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Weekly News Recap #Phispers
Drugs in Development
Details:
AVT06 (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is being evaluated in clinical studies for the treatment of Neovascular (Wet) AMD.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: AVT06
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EMA Accepts Marketing Application For AVT06, Biosimilar To Eylea®
Details : AVT06 (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is being evaluated in clinical studies for the treatment of Neovascular (Wet) AMD.
Brand Name : AVT06
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 15, 2024
Details:
Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: Enzeevu
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sandoz Receives FDA Approval for Enzeevu™, Strengthening US Biosimilar Position
Details : Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.
Brand Name : Enzeevu
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 12, 2024
Details:
ALT-L9 (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is being evaluated in phase 3 clinical studies for the treatment of Neovascular (Wet) AMD.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: ALT-L9
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Altos Biologics Files for Approval of Aflibercept Biosimilar
Details : ALT-L9 (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is being evaluated in phase 3 clinical studies for the treatment of Neovascular (Wet) AMD.
Brand Name : ALT-L9
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 01, 2024
Details:
Under the agreement, Alvotech will develop AVT06 (Aflibercept) biosimilar to Eylea. Advanz Pharma will be responsible for registration and commercializing in Europe, except for Germany and France.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: AVT06
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Advanz Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 19, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Advanz Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Alvotech And Advanz Sign Agreement For Eylea Biosimilar In Europe
Details : Under the agreement, Alvotech will develop AVT06 (Aflibercept) biosimilar to Eylea. Advanz Pharma will be responsible for registration and commercializing in Europe, except for Germany and France.
Brand Name : AVT06
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 19, 2024
Details:
The Company will fund the anticipated Phase 3 readouts evaluating OPT-302 (sozinibercept), a inhibitor of VEGF-C and D, with Aflibercept, for Neovascular Age-related Macular Degeneration.
Lead Product(s): Sozinibercept,Aflibercept
Therapeutic Area: Ophthalmology Brand Name: OPT-302
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Undisclosed
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement June 11, 2024
Lead Product(s) : Sozinibercept,Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $150.0 million
Deal Type : Private Placement
Opthea Announces Entitlement Offer to Raise A$227.3 Million (US$150 Million)
Details : The Company will fund the anticipated Phase 3 readouts evaluating OPT-302 (sozinibercept), a inhibitor of VEGF-C and D, with Aflibercept, for Neovascular Age-related Macular Degeneration.
Brand Name : OPT-302
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 11, 2024
Details:
OPT-302 (sozinibercept) is a VEGF-C/D inhibitor, which is being evaluated in combination with aflibercept, for the treatment of wet Age-related Macular Degeneration.
Lead Product(s): Sozinibercept,Aflibercept
Therapeutic Area: Ophthalmology Brand Name: OPT-302
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2024
Lead Product(s) : Sozinibercept,Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Opthea Completes Enrollment in Pivotal Ph 3 Clinical Program with Sozinibercept in Wet AMD
Details : OPT-302 (sozinibercept) is a VEGF-C/D inhibitor, which is being evaluated in combination with aflibercept, for the treatment of wet Age-related Macular Degeneration.
Brand Name : OPT-302
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 28, 2024
Details:
Yesafili (aflibercept) is a PGF & VEGF-A inhibitor, its single-dose vial formulation is approved for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: Yesafili
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Biocon Biologics gets FDA nod for Yesafili™, enters U.S. ophthalmology market
Details : Yesafili (aflibercept) is a PGF & VEGF-A inhibitor, its single-dose vial formulation is approved for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.
Brand Name : Yesafili
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 21, 2024
Details:
MS Pharma becomes a partner for the commercialization of FYB203, Formycon’s Biosimilar to Eylea® (Aflibercept), in the MENA Region for the treatment of neovascular age-related macular degeneration.
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: FYB203
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: MS Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 14, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
MS Pharma Partners for FYB203 Biosimilar Commercialization in MENA Region
Details : MS Pharma becomes a partner for the commercialization of FYB203, Formycon’s Biosimilar to Eylea® (Aflibercept), in the MENA Region for the treatment of neovascular age-related macular degeneration.
Brand Name : FYB203
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 14, 2024
Details:
OPT-302 (sozinibercept) is a VEGF-C/D inhibitor, which is being evaluated in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet Age-related Macular Degeneration (wet AMD).
