August 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 |
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| Acino International AG | Amgen Inc | FDA expanded indications of the drug for the treatment of adult patients with active psoriatic arthritis. It is also indicated in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. | Otezla | Solid dose packaging |
| Adare Pharma Solutions | Chimerix Inc | FDA approval of the drug indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. | Modeyso | Solid dose manufacture & Packaging |
| Agilent Technologies Inc | Novartis Pharmaceuticals Corp | FDA Expanded indications of the drug for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol. | Leqvio | Biologic API |
| Alcami Corp | Swedish Orphan Biovitrum AB | FDA expanded indications of the drug for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a medical or dental procedure, and for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment, persistent and chronic immune thrombocytopenia. | Doptelet Sprinkle | Solid dose packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug can be used as an option to treat cystic fibrosis in people 6 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 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 ivacaftor-tezacaftor-elexacaftor [Iva-Tez-Elx]), 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. For children or young people, this decision should be made jointly by the healthcare professional, the child or young person, and their parents or carers. | Alyftrek | Solid dose manufacture |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | NICE recommended the drug can be used as an option to treat cystic fibrosis in people 6 years and over who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 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 ivacaftor-tezacaftor-elexacaftor [Iva-Tez-Elx]), 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. For children or young people, this decision should be made jointly by the healthcare professional, the child or young person, and their parents or carers. | Alyftrek | Solid dose packaging |
| Almac Group Ltd | Kalvista Pharmaceuticals Ltd | UK MHRA approval of the drug indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. | Ekterly | Solid dose packaging |
| Astrea Pharma | Moderna Inc | EMA approval of the drug is indicated to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. | Spikevax LP.8.1 | Parenteral manufacture & packaging |
| Bachem Holding AG | Apellis Pharmaceuticals Inc | FDA Expanded indications of the drug for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) | Empaveli | Biologic API |
| Biogen Inc | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of adult patients with multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, | Darzalex | Biologic API |
| Bora Pharmaceuticals Co Ltd | Apellis Pharmaceuticals Inc | FDA Expanded indications of the drug for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) | Empaveli | Parenteral manufacture |
| Catalent CTS LLC | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of mantle cell lymphoma (MCL) who have received at least one prior therapy | Imbruvica | Solid dose manufacture & Packaging |
| Catalent Inc | DiaMedica Therapeutics Inc | Phase II Interim Results of the drug for the treatment of preeclampsia | rinvecalinase alfa | Biologic API |
| Catalent Inc | 4D Molecular Therapeutics Inc | Phase II Interim Results of the drug for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema | 4D-150 | Biologic API |
| Catalent Nottingham Ltd | Kalvista Pharmaceuticals Ltd | UK MHRA approval of the drug indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. | Ekterly | Solid dose manufacture |
| Celltrion Inc | Teva Pharmaceuticals USA Inc | FDA expanded indiactions of the drug for the preventive treatment of migraine in adults who have at least 4 migraine days per month, the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more. | Ajovy | Biologic API |
| Chemspec-API Inc | Chimerix Inc | FDA approval of the drug indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. | Modeyso | Small mol API |
| Chime Biologics Ltd | EOC Pharma Ltd | Trial planned - Phase II of the drug to evaluate pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. | eftilagimod alfa | Parenteral manufacture |
| Corden Pharma International GmbH | Novartis Pharmaceuticals Corp | FDA Expanded indications of the drug for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol. | Leqvio | Parenteral manufacture & packaging |
| Delorbis Pharmaceuticals Ltd | Neuraxpharm Spain SL | EMA approval of the drug for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). | Riulvy | Solid dose manufacture |
| Eisai Co Ltd | Swedish Orphan Biovitrum AB | FDA expanded indications of the drug for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a medical or dental procedure, and for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment, persistent and chronic immune thrombocytopenia. | Doptelet Sprinkle | Solid dose manufacture & Packaging |
| Esteve Pharmaceuticals SA | Insmed Pharmaceuticals Inc | FDA approval of the drug indicated for the treatment of non-cystic fibrosis bronchiectasis in adults and children 12 years and older. | Brinsupri | Small mol API |
| Esteve Quimica SA | Insmed Pharmaceuticals Inc | FDA approval of the drug indicated for the treatment of non-cystic fibrosis bronchiectasis in adults and children 12 years and older. | Brinsupri | Small mol API |
