July 2025 — CDMO Opportunities And Threats Report
By GlobalData
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 |
||||
| Aenova Holding GmbH | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| AGC Biologics Inc | Amgen Europe BV | EMA approval of the drug in adults for the treatment of moderate to severe thyroid eye disease (TED) | Tepezza | Biologic API |
| Ajinomoto Bio-Pharma Services | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Parenteral manufacture |
| Aldevron LLC | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Biologic API |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | EMA approval of the drug for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Alyftrek | Solid dose manufacture |
| Almac Group Ltd | Jazz Pharmaceuticals Plc | EMA approval of the drug for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy | Ziihera | Parenteral packaging |
| Almac Group Ltd | Kalvista Pharmaceuticals Inc | FDA approval of the drug for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older | Ekterly | Solid dose packaging |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indications of the drug for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent and treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent | Keytruda | Biologic API |
| Astrea Pharma | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| Avara Pharmaceutical Services Inc | Astellas Pharma Ltd | UK MHRA expanded indications of the drug for the treatment of neurogenic detrusor overactivity in paediatric patients aged 3 to 17 years | Mirabegron | Solid dose manufacture |
| Avid Bioservices Inc | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Biologic API |
| Boehringer Ingelheim Fremont Inc | Merck & Co Inc | FDA expanded indications of the drug for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent and treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca AB | EMA expanded indications of the drug for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by drug as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) | Imfinzi | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | FDA expanded indications of the drug for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent and treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Incyte Corp | FDA expanded indications of the drug in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) | Monjuvi | Biologic API; Parenteral manufacture & packaging |
| Bryllan LLC | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Parenteral manufacture & packaging |
| Carbogen Amcis AG | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Small mol API |
| Catalent CTS LLC | BeiGene Ltd | NICE recommended the drug can be used as an option to treat relapsed or refractory mantle cell lymphoma in adults who have had 1 line of treatment only. Drug can only be used if the company provides it according to the commercial arrangement. Use the least expensive option of the suitable treatments (including drug and ibrutinib), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements. 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 healthcare professional consider it appropriate to stop | Brukinsa | Solid dose manufacture |
| Catalent CTS LLC | AstraZeneca UK Ltd | NICE recommended the drug as an option to treat chronic kidney disease (CKD) in adults, if it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor antagonists, unless these are contraindicated, and people have an estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73 m2 to less than 45 ml/min/1.73 m2 or 45 ml/min/1.73 m2 to 90 ml/min/1.73 m2, and either a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or type 2 diabetes.If people with the condition and their healthcare professional consider drug to be 1 of a range of suitable treatments (including empagliflozin), after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. 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 healthcare professional consider it appropriate to stop | Forxiga | Solid dose manufacture |
| Catalent Germany Eberbach GmbH | Bayer Plc | UK MHRA approval of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause | Lynkuet | Solid dose manufacture |
| Catalent Germany Schorndorf GmbH | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Catalent Inc | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Biologic API; Parenteral manufacture & packaging |
| Catalent Nottingham Ltd | Kalvista Pharmaceuticals Inc | FDA approval of the drug for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older | Ekterly | Solid dose manufacture |
| Cenexi SAS | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Parenteral manufacture & packaging |
| Chime Biologics Ltd | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Biologic API; Parenteral manufacture |
| DHL Supply Chain (Netherlands) B.V | Sobi Inc | FDA expanded indications of the drug for the treatment of adult and pediatric (newborn and older) patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS and treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS | Gamifant | Parenteral packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | NICE recommended the drug as an option to treat chronic kidney disease (CKD) in adults, if it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor antagonists, unless these are contraindicated, and people have an estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73 m2 to less than 45 ml/min/1.73 m2 or 45 ml/min/1.73 m2 to 90 ml/min/1.73 m2, and either a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or type 2 diabetes.If people with the condition and their healthcare professional consider drug to be 1 of a range of suitable treatments (including empagliflozin), after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. 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 healthcare professional consider it appropriate to stop | Forxiga | Small mol API |
| Emergent BioSolutions Inc | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Parenteral manufacture |
