• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Index insights
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Topics » Regulatory » Courts

Courts
Courts RSS Feed RSS

Astellas patent survives ‘natural law’ decision

Sep. 19, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
Read More

Glenmark settles US civil price-fixing allegations

Sep. 10, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
Read More

Glenmark settles US civil price-fixing allegations

Sep. 5, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
Read More
Gavel and scales

Third Circuit: Royalties not always tied to patent expiration

Sep. 4, 2024
By Mari Serebrov
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
Read More
Gavel and vials

FTC noncompete ban struck down by district court

Aug. 22, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
Read More

FTC noncompete ban struck down by district court

Aug. 21, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses has been struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as had been planned on Sept. 4.
Read More
Patent gears

US Fed Circuit: Lower court wrong on Viberzi patents

Aug. 14, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
Read More

US HHS wins another round; associational standing questioned

Aug. 12, 2024
By Mari Serebrov
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Read More
U.S. flag on columned building

Cybersecurity looms ever larger in US False Claims Act litigation

Aug. 6, 2024
By Mark McCarty
U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.
Read More

US HHS scores another IRA win

Aug. 5, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 15 16 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 20, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 18, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 17, 2025
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • Enflonsia

    Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

    BioWorld
    With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe