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26-28 November, 2024
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28-30 October, 2024
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28 October-01 November, 2024
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Events
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CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
Saudi International Ex...Saudi International Expo
Industry Trade Show
Not Confirmed
28-30 October, 2024
SupplySide West 2024SupplySide West 2024
Industry Trade Show
Not Confirmed
28 October-01 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions
19 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/accord-healthcare-receives-positive-chmp-opinion-for-imuldosa-a-ustekinumab-biosimilar-to-stelara-302280374.html
10 Jul 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-10-2024-51523.pdf
16 Nov 2023
// Joseph Keenan FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/accord-healthcare-restarts-production-cancer-drug-cisplatin
08 Nov 2023
// EMA
https://www.ema.europa.eu/en/documents/overview/degarelix-accord-epar-medicine-overview_en.pdf
07 Nov 2023
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/accord-resumes-production-cancer-drug-methotrexate-amid-supply-shortage-2023-11-07/
04 Aug 2023
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/accord-and-hipra-enter-into-exclusive-distribution-agreement-to-commercialise-hipras-covid-19-vaccine-bimervax-in-the-united-kingdom-301892785.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20608
Submission : 2007-06-11
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 : 21930
Submission : 2008-10-23
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 : 17650
Submission : 2004-09-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20608
Submission : 2007-06-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21930
Submission : 2008-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17650
Submission : 2004-09-02
Status : Inactive
Type : II
Details:
Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: Imuldosa
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Gets Positive CHMP Opinion for Stelara® Biosimilar IMULDOSA®
Details : Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.
Brand Name : Imuldosa
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 19, 2024
Details:
Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.
Lead Product(s): Dimethyl Fumarate
Therapeutic Area: Neurology Brand Name: Tecfidera-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the Europea...
Details : Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.
Brand Name : Tecfidera-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2023
Details:
The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.
Lead Product(s): Recombinant, Adjuvanted Covid-19 Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Bimervax
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Laboratorios HIPRA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 04, 2023
Lead Product(s) : Recombinant, Adjuvanted Covid-19 Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Laboratorios HIPRA
Deal Size : Undisclosed
Deal Type : Agreement
Details : The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.
Brand Name : Bimervax
Molecule Type : Vaccine
Upfront Cash : Undisclosed
August 04, 2023
Details:
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Brand Name: Aubagio-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2023
Lead Product(s) : Teriflunomide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Healthcare Adds Generic Drug Approved for the Treatment of Relapsing MS
Details : Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis...
Brand Name : Aubagio-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 13, 2023
Details:
Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.
Lead Product(s): Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Lurasidone-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2023
Lead Product(s) : Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Healthcare Offers Generic Option for Treatment of Schizophrenia and Bipolar Depression
Details : Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.
Brand Name : Lurasidone-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 21, 2023
Details:
Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Lead Product(s): Plerixafor
Therapeutic Area: Oncology Brand Name: Mozobil-Generic
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2022
Lead Product(s) : Plerixafor
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EMA Recommends Granting a Marketing Authorisation for Plerixafor Accord
Details : Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Brand Name : Mozobil-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 10, 2022
Details:
Carmustine is an anti-cancer ("antineoplastic") chemotherapy drug classified as an alkylating agent. It works by helping to halt the growth of cancer cells (cancer cell division).
Lead Product(s): Carmustine
Therapeutic Area: Oncology Brand Name: Carmustine-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2022
Lead Product(s) : Carmustine
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Healthcare Launches Generic Drug for Treating Brain Tumors & Blood Cancers
Details : Carmustine is an anti-cancer ("antineoplastic") chemotherapy drug classified as an alkylating agent. It works by helping to halt the growth of cancer cells (cancer cell division).
Brand Name : Carmustine-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 23, 2022
Details:
Myovant will continue to lead the global development of Orgovyx (relugolix) and provide product supply to Accord. Accord will be responsible for certain local clinical development, commercialization for its territories, and has the option to manufacture relugolix in future.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Brand Name: Orgovyx
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Myovant Sciences
Deal Size: $140.5 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement May 09, 2022
Lead Product(s) : Relugolix
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Myovant Sciences
Deal Size : $140.5 million
Deal Type : Licensing Agreement
Details : Myovant will continue to lead the global development of Orgovyx (relugolix) and provide product supply to Accord. Accord will be responsible for certain local clinical development, commercialization for its territories, and has the option to manufacture ...
Brand Name : Orgovyx
Molecule Type : Small molecule
Upfront Cash : $50.0 million
May 09, 2022
Details:
Through this partnership with Foresee on the launch of CAMCEVI, Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Brand Name: Camcevi
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Foresee Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 04, 2022
Lead Product(s) : Leuprolide Acetate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Foresee Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Accord BioPharma, in Partnership with Foresee Pharmaceuticals, Launches CAMCEVI™ (Leuprolide) In...
Details : Through this partnership with Foresee on the launch of CAMCEVI, Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.
Brand Name : Camcevi
Molecule Type : Peptide
Upfront Cash : Undisclosed
April 04, 2022
Details:
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Brand Name: Camcevi
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Lead Product(s) : Leuprolide Mesylate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord BioPharma Announces U.S. Launch for CAMCEVI™ (Leuprolide) Injection Emulsion for the Trea...
Details : CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on D...
Brand Name : Camcevi
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 31, 2022
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-09-16
City : Durham
State : NC
Country/Area : US
Zip : 27703-8446
District : ATL
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-09-16
District Decision : No Action Indicated
Inspection End Date : 2011-05-25
City : Durham
State : NC
Country/Area : US
Zip : 27703-8446
District : ATL
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2011-05-25
District Decision : No Action Indicated
Inspection End Date : 2013-12-06
City : Durham
State : NC
Country/Area : US
Zip : 27703-8446
District : ATL
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2013-12-06
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-01
City : Rochester
State : NY
Country/Area : US
Zip : 14606-1956
District : NYK
Center : CFSAN
Project Area : Foodborne Biological Hazards
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-01
District Decision : No Action Indicated
Inspection End Date : 2014-08-18
City : Rochester
State : NY
Country/Area : US
Zip : 14606-1956
District : NYK
Center : CFSAN
Project Area : Foodborne Biological Hazards
District Decision : No Action Indicated
Inspection End Date : 2014-08-18
District Decision : No Action Indicated
Inspection End Date : 2017-01-19
City : Durham
State : NC
Country/Area : US
Zip : 27703-8446
District : ATL
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2017-01-19
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