January 2021 – CDMO Opportunities And Threats Report
Source: Outsourced Pharma
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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| Advent Srl | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Parenteral manufacture |
| Advent Srl | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Parenteral manufacture |
| Aenova Holding GmbH | Takeda Pharmaceutical Co Ltd | FDA expanded indication for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors | Iclusig | Solid dose packaging |
| AGC Biologics Inc | Swedish Orphan Biovitrum AB | FDA expanded indication for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) | Kineret | Large molecule API manufacture |
| AGC Biologics Inc | Kuur Therapeutics Ltd | Positive Phase III results for trial in patients with diabetic macular edema | Beovu | Large molecule API manufacture |
| AGC Biologics SpA | Orchard Therapeutics Plc | EMA approval for the treatment of metachromatic leukodystrophy (MLD), characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline | Libmeldy | Large molecule API and parenteral manufacture |
| Albany Molecular Research Inc | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Parenteral manufacture |
| Albany Molecular Research Inc | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Parenteral manufacture |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication in the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data | Trikafta | Solid dose manufacture and packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 6 years and older | Symdeko | Solid dose packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Solid dose packaging |
| Almac Group Ltd | BioNTech SE | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older | Comirnaty* | Parenteral packaging |
| Almac Group Ltd | Leading BioSciences Inc | Positive Phase I results for open-Label Gastrointestinal Surgery Study treated with the drug | Tranexamic acid | Small molecule API manufacture |
| AstraZeneca Plc | Merck & Co Inc | Trial planned - Phase I/II to evaluate the safety and efficacy of the drug, and MK-1308 in programmed cell-death 1 (PD-1) naïve or PD-1 exposed subjects with melanoma brain metastasis (MBM) and to identify the drug, and MK-1308, when used in combination, are superior to the current treatment options/historical control available | Keytruda | Large molecule API manufacture |
| AstraZeneca Plc | Merck & Co Inc | Positive Phase III results in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy | Keytruda | Large molecule API manufacture |
| Bachem Holding AG | Supernus Pharmaceuticals Inc | Positive Phase III results for trial in adults with ADHD | Viloxazine hydrochloride | Small molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | BeiGene Ltd | Trial planned - Phase II to evaluate the efficacy and safety in combination with or without BGB-A1217 in participants with previously treated recurrent or metastatic cervical cancer | Tislelizumab | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | Trial planned - Phase I/II to evaluate the safety and efficacy of pembrolizumab, MK-1308 in programmed cell-death 1 (PD-1) naïve or PD-1 exposed subjects with melanoma brain metastasis (MBM) and to identify the pembrolizumab, MK-1308, when used in combination, are superior to the current treatment options/historical control available | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | Positive Phase III results in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim International GmbH | Takeda Pharmaceutical Co Ltd | FDA expanded indication for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors | Iclusig | Solid dose manufacture and packaging |
| Boehringer Ingelheim RCV GmbH & Co KG | Swedish Orphan Biovitrum AB | FDA expanded indication for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) | Kineret | Large molecule API manufacture |
| BSP Pharmaceuticals SpA | CNS Pharmaceuticals Inc | Trial planned - Phase II to conduct study for glioblastoma multiforme (GBM). | Berubicin hydrochloride | Parenteral manufacture |
| Bushu Pharmaceuticals Ltd | Takeda Pharmaceutical Co Ltd | FDA approval for the treatment of adult patients with advanced prostate cancer | Orgovyx | Solid dose manufacture |
| Cambrex Corp | BioCryst Pharmaceuticals Inc | FDA approval for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older | Orladeyo | Small molecule API manufacture |
| Cambrex Corp | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Solid dose manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API, parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | Trial planned - Phase II to estimate the progression free survival of previously-untreated subjects with extensive stage small cell lung cancer | Imfinzi | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API, parenteral manufacture and packaging |
| Catalent Inc | BioCryst Pharmaceuticals Inc | FDA approval for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older | Orladeyo | Solid dose manufacture and packaging |
| Catalent Inc | Moderna Inc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | COVID-19 Vaccine* | Parenteral manufacture |
| Catalent Inc | AstraZeneca Plc | Trial planned - Phase I/II to determine maximum tolerated dose (MTD) of CKD-516 in combination with the drug and evaluate the safety and tolerability profile, efficacy of the combination treatment in patient with refractory solid tumors | Imfinzi | Parenteral manufacture and packaging |
| CMAB Biopharma Inc | Kintor Pharmaceutical Ltd | Positive Phase I/II results for trial in patients with Metastatic Hepatocellular Carcinoma (HCC) | Ascrinvacumab | Large molecule API manufacture |
| Cobra Biologics Ltd | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| Cobra Biologics Ltd | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| CordenPharma International | Rhythm Pharmaceuticals Inc | Positive Phase III results for trial in Bardet-Biedl and Alstrom Syndromes | Imcivree | Parenteral manufacture |