| Fujifilm Diosynth Biotechnologies Uk Ltd | Ascendis Pharma Inc | FDA Expanded indications of the drug for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. | Skytrofa | Biologic API |
| Industria Farmaceutica Galenica Senese | Recordati Rare Diseases SARL | EMA approval of the drug for the treatment of of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched chain amino acids free (BCAA- free) formulation. | Maapliv | Parenteral manufacture & packaging |
| Juzen Chemical Corp | Apellis Pharmaceuticals Inc | FDA Expanded indications of the drug for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) | Empaveli | Parenteral manufacture |
| Kemwell Biopharma Pvt Ltd | Janssen Therapeutics | FDA expanded indications of the drug as a part of combination therapy in the treatment of adult and pediatric patients 5 years and over with pulmonary multi-drug resistant tuberculosis (MDR-TB), also indicated for use as part of an appropriate combination regimen in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. | Sirturo | Small mol API, Solid dose manufacture & Packaging |
| Kymos Pharma Services SL | Celltrion Inc | FDA approval of the drug for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more previous DMARDs (Disease-Modifying Anti Rheumatic Drugs), including methotrexate (MTX), systemic juvenile idiopathic arthritis aged 2 years or older who have inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids and polyarticular juvenile idiopathic arthritis in patients aged 2 years or older who have inadequate response to methotrexate (MTX). | Avtozma | Parenteral manufacture |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharmaceuticals Ltd | UK MHRA expanded indications of the drug for the treatment of adult patients with advanced or metastatic hepatocellular carcinoma (hcc) who are intolerant to or have progressed on sorafenib therapy, and metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, and in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. | Opdivo | Biologic API |
| Lonza Group Ltd | Moderna Inc | EMA approval of the drug is indicated to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. | Spikevax LP.8.1 | Biologic API |
| Lonza Group Ltd | Amgen Inc | FDA expanded indications of the drug for the treatment of adult patients with active psoriatic arthritis. It is also indicated in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. | Otezla | Small mol API |
| Lonza Group Ltd | Ascendis Pharma Inc | FDA Expanded indications of the drug for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. | Skytrofa | Biologic API |
| MIAS Pharma Ltd | SpringWorks Therapeutics Inc | EMA approval of the drug for the treatment for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. | Ezmekly | Solid dose manufacture & Packaging |
| Midas Pharma GmbH | Celltrion Inc | FDA approval of the drug for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more previous DMARDs (Disease-Modifying Anti Rheumatic Drugs), including methotrexate (MTX), systemic juvenile idiopathic arthritis aged 2 years or older who have inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids and polyarticular juvenile idiopathic arthritis in patients aged 2 years or older who have inadequate response to methotrexate (MTX). | Avtozma | Parenteral manufacture & packaging |
| MilliporeSigma | Glaxo Group Ltd | EMA expanded indications of the drug for the treatment of multiple myeloma of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. | Blenrep | Biologic API |
| NextPharma Technologies Holding Ltd | PTC Therapeutics Inc | FDA approval of the drug treatment treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). | Sephience | Solid dose manufacture |
| Novartis AG | Genentech Inc | FDA Expanded indications of the drug treatment of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti-rheumatic drugs via intravenous and subcutaneous route. | Actemra | Biologic API |
| Novo Nordisk AS | Bristol-Myers Squibb Pharma EEIG | UK MHRA expanded indications of the drug for the treatment of unresectable or metastatic melanoma. Drug also used as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Drug in combination with opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. | Yervoy | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | FDA approval of the drug for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more previous DMARDs (Disease-Modifying Anti Rheumatic Drugs), including methotrexate (MTX), systemic juvenile idiopathic arthritis aged 2 years or older who have inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids and polyarticular juvenile idiopathic arthritis in patients aged 2 years or older who have inadequate response to methotrexate (MTX). | Avtozma | Parenteral manufacture & packaging |
| Patheon Biologics LLC | Novo Nordisk Inc | FDA expanded indications of the drug of adolescent and adult patients with hemophilia B (congenital factor IX [FIX] deficiency) who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes. | Alhemo | Biologic API |
| Patheon France SAS | Ipsen Pharma GmbH | EMA expanded indications of the drug for the treatment or the treatment of metastatic castration-resistant prostate cancer (MCRPC), neuroendocrine gastroenteropancreatic tumors (GEP-NET, pNET and epNET), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, | Cabometyx | Solid dose manufacture & Packaging |
| Patheon Italia SpA | Moderna Inc | EMA approval of the drug is indicated to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. | Spikevax LP.8.1 | Parenteral manufacture & packaging |
