May 2024 — 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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| AbbVie Inc | Takeda Pharmaceutical Co Ltd | FDA expanded indication of the drug for the maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with Entyvio intravenous | Entyvio | Biologic API |
| Acino International AG | Amgen Inc | FDA expanded indication of the drug for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy | Otezla | Solid dose packaging |
| Advanced BioScience Laboratories Inc | Imugene Ltd | Positive Phase I Interim results of the drug for the treatment of bile tract cancer | VAXINIA | Biologic API, Parenteral manufacture |
| Ajinomoto Bio-Pharma Services | Ipsen SA | EMA expanded indication of the drug in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas | Onivyde | Parenteral manufacture & packaging |
| Ajinomoto Bio-Pharma Services | MacroGenics Inc | EMA approval of the drug as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy | Zynyz | Parenteral manufacture |
| Allpack Group AG | Novartis AG | FDA expanded indication of the drug for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older | Entresto Sprinkle | Solid dose packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Solid dose packaging |
| Aptuit LLC | X4 Pharmaceuticals Inc | FDA approval of the drug in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes | Xolremdi | Small mol API |
| AstraZeneca Plc | Merck & Co Inc | NICE recommended the drug as an option for treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over who have had at least 2 previous treatments and cannot have an autologous stem cell transplant (ASCT). It is recommended only if: they have already had brentuximab vedotin and the drug is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Baccinex SA | Ascendis Pharma AS | UK MHRA approval of the drug for the treatment of adults with chronic hypoparathyroidism | Yorvipath | Parenteral manufacture & packaging |
| Bachem Holding AG | Ascendis Pharma AS | UK MHRA approval of the drug for the treatment of adults with chronic hypoparathyroidism | Yorvipath | Biologic API |
| Bachem Holding AG | Apellis Pharmaceuticals Inc | EMA expanded indication of the drug as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia | Aspaveli | Biologic API |
| Baxter International Inc | MacroGenics Inc | EMA approval of the drug as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy | Zynyz | Parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals China Ltd | BeiGene Ltd | EMA expanded indication of the drug in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC; in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC | Tizveni | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | NICE recommended the drug as an option for treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over who have had at least 2 previous treatments and cannot have an autologous stem cell transplant (ASCT). It is recommended only if: they have already had brentuximab vedotin and the drug is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Bora Pharmaceuticals Co Ltd | Aslan Pharmaceuticals Ltd | Positive Phase II Interim results of the drug in moderate-to-severe atopic dermatitis (AD) adult patients previously treated with dupilumab, TREK-DX | eblasakimab | Parenteral manufacture |
| Cambrex Corp | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Catalent CTS LLC | Travere Therapeutics Inc | EMA approval of the drug for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥ 0.75 g/g | Filspari | Solid dose manufacture |
| Catalent CTS LLC | Karyopharm Therapeutics Inc | NICE recommended the drug plus dexamethasone, within its marketing authorization, for treating multiple myeloma in adults when: they have had 4 or more treatments, and the condition is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti‑CD38 monoclonal antibody (penta-refractory), and the condition has progressed on the last treatment, and the company provides it according to the commercial arrangement |
Nexpovio | Solid dose manufacture |
| Catalent CTS LLC | Exelixis Inc | NICE recommended the drug with nivolumab as an option for untreated advanced renal cell carcinoma in adults, only if: their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and the companies provide the drug and nivolumab according to their commercial arrangements. This recommendation is not intended to affect treatment with the drug with nivolumab 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 | Cabometyx | Solid dose manufacture & packaging |
| Catalent Inc | Pfizer Inc | EMA expanded indication of the drug as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy | Xtandi | Solid dose manufacture |
| Catalent Inc | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Solid dose manufacture |
| Charles River Laboratories International Inc | Accord Healthcare SLU | FDA approval of the drug for the treatment of HER2-overexpressing breast cancer and metastatic gastric nor gastroesophageal junction adenocarcinoma | Hercessi | Biologic API |
| Chime Biologics Ltd | EOC Pharma Ltd | Positive Phase II Interim results of the drug in combination with Radiotherapy plus pembrolizumab for patients with Soft Tissue Sarcomas | eftilagimod alfa | Parenteral manufacture |
