September 2022 – 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 |
||||
| AbbVie Inc | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Small mol API & solid dose |
| AGC Biologics Inc | MacroGenics Inc | Trial planned - Phase I to determine if the study drug, is safe and tolerable when given to subjects with acute myeloid leukemia (AML) that has relapsed after transplant | Flotetuzumab | Biologic API |
| AGC Biologics Inc | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Biologic API |
| AGC Biologics Inc | Athenex Inc | NICE approval as an option for treating visual impairment due to diabetic macular oedema in adults, only if the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and the company provides drug according to the commercial arrangement |
Beovu | Biologic API |
| Agilent Technologies Inc | IVERIC bio Inc | Positive Phase III top-line results for Geographic Atrophy | Zimura | Biologic API |
| Ajinomoto Bio-Pharma Services | MacroGenics Inc | Trial planned - Phase I to determine if the study drug, is safe and tolerable when given to subjects with acute myeloid leukemia (AML) that has relapsed after transplant | Flotetuzumab | Parenteral manufacture & packaging |
| Ajinomoto Bio-Pharma Services | IVERIC bio Inc | Positive Phase III top-line results for Geographic Atrophy | Zimura | Parenteral manufacture |
| Aldevron LLC | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Biologic API |
| Allergopharma GmbH & Co KG | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Solid dose packaging |
| Asymchem Inc | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Small mol API |
| Baxter Biopharma Solutions | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Parenteral manufacture |
| Baxter Biopharma Solutions | Daiichi Sankyo Co Ltd | FDA expanded indications for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy | Enhertu | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Baxter International Inc | MacroGenics Inc | Trial planned - Phase I to determine if the study drug, is safe and tolerable when given to subjects with acute myeloid leukemia (AML) that has relapsed after transplant | Flotetuzumab | Parenteral manufacture & packaging |
| Biofabri SL | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Biologic API |
| BioReliance Corp | bluebird bio Inc | FDA approval for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions | Zynteglo | Biologic API |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | NICE approval as an option for treating unresectable triple-negative locally advanced or metastatic breast cancer in adults after 2 or more systemic therapies, at least 1 of which was for advanced disease. It is recommended only if the company provides drug according to the commercial arrangement. | Trodelvy | Biologic API |
| BSP Pharmaceuticals SpA | Gilead Sciences Inc | NICE approval as an option for treating unresectable triple-negative locally advanced or metastatic breast cancer in adults after 2 or more systemic therapies, at least 1 of which was for advanced disease. It is recommended only if the company provides drug according to the commercial arrangement. | Trodelvy | Parenteral manufacture |
| Cascade Chemistry | Algernon Pharmaceuticals Inc | Positive Phase II final results for Idiopathic Pulmonary Fibrosis and Chronic Cough | ifenprodil | Small mol API |
| Catalent Inc | Bristol-Myers Squibb Co | NICE approval for the drug plus ipilimumab is recommended as an option for untreated unresectable malignant pleural mesothelioma in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides it according to the commercial arrangement | Opdivo + Yervoy | Parenteral manufacture & packaging |
| Catalent Inc | AstraZeneca Plc | FDA expanded indications for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin | Imfinzi | Parenteral manufacture & packaging |
| Catalent Inc | AbbVie Inc | FDA expanded indications for the treatment of pediatric patients one year to 12 years with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy | Imbruvica | Small mol API & solid dose |
| Catalent Inc | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture |
| Catalent Inc | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Cenexi SAS | Oncopeptides AB | EMA approval for drug indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody | Pepaxti | Parenteral manufacture |
| Corden Pharma International GmbH | Rhythm Pharmaceuticals Inc | EMA expanded indications for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), 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 |
| Delpharm SAS | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Emergent BioSolutions Inc | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Biologic API & parenteral manufacture |
| Esteve Pharmaceuticals SA | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Small mol API |
| EuroAPI | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture |
| Exelead Inc | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Fresenius SE & Co KGaA | FDA approval to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia | Stimufend | Biologic API |
| GSK Plc | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Parenteral manufacture & packaging |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | FDA approval for the treatment of generalized pustular psoriasis flares in adults | Spevigo | Parenteral packaging |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Small mol API |
| Jubilant HollisterStier LLC | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Parenteral manufacture & packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Biologic API, parenteral manufacture & packaging |
| Lek dd | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Bristol-Myers Squibb Co | NICE approval for the drug plus ipilimumab is recommended as an option for untreated unresectable malignant pleural mesothelioma in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides it according to the commercial arrangement | Opdivo + Yervoy | Biologic API |
| Lonza Group Ltd | bluebird bio Inc | FDA approval for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions | Zynteglo | Biologic API |
| Lonza Group Ltd | AbbVie Inc | FDA expanded indications for the treatment of pediatric patients one year to 12 years with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy | Imbruvica | Small mol API |
| Lonza Group Ltd | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Lonza Group Ltd | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Biologic API |