| Patheon NV | Ipsen Pharma GmbH | EMA expanded indications of the drug for the treatment or the treatment of metastatic castration-resistant prostate cancer (MCRPC), neuroendocrine gastroenteropancreatic tumors (GEP-NET, pNET and epNET), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, | Cabometyx | Solid dose manufacture & Packaging |
| Patheon NV | Moderna Inc | EMA approval of the drug is indicated to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. | Spikevax LP.8.1 | Parenteral manufacture & packaging |
| Patheon NV | Amgen Inc | FDA expanded indications of the drug for the treatment of adult patients with active psoriatic arthritis. It is also indicated in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. | Otezla | Solid dose manufacture & Packaging |
| Patheon NV | Insmed Pharmaceuticals Inc | FDA approval of the drug indicated for the treatment of non-cystic fibrosis bronchiectasis in adults and children 12 years and older. | Brinsupri | Solid dose manufacture & Packaging |
| PCI Pharma Services | Hutchmed China Ltd | NICErecommended the drug can be used as an option at third line or later to treat metastatic colorectal cancer in adults when previous treatment has included: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without anti-vascular endothelial growth factor (VEGF) treatment, and anti-epidermal growth factor receptor (EGFR) treatment if the cancer is RAS wild-type, unless this was not suitable. Drug can only be used if: | Fruzaqla | Solid dose packaging |
| PCI Pharma Services | Hutchmed China Ltd | trifluridine–tipiracil with bevacizumab is not suitable. The company provides it according to the commercial arrangement. | Fruzaqla | Solid dose packaging |
| PCI Pharma Services | Hutchmed China Ltd | 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 | Fruzaqla | Solid dose packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of mantle cell lymphoma (MCL) who have received at least one prior therapy | Imbruvica | Solid dose packaging |
| PCI Pharma Services | Apellis Pharmaceuticals Inc | FDA Expanded indications of the drug for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) | Empaveli | Parenteral packaging |
| Piramal Pharma Solutions Inc | Ipsen Pharma GmbH | EMA expanded indications of the drug for the treatment of metastatic castration-resistant prostate cancer (MCRPC), neuroendocrine gastroenteropancreatic tumors (GEP-NET, pNET and epNET), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, | Cabometyx | Small mol API |
| Recipharm AB | OS Therapies Inc | Phase II Interim Results of the drug for the treatment of osteosarcoma | ADXSHER-2 | Biologic API |
| Rottendorf Pharma GmbH | Ipsen Pharma GmbH | EMA expanded indications of the drug for the treatment or the treatment of metastatic castration-resistant prostate cancer (MCRPC), neuroendocrine gastroenteropancreatic tumors (GEP-NET, pNET and epNET), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, | Cabometyx | Solid dose manufacture & Packaging |
| ROVI Pharma Industrial Services SA | Moderna Inc | EMA approval of the drug is indicated to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. | Spikevax LP.8.1 | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | UK MHRA expanded indications of the drug for the treatment of unresectable or metastatic melanoma. Drug also used as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Drug in combination with opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. | Yervoy | Biologic API, Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharmaceuticals Ltd | UK MHRA expanded indications of the drug for the treatment of adult patients with advanced or metastatic hepatocellular carcinoma (hcc) who are intolerant to or have progressed on sorafenib therapy, and metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, and in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Genentech Inc | FDA Expanded indications of the drug treatment of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti-rheumatic drugs via intravenous and subcutaneous route. | Actemra | Biologic API |
| Sandoz GmbH | Novartis Pharmaceuticals Corp | FDA Expanded indications of the drug for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol. | Leqvio | Parenteral manufacture & packaging |
| Sharp Packaging Services LLC | Bayer AG | EMA expanded indications of the drug in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer. | Nubeqa | Solid dose packaging |
| Simtra US LLC | Bristol-Myers Squibb Pharma EEIG | UK MHRA expanded indications of the drug for the treatment of unresectable or metastatic melanoma. Drug also used as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Drug in combination with opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. | Yervoy | Parenteral manufacture |
| Skyepharma Production SAS | Purpose Pharma International AB | EMA approval of the drug for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. | Attrogy | Solid dose manufacture & Packaging |
| Southwest Research Institute | Lantern Pharma Inc | Trial planned - Phase I of the drug to test LP-184 as a monotherapy specifically in advanced, recurrent bladder cancer subjects with DNA damage repair mutations. | LP-184 | Small mol API |
