Guest Column | July 3, 2025

June 2025 — CDMO Opportunities And Threats Report

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Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Contractor BioPharma Company Event Product Relationship

POTENTIALLY POSITIVE

Ajinomoto Bio-Pharma Services GlaxoSmithKline UK Ltd NICE recommended the drug with platinum-based chemotherapy can be used as an option to treat primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults when systemic therapy is suitable. Drug can only be used if the company provides it according to the commercial arrangement Jemperli Parenteral manufacture & packaging
Andelyn Biosciences Inc Nationwide Children's Hospital Trial planned - Phase I/II  to determine the safety and estimate the efficacy of CD33 CAR-NK cells combined with FLA-VEN chemotherapy in patients age 1-39.99 with relapsed or refractory acute myeloid leukemia CD38KO CD33CAR-NK Cell Therapy Biologic API
Boehringer Ingelheim Pharma GmbH & Co KG Pfizer Inc FDA expanded indications of the drug for the treatment of adult patients with moderate to severe pemphigus vulgaris Ruxience Biologic API
Bora Pharmaceuticals Co Ltd Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Parenteral manufacture
BSP Pharmaceuticals SpA Takeda Pharma AS EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma Adcetris Biologic API; Parenteral manufacture & packaging
Central Pharma Contract Packing Ltd Cycle Pharmaceuticals Ltd FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) Harliku Solid dose packaging
CSBio Co Inc NervGen Pharma Corp Positive Phase  I/II top-line results to evaluate safety and tolerability of NVG-291 in a Spinal Cord Injury (SCI) subjects NVG-291 Small mol API
Delpharm SAS Takeda Pharma AS EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma Adcetris Parenteral manufacture & packaging
Delpharm SAS Roche Products Ltd UK MHRA expanded indications of the drug in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric patients (aged 1 to 18 years) receiving allogeneic renal, cardiac or hepatic transplants Cellcept Solid dose packaging
Evergreen Theragnostics Inc Molecular Targeting Technologies Inc Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer EBTATE Small mol API
Fareva SA Takeda Pharma AS EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma Adcetris Parenteral manufacture & packaging
Fareva SA Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg Sivextro Solid dose manufacture
Ferndale Pharma Group Inc Quoin Pharmaceuticals Ltd Positive Phase I Interim results to evaluate the safety and efficacy of drug in a pediatric patient with peeling skin syndrome (PSS) QRX003 Non-sterile semi-solid manufacture
Fujifilm Diosynth Biotechnologies Uk Ltd Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Biologic API
Galephar Pharmaceutical Research Inc Aphaia Pharma AG Trial planned - Phase II to evaluate the superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (drug and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (drug and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities APHD-012 Non-sterile semi-solid manufacture
GSK plc Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Parenteral manufacture & packaging
Isotopia Molecular Imaging Ltd Molecular Targeting Technologies Inc Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer EBTATE Small mol API
ITM Isotope Technologies Munich SE Molecular Targeting Technologies Inc Trial planned - Phase I/II to evaluate the safety, dosimetry and efficacy of a 3-dose regimen of escalating doses of drug in adult subjects with metastatic, radioactive iodine non-responsive oncocytic (hurthle-cell) thyroid cancer EBTATE Small mol API
Kymos Pharma Services SL Celltrion Healthcare Hungary Kft EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis Qoyvolma Parenteral manufacture
Kymos Pharma Services SL Teva Pharmaceuticals USA Inc FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients Truxima Parenteral manufacture
Lonza Biologics Inc Bristol-Myers Squibb Pharma EEIG EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% Opdivo Biologic API
Lonza Biologics Inc Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Opdivo Biologic API
Lonza Group Ltd Takeda Pharma AS EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma Adcetris Biologic API
Lonza Group Ltd Trevi Therapeutics Inc Positive Phase II top-line results to evaluate the efficacy, safety and quality of life of Haduvio (albuphine hydrochloride ER) for the treatment of cough in idiopathic pulmonary fibrosis (IPF) Nalbuphine hydrochloride ER Solid dose manufacture
Mabion SA Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Biologic API
MassBiologics SparingVision SAS Trial planned - Phase I to assess the safety and tolerability of a single intravitreal injection of drug in subjects with no light perception due to end stage rod cone dystrophy, and who retain dormant foveal cone photoreceptors SPVN-20 Biologic API
Midas Pharma GmbH Celltrion Healthcare Hungary Kft EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis Qoyvolma Parenteral manufacture
Midas Pharma GmbH Teva Pharmaceuticals USA Inc FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients Truxima Parenteral manufacture & packaging
Nanolek LLC Sanofi Pasteur Inc FDA expanded indications of the drug for its meningococcal conjugate vaccine to include children 2 years through 10 years of age Menactra Parenteral manufacture & packaging
Novo Nordisk AS Bristol-Myers Squibb Co FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) Yervoy Parenteral manufacture & packaging
Novo Nordisk AS Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Yervoy Parenteral manufacture & packaging
NUVISAN Pharma Holding GmbH Teva Pharmaceuticals USA Inc FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients Truxima Parenteral manufacture & packaging
NUVISAN Pharma Holding GmbH Celltrion Healthcare Hungary Kft EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis Qoyvolma Parenteral manufacture