| Lonza Group Ltd | Athenex Inc | NICE approval as an option for treating visual impairment due to diabetic macular oedema in adults, only if the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and the company provides drugs according to the commercial arrangement |
Beovu | Biologic API |
| Mabion SA | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Biologic API |
| Magle Chemoswed AB | Oncopeptides AB | EMA approval for drug indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody | Pepaxti | Biologic API |
| Mibe GmbH Arzneimittel | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Minaris Regenerative Medicine LLC | bluebird bio Inc | FDA approval for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions | Zynteglo | Biologic API, parenteral manufacture & packaging |
| National Resilience Inc | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Biologic API |
| Nortec Quimica SA | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Small mol API |
| Novartis AG | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Novasep Holding SAS | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Small mol API |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | EMA approval for Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Peritoneal Cancer | Vegzelma | Parenteral manufacture |
| Par Sterile Products LLC | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Parenteral manufacture |
| Patheon NV | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Solid dose |
| Patheon NV | bluebird bio Inc | FDA approval for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions | Zynteglo | Biologic API |
| Patheon NV | Sanofi | FDA approval for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients | Xenpozyme | Biologic API |
| Patheon NV | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| Patheon NV | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| PCI Pharma Services | Celltrion Inc | EMA approval for Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Peritoneal Cancer | Vegzelma | Parenteral packaging |
| PCI Pharma Services | Oncopeptides AB | EMA approval for drug indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody | Pepaxti | Parenteral packaging |
| PCI Pharma Services | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Solid dose packaging |
| PCI Pharma Services | AbbVie Inc | FDA expanded indications for the treatment of pediatric patients one year to 12 years with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy | Imbruvica | Solid dose packaging |
| PCI Pharma Services | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Solid dose packaging |
| Pharmaceutical Manufacturing Research Services Inc | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Solid dose |
| Piramal Pharma Solutions Inc | Kyowa Kirin Co Ltd | EMA expanded indications for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) | Crysvita | Parenteral manufacture & packaging |
| Polymun Scientific ImmunbiologischeForschung GmbH | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture |
| PolyPeptide Group AG | Rhythm Pharmaceuticals Inc | EMA expanded indications for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), 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 mol API |
| Recipharm AB | Rhythm Pharmaceuticals Inc | EMA expanded indications for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), 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 & packaging |
| Recipharm AB | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Solid dose |
| Recipharm AB | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Rentschler Biopharma SE | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Biologic API |
| Samsung Biologics Co Ltd | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Gilead Sciences Inc | NICE approval as an option for treating unresectable triple-negative locally advanced or metastatic breast cancer in adults after 2 or more systemic therapies, at least 1 of which was for advanced disease. It is recommended only if the company provides drug according to the commercial arrangement. | Trodelvy | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | NICE approval for the drug plus ipilimumab is recommended as an option for untreated unresectable malignant pleural mesothelioma in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides it according to the commercial arrangement | Opdivo + Yervoy | Biologic API |
| Sanofi | Moderna Inc | FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 18 years of age and older | Spikevax** | Parenteral manufacture & packaging |
| Sharp Packaging Services | Shionogi & Co Ltd | FDA expanded indications for the prevention of post-exposure prophylaxis of influenza in children aged five to less than 12 years of age following contact with someone with influenza | Xofluza | Solid dose packaging |
| Siegfried Holding AG | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Parenteral manufacture & packaging |
| Siegfried Holding AG | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture & packaging |
| SK Bioscience Ltd | Novavax Inc | UK MHRA expanded indications for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 | Nuvaxovid** | Biologic API |
| The Biovac Institute | Pfizer Inc/BioNTech SE | FDA amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for use as a single booster dose in individuals 12 years of age and older | Comirnaty** | Parenteral manufacture |
| Tjoapack BV | Incyte Corp | FDA expanded indications for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement | Pemazyre | Solid dose packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Plc | FDA expanded indications for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin | Imfinzi | Parenteral manufacture |
| Viela Bio Inc | AstraZeneca Plc | FDA expanded indications for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin | Imfinzi | Biologic API |
| West Pharmaceutical Services Inc | Oncopeptides AB | EMA approval for drug indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody | Pepaxti | Parenteral packaging |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | FDA expanded indications to include children with cystic fibrosis (CF) ages 12 to less than 24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene | Orkambi | Small mol API |
| WuXi STA (Shanghai) Co Ltd | Pfizer Inc | US Army awarded Pfizer a $4.85B contract for the oral COVID-19 treatment. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023 | Paxlovid** | Small mol 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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