August 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 |
||||
| Agno Pharmaceuticals LLC | Inhibikase Therapeutics Inc | Trial planned - Phase I for the treatment of Parkinson’s disease | IkT-148009 | Small molecule API manufacture |
| Ajinomoto Bio-Pharma Services | Incyte Corp | Trial planned - Phase I for the treatment of subjects with specific advanced solid tumors | Retifanlimab | Parenteral manufacture and packaging |
| Aldevron LLC | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Large molecule API manufacture |
| Aldevron LLC | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Large molecule API manufacture |
| Allergopharma GmbH & Co KG | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture and packaging |
| Allpack Group AG | Nippon Shinyaku Co Ltd | FDA expanded indications for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy | Uptravi | Solid dose packaging |
| Almac Group Ltd | AbbVie Inc | FDA expanded indications for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms in pediatric patients from birth to less than 18 years of age | Dalvance | Parenteral packaging |
| Almac Group Ltd | Nippon Shinyaku Co Ltd | FDA expanded indications for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy | Uptravi | Small molecule API manufacture |
| Almac Group Ltd | Amicus Therapeutics Inc | EMA expanded indications for use in adolescents aged 12 to <16 years weighing ≥ 45 kg with a confirmed diagnosis of Fabry disease and who have an amenable mutation | Galafold | Solid dose manufacture and packaging |
| Almac Group Ltd | Palisade Bio Inc | Positive Phase II results in accelerating the return of bowel function in patients undergoing elective bowel resection surgery | Tranexamic acid | Small molecule API manufacture |
| Almac Group Ltd | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral packaging |
| AstraZeneca Plc | Merck & Co Inc | Trial planned - Phase II for multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer (BTC) | Keytruda | Large molecule API manufacture |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indication for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery | Keytruda | Large molecule API manufacture |
| Asymchem Inc | BeyondSpring Inc | Positive Phase III results for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) with EGFR wild type | Plinabulin | Small molecule API manufacture |
| Baxter Biopharma Solutions | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| Baxter International Inc | Incyte Corp | Trial planned - Phase I for the treatment of subjects with specific advanced solid tumors | Retifanlimab | Parenteral manufacture and packaging |
| Biogen Inc | Johnson & Johnson | FDA expanded indications for the treatment of adult patients with multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor | Darzalex Faspro | Large molecule API manufacture |
| BioReliance Corp | bluebird bio Inc | EMA expanded indications for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell | Skysona | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Large molecule API manufacture and parenteral manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | Trial planned - Phase II for multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer (BTC) | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | FDA expanded indication for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery | Keytruda | Large molecule API manufacture |
| Boehringer Ingelheim International GmbH | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Parenteral packaging |
| Bristol Myers Squibb Co | AstraZeneca Plc | EMA expanded indications for the treatment of chronic kidney disease | Forxiga | Solid dose manufacture |
| Carbogen Amcis AG | Amicus Therapeutics Inc | EMA expanded indications for use in adolescents aged 12 to <16 years weighing ≥ 45 kg with a confirmed diagnosis of Fabry disease and who have an amenable mutation | Galafold | Small molecule API manufacture |
| Catalent Inc | Bristol Myers Squibb Co | NICE approval for treating metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency after fluoropyrimidine-based combination chemotherapy | Opdivo + Yervoy | Parenteral manufacture and packaging |
| Catalent Inc | Pfizer Inc | NICE approval for treating hormone-sensitive metastatic prostate cancer in adults | Xtandi | Solid dose manufacture |
| Catalent Inc | Ono Pharmaceutical Co Ltd | NICE approval for treating locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | Trial planned - Phase III for perioperative treatment in subjects ineligible for cisplatin undergoing radical cystectomy for muscle invasive bladder cancer | Imfinzi | Parenteral manufacture and packaging |
| Catalent Inc | Novavax Inc | Trial planned - Phase I/II for the safety and immunogenicity of influenza and COVID-19 combination vaccine | NanoFlu** | Large molecule API manufacture |
| Catalent Inc | Biohaven Pharmaceutical Holding Company Ltd | Trial planned - Phase I to assess the safety and efficacy of oral zavegepant in subjects with mild allergic asthma | Zavegepant hydrochloride | Intranasal dose manufacture |
| Catalent Inc | Johnson & Johnson | FDA expanded indications for the treatment of adult patients with multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor | Darzalex Faspro | Large molecule API manufacture |