Par Sterile Products LLC Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Parenteral manufacture & packaging
Patheon France SAS Theramex HQ UK Ltd NICE recommended the drug with hormonal add-back therapy can be used within its marketing authorisation as an option to treat symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for their endometriosis Yselty Solid dose manufacture & packaging
Patheon Italia SpA Celltrion Healthcare Hungary Kft EMA expanded indications of the drug for the treatment of moderate to severe plaque psoriasis Qoyvolma Parenteral manufacture & packaging
Patheon NV Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg Sivextro Solid dose manufacture & packaging
Patheon UK Ltd Merck Sharp & Dohme (UK) Ltd UK MHRA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections in adults, adolescents and children weighing ≥35kg Sivextro Solid dose manufacture
PCI Pharma Services Cycle Pharmaceuticals Ltd FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) Harliku Solid dose manufacture & packaging
PCI Pharma Services Teva Pharmaceuticals USA Inc FDA expanded indications of the drug for the treatment of moderate to severe pemphigus vulgaris in adult patients Truxima Parenteral manufacture & packaging
Pharmaron Manufacturing Services (UK) Ltd Cycle Pharmaceuticals Ltd FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) Harliku Small mol API
Piramal Pharma Solutions Inc Takeda Pharma AS EMA expanded indications of the drug in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) a chemotherapy regimen in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma Adcetris Biologic API
Piramal Pharma Solutions Inc George Medicines Pty Ltd FDA approval of the drug for the treatment of hypertension, including as initial treatment, to lower blood pressure, lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Widaplik Solid dose manufacture
Rivopharm SA Cycle Pharmaceuticals Ltd FDA expanded indications of the drug for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU) Harliku Solid dose manufacture & packaging
Samsung Biologics Co Ltd Bristol-Myers Squibb Pharma EEIG EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% Opdivo Biologic API
Samsung Biologics Co Ltd Bristol-Myers Squibb Co FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) Yervoy Biologic API; Parenteral manufacture
Samsung Biologics Co Ltd Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Opdivo Biologic API
Samsung Biologics Co Ltd Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Yervoy Biologic API; Parenteral manufacture
Serum Institute of India Pvt Ltd Novavax Inc FDA approval of the for active immunization to prevent COVID-19 in individuals aged 12 and older Covid-19 (Omicron JN.1) Vaccine Biologic API
Sharp Packaging Services LLC Bayer HealthCare Pharmaceuticals Inc FDA expanded indications of the drug for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC) Nubeqa Solid dose packaging
Siegfried Holding AG Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Parenteral manufacture & packaging
Simtra US LLC Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Parenteral manufacture
Simtra US LLC Bristol-Myers Squibb Co FDA expanded indications of the drug in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) Yervoy Parenteral manufacture
Simtra US LLC Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Yervoy Parenteral manufacture
SK Bioscience Ltd Novavax Inc FDA expanded indications of the drug to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older Nuvaxovid Biologic API
TopChem Pharmaceuticals Ltd Quoin Pharmaceuticals Ltd Positive Phase I Interim results to evaluate the safety and efficacy of drug in a pediatric patient with peeling skin syndrome (PSS) QRX003 Small mol API
Vetter Pharma-Fertigung GmbH & Co KG Bristol-Myers Squibb Pharma EEIG EMA expanded indications of the drug and chemotherapy followed by surgery and adjuvant drug for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1% Opdivo Parenteral manufacture
Vetter Pharma-Fertigung GmbH & Co KG Bristol-Myers Squibb Pharma EEIG NICE recommended the drug plus ipilimumab can be used, within its marketing authorisation, as an option for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. Drug plus ipilimumab can be used only if the company provides it according to the commercial arrangements Opdivo Parenteral manufacture
WuXi Biologics Co Ltd GlaxoSmithKline UK Ltd NICE recommended the drug with platinum-based chemotherapy can be used as an option to treat primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults when systemic therapy is suitable. Drug can only be used if the company provides it according to the commercial arrangement Jemperli Biologic API

POTENTIALLY NEGATIVE

Lonza Biologics Inc Argenx SE NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Vyvgart Biologic API
Lonza Biologics Plc Argenx SE NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Vyvgart Biologic API
Lonza Group Ltd Argenx SE NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Vyvgart Biologic API
Patheon NV Argenx SE NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Vyvgart Parenteral manufacture
Sharp Packaging Services LLC BeiGene Ltd NICE is unable to make a recommendation on drug for treating unresectable advanced oesophageal squamous cell cancer after platinum-based chemotherapy in adults. This is because BeiGene withdrew its evidence submission Tevimbra Parenteral packaging
Vetter Pharma-Fertigung GmbH & Co KG Argenx SE NICE rejection for the drug, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This recommendation is not intended to affect treatment with drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop Vyvgart Parenteral manufacture & packaging

 

Notes:

Source: GlobalData, Pharma Intelligence Center ©GlobalData
EMA = European Medicines Agency; NICE = National Institute for Health and Care Excellence
* New molecular entities are in bold
** Denotes product being marketed or in the pipeline for COVID-19 therapy area