| Chime Biologics Ltd | EOC Pharma Ltd | Positive Phase II Top-line results of the drug in combination with pembrolizumab as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression | eftilagimod alfa | Parenteral manufacture |
| Curia Global Inc | Pfizer Inc | EMA expanded indication of the drug as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy | Xtandi | Small mol API |
| Delpharm SAS | Chugai Pharmaceutical Co Ltd | FDA expanded indication of the drug as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test | Alecensa | Solid dose packaging |
| Delpharm SAS | Takeda Pharmaceutical Co Ltd | FDA expanded indication of the drug for the maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with Entyvio intravenous | Entyvio | Parenteral manufacture |
| Emergent BioSolutions Inc | Apellis Pharmaceuticals Inc | EMA expanded indication of the drug as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia | Aspaveli | Parenteral manufacture |
| Esteve Pharmaceuticals SA | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Small mol API |
| Evonik Industries AG | Chugai Pharmaceutical Co Ltd | FDA expanded indication of the drug as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test | Alecensa | Small mol API |
| Excella GmbH & Co KG | Chugai Pharmaceutical Co Ltd | FDA expanded indication of the drug as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test | Alecensa | Solid dose manufacture |
| Fareva SA | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Flamma SpA | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Hikma Pharmaceuticals Plc | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Small mol API |
| Hubei Haosun Pharmaceutical Co Ltd | Ipsen SA | EMA expanded indication of the drug in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas | Onivyde | Small mol API |
| Jubilant HollisterStier LLC | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Juzen Chemical Corp | Apellis Pharmaceuticals Inc | EMA expanded indication of the drug as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia | Aspaveli | Parenteral manufacture |
| Konapharma AG | Novartis AG | FDA expanded indication of the drug for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older | Entresto Sprinkle | Solid dose packaging |
| Lonza Group Ltd | Context Therapeutics Inc | Trial planned - Phase I to evaluate the safety and efficacy of the drug in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer | Biologic API, Parenteral manufacture | |
| Lonza Group Ltd | Vaxart Inc | Positive Phase I Top-line results of the drug in healthy Lactating Females = 18 Years Old and their Breast-feeding Infants | VXAG-1.1NN; Norovirus [strains Norwalk GI.1 + Sydney GII.4] (bivalent) vaccine | Biologic API |
| Lonza Group Ltd | Amgen Inc | FDA expanded indication of the drug for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy | Otezla | Small mol API |
| Lonza Group Ltd | Takeda Pharmaceutical Co Ltd | FDA expanded indication of the drug for the maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with Entyvio intravenous | Entyvio | Biologic API |
| Mayne Pharma Group Ltd | X4 Pharmaceuticals Inc | FDA approval of the drug in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes | Xolremdi | Solid dose manufacture & packaging |
| MIAS Pharma Ltd | Karyopharm Therapeutics Inc | NICE recommended the drug plus dexamethasone, within its marketing authorization, for treating multiple myeloma in adults when: they have had 4 or more treatments, and the condition is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti‑CD38 monoclonal antibody (penta-refractory), and the condition has progressed on the last treatment, and the company provides it according to the commercial arrangement |
Nexpovio | Solid dose manufacture |
| Noramco Inc | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Solid dose manufacture & packaging |
| Organon & Co | Merck & Co Inc | NICE recommended the drug as an option for treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over who have had at least 2 previous treatments and cannot have an autologous stem cell transplant (ASCT). It is recommended only if: they have already had brentuximab vedotin and the drug is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and the company provides it according to the commercial arrangement | Keytruda | Parenteral packaging |
| Patheon NV | Aslan Pharmaceuticals Ltd | Positive Phase II Interim results of the drug in moderate-to-severe atopic dermatitis (AD) adult patients previously treated with dupilumab, TREK-DX | eblasakimab | Biologic API, Parenteral manufacture |
| Patheon NV | Amgen Inc | FDA expanded indication of the drug for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy | Otezla | Solid dose manufacture & packaging |
| Patheon NV | Day One Biopharmaceuticals Inc | FDA approval of the drug for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation | Ojemda | Solid dose packaging |
| Patheon NV | Neurocrine Biosciences Inc | FDA expanded indication of the drug for the treatment of adults with tardive dyskinesia; for the treatment of adults with chorea associated with Huntington’s disease | Ingrezza Sprinkle | Solid dose manufacture & packaging |