| Catalent Inc | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture and packaging |
| Catalent Inc | AstraZeneca Plc | EMA expanded indications for the treatment of chronic kidney disease | Forxiga | Solid dose manufacture and packaging |
| Catalent Inc | Ono Pharmaceutical Co Ltd | EMA expanded indications for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT) | Opdivo | Parenteral manufacture and packaging |
| Catalent Inc | BeiGene Ltd | Positive Phase III results for patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma | Brukinsa | Solid dose manufacture |
| Catalent Inc | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture and packaging |
| Charles River Laboratories International Inc | Johnson & Johnson | FDA expanded indications for the treatment of adult patients with multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor | Darzalex Faspro | Large molecule API manufacture |
| Comprehensive Cell Solutions | ExCellThera Inc | Trial planned - Phase I/II for pediatric and young adult patients with high-risk myeloid malignancies | ECT-001 | Large molecule API manufacture |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | EMA approval for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above | Imcivree | Parenteral manufacture |
| Curia Inc | Pfizer Inc | NICE approval for treating hormone-sensitive metastatic prostate cancer in adults | Xtandi | Small molecule API manufacture |
| Curia Inc | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Parenteral manufacture and packaging |
| Delpharm SAS | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| EMD Serono Inc | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Large molecule API manufacture |
| Emergent BioSolutions Inc | Novavax Inc | Trial planned - Phase I/II for the safety and immunogenicity of influenza and COVID-19 combination vaccine | NanoFlu** | Large molecule API manufacture |
| Excella GmbH & Co KG | Nippon Shinyaku Co Ltd | FDA expanded indications for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy | Uptravi | Solid dose manufacture |
| Excella GmbH & Co KG | Myovant Sciences Ltd | EMA approval for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age | Ryeqo | Small molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Johnson & Johnson | FDA expanded indications for the treatment of adult patients with multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor | Darzalex Faspro | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Outlook Therapeutics Inc | Positive Phase III results for neovascular age-related macular degeneration | Lytenava | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Alexion Pharmaceuticals Inc | Positive Phase III results for generalized myasthenia gravis | Ultomiris | Large molecule API manufacture |
| Gnosis by Lesaffre | AbbVie Inc | FDA expanded indications for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms in pediatric patients from birth to less than 18 years of age | Dalvance | Small molecule API manufacture |
| Hanmi Pharmaceuticals Co Ltd | Advenchen Laboratories LLC | Trial planned - Phase I/II for the treatment of advanced osteosarcoma, ewing's sarcoma, chordoma and chondrosarcoma | Aitan | Small molecule API manufacture |
| Johnson Matthey Plc | BeyondSpring Inc | Positive Phase III results for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) with EGFR wild type | Plinabulin | Small molecule API manufacture |
| Jubilant HollisterStier LLC | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Large molecule API, parenteral manufacture and packaging |
| Lonza Group Ltd | Bristol Myers Squibb Co | NICE approval for treating metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency after fluoropyrimidine-based combination chemotherapy | Opdivo + Yervoy | Large molecule API manufacture |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | NICE approval for treating locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Gilead Sciences Inc | Trial planned - Phase II for metastatic triple-negative breast cancer (mTNBC) | Magrolimab | Large molecule API manufacture |
| Lonza Group Ltd | Alzamend Neuro Inc | Trial planned - Phase I for subjects with dementia related to mild, moderate and severe cognitive impairment associated with Alzheimer’s disease | LiProSal | Small molecule API manufacture |
| Lonza Group Ltd | AstraZeneca Plc | FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years to 17 years with type 2 diabetes mellitus | Bydureon | Small molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Large molecule API manufacture |
| Lonza Group Ltd | bluebird bio Inc | EMA expanded indications for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell | Skysona | Large molecule API manufacture |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indications for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT) | Opdivo | Large molecule API manufacture |
| Lonza Group Ltd | Galectin Therapeutics Inc | Positive Phase I results for advanced metastatic melanoma and head and neck cancer | Belapectin | Small molecule API manufacture |
| Lonza Group Ltd | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Large molecule API manufacture |
| Mallinckrodt Plc | AstraZeneca Plc | FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years to 17 years with type 2 diabetes mellitus | Bydureon | Small molecule API manufacture |
