January 2024 — CDMO Opportunities And Threats Report
Source: Outsourced Pharma
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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| Aenova Holding GmbH | Basilea Pharmaceutica Ltd | FDA expanded indication of the drug for the treatment of invasive mucormycosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive mucormycosis as capsules for adults and pediatric patients 6 years of age and older; for the treatment of invasive aspergillosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive aspergillosis as capsules for adults and pediatric patients 6 years of age and older who weigh 16 kilograms | Cresemba | Parenteral manufacture |
| Afton Scientific Corp | Biotest AG | FDA expanded indication of the drug for the treatment primary humoral immunodeficiency in pediatric patients 2 years of age and older | Bivigam | Parenteral manufacture & packaging |
| Ajinomoto Bio-Pharma Services | Biotest AG | FDA expanded indication of the drug for the treatment primary humoral immunodeficiency in pediatric patients 2 years of age and older | Bivigam | Parenteral manufacture & packaging |
| Almac Group Ltd | Basilea Pharmaceutica Ltd | FDA expanded indication of the drug for the treatment of invasive mucormycosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive mucormycosis as capsules for adults and pediatric patients 6 years of age and older; for the treatment of invasive aspergillosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive aspergillosis as capsules for adults and pediatric patients 6 years of age and older who weigh 16 kilograms | Cresemba | Parenteral manufacture & packaging |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indication of the drug in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Biologic API |
| AstraZeneca Plc | Merck & Co Inc | NICE approval for the drug with chemotherapy with or without bevacizumab is recommended as an option for treating persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD‑L1 with a combined positive score of at least 1. It is recommended only if: the drug is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangements. 1.2 This recommendation is not intended to affect treatment with the drug plus chemotherapy with or without bevacizumab 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 | Keytruda | Parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | EMA expanded indication of the drug in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Biologic API |
| Boehringer Ingelheim International GmbH | Merck & Co Inc | NICE approval for the drug with chemotherapy with or without bevacizumab is recommended as an option for treating persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD‑L1 with a combined positive score of at least 1. It is recommended only if: the drug is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangements. 1.2 This recommendation is not intended to affect treatment with the drug plus chemotherapy with or without bevacizumab 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 | Keytruda | Parenteral manufacture |
| Cambrex Corp | Grunenthal GmbH | FDA expanded indication of the drug for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg | Nucynta | Solid dose |
| Catalent Inc | PharmAust Ltd | Trial planned - Phase I to investigate the long term safety, tolerability and efficacy of oral drug in individuals with motor neurone disease who previously completed study MON-2021-001 | monepantel | Solid dose |
| Catalent Inc | TFF Pharmaceuticals Inc | Positive Phase II Interim results of the drug for the treatment of lung transplant rejection | tacrolimus | Solid dose |
| Catalent Inc | Celltrion Inc | FDA expanded indication of the drug for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients | Yuflyma | Parenteral manufacture & packaging |
| Catalent Inc | AstraZeneca Plc | FDA expanded indication of the drug to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable | Adbry | Parenteral manufacture & packaging |
| Catalent Inc | Blueprint Medicines Corp | EMA expanded indication of the drug for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment | Ayvakyt | Solid dose |
| Centre for Probe Development and Commercialization | Point Biopharma Corp | Positive Phase III top-line results of the drug for the treatment of metastatic castration resistant prostate cancer after progression on an androgen receptor pathway inhibitor (ARPI) | lutetium (177Lu) zadavotide guraxetan | Parenteral manufacture |
| CoreRx Inc | TFF Pharmaceuticals Inc | Positive Phase II Interim results of the drug for the treatment of lung transplant rejection | tacrolimus | Solid dose |
| Divi's Laboratories Ltd | Basilea Pharmaceutica Ltd | FDA expanded indication of the drug for the treatment of invasive mucormycosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive mucormycosis as capsules for adults and pediatric patients 6 years of age and older; for the treatment of invasive aspergillosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive aspergillosis as capsules for adults and pediatric patients 6 years of age and older who weigh 16 kilograms | Cresemba | Small mol API |
| Evergreen Theragnostics Inc | Cellectar Biosciences Inc | Positive Phase II top-line results of the drug for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) | iopofosine i-131 | Small mol API |
| Evonik Industries AG | Cassava Sciences Inc | Trial planned - Phase I to evaluate the absorption, metabolism, and excretion of [14C]-drug in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi)[14C]-drug | simufilam hydrochloride | Small mol API |
| Excella GmbH & Co KG | Pfizer Inc | EMA expanded indication of the drug in combination with enzalutamide (Xtandi) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated | Talzenna | Solid dose manufacture & packaging |
| Fareva SA | Cidara Therapeutics Inc | EMA approval of the drug for the treatment of invasive candidiasis in adults | Rezzayo | Parenteral manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Spyre Therapeutics Inc | EMA approval of the drug for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older | Loargys | Biologic API |
