Medicare drug price rule may target under-the-skin Keytruda and Opdivo
For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.
biopharma_dive · 1mo ago

brand

Opdivo Qvantig

generic

(hyaluronidase-nvhy (recombinant, human) + nivolumab)

MOA

12.1 Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days. Hyaluronidase increases permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan. In the doses administered, hyaluronidase in OPDIVO QVANTIG acts transiently and locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

indication

Adenocarcinoma Of The Gastroesophageal Junction

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 27m ago

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drug

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(hyaluronidase (recombinant, human) + nivolumab)

Marketedupdated 3mo ago

by Bristol-Myers Squibb Co

Approved

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Antibody drug with a maximum clinical stage of Approval (across all indications), with 15 approved and 112 investigational indications.

indications

investigational

NSCLCMelanoma

all catalysts(5)

approval · 5

OPDIVO QVANTIG (NIVOLUMAB) — FDA approval

(hyaluronidase (recombinant, human) + nivolumab)

OPDIVO QVANTIG (NIVOLUMAB) — FDA approval

(hyaluronidase (recombinant, human) + nivolumab)

OPDIVO QVANTIG (NIVOLUMAB) — FDA approval

(hyaluronidase (recombinant, human) + nivolumab)

OPDIVO QVANTIG (NIVOLUMAB) — FDA approval

(hyaluronidase (recombinant, human) + nivolumab)

OPDIVO QVANTIG (NIVOLUMAB) — FDA approval

(hyaluronidase (recombinant, human) + nivolumab)

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News(1)

Medicare drug price rule may target under-the-skin Keytruda and Opdivo
For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.
biopharma_dive · 1mo ago

brand

Opdivo Qvantig

generic

(hyaluronidase-nvhy (recombinant, human) + nivolumab)

MOA

indication

Adenocarcinoma Of The Gastroesophageal Junction

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 27m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

(hyaluronidase (recombinant, human) + nivolumab)

🐶 often sniffed alongside

indications

all catalysts(5)

News(1)

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(hyaluronidase (recombinant, human) + nivolumab)

🐶 often sniffed alongside

indications

all catalysts(5)

News(1)

Report a data issue

comments(0)