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Pharmaceutical News

@LegalAlerts

News & analysis for anyone interested in regulatory developments in Pharma, including: patents, biosimilars, FDA, medical devices, generics. A @JDSupra feed.

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Joined May 2009
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Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv® / Xbryk® (denosumab-dssb) / Stoboclo® / Osenvelt®... jdsupra.com/legalnews/spotli…
Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv® /...

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv® /...

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each...

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Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - August 2026 jdsupra.com/legalnews/spotli…
Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) -...

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) -...

Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent...

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Western District Of Texas Dismisses Antitrust Claims Against Pharmaceutical Firms jdsupra.com/legalnews/wester…
Western District Of Texas Dismisses Antitrust Claims Against Pharmaceutical Firms

Western District Of Texas Dismisses Antitrust Claims Against Pharmaceutical Firms

On August 5, 2026, the U.S. District Court for the Western District of Texas dismissed pharmaceutical manufacturer Strive Specialties’ antitrust claims alleging that Eli Lilly and Novo Nordisk...

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340B Rebates 2.0: HRSA Revives Its Pilot Program — and Sets Up a Collision Course With Congress jdsupra.com/legalnews/340b-r…
340B Rebates 2.0: HRSA Revives Its Pilot Program — and Sets Up a Collision Course With Congress

340B Rebates 2.0: HRSA Revives Its Pilot Program — and Sets Up a Collision Course With Congress

The Trump administration advances a claims-based rebate model for select 340B drugs as a new bipartisan Senate bill would block it, forcing health systems to track three reform paths at once.

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Spotlight On: Biosimilar Litigations - August 2026 jdsupra.com/legalnews/spotli…
Spotlight On: Biosimilar Litigations - August 2026

Spotlight On: Biosimilar Litigations - August 2026

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference...

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Biotechnology and National Security: Washington’s Expanding Scrutiny of the Life Sciences jdsupra.com/legalnews/biotec…
Biotechnology and National Security: Washington’s Expanding Scrutiny of the Life Sciences

Biotechnology and National Security: Washington’s Expanding Scrutiny of the Life Sciences

Biotechnology is increasingly viewed in Washington through a national security lens. What was once treated primarily as a matter of public health and commercial competition is now the subject of...

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California Supreme Court Rejects Duty to Innovate jdsupra.com/legalnews/califo…
California Supreme Court Rejects Duty to Innovate

California Supreme Court Rejects Duty to Innovate

On August 3, 2026, the California Supreme Court issued its decision in the closely watched Gilead Tenofovir Cases, No. S283862, — Cal.5th —, 2026 WL 2223748 (Cal. Aug. 3, 2026), rejecting the...

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The Post-IEEPA Tariff Regime: Legal Substitution, Commercial Complexity and Enforcement Risk jdsupra.com/legalnews/the-po…
The Post-IEEPA Tariff Regime: Legal Substitution, Commercial Complexity and Enforcement Risk

The Post-IEEPA Tariff Regime: Legal Substitution, Commercial Complexity and Enforcement Risk

The Supreme Court’s rejection of the Trump Administration’s use of the International Emergency Economic Powers Act (IEEPA) did not end the Administration’s effort to establish a broad tariff...

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HRSA announces updated 340B Rebate Model Pilot Program, limited to drugs subject to a Maximum Fair Price (MFP) for 2026 and 2027 jdsupra.com/legalnews/hrsa-a…
HRSA announces updated 340B Rebate Model Pilot Program, limited to drugs subject to a Maximum Fair...

HRSA announces updated 340B Rebate Model Pilot Program, limited to drugs subject to a Maximum Fair...

On August 3, 2026, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (2026 Notice) announcing a new 340B Rebate Model Pilot Program (Pilot...

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FDA Launches New Tool to Help Identify Dangerous Drugs jdsupra.com/legalnews/fda-la…
FDA Launches New Tool to Help Identify Dangerous Drugs

FDA Launches New Tool to Help Identify Dangerous Drugs

The U.S. Food and Drug Administration (FDA) recently launched a new tool designed to help patients, family members and healthcare providers identify dangerous drugs.

