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11-14 November, 2024
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11-13 November, 2024
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CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
Industry Trade Show
Not Confirmed
11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
Industry Trade Show
Not Confirmed
11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients
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07 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/07/2977107/29517/en/MannKind-Corporation-Reports-2024-Third-Quarter-Financial-Results-and-Provides-Business-Update.html
05 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/05/2975234/29517/en/MannKind-to-Present-at-2024-UBS-Healthcare-Conference.html
04 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/04/2973832/29517/en/MannKind-Successfully-Completes-Phase-1-Trial-of-Nintedanib-DPI-for-Pulmonary-Fibrotic-Diseases.html
31 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/10/31/2973014/29517/en/MannKind-Corporation-to-Hold-2024-Third-Quarter-Financial-Results-Conference-Call-on-November-7-2024.html
30 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/10/31/2972227/29517/en/First-Site-Initiated-in-Australia-for-MannKind-s-Phase-3-Clinical-Trial-Evaluating-Clofazimine-Inhalation-Suspension-for-the-Treatment-of-Nontuberculous-Mycobacterial-NTM-Lung-Dise.html
30 Sep 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/en/news-release/2024/09/30/2954980/29517/en/More-Adults-With-Type-1-Diabetes-Achieved-A1C-Goal-7-After-Switching-From-Multiple-Daily-Insulin-Injections-or-Automated-Pumps-to-Inhaled-Insulin-Afrezza.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28677
Submission : 2014-10-15
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33169
Submission : 2018-10-17
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16482
Submission : 2003-03-26
Status : Inactive
Type : II
Details:
MNKD-101 (clofazimine) is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro, being developed for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Brand Name: MNKD-101
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2024
Lead Product(s) : Clofazimine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind Receives PMDA Clearance for Phase 3 Trial of Clofazimine in NTM Lung Disease
Details : MNKD-101 (clofazimine) is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro, being developed for pulmonary nontuberculous mycobacteria.
Brand Name : MNKD-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2024
Details:
MannKind will grant Pulmatrix a royalty free, exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of PUR3100, a proprietary formulation of dihydroergotamine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Brand Name: PUR3100
Study Phase: Phase IProduct Type: Small molecule
Sponsor: Pulmatrix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 30, 2024
Lead Product(s) : Dihydroergotamine Mesylate
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Pulmatrix
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Pulmatrix Announces Cross License Agreement and Transfer of Laboratory to MannKind
Details : MannKind will grant Pulmatrix a royalty free, exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of PUR3100, a proprietary formulation of dihydroergotamine.
Brand Name : PUR3100
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 30, 2024
Details:
MNKD-101 (clofazimine) has antimicrobial and anti-inflammatory effects, active against mycobacteria and Gram-positive bacteria, and is being developed for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Brand Name: MNKD-101
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2024
Lead Product(s) : Clofazimine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind Receives Fast Track Designation for Clofazimine Inhalation for NTM Lung Disease
Details : MNKD-101 (clofazimine) has antimicrobial and anti-inflammatory effects, active against mycobacteria and Gram-positive bacteria, and is being developed for pulmonary nontuberculous mycobacteria.
Brand Name : MNKD-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 06, 2024
Details:
The inhaled therapeutic candidate MNKD-201 (nintedanib) is being evaluated in early-stage clinical trial studies for treating patients suffering from pulmonary fibrotic diseases.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: MNKD-201
Study Phase: IND EnablingProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2024
Lead Product(s) : Nintedanib Esylate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind Proceeds with Phase 1 Nintedanib Dpi Study for Pulmonary Fibrotic Diseases
Details : The inhaled therapeutic candidate MNKD-201 (nintedanib) is being evaluated in early-stage clinical trial studies for treating patients suffering from pulmonary fibrotic diseases.
Brand Name : MNKD-201
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 30, 2024
Details:
MNKD-101 (clofazimine) has antimicrobial and anti-inflammatory effects, active against mycobacteria and Gram-positive bacteria, and is being developed for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Brand Name: MNKD-101
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Lead Product(s) : Clofazimine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind Announces IND Clearance for Phase 3 Study of Clofazimine Inhalation
Details : MNKD-101 (clofazimine) has antimicrobial and anti-inflammatory effects, active against mycobacteria and Gram-positive bacteria, and is being developed for pulmonary nontuberculous mycobacteria.
Brand Name : MNKD-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 29, 2024
Details:
Afrezza (technosphere insulin) is a USFDA approved insulin receptor agonist which is being evaluated for the treatment of type 1 or type 2 diabetes in pediatric patients.
Lead Product(s): Technosphere Insulin,Degludec
Therapeutic Area: Endocrinology Brand Name: Afrezza
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2024
Lead Product(s) : Technosphere Insulin,Degludec
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind Completes Enrollment Goal for INHALE-1 Pediatric Diabetes Trial with Afrezza®
Details : Afrezza (technosphere insulin) is a USFDA approved insulin receptor agonist which is being evaluated for the treatment of type 1 or type 2 diabetes in pediatric patients.
Brand Name : Afrezza
Molecule Type : Peptide
Upfront Cash : Not Applicable
February 15, 2024
Details:
Under the agreement, Sagard will receive royalties of Tyvaso DPI, inhalation powder indicated for pulmonary hypertension associated with interstitial lung disease.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tyvaso DPI
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Sagard Healthcare
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Agreement January 02, 2024
Lead Product(s) : Treprostinil Sodium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Recipient : Sagard Healthcare
Deal Size : $200.0 million
Deal Type : Agreement
MannKind and Sagard Enter Into Royalty Purchase Agreement for up to $200 Million
Details : Under the agreement, Sagard will receive royalties of Tyvaso DPI, inhalation powder indicated for pulmonary hypertension associated with interstitial lung disease.
Brand Name : Tyvaso DPI
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 02, 2024
Details:
Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, which is investigated in combination with insulin degludec for the treatment of type 1 diabetes.
Lead Product(s): Insulin Lispro
Therapeutic Area: Endocrinology Brand Name: Afrezza
Study Phase: Phase IVProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2023
Lead Product(s) : Insulin Lispro
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Afrezza (human Insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist, which is investigated in combination with insulin degludec for the treatment of type 1 diabetes.
Brand Name : Afrezza
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 06, 2023
Details:
Afrezza (human insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist and works as starts lowering blood sugars in ~12 minutes for adults living with type 1 or type 2 diabetes.
Lead Product(s): Insulin Lispro
Therapeutic Area: Endocrinology Brand Name: Afrezza
Study Phase: Phase IVProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Lead Product(s) : Insulin Lispro
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Afrezza (human insulin) is the only ultra rapid-acting inhaled insulin that act as Insulin receptor agonist and works as starts lowering blood sugars in ~12 minutes for adults living with type 1 or type 2 diabetes.
Brand Name : Afrezza
Molecule Type : Peptide
Upfront Cash : Not Applicable
June 22, 2023
Details:
MNKD-101 (clofazimine) possesses antimicrobial and anti-inflammatory properties. It is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro. It is currently being developemnt for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Brand Name: MNKD-101
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2023
Lead Product(s) : Clofazimine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study For Potential Treatme...
Details : MNKD-101 (clofazimine) possesses antimicrobial and anti-inflammatory properties. It is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro. It is currently being developemnt for pulmonary nontuberc...
Brand Name : MNKD-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 23, 2023
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Mannkind is a supplier offers 3 products (APIs, Excipients or Intermediates).
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