| CoreRx Inc | Aimmune Therapeutics Inc | EMA approval for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy | Palforzia | Solid dose manufacture |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Parenteral manufacture |
| Daiichi Sankyo Biotech Co Ltd | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Parenteral manufacture |
| Delpharm SAS | BioNTech SE | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older | Comirnaty* | Parenteral manufacture |
| Emergent BioSolutions Inc | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| Emergent BioSolutions Inc | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Esteve Pharmaceuticals SA | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 6 years and older | Symdeko | Small molecule API, solid dose manufacture and packaging |
| Esteve Pharmaceuticals SA | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Small molecule API manufacture |
| Excella GmbH & Co KG | Takeda Pharmaceutical Co Ltd | FDA approval for the treatment of adult patients with advanced prostate cancer | Orgovyx | Small molecule API manufacture |
| Fabbrica Italiana Sintetici SpA | Vertex Pharmaceuticals Inc | FDA expanded indication in the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data | Trikafta | Small molecule API manufacture |
| Halix BV | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| Halix BV | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indication in the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data | Trikafta | Solid dose manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 6 years and older | Symdeko | Small molecule API, solid dose manufacture and packaging |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Small molecule API manufacture |
| IDT Biologika GmbH | Merz Pharma GmbH & Co KgaA | FDA expanded indication for the treatment of chronic sialorrhea in pediatric patients 2 to 17 years of age | Xeomin | Parenteral manufacture and packaging |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| JCR Pharmaceuticals Co Ltd | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | COVID-19 Vaccine* | Parenteral manufacture and packaging |
| Lonza Group Ltd | Genmab AS | Trial planned - Phase III to assess the efficacy compared to chemotherapy in subjects with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy | Tisotumab vedotin | Large molecule API manufacture |
| Lonza Group Ltd | AstraZeneca Plc | FDA expanded indication as an adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations | Tagrisso | Small molecule API manufacture |
| Lonza Group Ltd | Karyopharm Therapeutics Inc | FDA expanded indication for the combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Xpovio | Small molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | COVID-19 Vaccine* | Large molecule API manufacture |
| Lonza Group Ltd | Kuur Therapeutics Ltd | Positive Phase III results for trial in patients with diabetic macular edema | Beovu | Large molecule API manufacture |
| Lonza Group Ltd | Gilead Sciences Inc | Positive Phase II results for trial in patients with High-Risk Large B-cell Lymphoma | Yescarta | Parenteral manufacture |
| MilliporeSigma | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| MilliporeSigma | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Neuland Laboratories Ltd | Rhythm Pharmaceuticals Inc | Positive Phase III results for trial in Bardet-Biedl and Alstrom Syndromes | Imcivree | Large molecule API manufacture |
| Niels Clauson- Kaas AS | CNS Pharmaceuticals Inc | Trial planned - Phase II to conduct study for glioblastoma multiforme (GBM). | Berubicin hydrochloride | Small molecule API manufacture |
| Novasep Holding SAS | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| Novasep Holding SAS | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| Oxford BioMedica Plc | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| Patheon NV | Sanofi | NICE approval with plasma exchange and immunosuppression is recommended, within its marketing authorisation, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults, and in young people aged 12 years and over who weigh at least 40 k | Cablivi | Parenteral manufacture and packaging |
| Patheon NV | Eisai Co Ltd | Trial planned - Phase I/II to evaluate the safety and efficacy of pembrolizumab, MK-1308 in programmed cell-death 1 (PD-1) naïve or PD-1 exposed subjects with melanoma brain metastasis (MBM) and to identify the pembrolizumab, MK-1308, when used in combination, are superior to the current treatment options/historical control available | Lenvima | Solid dose manufacture and packaging |
| Patheon NV | Swedish Orphan Biovitrum AB | FDA expanded indication for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) | Kineret | Parenteral manufacture |
| Patheon NV | BioCryst Pharmaceuticals Inc | FDA approval for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older | Orladeyo | Solid dose manufacture |
| Patheon NV | Eisai Co Ltd | Positive Phase III results in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy | Lenvima | Solid dose manufacture |
| Patheon NV | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Solid dose manufacture |
| Patheon NV | Takeda Pharmaceutical Co Ltd | FDA expanded indication for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors | Iclusig | Solid dose manufacture and packaging |
| PCI Pharma Services | BioCryst Pharmaceuticals Inc | FDA approval for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older | Orladeyo | Solid dose packaging |
| PCI Pharma Services | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Solid dose packaging |
| PCI Pharma Services | Aimmune Therapeutics Inc | EMA approval for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy | Palforzia | Solid dose packaging |
| Pfizer Inc | Swedish Orphan Biovitrum AB | FDA expanded indication for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) | Kineret | Large molecule API manufacture |
| Pfizer Inc | GlaxoSmithKline Plc | FDA expanded indication for the treatment of adult patients with active lupus nephritis who are receiving standard therapy | Benlysta | Parenteral manufacture and packaging |
| Pharma Packaging Solutions | Karyopharm Therapeutics Inc | FDA expanded indication for the combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Xpovio | Solid dose packaging |
