Try our Advanced Search for more refined results
Life Sciences
-
December 04, 2024
Colo. Co.'s Alleged Kickback Scheme Ends In $2M Settlements
A Colorado neuromonitoring company, its founder and two others have agreed to pay more than $2 million to end a False Claims Act lawsuit alleging they participated in a kickback scheme to get surgeons to order neuromonitoring services covered by federal programs.
-
December 04, 2024
DEA Judge Sets Pot Rescheduling Hearings
The Drug Enforcement Administration will kick off six weeks of hearings in late January on the merits of the attorney general's proposal to loosen restrictions on marijuana, an agency administrative law judge said Wednesday.
-
December 04, 2024
Fed. Circ. Judge Condemns 'Nonsense' Law In Antibody Fight
U.S. Circuit Judge Todd Hughes called the Federal Circuit's case law on interpreting preambles in patent claims "nonsense" on Wednesday, expressing frustration as a panel tried to work through whether Xencor Inc.'s antibody patent application was too broad.
-
December 04, 2024
Takeda Exec Duped Beau Into $2M Fraud, Jury Told
A Massachusetts man is accusing his wife, a former Takeda Pharmaceuticals vice president, of playing "puppet master" by tricking him into joining a scheme to steal millions from the drug company through fake invoices.
-
December 04, 2024
Justices Seem To Back Ban On Transgender Youth Care
The U.S. Supreme Court's conservative majority on Wednesday seemed poised to greenlight a Tennessee ban on minors receiving gender-affirming care, despite arguments from the court's liberal block that finding the law constitutional would fly in the face of the court's equal-protection precedents.
-
December 03, 2024
Mich. AG Deal, NIH 4th Circ. Win And X Corp Bid In HIPAA Row
Michigan's attorney general has agreed not to hold a Christian healthcare provider accountable to certain antidiscrimination protections related to gender and sexuality while the provider challenges them in court. Meanwhile, a New York federal judge decided to keep the largest anesthesiology provider in the U.S. on the hook for antitrust claims over its noncompete agreements with clinicians.
-
December 03, 2024
Calif. Unveils Reproductive Rights Bills To Prep For Trump
California lawmakers plan to introduce a pair of bills aimed at protecting access to abortion in the Golden State as Donald Trump returns to office, according to an announcement made Monday, the first day of a special legislative session called by Gov. Gavin Newsom.
-
December 03, 2024
SEC Says Biopharma's Cooperation Helped It Avoid Penalty
A Houston biopharmaceutical company accused of misleading investors about the regulatory status of two cancer drugs agreed to settle the U.S. Securities and Exchange Commission's action against it on Tuesday without paying a dime, in recognition of what the SEC said was the company's self-reporting and cooperation with investigators.
-
December 03, 2024
J&J's Neosporin Forever Discolored Man's Groin, Suit Says
Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.
-
December 03, 2024
$1B Sandoz Placeholder Bid Needs More Support, Judge Says
A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.
-
December 03, 2024
USPTO Abandons Polarizing Proposal Over Double Patenting
The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.
-
December 03, 2024
Vidal Aimed To Put USPTO Rulemaking In The Spotlight
Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.
-
December 03, 2024
FDA Issues Guidance On Potential Infant Formula Shortages
The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.
-
December 03, 2024
4 Mass. State Court Rulings You May Have Missed In Nov.
An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.
-
December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
-
December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
-
December 02, 2024
Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud
A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.
-
December 02, 2024
Justices Seem Inclined To Back FDA Block Of Flavored Vapes
U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.
-
December 02, 2024
Investor Alleges Medical Device Co. Misled On FDA Clearance
The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.
-
December 02, 2024
Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal
A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.
-
December 02, 2024
Chancery OKs $21M Deal To End Gene Co. Class Suit
A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.
-
December 02, 2024
Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing
The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.
-
December 02, 2024
Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK
A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.
-
December 02, 2024
DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan
The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.
-
December 02, 2024
Ex-Parexel Worker Says Vax Rule Lacked 'Informed Consent'
A former employee of clinical research firm Parexel International says the company's COVID-19 vaccine requirement was a breach of contract because she and other workers did not have the option of giving informed consent for what she calls an "experimental medical treatment," according to a lawsuit filed in Massachusetts state court.
Expert Analysis
-
Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
-
Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
-
Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
-
Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
-
FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
-
Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
-
How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
-
Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
-
What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
-
Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.
-
3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
-
1 Year At The UPC: Implications For Transatlantic Disputes
In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.
-
Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
-
Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
-
Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.