| Merck KGaA | Eli Lilly and Co | Trial planned - Phase II for metastatic colorectal cancer (mCRC) with BRAF V600E mutation after first-line treatment | Erbitux | Large molecule API manufacture, parenteral manufacture and packaging |
| Mibe GmbH Arzneimittel | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| Minaris Regenerative Medicine LLC | bluebird bio Inc | EMA expanded indications for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell | Skysona | Large molecule API, parenteral manufacture and packaging |
| Nikon CeLL innovation Co Ltd | Athersys Inc | Positive Phase II results for acute respiratory distress syndrome | Multistem | Large molecule API manufacture |
| Novartis AG | Chugai Pharmaceutical Co Ltd | Trial planned - Phase II for circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment | Actemra | Large molecule API manufacture |
| Novartis AG | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture and packaging |
| Organon & Co | Merck & Co Inc | Trial planned - Phase II for multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer (BTC) | Keytruda | Parenteral packaging |
| Organon & Co | Merck & Co Inc | FDA expanded indication for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery | Keytruda | Parenteral packaging |
| Patheon NV | Eisai Co Ltd | Trial planned - Phase II for multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer (BTC) | Lenvima | Solid dose manufacture and packaging |
| Patheon NV | SpringWorks Therapeutics Inc | Trial planned - Phase I/II for combination therapy in postmenopausal subjects with ER+ mBC harboring NF1 loss of function or other alterations of the MAPK pathway and as a monotherapy in adult subjects with advanced solid cancers driven by the alterations of the MAPK pathway, including MEK1 or MEK2 mutations | Mirdametinib | Small molecule API manufacture and solid dose manufacture |
| Patheon NV | Myovant Sciences Ltd | EMA approval for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age | Ryeqo | Solid dose manufacture |
| Patheon NV | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture and packaging |
| Patheon NV | Alexion Pharmaceuticals Inc | Positive Phase III results for generalized myasthenia gravis | Ultomiris | Large molecule API manufacture |
| Patheon NV | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture and packaging |
| PCI Pharma Services | Pfizer Inc | NICE approval for treating hormone-sensitive metastatic prostate cancer in adults | Xtandi | Solid dose packaging |
| PCI Pharma Services | Myovant Sciences Ltd | EMA approval for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age | Ryeqo | Solid dose packaging |
| PepTech Corp | Inhibikase Therapeutics Inc | Trial planned - Phase I for the treatment of Parkinson’s disease | IkT-148009 | Small molecule API manufacture |
| Pfizer Inc | AbbVie Inc | FDA expanded indications for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms in pediatric patients from birth to less than 18 years of age | Dalvance | Parenteral manufacture and packaging |
| Pharmaceutics International Inc | BeyondSpring Inc | Positive Phase III results for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) with EGFR wild type | Plinabulin | Parenteral manufacture |
| Pharmstandard | Eisai Co Ltd | Trial planned - Phase II for multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer (BTC) | Lenvima | Solid dose manufacture |
| Polymun Scientific ImmunbiologischeForschung GmbH | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| PolyPeptide Group AG | AstraZeneca Plc | FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years to 17 years with type 2 diabetes mellitus | Bydureon | Small molecule API manufacture |
| PolyPeptide Group AG | Rhythm Pharmaceuticals Inc | EMA approval for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above | Imcivree | Small molecule API manufacture |
| Recipharm AB | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture |
| Recipharm AB | Rhythm Pharmaceuticals Inc | EMA approval for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above | Imcivree | Parenteral manufacture and packaging |
| Recipharm AB | Opiant Pharmaceuticals Inc | Positive Phase I results for opioid overdose | Nalmefene | Intranasal dose manufacture |
| Recipharm AB | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture |
| Rentschler Biopharma SE | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Bristol Myers Squibb Co | NICE approval for treating metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency after fluoropyrimidine-based combination chemotherapy | Opdivo + Yervoy | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | NICE approval for treating locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture and packaging |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | EMA expanded indications for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT) | Opdivo | Large molecule API manufacture |
| Samsung Biologics Co Ltd | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture and packaging |
| Sanofi | Moderna Inc | EMA expanded indications for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 to 17 years | Spikevax** | Parenteral manufacture |
| Sanofi | Moderna Inc | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Spikevax** | Parenteral manufacture |
