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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Goodwin

Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

Goodwin on

On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

Latham & Watkins LLP

US State Regulatory Spotlight on Healthcare Transactions: Reflections From 2024

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State-level oversight of M&A and other strategic transactions involving healthcare is continuing to expand into new markets and impact growth strategies. The interest and need for healthcare services transactions in the...more

Venable LLP

Accord BioPharma’s Stelara® Biosimilar Imuldosa™ Approved by FDA

Venable LLP on

On October 10, 2024, the FDA approved Accord BioPharma’s Imuldosa™ (ustekinumab-srlf), the fifth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa™ was developed by Dong-A ST in collaboration with...more

Parker Poe Adams & Bernstein LLP

Ninth Circuit Upholds Montana Vaccination Status Discrimination Law

As part of the backlash against employer-mandated COVID-19 vaccinations, Montana amended its antidiscrimination law to add vaccination status as a protected category. This means that employers are prohibited from inquiring or...more

Arnall Golden Gregory LLP

CMS Releases Update to CMS-855A Enrollment Form With Significant Increase in Disclosure Requirements for SNFs

The Centers for Medicare & Medicaid Services (“CMS”) has issued an updated version of the Form CMS-855A that requires additional disclosures for skilled nursing facilities (“SNFs”). Effective October 1, 2024, the revised Form...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences - September 2024

WilmerHale on

Novo Nordisk May Proceed with Its Ozempic Suit Against DCA Pharmacy. A Tennessee federal court denied DCA Pharmacy’s motion to dismiss a lawsuit filed by Novo Nordisk Inc. alleging a violation of Tennessee state unfair and...more

ArentFox Schiff

Silence Is Golden: Court of Appeal Expands Legal Protections for California Medical Staffs

ArentFox Schiff on

Expanding on the peer review protections established in Bonni v. St. Joseph Health System, the California Court of Appeal in Dignity Health v. Mounts held that a wide array of medical staff communications regarding peer...more

ArentFox Schiff

California Requires Disclaimers for Health Care Providers’ AI-Generated Patient Communications

ArentFox Schiff on

In a significant move toward regulating artificial intelligence (AI) in health care, Assembly Bill (AB) 3030 will require health facilities, clinics, and physician practices in California to provide disclaimers to patients...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

Schwabe, Williamson & Wyatt PC

Year-End Compliance Considerations for Employee Benefit Plans

Open enrollment is right around the corner (at least for employers that run calendar-year health benefit plans), so many employers will be updating their benefit communication plans. Though not comprehensive, the following is...more

Mintz

[Podcast] Health Law Diagnosed – Women Leaders in Health Care: Investing in Women’s Health

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In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host...more

Bradley Arant Boult Cummings LLP

FTC Finalizes Changes to Premerger Notification Form: What It Means for Healthcare Transactions

At long last, we have a rule. On October 10, 2024, the Federal Trade Commission (FTC) unanimously issued a final rule updating the Hart-Scott-Rodino Act (HSR Act) premerger notification process (the Final Rule). The Final...more

Knobbe Martens

Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval

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The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024)

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering...more

Cozen O'Connor

Broad Street Brief: City, CCP Launch Municipal Employment College

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Last week, Mayor Cherelle Parker joined the Community College of Philadelphia (CCP) to launch the new City College for Municipal Employment, which will train students specifically for local government jobs. The program aims...more

Fox Rothschild LLP

The John W. Rheay Act: A Step Forward in Florida’s Fight Against HIV

Fox Rothschild LLP on

In a significant move to enhance public health and expand HIV prevention measures, Florida has recently enacted the “John W. Rheay Act” (Fla. Stat. § 465.1861), effective as of July 1, 2024. This legislation aims to enhance...more

Conn Maciel Carey LLP

OSHA Updates Animal Slaughtering and Processing Worker Safety Enforcement Inspection Guidance

Conn Maciel Carey LLP on

On October 15, 2024, OSHA issued Inspection Guidance for Animal Slaughtering and Processing Establishments that updates enforcement protocols for the agency’s field staff and compliance guidance for employers in NAICS Code...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Inventorship Considerations in AI-assisted Drug Development

The utilization of artificial intelligence (“AI”) is becoming ubiquitous across a wide range of industry sectors. The biotech industry is no exception. AI-driven platforms have become increasingly useful to biotech...more

Fishman Haygood LLP

U.S. Fifth Circuit Reverses District Court and Awards Benefits to ERISA Plan Participant for Hospitalization

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Case Background - When she was a preteen, E.D. began experiencing symptoms of anorexia nervosa. Her condition worsened, and her parents, the Dwyers, took her to Avalon Hills, a residential treatment facility....more

Cozen O'Connor

GOP AGs Challenge Nursing Home Staffing Rule

Cozen O'Connor on

A group of 20 Republican AGs along with industry organizations have filed a lawsuit challenging the Department of Health and Human Services, Centers for Medicare & Medicaid Services’ (CMS) Final Rule establishing minimum...more

Foley & Lardner LLP

New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

Foley & Lardner LLP on

After considerable pressure from both Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on October...more

Dinsmore & Shohl LLP

[Webinar] Don't Be the Next Change Healthcare: How to Avoid a Breach and Prepare Your Response Plan - October 29th, 12:00 pm -...

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During the first half of this webinar, Jen Mitchell, Bryan Murray and Laura Fryan, will focus on practical tips and pointers on avoiding a HIPAA breach and what lessons you can take away from the Change Healthcare breach. ...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Cybersecurity

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Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading...more

Stikeman Elliott LLP

Health Canada: Changes to the Cosmetic Regulations

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The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) (the “Amended Cosmetic Regulations), published on April 24, 2024, took effect on October 9th (with the exception of...more

Dentons

Ep. 36 – What to Consider When Terminating a Patient-Care Relationship

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Healthcare workers nationally are facing an increase in workplace violence, often instigated by patients and visitors. A study published earlier this year reported that almost 20% of healthcare workers have faced physical...more

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