| Farmhispania SA | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Small mol API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim Ltd | NICE recommended the drug as an option for treating generalised pustular psoriasis (GPP) flares in adults, only if it is used to treat initial moderate to severe flares when the Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score is 3 or more (at least moderate), and there are fresh pustules (new appearance or worsening of existing pustules), and the GPPGA pustulation subscore is at least 2 (at least mild), and at least 5% of the body's surface area is covered with erythema (abnormal redness of the skin or mucous membranes) and has pustules subsequent flares with a GPPGA pustulation subscore of 2 or more (at least mild), if the last flare was treated with drug and resolved to a GPPGA pustulation subscore of 0 or 1 (clear or almost clear skin). Drug can only be used if the company provides it according to the commercial arrangement | Spevigo | Parenteral packaging |
| IBERFAR Industria Farmaceutica SA | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Biologic API |
| Lonza Biologics Inc | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Biologic API |
| Lonza Biologics Plc | Argenx SE | EMA expanded indications of the drug as monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins | Vyvgart | Biologic API |
| Lonza Group Ltd | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Biologic API |
| Lonza Group Ltd | Ankyra Therapeutics Inc | Trial planned - Phase I to evaluate the effect of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1(PD-1)/programmed cell death ligand 1 (PD-L1) antibody in subjects with advanced or metastatic non-small cell lung cancer (NSCLC) | tolododekin alfa | Biologic API; Parenteral manufacture |
| Lonza Group Ltd | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Biologic API |
| Lonza Group Ltd | Vaxart Inc | Positive Phase I top-line results of the drug for norovirus gastroenteritis | Norovirus [strains Norwalk GI.1 + Sydney GII.4] (bivalent) vaccine | Biologic API |
| Lonza Group Ltd | Argenx SE | EMA expanded indications of the drug as monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins | Vyvgart | Biologic API |
| Mabxience Holding SL | Zentiva Group AS | EMA expanded indications of the drug for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture | Enwylma | Biologic API; Parenteral manufacture & packaging |
| National Resilience Inc | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Biologic API |
| Novo Nordisk AS | Bayer Plc | UK MHRA expanded indications of the drug in adults for the treatment of neovascular (wet) age-related macular degeneration and visual impairment due to diabetic macular oedema | Eylea | Parenteral manufacture |
| Novo Nordisk AS | AstraZeneca AB | EMA expanded indications of the drug for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by drug as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) | Imfinzi | Parenteral manufacture & packaging |
| Novo Nordisk AS | Amgen Europe BV | EMA approval of the drug in adults for the treatment of moderate to severe thyroid eye disease (TED) | Tepezza | Biologic API; Parenteral manufacture & packaging |
| Novo Nordisk AS | Sanofi-Aventis US LLC | FDA expanded indications of the drug for the treatment of adult patients with bullous pemphigoid (BP) | Dupixent | Parenteral manufacture & packaging |
| Novo Nordisk AS | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Galderma (UK) Ltd | NICE recommended the drug with topical corticosteroids or calcineurin inhibitors, or both, can be used as an option to treat moderate to severe atopic dermatitis. It can be used in people 12 years and over with a body weight of 30 kg or more when systemic treatment is suitable, only if the atopic dermatitis has not responded to at least 1 systemic immunosuppressant, or these treatments are not suitable, and a biological medicine would otherwise be offered, and the company provides drug according to the commercial arrangement | Nemluvio | Parenteral manufacture & packaging |
| Organon & Co | Merck & Co Inc | FDA expanded indications of the drug for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent and treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent | Keytruda | Parenteral manufacture & packaging |
| Patheon France SAS | Averoa SAS | EMA expanded indications of the drug for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD) | Xoanacyl | Solid dose manufacture & packaging |
| Patheon Italia SpA | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture |
| Patheon NV | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Biologic API |
| Patheon NV | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| Patheon NV | Averoa SAS | EMA expanded indications of the drug for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD) | Xoanacyl | Solid dose manufacture & packaging |
| Patheon NV | Sobi Inc | FDA expanded indications of the drug for the treatment of adult and pediatric (newborn and older) patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS and treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS | Gamifant | Parenteral manufacture & packaging |
| Patheon NV | Argenx SE | EMA expanded indications of the drug as monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins | Vyvgart | Parenteral manufacture |
| PCI Pharma Services | BeiGene Ltd | NICE recommended the drug can be used as an option to treat relapsed or refractory mantle cell lymphoma in adults who have had 1 line of treatment only. Drug can only be used if the company provides it according to the commercial arrangement. Use the least expensive option of the suitable treatments (including drug and ibrutinib), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements. 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 healthcare professional consider it appropriate to stop | Brukinsa | Solid dose manufacture & packaging |
| PCI Pharma Services | Humanigen Inc | Trial planned - Phase II to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS | lenzilumab | Parenteral packaging |
| PCI Pharma Services | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| PCI Pharma Services | Incyte Corp | FDA expanded indications of the drug in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) | Monjuvi | Parenteral packaging |
| Rechon Life Science AB | Camurus AB | EMA approval of the drug for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues | Oczyesa | Parenteral manufacture & packaging |
