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NDC Package Code : 70596-1002
Start Marketing Date : 2021-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42931-712
Start Marketing Date : 2024-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.
About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
About the Company : For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacture...
About the Company : Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and effici...
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Details:
Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 07, 2024
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EnPlusOne Biosciences Reveals Breakthrough Enzymatic Synthesis of Leqvio® Antisense Strand
Details : Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
September 07, 2024
Details:
Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 28, 2024
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis' Leqvio® Shows Significant LDL-C Lowering As Monotherapy
Details : Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
August 28, 2024
Details:
Leqvio (inclisiran), the first and only approved small interfering RNA therapy to lower LDL-C, gains expanded approval for adults with high LDL-C and who are at increased risk of heart disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 04, 2024
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Data Show Twice-Yearly Leqvio® Reduces LDL-C in ASCVD Patients
Details : Leqvio (inclisiran), the first and only approved small interfering RNA therapy to lower LDL-C, gains expanded approval for adults with high LDL-C and who are at increased risk of heart disease.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
June 04, 2024
Details:
Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 07, 2023
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
October 07, 2023
Details:
Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 28, 2023
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Presents New Long-Term Leqvio® (inclisiran) Data Demonstrating Consistent Efficacy and S...
Details : Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
August 28, 2023
Details:
LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 26, 2022
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Undisclosed
Deal Type : Partnership
Details : LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Undisclosed
July 26, 2022
Details:
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-lowering medications.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 11, 2022
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Long-term Leqvio® (inclisiran) Data From Novartis Show Sustained Efficacy And Safety Over Fou...
Details : Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-loweri...
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
July 11, 2022
Details:
The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2021
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduc...
Details : The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
December 22, 2021
Details:
Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Phase IIIProduct Type: Oligonucleotide
Sponsor: Alnylam Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 31, 2021
Lead Product(s) : Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Alnylam Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular ...
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
August 31, 2021
Details:
Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
Lead Product(s): Inclisiran,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Alnylam Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 11, 2021
Lead Product(s) : Inclisiran,Ezetimibe
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Alnylam Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Leqvio®* (Inclisiran) Reduced LDL-C in People who Are Overweight or Obese
Details : Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
Product Name : Leqvio
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
August 11, 2021
Regulatory Info : RX
Registration Country : USA
Brand Name : LEQVIO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Packaging :
Approval Date : 2021-12-22
Application Number : 214012
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Leqvio
Dosage Form : Inj L?s
Dosage Strength : 284mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Leqvio
Dosage Form : Inj L?s
Dosage Strength : 284mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Leqvio
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Leqvio
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
Brand Name : LEQVIO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Approval Date : 2021-12-22
Application Number : 214012
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Leqvio
Dosage Form : Inj L?s
Dosage Strength : 284mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Leqvio
Dosage Form : Inj L?s
Dosage Strength : 284mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Leqvio
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Leqvio
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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