderful LLC v. The Coca-Cola Company, say attorneys at Nixon Peabody LLP.
Courts remain largely skeptical about allowing litigants to serve and notify evasive parties of legal proceedings through their social media accounts. A recent split ruling by the Oklahoma Supreme Court shows the competing considerations, say Steven Richard and Britt Killian of Nixon Peabody LLP.
Although the U.S. has not signed or ratified the Nagoya Protocol, U.S. companies that utilize genetic resources from other countries for scientific research or commercial purposes will be subjected to these new requirements and restrictions. With many countries already vigorously enforcing such restrictions, the consequences of not fully complying may be draconian, says Bruce Manheim of WilmerHale.
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.
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.