| Fujimoto Chemicals Co Ltd | Astellas Pharma Inc | EMA approval of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause | Veoza | Small mol API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | NICE recommended the drug as an option for treating chronic kidney disease (CKD) in adults, only if: it is an add-on to optimized standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and people have an estimated glomerular filtration rate 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. 1.2 If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments (including dapagliflozin), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose, and commercial arrangements 1.3 This recommendation does not affect treatment with the drug 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 | Jardiance | Solid dose packaging |
| Hovione FarmaCiencia SA | Basilea Pharmaceutica Ltd | FDA expanded indication of the drug for the treatment of invasive mucormycosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive mucormycosis as capsules for adults and pediatric patients 6 years of age and older; for the treatment of invasive aspergillosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive aspergillosis as capsules for adults and pediatric patients 6 years of age and older who weigh 16 kilograms | Cresemba | Small mol API |
| Isotopia Molecular Imaging Ltd | Point Biopharma Corp | Positive Phase III top-line results of the drug for the treatment of metastatic castration resistant prostate cancer after progression on an androgen receptor pathway inhibitor (ARPI) | lutetium (177Lu) zadavotide guraxetan | Small mol API |
| ITM Isotope Technologies Munich SE | Point Biopharma Corp | Positive Phase III top-line results of the drug for the treatment of metastatic castration resistant prostate cancer after progression on an androgen receptor pathway inhibitor (ARPI) | lutetium (177Lu) zadavotide guraxetan | Small mol API |
| Juzen Chemical Corp | Astellas Pharma Inc | EMA approval of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause | Veoza | Small mol API |
| KBI Biopharma Inc | Shattuck Labs Inc | Positive Phase I top-line results of the drug in combination with Azacitidine in Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) | SL-172154 | Biologic API |
| Lichtenheldt GmbH | Chiesi Farmaceutici SpA | FDA approval of the drug for treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older | Filsuvez | Solid dose |
| Lonza Group Ltd | Astellas Pharma Inc | FDA expanded indication of the drug in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy | Padcev | Biologic API |
| Mallinckrodt Plc | Hikma Pharmaceuticals Plc | FDA expanded indicationof the drug oral Solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate | Codeine Sulfate | Small mol API |
| MIAS Pharma Ltd | TaiMed Biologics Inc | FDA expanded indication of the drug in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen | Trogarzo | Parenteral manufacture & packaging |
| Minakem SAS | Calliditas Therapeutics AB | NICE recommended the drug as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more. Targeted-release drug is recommended only if: it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated by the company provides it according to the commercial arrangement. 1.2 This recommendation is not intended to affect treatment with targeted-release budesonide 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. |
Kinpeygo | Small mol API |
| Minaris Regenerative Medicine LLC | bluebird bio Inc | FDA approval of the drug for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events | Lyfgenia | Parenteral manufacture |
| Noramco Inc | Grunenthal GmbH | FDA expanded indication of the drug for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg | Nucynta | Small mol API |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | FDA expanded indication of the drug for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients | Yuflyma | Parenteral manufacture |
| Organon & Co | Merck & Co Inc | EMA expanded indication of the drug in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Parenteral packaging |
| Organon & Co | Merck & Co Inc | NICE approval for the drug with chemotherapy with or without bevacizumab is recommended as an option for treating persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD‑L1 with a combined positive score of at least 1. It is recommended only if: the drug is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and the company provides it according to the commercial arrangements. 1.2 This recommendation is not intended to affect treatment with the drug plus chemotherapy with or without bevacizumab 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 | Keytruda | Parenteral packaging |
| Patheon NV | TFF Pharmaceuticals Inc | Positive Phase II Interim results of the drug for the treatment of lung transplant rejection | tacrolimus | Solid dose |
| Patheon NV | Grunenthal GmbH | FDA expanded indication of the drug for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg | Nucynta | Solid dose manufacture & packaging |
| Patheon NV | Cidara Therapeutics Inc | EMA approval of the drug for the treatment of invasive candidiasis in adults | Rezzayo | Parenteral manufacture |
| Patheon NV | Calliditas Therapeutics AB | NICE recommended the drug as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more. Targeted-release drug is recommended only if: it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated by the company provides it according to the commercial arrangement. 1.2 This recommendation is not intended to affect treatment with targeted-release budesonide 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. |
Kinpeygo | Solid dose |
| PCI Pharma Services | Esperion Therapeutics Inc | FDA expanded indication of the drug as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C | Nexlizet | Solid dose packaging |
| PCI Pharma Services | Celltrion Inc | FDA expanded indication of the drug for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients | Yuflyma | Parenteral packaging |
| PCI Pharma Services | Esperion Therapeutics Inc | FDA expanded indication of the drug as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C | Nexletol | Solid dose packaging |
| PCI Pharma Services | Blueprint Medicines Corp | EMA expanded indication of the drug for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment | Ayvakyt | Solid dose packaging |
| PCI Pharma Services | Astellas Pharma Inc | EMA approval of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause | Veoza | Solid dose packaging |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | FDA expanded indication of the drug as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C | Nexlizet | Solid dose |