Lead Product(s): Sozinibercept,Aflibercept
Therapeutic Area: Ophthalmology Brand Name: OPT-302
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2024
Lead Product(s) : Sozinibercept,Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Opthea Completes Enrollment in First Pivotal Trial with Sozinibercept
Details : OPT-302 (sozinibercept) is a VEGF-C/D inhibitor, which is being evaluated in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet Age-related Macular Degeneration (wet AMD).
Brand Name : OPT-302
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 14, 2024
Details:
The Company intends to use the net proceeds to fund its ongoing and planned clinical and preclinical development of our product candidates, including ongoing clinical trials for 4D-150, 4D-710, 4D-310, 4D-125 and 4D-110. 4D-150 is a dual-transgene, intravitreal gene therapy.
Lead Product(s): 4D-150,Aflibercept
Therapeutic Area: Ophthalmology Brand Name: 4D-150
Study Phase: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Sponsor: Goldman Sachs & Co. LLC
Deal Size: $250.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 05, 2024
Lead Product(s) : 4D-150,Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Goldman Sachs & Co. LLC
Deal Size : $250.0 million
Deal Type : Public Offering
4D Molecular Therapeutics Announces Proposed Public Offering of Common Stock
Details : The Company intends to use the net proceeds to fund its ongoing and planned clinical and preclinical development of our product candidates, including ongoing clinical trials for 4D-150, 4D-710, 4D-310, 4D-125 and 4D-110. 4D-150 is a dual-transgene, intra...
Brand Name : 4D-150
Molecule Type : Cell and Gene therapy
Upfront Cash : Undisclosed
February 05, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : ZALTRAP
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number : 125418
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : ZALTRAP
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 25 MG / ML
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zaltrap
Dosage Form : Inf Conc
Dosage Strength : 100mg/4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zaltrap
Dosage Form : Inf Conc
Dosage Strength : 200mg/8ml
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Eylea
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 40 MG/ML
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Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eylea
Dosage Form : Inj L?s
Dosage Strength : 2mg/0.05ml
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eylea
Dosage Form : Inj L?s
Dosage Strength : 8mg/0.07ml
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Eylea
Dosage Form : INJ
Dosage Strength : 40mg/ml
Packaging : 0.1X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ZALTRAP
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 4MG
Approval Date :
Application Number : 125418
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EYLEA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 40MG/ML
Approval Date :
Application Number : 125387
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EYLEA HD
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 8MG(0.07ML;114.3MG/ML)
Approval Date :
Application Number : 761355
RX/OTC/DISCN :
RLD :
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : ZALTRAP
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 25 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zaltrap
Dosage Form : Inf Conc
Dosage Strength : 100mg/4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zaltrap
Dosage Form : Inf Conc
Dosage Strength : 200mg/8ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Eylea
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 40 MG/ML
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Eylea
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 40 MG/ML
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Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Eylea
Dosage Form : Solution for injection
Dosage Strength : 114.3 mg/ml
Packaging : Vials 1 0.263ml
Approval Date :
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Eylea
Dosage Form : Solution for injection
Dosage Strength : 40 mg/ml
Packaging : Pre-filled syringe 0.09ml
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Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eylea
Dosage Form : Inj L?s
Dosage Strength : 2mg/0.05ml
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Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eylea
Dosage Form : Inj L?s
Dosage Strength : 2mg/0.05ml
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eylea
Dosage Form : Inj L?s
Dosage Strength : 8mg/0.07ml
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Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : EYLEA
Dosage Form : SOLUTION
Dosage Strength : 2MG/0.05ML
Packaging :
Approval Date :
Application Number : 2505355
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : EYLEA
Dosage Form : SOLUTION
Dosage Strength : 2MG/0.05ML
Packaging : 278 MICROLITERS
Approval Date :
Application Number : 2415992
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Eylea
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Packaging : 1
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Registration Country : Australia
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Registration Country : Australia
Brand Name : Eylea
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Registration Country : Australia
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Brand Name : Eylea
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Registration Country : Australia
Brand Name : Eylea
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Brand Name : Eylea
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Registration Country : Australia
Brand Name : Eylea
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Registration Country : Australia
Brand Name : Eylea
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Registration Country : Australia
Brand Name : Eylea
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Brand Name : Eylea
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Brand Name : Eylea
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Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Eylea
Dosage Form : INJ
Dosage Strength : 40mg/ml
Packaging : 0.1X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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