| Patheon NV | Takeda Pharmaceutical Co Ltd | FDA expanded indication of the drug for the maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with Entyvio intravenous | Entyvio | Parenteral manufacture & packaging |
| Patheon NV | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Solid dose manufacture |
| Patheon NV | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Patheon NV | Exelixis Inc | NICE recommended the drug with nivolumab as an option for untreated advanced renal cell carcinoma in adults, only if: their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and the companies provide the drug and nivolumab according to their commercial arrangements. This recommendation is not intended to affect treatment with the drug with nivolumab 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 | Cabometyx | Solid dose manufacture & packaging |
| PCI Pharma Services | Neurocrine Biosciences Inc | FDA expanded indication of the drug for the treatment of adults with tardive dyskinesia; for the treatment of adults with chorea associated with Huntington’s disease | Ingrezza Sprinkle | Solid dose packaging |
| PCI Pharma Services | Pfizer Inc | EMA expanded indication of the drug as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy | Xtandi | Solid dose packaging |
| PCI Pharma Services | Apellis Pharmaceuticals Inc | EMA expanded indication of the drug as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia | Aspaveli | Parenteral packaging |
| PCI Pharma Services | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Pfizer Inc | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Pharma Packaging Solutions | Karyopharm Therapeutics Inc | NICE recommended the drug plus dexamethasone, within its marketing authorization, for treating multiple myeloma in adults when: they have had 4 or more treatments, and the condition is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti‑CD38 monoclonal antibody (penta-refractory), and the condition has progressed on the last treatment, and the company provides it according to the commercial arrangement |
Nexpovio | Solid dose packaging |
| Piramal Pharma Solutions Inc | Exelixis Inc | NICE recommended the drug with nivolumab as an option for untreated advanced renal cell carcinoma in adults, only if: their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and the companies provide the drug and nivolumab according to their commercial arrangements. This recommendation is not intended to affect treatment with the drug with nivolumab 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 | Cabometyx | Small mol API |
| Quotient Sciences Ltd | Day One Biopharmaceuticals Inc | FDA approval of the drug for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation | Ojemda | Solid dose manufacture |
| Recipharm AB | Karo Pharma AB | FDA approval of the drug for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli (E. coli), Proteus mirabilis, and Staphylococcus saprophyticus | Pivya | Solid dose manufacture |
| Recipharm AB | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Solid dose manufacture & packaging |
| Rentschler Biopharma SE | UCB SA | EMA expanded indication of the drug for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy | Bimzelx | Biologic API |
| Samsung Biologics Co Ltd | UCB SA | EMA expanded indication of the drug for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy | Bimzelx | Biologic API |
| ScinoPharm Taiwan Ltd | Ipsen SA | EMA expanded indication of the drug in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas | Onivyde | Small mol API |
| SEQENS | Biophytis SA | Trial planned - Phase II to assess efficacy of the drug in obese subjects to maintain muscle function treated with GLP-1 RAs and following hypocaloric dieting | Ruvembri | Small mol API |
| Sharp Packaging Services | BeiGene Ltd | EMA expanded indication of the drug in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC; in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC | Tizveni | Parenteral packaging |
| Simtra BioPharma Solutions | Ipsen SA | EMA expanded indication of the drug in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas | Onivyde | Parenteral packaging |
| Skyepharma Production SAS | Biophytis SA | Trial planned - Phase II to assess efficacy of the drug in obese subjects to maintain muscle function treated with GLP-1 RAs and following hypocaloric dieting | Ruvembri | Solid dose manufacture |
| Takeda Pharmaceutical Co Ltd | Ipsen SA | EMA expanded indication of the drug in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas | Onivyde | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | F. Hoffmann-La Roche Ltd | FDA expanded indication of the drug for the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their haemoglobin level was stabilized with an ESA | Mircera | Parenteral packaging |
| WuXi AppTec Co Ltd | Immutep Ltd | Positive Phase II Interim results of the drug in combination with Radiotherapy plus pembrolizumab for patients with Soft Tissue Sarcomas | eftilagimod alfa | Parenteral manufacture |
| WuXi AppTec Co Ltd | Immutep Ltd | Positive Phase II Top-line results of the drug in combination with pembrolizumab as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression | eftilagimod alfa | Parenteral manufacture |