| Rechon Life Science AB | Sobi Inc | FDA expanded indications of the drug for the treatment of adult and pediatric (newborn and older) patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS and treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS | Gamifant | Parenteral packaging |
| Recipharm AB | Kancera AB | Positive Phase I/II top-line results of the drug for ovarian cancer | Rugocrixan | Parenteral manufacture |
| Rentschler Biopharma SE | AbbVie UK Ltd | UK MHRA expanded indications of the drug for treatment of adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy | Tepkinly | Biologic API |
| ROVI Pharma Industrial Services SA | Rad Neurim Pharmaceuticals Eec Ltd | UK MHRA expanded indications of the drug for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| ROVI Pharma Industrial Services SA | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | AstraZeneca AB | EMA expanded indications of the drug for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by drug as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) | Imfinzi | Biologic API |
| Samsung Biologics Co Ltd | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| Sanofi | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| Sharp Packaging Services LLC | AstraZeneca AB | EMA expanded indications of the drug for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by drug as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) | Imfinzi | Parenteral packaging |
| Sharp Packaging Services LLC | BeOne Medicines Ltd | EMA expanded indications of the drug in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic Nasopharyngeal Carcinoma | Tevimbra | Parenteral packaging |
| Sharp Packaging Services LLC | Bayer HealthCare Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40% | Kerendia | Solid dose packaging |
| Simtra US LLC | Moderna Inc | FDA expanded indications of the drug for use in children 6 months through 11 years of age who are at increased risk for COVID-19 disease | Spikevax | Parenteral manufacture & packaging |
| SK Pharmteco Inc | AstraZeneca UK Ltd | NICE recommended the drug as an option to treat chronic kidney disease (CKD) in adults, if it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor antagonists, unless these are contraindicated, and people have an estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73 m2 to less than 45 ml/min/1.73 m2 or 45 ml/min/1.73 m2 to 90 ml/min/1.73 m2, and either a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or type 2 diabetes.If people with the condition and their healthcare professional consider drug to be 1 of a range of suitable treatments (including empagliflozin), after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. 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 healthcare professional consider it appropriate to stop | Forxiga | Small mol API |
| Sumitomo Chemical Co Ltd | Astellas Pharma Ltd | UK MHRA expanded indications of the drug for the treatment of neurogenic detrusor overactivity in paediatric patients aged 3 to 17 years | Mirabegron | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Galderma (UK) Ltd | NICE recommended the drug with topical corticosteroids or calcineurin inhibitors, or both, can be used as an option to treat moderate to severe atopic dermatitis. It can be used in people 12 years and over with a body weight of 30 kg or more when systemic treatment is suitable, only if the atopic dermatitis has not responded to at least 1 systemic immunosuppressant, or these treatments are not suitable, and a biological medicine would otherwise be offered, and the company provides drug according to the commercial arrangement | Nemluvio | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Bayer Plc | UK MHRA expanded indications of the drug in adults for the treatment of neovascular (wet) age-related macular degeneration and visual impairment due to diabetic macular oedema | Eylea | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca AB | EMA expanded indications of the drug for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by drug as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) | Imfinzi | Parenteral manufacture & packaging |
| WuXi Biologics Co Ltd | Jazz Pharmaceuticals Plc | EMA approval of the drug for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy | Ziihera | Parenteral manufacture |
| WuXi XDC Cayman Inc | BeiGene Ltd | NICE recommended the drug can be used as an option to treat relapsed or refractory mantle cell lymphoma in adults who have had 1 line of treatment only. Drug can only be used if the company provides it according to the commercial arrangement. Use the least expensive option of the suitable treatments (including drug and ibrutinib), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements. 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 healthcare professional consider it appropriate to stop | Brukinsa | Small mol API |
| Zambon Co SpA | Kalvista Pharmaceuticals Inc | FDA approval of the drug for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older | Ekterly | Small mol API |
POTENTIALLY NEGATIVE |
||||
| Alcami Corp | Sentynl Therapeutics Inc | NICE is unable to make a recommendation on drug for treating molybdenum cofactor deficiency type A in people of all ages. This is because Sentynl Therapeutics has withdrawn from the appraisal | Nulibry | Parenteral manufacture & packaging |
| PCI Pharma Services | Sentynl Therapeutics Inc | NICE is unable to make a recommendation on drug for treating molybdenum cofactor deficiency type A in people of all ages. This is because Sentynl Therapeutics has withdrawn from the appraisal | Nulibry | Parenteral packaging |
| Sharp Packaging Services LLC | Bristol-Myers Squibb Co | NICE is unable to make a recommendation on drug for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer in adults. This is because Bristol Myers Squibb will consider restarting this evaluation when the final overall survival analysis can be included in the economic model | Krazati | Solid dose packaging |
| Sharp Packaging Services LLC | BeiGene Ltd | NICE is unable to make a recommendation on drug for treating advanced non-small-cell lung cancer after platinum-based chemotherapy in adults. This is because BeiGene withdrew its evidence submission | Tevimbra | Parenteral 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