| Sanofi | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| Sharp Packaging Services | AstraZeneca Plc | FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years to 17 years with type 2 diabetes mellitus | Bydureon | Parenteral packaging |
| Siegfried Holding AG | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture and packaging |
| SK Biotek Co Ltd | AstraZeneca Plc | EMA expanded indications for the treatment of chronic kidney disease | Forxiga | Small molecule API manufacture |
| Stason Pharmaceuticals Inc | Advenchen Laboratories LLC | Trial planned - Phase I/II for the treatment of advanced osteosarcoma, ewing's sarcoma, chordoma and chondrosarcoma | Aitan | Solid dose manufacture |
| Summit Biosciences Inc | Opiant Pharmaceuticals Inc | Positive Phase I results for opioid overdose | Nalmefene | Intranasal dose manufacture |
| The Biovac Institute | BioNTech SE | FDA amended the emergency use authorization (EUA) and authorized the vaccine booster dose for immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise | Comirnaty** | Parenteral manufacture |
| University of Iowa Pharmaceuticals | Galectin Therapeutics Inc | Positive Phase I results for advanced metastatic melanoma and head and neck cancer | Belapectin | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | Trial planned - Phase III for perioperative treatment in subjects ineligible for cisplatin undergoing radical cystectomy for muscle invasive bladder cancer | Imfinzi | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Chugai Pharmaceutical Co Ltd | Trial planned - Phase II for circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment | Actemra | Parenteral manufacture and packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | FDA expanded indication as an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years to 17 years with type 2 diabetes mellitus | Bydureon | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Alnylam Pharmaceuticals Inc | Positive Phase III results for advanced primary hyperoxaluria type 1 | Oxlumo | Parenteral manufacture |
| Viela Bio Inc | AstraZeneca Plc | Trial planned - Phase III for perioperative treatment in subjects ineligible for cisplatin undergoing radical cystectomy for muscle invasive bladder cancer | Imfinzi | Large molecule API manufacture |
| WuXi Biologics Cayman Inc | Bayer AG | EMA approval for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy | Verquvo | Solid dose manufacture |
| WuXi STA (Shanghai) Co Ltd | Inhibikase Therapeutics Inc | Trial planned - Phase I for the treatment of Parkinson’s disease | IkT-148009 | Small molecule API manufacture |
POTENTIALLY NEGATIVE |
||||
| AstraZeneca Plc | Bristol Myers Squibb Co | NICE rejection for Philadelphia-chromosome-positive acute lymphoblastic leukaemia in children and adults | Sprycel | Solid dose manufacture and packaging |
| Baxter Biopharma Solutions | Novavax Inc | US government pauses funding | NVX-CoV2373** | Parenteral manufacture |
| Biofabri SL | Novavax Inc | US government pauses funding | NVX-CoV2373** | Large molecule API manufacture |
| Boehringer Ingelheim RCV GmbH & Co KG | AstraZeneca Plc | Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request | Lumoxiti | Large molecule API manufacture |
| Catalent Inc | Secura Bio Inc | NICE rejection for treating relapsed follicular lymphoma after 2 or more systemic therapies in adults | Copiktra | Solid dose manufacture |
| Catalent Inc | Bristol Myers Squibb Co | NICE rejection for Philadelphia-chromosome-positive acute lymphoblastic leukaemia in children and adults | Sprycel | Solid dose packaging |
| Curia Inc | Secura Bio Inc | NICE rejection for treating relapsed follicular lymphoma after 2 or more systemic therapies in adults | Copiktra | Small molecule API and solid dose manufacture |
| Emergent BioSolutions Inc | Novavax Inc | US government pauses funding | NVX-CoV2373** | Large molecule API manufacture |
| Fujifilm Diosynth Biotechnologies USA Inc | Novavax Inc | US government pauses funding | NVX-CoV2373** | Large molecule API manufacture |
| GlaxoSmithKline Plc | Novavax Inc | US government pauses funding | NVX-CoV2373** | Parenteral manufacture and packaging |
| Jubilant HollisterStier LLC | Novavax Inc | US government pauses funding | NVX-CoV2373** | Parenteral manufacture |
| Par Sterile Products LLC | Novavax Inc | US government pauses funding | NVX-CoV2373** | Parenteral manufacture |
| PCI Pharma Services | Secura Bio Inc | NICE rejection for treating relapsed follicular lymphoma after 2 or more systemic therapies in adults | Copiktra | Solid dose packaging |
| Siegfried Holding AG | Bristol Myers Squibb Co | NICE rejection for Philadelphia-chromosome-positive acute lymphoblastic leukaemia in children and adults | Sprycel | Small molecule API manufacture |
| Siegfried Holding AG | Novavax Inc | US government pauses funding | NVX-CoV2373** | Parenteral manufacture |
| SK Bioscience Co Ltd | Novavax Inc | US government pauses funding | NVX-CoV2373** | Large molecule API manufacture |
| SK Biotek Co Ltd | Bristol Myers Squibb Co | NICE rejection for Philadelphia-chromosome-positive acute lymphoblastic leukaemia in children and adults | Sprycel | Small molecule API manufacture |
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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