| WuXi Biologics Cayman Inc | Immutep Ltd | Positive Phase II Interim results of the drug in combination with Radiotherapy plus pembrolizumab for patients with Soft Tissue Sarcomas | eftilagimod alfa | Biologic API |
| WuXi Biologics Cayman Inc | Immutep Ltd | Positive Phase II Top-line results of the drug in combination with pembrolizumab as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression | eftilagimod alfa | Biologic API |
| WuXi STA (Shanghai) Co Ltd | Day One Biopharmaceuticals Inc | FDA approval of the drug for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation | Ojemda | Small mol API |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | EMA expanded indication of the drug for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Kalydeco | Small mol API |
| Xellia Pharmaceuticals ApS | Gilead Sciences Inc | NICE recommended the drug as an option for treating COVID‑19 in hospitals in: adults, only if they have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID-19) babies, children, and young people, only if they: are aged 4 weeks to 17 years and weigh at least 3 kg, and: have pneumonia, and need supplemental oxygen, or weigh at least 40 kg, and have a high risk of serious illness (risk factors as defined in section 5 of NICE's technology appraisal guidance on nirmatrelvir plus ritonavir, sotrovimab, and tocilizumab for treating COVID‑19). The drug is only recommended if the company provides it according to the commercial arrangement | Veklury | Small mol API |
| Yposkesi SAS | Genethon SA | Positive Phase II/III Interim results of the drug for the treatment of Duchenne muscular dystrophy | GNT-0004 | Parenteral manufacture |
| Yposkesi SAS | Sio Gene Therapies Inc | Positive Phase I/II Interim results of the drug for the treatment Oculopharyngeal Muscular Dystrophy | BB-301 | Parenteral manufacture |
POTENTIALLY NEGATIVE |
||||
| AstraZeneca Plc | Merck & Co Inc | NICE rejection for the drug for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin. This recommendation has been updated and replaced by NICE technology appraisal 967. These recommendations are not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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 and NICE is unable to make a recommendation on the drug with gemcitabine and cisplatin for untreated advanced biliary tract cancer in adults. This is because Merck Sharp & Dohme did not provide an evidence submission. We will review this decision if the company decides to make a submission | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | NICE rejection for the drug for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin. This recommendation has been updated and replaced by NICE technology appraisal 967. These recommendations are not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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 and NICE is unable to make a recommendation on the drug with gemcitabine and cisplatin for untreated advanced biliary tract cancer in adults. This is because Merck Sharp & Dohme did not provide an evidence submission. We will review this decision if the company decides to make a submission | Keytruda | Biologic API |
| Lonza Group Ltd | AstraZeneca Plc | NICE rejection for the drug plus cilgavimab, within its marketing authorization, for treating COVID‑19 in adults who do not need supplemental oxygen and who have an increased risk of progression to severe COVID‑19 | Evusheld | Parenteral manufacture |
| Magle Chemoswed AB | Oncopeptides AB | NICE is unable to make a recommendation for the drug for treating relapsed or refractory multiple myeloma in adults. This is because Oncopeptides did not provide an evidence submission. We will review this decision if the company decides to make a submission | Pepaxti | Small mol API |
| Organon & Co | Merck & Co Inc | NICE rejection for the drug for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin. This recommendation has been updated and replaced by NICE technology appraisal 967. These recommendations are not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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 and NICE is unable to make a recommendation on the drug with gemcitabine and cisplatin for untreated advanced biliary tract cancer in adults. This is because Merck Sharp & Dohme did not provide an evidence submission. We will review this decision if the company decides to make a submission | Keytruda | Parenteral packaging |
| Samsung Biologics Co Ltd | AstraZeneca Plc | NICE rejection for the drug plus cilgavimab, within its marketing authorization, for treating COVID‑19 in adults who do not need supplemental oxygen and who have an increased risk of progression to severe COVID‑19 | Evusheld | Biologic API, Parenteral manufacture & packaging |
| WuXi Biologics Co Ltd | AstraZeneca Plc | NICE rejection for the drug plus cilgavimab, within its marketing authorization, for treating COVID‑19 in adults who do not need supplemental oxygen and who have an increased risk of progression to severe COVID‑19 | Evusheld | Biologic API |
Notes:
Source: GlobalData, Pharma Intelligence Center (Accessed March 10, 2021) ©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
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