| Pharmaceutics International Inc | CNS Pharmaceuticals Inc | Trial planned - Phase II to conduct study for glioblastoma multiforme (GBM). | Berubicin hydrochloride | Parenteral manufacture |
| Pharmasyntez | Gamaleya Federal Research Center of Epidemiology and Microbiology | Trial planned - Phase II to assess the safety and tolerability of one IM dose of AZD1222 followed by one IM dose of component of vaccine in adults ≥ 18 years of age | Sputnik V | Parenteral manufacture |
| Pharmstandard | Eisai Co Ltd | Trial planned - Phase I/II to evaluate the safety and efficacy of pembrolizumab, MK-1308 in programmed cell-death 1 (PD-1) naïve or PD-1 exposed subjects with melanoma brain metastasis (MBM) and to identify the pembrolizumab, MK-1308, when used in combination, are superior to the current treatment options/historical control available | Lenvima | Solid dose manufacture |
| Pharmstandard | Eisai Co Ltd | Positive Phase III results in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy | Lenvima | Solid dose manufacture and packaging |
| Piramal Pharma Solutions Inc | Takeda Pharmaceutical Co Ltd | FDA expanded indication for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors | Iclusig | Small molecule API manufacture |
| Polymun Scientific Immunbiologische Forschung GmbH | BioNTech SE | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older | Comirnaty* | Parenteral manufacture |
| PolyPeptide Group | Rhythm Pharmaceuticals Inc | Positive Phase III results for trial in Bardet-Biedl and Alstrom Syndromes | Imcivree | Large molecule API manufacture |
| Rechon Life Science AB | Swedish Orphan Biovitrum AB | FDA expanded indication for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) | Kineret | Parenteral packaging |
| Recipharm AB | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Solid dose manufacture and packaging |
| Recipharm AB | Moderna Inc | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | COVID-19 Vaccine* | Parenteral manufacture |
| Recipharm AB | Rhythm Pharmaceuticals Inc | Positive Phase III results for trial in Bardet-Biedl and Alstrom Syndromes | Imcivree | Parenteral manufacture |
| Rentschler Biopharma SE | BioNTech SE | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older | Comirnaty* | Large molecule API manufacture |
| Richter-Helm BioLogics GmbH & Co KG | Sanofi | NICE approval with plasma exchange and immunosuppression is recommended, within its marketing authorisation, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults, and in young people aged 12 years and over who weigh at least 40 k | Cablivi | Large molecule API manufacture |
| Sharp Packaging Services | Sanofi | NICE approval with plasma exchange and immunosuppression is recommended, within its marketing authorisation, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults, and in young people aged 12 years and over who weigh at least 40 k | Cablivi | Parenteral packaging |
| Sharp Packaging Services | Takeda Pharmaceutical Co Ltd | FDA expanded indication for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors | Iclusig | Solid dose packaging |
| Siegfried Holding AG | BioNTech SE | EMA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older | Comirnaty* | Parenteral manufacture and packaging |
| SK Bioscience | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Large molecule API manufacture |
| SK Bioscience | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Large molecule API manufacture |
| STA Pharmaceutical Co Ltd | GlaxoSmithKline Plc | Trial planned - Phase II to assess induction and maintenance treatment with PARP inhibitor (niraparib) and immunotherapy (dostarlimab) in HPV-negative head and neck squamous cell carcinoma (HNSCC) | Zejula | Small molecule API manufacture |
| STA Pharmaceutical Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication in the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data | Trikafta | Small molecule API manufacture |
| STA Pharmaceutical Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 6 years and older | Symdeko | Small molecule API manufacture |
| STA Pharmaceutical Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Small molecule API manufacture |
| Symbiosis Pharmaceutical Services Ltd | AstraZeneca Plc | Trial planned - Phase II to assess the safety and tolerability of one IM dose of vaccine followed by one IM dose of rAd26-S, component of vaccine in adults ≥ 18 years of age | AZD-1222* | Parenteral manufacture |
| Symbiosis Pharmaceutical Services Ltd | AstraZeneca Plc | MHRA conditional approval for supply of Vaccine for the active immunization of individuals 18 years or older | AZD-1222* | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | Trial planned - Phase II to estimate the progression free survival of previously-untreated subjects with extensive stage small cell lung cancer | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | Trial planned - Phase I/II to determine maximum tolerated dose (MTD) of CKD-516 in combination with the drug and evaluate the safety and tolerability profile, efficacy of the combination treatment in patient with refractory solid tumors | Imfinzi | Parenteral manufacture |
| WuXi AppTec Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indication for the treatment of additional responsive mutations in people with Cystic Fibrosis aged 4 months and older | Kalydeco | Small molecule API manufacture |
POTENTIALLY NEGATIVE |
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| Catalent Inc | Sandoz International GmbH | Withdrawal/Discontinuation at the marketing authorization holder request | Halimatoz | Large molecule API manufacture |
| CordenPharma International | Novartis AG | Approval delayed after the complete response letter from FDA due to unresolved facility inspection-related conditions | Leqvio | Parenteral manufacture |
| Patheon NV | AbbVie Inc | Withdrawal/Discontinuation at the marketing authorization holder request | Truberzi | Small molecule API, solid dose manufacture and packaging |
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