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Weekly News Recap #Phispers
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39465
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
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DMF Number : 39655
Submission : 2024-03-17
Status : Active
Type : II
USDMF
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DMF Review : N/A
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DMF Number : 40166
Submission : 2024-06-27
Status : Active
Type : II
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USDMF
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DMF Number : 39900
Submission : 2024-06-28
Status : Active
Type : II
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DMF Number : 39611
Submission : 2024-02-28
Status : Active
Type : II
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Registrant Name : Korea Lily (U.S.)
Registration Date : 2023-06-28
Registration Number : Su253-11-ND
Manufacturer Name : Corden Pharma Colorado, Inc.
Manufacturer Address : 2075 55th Street, Boulder, Colorado (CO) 80301, United States (USA)
NDC Package Code : 42973-383
Start Marketing Date : 2024-06-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14403-0017
Start Marketing Date : 2024-04-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76177-192
Start Marketing Date : 2023-01-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 83726-101
Start Marketing Date : 2023-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
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NDC Package Code : 84347-002
Start Marketing Date : 2024-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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NDC Package Code : 84666-001
Start Marketing Date : 2024-08-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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Digital Content
Website
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NDC Package Code : 14403-0017
Start Marketing Date : 2024-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 14403-0017
Start Marketing Date : 2024-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
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NDC Package Code : 86184-392
Start Marketing Date : 2024-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
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NDC Package Code : 84196-101
Start Marketing Date : 2024-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...
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...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
About the Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Union and Japan), Brande...
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 : Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the...
About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...
About the Company : Hybio is a hi-tech enterprise specializing in the R&D and manufacturing of diverse peptide products. Founded in 1998, after decades of effort, we have grown to be one of the larges...
Details:
Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2024
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Palatin Starts Phase 2 Study of Bremelanotide with Tirzepatide for Obesity
Details : Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Brand Name : Vyleesi
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 22, 2024
Details:
Zepbound (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently being studied for adults with heart failure with preserved ejection fraction and obesity.
Lead Product(s): Tirzepatide
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zepbound
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lilly’s Tirzepatide Shows Benefit in Phase 3 Study for Heart Failure and Obesity
Details : Zepbound (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently being studied for adults with heart failure with preserved ejection fraction and obesity.
Brand Name : Zepbound
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 01, 2024
Details:
BGE-105 (azelaprag), an oral apelin receptor agonist in combination with Lilly’s Zepbound (tirzepatide) and other incretins for the treatment of obesity.
Lead Product(s): Azelaprag,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: BGE-105
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2024
Lead Product(s) : Azelaprag,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioAge Doses First Patient in Phase 2 Trial of Azelaprag for Obesity with Tirzepatide
Details : BGE-105 (azelaprag), an oral apelin receptor agonist in combination with Lilly’s Zepbound (tirzepatide) and other incretins for the treatment of obesity.
Brand Name : BGE-105
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 29, 2024
Details:
Zepbound (tirzepatide) injection is a first obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Lead Product(s): Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Zepbound
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eli Lilly's weight loss drug tirzepatide gets approval in China
Details : Zepbound (tirzepatide) injection is a first obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Brand Name : Zepbound
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 19, 2024
Details:
Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2024
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Palatin Initiates Phase 2 Clinical Study of Bremelanotide for the Treatment of Obesity
Details : Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Brand Name : Vyleesi
Molecule Type : Peptide
Upfront Cash : Not Applicable
June 12, 2024
Details:
PT-141 (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: PT-141
Study Phase: Phase IProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2024
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PT-141 (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for the treatment of obesity.
Brand Name : PT-141
Molecule Type : Peptide
Upfront Cash : Not Applicable
May 02, 2024
Details:
Zepbound (tirzepatide) injection acts by activating both, glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 hormone receptors. It is being evaluated for obstructive sleep apnea & obesity.
Lead Product(s): Tirzepatide
Therapeutic Area: Sleep Brand Name: Zepbound
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Zepbound (tirzepatide) injection acts by activating both, glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 hormone receptors. It is being evaluated for obstructive sleep apnea & obesity.
Brand Name : Zepbound
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 17, 2024
Details:
The funding will be used to support Phase II clinical development of BioAge’s lead compound BGE-105 (azelaprag), an oral apelin receptor agonist in combination with Lilly’s Zepbound (tirzepatide) and other incretins for the treatment of obesity.
Lead Product(s): Azelaprag,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: BGE-105
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Sofinnova Investments
Deal Size: $170.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing February 13, 2024
Lead Product(s) : Azelaprag,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Sofinnova Investments
Deal Size : $170.0 million
Deal Type : Series D Financing
Details : The funding will be used to support Phase II clinical development of BioAge’s lead compound BGE-105 (azelaprag), an oral apelin receptor agonist in combination with Lilly’s Zepbound (tirzepatide) and other incretins for the treatment of obesity.
Brand Name : BGE-105
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 13, 2024
Details:
Zepbound™ (tirzepatide) injection is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Lead Product(s): Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Zepbound
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2023
Lead Product(s) : Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Lilly's Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Optio...
Details : Zepbound™ (tirzepatide) injection is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
Brand Name : Zepbound
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 08, 2023
Details:
As part of the collaboration, Lilly will supply tirzepatide and Chorus will provide clinical trial design and execution expertise. BioAge retains worldwide exclusive rights to develop and commercialize BGE-105 (azelaprag) for all indications.
Lead Product(s): Azelaprag,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: BGE-105
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 26, 2023
Lead Product(s) : Azelaprag,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Eli Lilly
Deal Size : Undisclosed
Deal Type : Collaboration
Details : As part of the collaboration, Lilly will supply tirzepatide and Chorus will provide clinical trial design and execution expertise. BioAge retains worldwide exclusive rights to develop and commercialize BGE-105 (azelaprag) for all indications.
Brand Name : BGE-105
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 26, 2023
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541041
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541068
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541076
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 10MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541084
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 12.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541092
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 15MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541106
Regulatory Info : Prescription
Registration Country : Canada
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