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NEWS #PharmaBuzz
18 Nov 2025
// PHARMIWEB
https://www.pharmiweb.com/press-release/2025-11-18/almac-announces-multi-million-pound-investment-in-singapore
14 Oct 2025
// PHARMIWEB
https://www.pharmiweb.com/press-release/2025-10-14/almac-trial-coordinator-launched-in-48-million-investment-to-advance-integrated-eclinical-technologies
09 Sep 2025
// PHARMAWEB
https://www.pharmiweb.com/press-release/2025-09-09/almac-group-expands-bioavailability-enhancement-capabilities
07 Jul 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/almac-clinical-services-enhances-cold-chain-capabilities/
06 May 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-and-almac-discovery-announce-licensing-agreement-for-alm-401-a-first-in-class-bispecific-adc-targeting-egfrror1-for-the-treatment-of-solid-tumors-302447143.html
11 Mar 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/almac-opens-83-9m-commercial-manufacturing-facility-in-craigavon/
Drugs in Development
Details:
The agreement aims for exclusive rights to the commercialization of ALM-401, a first-in-class, bispecific ADC for the treatment of solid tumors characterized by the dual expression of EGFR and ROR1.
Lead Product(s): ALM-401
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Antibody-drug Conjugate
Recipient: Formosa Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 06, 2025
Lead Product(s) : ALM-401
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Recipient : Formosa Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Formosa and Almac Ink License Deal for ALM-401 Bispecific ADC for Tumors
Details : The agreement aims for exclusive rights to the commercialization of ALM-401, a first-in-class, bispecific ADC for the treatment of solid tumors characterized by the dual expression of EGFR and ROR1.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Undisclosed
May 06, 2025
Details:
PKU Easy Microtabs Plus is a Dietary Supplement drug candidate, which is currently being evaluated in clinical studies for the treatment of Phenylketonurias.
Lead Product(s): PKU Easy Microtabs Plus
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Dietary Supplement
Sponsor: Birmingham Women's and Children's NHS Foundation Trust
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 19, 2024
Lead Product(s) : PKU Easy Microtabs Plus
Therapeutic Area : Genetic Disease
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Birmingham Women's and Children's NHS Foundation Trust
Deal Size : Inapplicable
Deal Type : Inapplicable
PKU EASY Microtabs Plus - Acceptability and Tolerance
Details : PKU Easy Microtabs Plus is a Dietary Supplement drug candidate, which is currently being evaluated in clinical studies for the treatment of Phenylketonurias.
Product Name : Undisclosed
Product Type : Dietary Supplement
Upfront Cash : Inapplicable
November 19, 2024
Details:
The agreement aims for the potential launch and commercialization of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a centrally acting, non-opioid medication, in the US.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Brand Name: Tonmya
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 20, 2024
Lead Product(s) : Cyclobenzaprine
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Tonix Pharmaceuticals Holding Corp
Deal Size : Undisclosed
Deal Type : Agreement
Tonix Selects Two Contract Manufacturers For Launch Of Tonmya For Fibromyalgia Management
Details : The agreement aims for the potential launch and commercialization of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a centrally acting, non-opioid medication, in the US.
Product Name : Tonmya
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 20, 2024
Details:
This funding supports efforts to combat the COVID-19 pandemic through the rapid process development and manufacturing of remdesivir.
Lead Product(s): Remdesivir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Veklury
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: COVID-19 Therapeutics Accelerator
Deal Size: $0.5 million Upfront Cash: Undisclosed
Deal Type: Funding November 17, 2020
Lead Product(s) : Remdesivir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : COVID-19 Therapeutics Accelerator
Deal Size : $0.5 million
Deal Type : Funding
Almac Group Works to Enable Efficient Manufacturing of Remdesivir in Response to COVID-19
Details : This funding supports efforts to combat the COVID-19 pandemic through the rapid process development and manufacturing of remdesivir.
Product Name : Veklury
Product Type : Miscellaneous
Upfront Cash : Undisclosed
November 17, 2020
Details:
Presentations highlight significant new data for key oncology drug development programmes - USP7 small molecule inhibitors and ROR1 Protein: Drug Conjugates.
Lead Product(s): ADP-c165
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: DiscoveryProduct Type: Protein-drug Conjugate
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 18, 2020
Details : Presentations highlight significant new data for key oncology drug development programmes - USP7 small molecule inhibitors and ROR1 Protein: Drug Conjugates.
Product Name : Undisclosed
Product Type : Protein-drug Conjugate
Upfront Cash : Inapplicable
June 18, 2020
Details:
The agreement aims at advancing the development and commercialisation of Almac's portfolio projects – ALM301. The molecule is currently in late-stage pre-clinical development, and the partner will complete this before progressing into the clinical development phase.
Lead Product(s): VAD044
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 14, 2020
Lead Product(s) : VAD044
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Almac Discovery Enters Into Licensing Agreement for the Development & Commercialisation of ALM301
Details : The agreement aims at advancing the development and commercialisation of Almac's portfolio projects – ALM301. The molecule is currently in late-stage pre-clinical development, and the partner will complete this before progressing into the clinical deve...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 14, 2020
Details:
Research collaboration will focus on developing new small molecule inhibitors against specific targets of Deubiquitinase to treat a variety of neurodegenerative and other diseases.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: DiscoveryProduct Type: Undisclosed
Sponsor: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 29, 2020
Lead Product(s) : Undisclosed
Therapeutic Area : Neurology
Highest Development Status : Discovery
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Undisclosed
Deal Type : Collaboration
Merck Taps Almac in Neurodegenerative Drug Discovery Deal
Details : Research collaboration will focus on developing new small molecule inhibitors against specific targets of Deubiquitinase to treat a variety of neurodegenerative and other diseases.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
April 29, 2020
Details:
ALM201 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Lead Product(s): ALM201
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 09, 2018
Details : ALM201 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
February 09, 2018
Details:
Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Nefopam Hydrochloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 16, 2017
Lead Product(s) : Nefopam Hydrochloride
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy S...
Details : Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 16, 2017
Details:
Co-Codamol is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Co-Codamol
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 12, 2017
Lead Product(s) : Co-Codamol
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Co-Codamol is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
September 12, 2017
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Sub Category : Design
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Inspections and registrations
FDA
District Decision : No Action Indicated
Inspection End Date : 2025-05-29
City : Souderton
State : Pennsylvania
Country/Area : U.S.A
Zip : 18964
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2025-05-29
District Decision : Voluntary Action Indicated
Inspection End Date : 2025-01-29
City : Athlone
State :
Country/Area : Ireland
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2025-01-29
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-09-16
City : Craigavon
State :
Country/Area : United Kingdom
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-09-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2021-08-27
City : Dundalk
State :
Country/Area : Ireland
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2021-08-27
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-09-13
City : Craigavon
State :
Country/Area : United Kingdom
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-09-13
District Decision : No Action Indicated
Inspection End Date : 2019-09-06
City : Craigavon
State :
Country/Area : United Kingdom
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2019-09-06
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-06-11
City : Athlone
State :
Country/Area : Ireland
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-06-11
District Decision : No Action Indicated
Inspection End Date : 2018-08-01
City : Souderton
State : Pennsylvania
Country/Area : U.S.A
Zip : 18964
District :
Center :
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2018-08-01
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-22
City : Souderton
State : Pennsylvania
Country/Area : U.S.A
Zip : 18964
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-22
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-07
City : Audubon
State : Pennsylvania
Country/Area : U.S.A
Zip : 19403
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-07
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