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Arkansas Suspends Enforcement of Act 630 Following Constitutional Challenges to Restrictions on Use of Limited Distribution Networks jdsupra.com/legalnews/arkans…

Arkansas Suspends Enforcement of Act 630 Following Constitutional Challenges to Restrictions on Use...

On July 28, following several constitutional challenges by drug manufacturers and specialty pharmacies, the Arkansas State Board of Pharmacy (Board) adopted a resolution indefinitely suspending...

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Arbutus Responds to Moderna’s Appeal of District Court Infringement Judgment over COVID Vaccines jdsupra.com/legalnews/arbutu…

Arbutus Responds to Moderna’s Appeal of District Court Infringement Judgment over COVID Vaccines

Arbutus Biopharma and Genevant Sciences, having prevailed in district court litigation against Moderna involving infringement of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435,...

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China continues to strengthen regulation of Artificial Intelligence (AI) in the Life Sciences sectors: New compliance challenges for businesses jdsupra.com/legalnews/china-…
China continues to strengthen regulation of Artificial Intelligence (AI) in the Life Sciences...

China continues to strengthen regulation of Artificial Intelligence (AI) in the Life Sciences...

In recent years, artificial intelligence (AI) technologies have rapidly penetrated the life sciences industries and have been widely applied in areas such as new drug research and development,...

jdsupra.com
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What the FDA's Botox Warning Letter Means for DSCSA Compliance jdsupra.com/legalnews/what-t…

What the FDA's Botox Warning Letter Means for DSCSA Compliance

In this episode, Gabe Scott, Natalia Nino, and Darrell White discuss the Drug Supply Chain Security Act following the FDA's warning letter to a medical spa over Botox products. Their conversation...

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Simulation-guided clinical trials: Is EU law ready? jdsupra.com/legalnews/simula…
Simulation-guided clinical trials: Is EU law ready?

Simulation-guided clinical trials: Is EU law ready?

Before enrolling real patients, clinical trials can be “test-flown” on a computer, running thousands of virtual versions to assess how reliable, fast, and safe the chosen design will be.

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Bulk-list bound? PCAC backs majority of peptides in two-day public meeting jdsupra.com/legalnews/bulk-l…
Bulk-list bound? PCAC backs majority of peptides in two-day public meeting

Bulk-list bound? PCAC backs majority of peptides in two-day public meeting

On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee (PCAC) recommended the addition of BPC-157, KPV, TB-500, MOTs-c, Epitalon, and Semax, each in free base and acetate...

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FDA Advisory Committee Endorses Compounding of Certain Peptides jdsupra.com/legalnews/fda-ad…
FDA Advisory Committee Endorses Compounding of Certain Peptides

FDA Advisory Committee Endorses Compounding of Certain Peptides

The U.S. Food and Drug Administration's (FDA) Pharmacy Compounding Advisory Committee (PCAC) voted at its July 23-24, 2026, meeting to recommend adding certain peptides to the 503A compounding...

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Tariffs for UK Origin Patented Pharmaceuticals Reduced from 10% to Zero jdsupra.com/legalnews/tariff…
Tariffs for UK Origin Patented Pharmaceuticals Reduced from 10% to Zero

Tariffs for UK Origin Patented Pharmaceuticals Reduced from 10% to Zero

The Trump Administration has officially reduced tariffs on patented pharmaceuticals and associated pharmaceutical ingredients imported from the United Kingdom (“UK”) from 10% to 0%. This change,...

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Moderna Appeals District Court Infringement Judgment over COVID Vaccines jdsupra.com/legalnews/modern…
Moderna Appeals District Court Infringement Judgment over COVID Vaccines

Moderna Appeals District Court Infringement Judgment over COVID Vaccines

One of the beneficial characteristics of the response to the COVID-19 pandemic were pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to...

jdsupra.com
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FDA Warning Letters Highlight Talc Testing jdsupra.com/legalnews/fda-wa…
FDA Warning Letters Highlight Talc Testing

FDA Warning Letters Highlight Talc Testing

Last month, FDA issued a series of Warning Letters to drug manufacturers concerning talc used in drug products. The nine Warning Letters allege violations of current Good Manufacturing Practices...

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