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CPhI India 2024CPhI India 2024
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26-28 November, 2024
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19-21 November, 2024
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19-21 November, 2024
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Events
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CPhI India 2024CPhI India 2024
Industry Trade Show
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26-28 November, 2024
Industry Trade Show
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19-21 November, 2024
Industry Trade Show
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19-21 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
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities
18 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/18/2982450/29446/en/BioCryst-Launches-ORLADEYO-berotralstat-in-Ireland.html
06 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/06/2975588/29446/en/BioCryst-to-Present-at-Upcoming-Investor-Conferences.html
05 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/05/2974802/29446/en/BioCryst-Reports-Inducement-Grants-Under-Nasdaq-Listing-Rule-5635-c-4.html
04 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/04/2973912/29446/en/BioCryst-Reports-Third-Quarter-2024-Financial-Results-and-Provides-Business-Update.html
24 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com//news-release/2024/10/24/2968668/29446/en/BioCryst-Presents-New-Real-World-Evidence-Showing-High-Adherence-and-Persistence-Rates-with-ORLADEYO-berotralstat.html
21 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/10/21/2966077/29446/en/BioCryst-to-Report-Third-Quarter-2024-Financial-Results-on-November-4.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18961
Submission : 2005-11-17
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17583
Submission : 2004-08-03
Status : Inactive
Type : II
Details:
BCX17725 is designed to treat the underlying protein deficiency that causes Netherton syndrome by inhibiting KLK5, a serine protease in the skin that is unregulated in people with Netherton syndrome.
Lead Product(s): BCX17725
Therapeutic Area: Rare Diseases and Disorders Brand Name: BCX17725
Study Phase: Phase IProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2024
Lead Product(s) : BCX17725
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Begins Enrollment in Phase 1 Trial Evaluating BCX17725 For Netherton Syndrome
Details : BCX17725 is designed to treat the underlying protein deficiency that causes Netherton syndrome by inhibiting KLK5, a serine protease in the skin that is unregulated in people with Netherton syndrome.
Brand Name : BCX17725
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 02, 2024
Details:
Rapivab (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days.
Lead Product(s): Peramivir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Rapivab
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: U.S. Department of Health and Human Services
Deal Size: $69.0 million Upfront Cash: Undisclosed
Deal Type: Funding September 30, 2024
Lead Product(s) : Peramivir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : U.S. Department of Health and Human Services
Deal Size : $69.0 million
Deal Type : Funding
BioCryst Wins $69M RAPIVAB® Contract For National Stockpile
Details : Rapivab (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days.
Brand Name : Rapivab
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 30, 2024
Details:
Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Pint Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2024
Lead Product(s) : Berotralstat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Pint Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Pint Pharma Approves ORLADEYO® (berotralstat) for HAE Prevention in Mexico for Ages 12+
Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 13, 2024
Details:
Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Pint Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
Lead Product(s) : Berotralstat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Pint Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Pint Pharma Approves ORLADEYO (berotralstat) for HAE Prevention in Brazil for Ages 12+
Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 16, 2024
Details:
Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat Dihydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2024
Lead Product(s) : Berotralstat Dihydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Launches ORLADEYO® (berotralstat) in Italy
Details : Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 19, 2024
Details:
Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Lead Product(s) : Berotralstat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, ...
Details : Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2023
Details:
Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Lead Product(s) : Berotralstat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Launches ORLADEYO® (berotralstat) in Spain
Details : Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 21, 2023
Details:
Under the agreement, BioCryst to develop its investigational plasma kallikrein inhibitor, avoralstat, with Clearside’s SCS Microinjector® to deliver avoralstat directly to the back of the eye through the suprachoroidal space to treat patients with diabetic macular edema (DME).
Lead Product(s): Avoralstat
Therapeutic Area: Ophthalmology Brand Name: BCX4161
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: Clearside Biomedical
Deal Size: $82.5 million Upfront Cash: $5.0 million
Deal Type: Licensing Agreement November 06, 2023
Lead Product(s) : Avoralstat
Therapeutic Area : Ophthalmology
Highest Development Status : Preclinical
Recipient : Clearside Biomedical
Deal Size : $82.5 million
Deal Type : Licensing Agreement
Details : Under the agreement, BioCryst to develop its investigational plasma kallikrein inhibitor, avoralstat, with Clearside’s SCS Microinjector® to deliver avoralstat directly to the back of the eye through the suprachoroidal space to treat patients with dia...
Brand Name : BCX4161
Molecule Type : Small molecule
Upfront Cash : $5.0 million
November 06, 2023
Details:
BCX10013 as a potential best-in-class, once-daily, oral Factor D inhibitor for multiple complement-mediated diseases. It is being investigated for paroxysmal nocturnal hemoglobinuria and other complement-mediated diseases.
Lead Product(s): BCX10013
Therapeutic Area: Genetic Disease Brand Name: BCX10013
Study Phase: Phase IProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2023
Lead Product(s) : BCX10013
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : BCX10013 as a potential best-in-class, once-daily, oral Factor D inhibitor for multiple complement-mediated diseases. It is being investigated for paroxysmal nocturnal hemoglobinuria and other complement-mediated diseases.
Brand Name : BCX10013
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 26, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Lead Product(s) : Berotralstat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
INESSS Recommends Public Reimbursement for BioCryst’s ORLADEYO® (berotralstat) for the Preventi...
Details : Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Brand Name : Orladeyo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2023
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