| Tjoapack BV | Ipsen Pharma GmbH | EMA expanded indications of the drug for the treatment or the treatment of metastatic castration-resistant prostate cancer (MCRPC), neuroendocrine gastroenteropancreatic tumors (GEP-NET, pNET and epNET), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, | Cabometyx | Solid dose manufacture & Packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Teva Pharmaceuticals USA Inc | FDA expanded indiactions of the drug for the preventive treatment of migraine in adults who have at least 4 migraine days per month, the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more. | Ajovy | Parenteral packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Ascendis Pharma Inc | FDA Expanded indications of the drug for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. | Skytrofa | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharmaceuticals Ltd | UK MHRA expanded indications of the drug for the treatment of adult patients with advanced or metastatic hepatocellular carcinoma (hcc) who are intolerant to or have progressed on sorafenib therapy, and metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, and in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Genentech Inc | FDA Expanded indications of the drug treatment of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti-rheumatic drugs via intravenous and subcutaneous route. | Actemra | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Alnylam UK Ltd | UK MHRA expanded indications of the drug for the treatemnt of familial amyloid polyneuropathy (FAP/hereditary transthyretin amyloidosis), transthyretin amyloid cardiomyopathy (ATTR). | Amvuttra | Parenteral manufacture & packaging |
| Wacker Chemie AG | OS Therapies Inc | Phase II Interim Results of the drug for the treatment of osteosarcoma | ADXSHER-2 | Biologic API |
| WuXi AppTec Co Ltd | WuXi AppTec Co Ltd | Phase II Interim Results of the drug for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema | 4D-150 | Biologic API |
| WuXi Biologics Cayman Inc | Immutep Ltd | Trial planned - Phase II of the drug to evaluate pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. | eftilagimod alfa | Biologic API |
| WuXi STA (Shanghai) Co Ltd | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of mantle cell lymphoma (MCL) who have received at least one prior therapy | Imbruvica | Small mol API |
| WuXi XDC Cayman Inc | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of mantle cell lymphoma (MCL) who have received at least one prior therapy | Imbruvica | Small mol API |
| Zambon Co SpA | Kalvista Pharmaceuticals Ltd | UK MHRA approval of the drug indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. | Ekterly | Small mol API |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis AG | NICE recommended the drug with an aromatase inhibitor can be used, within its marketing authorisation, as an option for the adjuvant treatment of hormone receptor-positive, HER2-negative, early breast cancer at high risk of recurrence in adults. Combine the aromatase inhibitor with a luteinising hormone-releasing hormone agonist, unless after menopause. Drug is recommended only if the company provides it according to the commercial arrangement. | Kisqali | Small mol API |
POTENTIALLY NEGATIVE |
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| Bachem Holding AG | Relief Therapeutics Holding AG | Trial was Withdrawn because evidence for initiation of the trial could not be obtained | aviptadil | Biologic API |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | NICE is unable to make a recommendation on drug for treating hormone receptor-positive HER2-negative metastatic breast cancer after 2 or more treatments in adults. This is because Gilead has confirmed that it does not intend to make an evidence submission for the appraisal. Gilead considers that the technology is unlikely to be a cost-effective use of NHS resources. | Trodelvy | Biologic API |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | NICE is unable to make a recommendation on drug for treating hormone receptor-positive HER2-negative metastatic breast cancer after 2 or more treatments in adults. This is because Gilead has confirmed that it does not intend to make an evidence submission for the appraisal. Gilead considers that the technology is unlikely to be a cost-effective use of NHS resources. | Trodelvy | Parenteral manufacture |
| Catalent Inc | Emalex Biosciences Inc | Trial was suspended because of unknown reason | ecopipam hydrochloride | Solid dose manufacture |
| Curia Global Inc | Relief Therapeutics Holding AG | Trial was Withdrawn because evidence for initiation of the trial could not be obtained | aviptadil | Parenteral manufacture |
| Nephron Pharmaceuticals Corp | Relief Therapeutics Holding AG | Trial was Withdrawn because evidence for initiation of the trial could not be obtained | aviptadil | Parenteral manufacture |
| PolyPeptide Group AG | NeuroRx Inc | Trial was Withdrawn because evidence for initiation of the trial could not be obtained | aviptadil | Biologic API |
| Samsung Biologics Co Ltd | Gilead Sciences Inc | NICE is unable to make a recommendation on drug for treating hormone receptor-positive HER2-negative metastatic breast cancer after 2 or more treatments in adults. This is because Gilead has confirmed that it does not intend to make an evidence submission for the appraisal. Gilead considers that the technology is unlikely to be a cost-effective use of NHS resources. | Trodelvy | Biologic API |
| W. R. Grace & Co | Emalex Biosciences Inc | Trial was suspended because of unknown reason | ecopipam hydrochloride | Small mol API |
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