| Piramal Pharma Solutions Inc | Esperion Therapeutics Inc | FDA expanded indication of the drug as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C | Nexletol | Solid dose |
| Praxis Packaging Solutions | Boehringer Ingelheim International GmbH | NICE recommended the drug as an option for treating chronic kidney disease (CKD) in adults, only if: it is an add-on to optimized standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and people have an estimated glomerular filtration rate 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. 1.2 If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments (including dapagliflozin), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose, and commercial arrangements 1.3 This recommendation does not affect treatment with the drug 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 | Jardiance | Solid dose packaging |
| Roslin Cell Therapies Ltd | Vertex Pharmaceuticals Inc | FDA approval of the drug for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises (VOCs) | Casgevy | Biologic API |
| Samsung Biologics Co Ltd | TaiMed Biologics Inc | FDA expanded indication of the drug in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen | Trogarzo | Biologic API |
| Sharp Packaging Services | TaiMed Biologics Inc | FDA expanded indication of the drug in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen | Trogarzo | Parenteral packaging |
| Simtra BioPharma Solutions | Astellas Pharma Inc | FDA expanded indication of the drug in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy | Padcev | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Basilea Pharmaceutica Ltd | FDA expanded indication of the drug for the treatment of invasive mucormycosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive mucormycosis as capsules for adults and pediatric patients 6 years of age and older; for the treatment of invasive aspergillosis as injection for adults and pediatric patients 1 year of age and older; for the treatment of invasive aspergillosis as capsules for adults and pediatric patients 6 years of age and older who weigh 16 kilograms | Cresemba | Parenteral manufacture & packaging |
| Societal CDMO Inc | Longboard Pharmaceuticals Inc | Positive Phase I/II top-line results of the drug for the treatment of developmental and epileptic encephalopathies (DEEs) | bexicaserin | Solid dose |
| Syngene International Ltd | PharmAust Ltd | Trial planned - Phase I to investigate the long term safety, tolerability and efficacy of oral drug in individuals with motor neurone disease who previously completed study MON-2021-001 | monepantel | Small mol API |
| Teva Pharmaceutical Industries Ltd | Calliditas Therapeutics AB | NICE recommended the drug as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more. Targeted-release drug is recommended only if: it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated by the company provides it according to the commercial arrangement. 1.2 This recommendation is not intended to affect treatment with targeted-release budesonide 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. |
Kinpeygo | Small mol API |
| Tjoapack BV | Calliditas Therapeutics AB | NICE recommended the drug as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more. Targeted-release drug is recommended only if: it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated by the company provides it according to the commercial arrangement. 1.2 This recommendation is not intended to affect treatment with targeted-release budesonide 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. |
Kinpeygo | Solid dose packaging |
| Unimedic AB | Spyre Therapeutics Inc | EMA approval of the drug for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older | Loargys | Parenteral manufacture |
| Unither Pharmaceuticals SAS | Pharnext SA | Positive Phase III top-line results of the drug for the treatment of Charcot-Marie-Tooth disease type 1A (CMT1A) | (baclofen + naltrexone hydrochloride + sorbitol) | Solid dose manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Aslan Pharmaceuticals Ltd | Positive Phase II top-line results of the drug for the treatment in high-risk ST-elevation myocardial infarction (STEMI) patients undergoing acute percutaneous coronary intervention (PCI) | KAND-567 | Solid dose |
| WuXi Biologics Cayman Inc | TaiMed Biologics Inc | FDA expanded indication of the drug in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen | Trogarzo | Biologic API & Parenteral manufacture |
POTENTIALLY NEGATIVE |
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| Catalent Inc | Regeneron Pharmaceuticals Inc | NICE is unable to make a recommendation on the drug for treating eosinophilic oesophagitis in people 12 years and over. This is because Sanofi did not provide an evidence submission. We will review this decision if the company decides to make a submission | Dupixent | Parenteral manufacture & packaging |
| Catalent Inc | Regeneron Pharmaceuticals Inc | NICE is unable to make a recommendation on the drug for treating eosinophilic oesophagitis in people 12 years and over. This is because Sanofi did not provide an evidence submission. We will review this decision if the company decides to make a submission | Dupixent | Parenteral manufacture & packaging |
| FUJIFILM Diosynth Biotechnologies USA Inc | Alexion Pharmaceuticals Inc | NICE is unable to make a recommendation on the drug for treating generalized myasthenia gravis in adults and for treating AQP4 antibody-positive neuromyelitis optica spectrum disorder in adults. This is because Alexion Pharma UK withdrew its evidence submission. We will review this decision if the company decides to make a submission | Ultomiris | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Samsung Bioepis Co Ltd | EMA withdrawal/discontinuation at the MAH's request | Onbevzi | Biologic API & Parenteral manufacture |
| Patheon NV | Alexion Pharmaceuticals Inc | NICE is unable to make a recommendation on the drug for treating generalized myasthenia gravis in adults and for treating AQP4 antibody-positive neuromyelitis optica spectrum disorder in adults. This is because Alexion Pharma UK withdrew its evidence submission. We will review this decision if the company decides to make a submission | Ultomiris | Biologic API |
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