February 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 | EMA approval for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 | Paxlovid** | Small mol API & solid dose |
| AGC Biologics Inc | Novartis AG | Positive phase II/III topline results to evaluate the safety and efficacy in the treatment of COVID-19 Patients | Ensovibep** | Biologic API |
| AGC Biologics Inc | Immunocore Holdings Plc | FDA approval for the treatment of unresectable or metastatic uveal melanoma. | Kimmtrak | Biologic API |
| Ajinomoto Bio-Pharma Services | H. Lundbeck AS | EMA approval for the prophylaxis of migraine in adults who have at least 4 migraine days per month | Vyepti | Biologic API & dose |
| Aldevron LLC | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Biologic API |
| AstraZeneca Plc | Merck & Co Inc | NICE approval with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer; adjuvant treatment of completely resected stage 3 melanoma | Keytruda | Biologic API |
| AstraZeneca Plc | Merck & Co Inc | EMA expanded indication for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions | Keytruda | Biologic API |
| Baxter Biopharma Solutions | Johnson & Johnson | NICE approval in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable | Darzalex | Parenteral manufacture |
| Baxter Biopharma Solutions | Immunocore Holdings Plc | FDA approval for the treatment of unresectable or metastatic uveal melanoma. | Kimmtrak | Parenteral manufacture & packaging |
| Baxter Biopharma Solutions | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Baxter Biopharma Solutions | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Parenteral manufacture |
| Baxter International Inc | Takeda Pharmaceutical Co Ltd | FDA expanded indications for routine prophylaxis to reduce the frequency of bleeding episodes in adults diagnosed with severe Type 3 von Willebrand Disease receiving on demand therapy. | Vonvendi | Biologic API & parenteral manufacture |
| Biofabri SL | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Biologic API |
| Biogen Inc | Johnson & Johnson | NICE approval in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable | Darzalex | Biologic API |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | NICE approval with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer; adjuvant treatment of completely resected stage 3 melanoma | Keytruda | Biologic API |
| Boehringer Ingelheim Biopharmaceuticals GmbH | AbbVie Inc | FDA expanded indications for the treatment of active psoriatic arthritis in adults. | Skyrizi | Biologic API |
| Boehringer Ingelheim Biopharmaceuticals GmbH | Merck & Co Inc | EMA expanded indication for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions | Keytruda | Biologic API |
| Bristol-Myers Squibb Co | AstraZeneca Plc | FDA expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction | Xigduo XR | Solid dose |
| Cambrex Corp | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Small mol API |
| Catalent Inc | Lupin Ltd | FDA expanded indications for the treatment of bacterial vaginosis and trichomoniasis in patients 12 years of age and older. | Solosec | Solid dose & packaging |
| Catalent Inc | AstraZeneca Plc | FDA expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction | Xigduo XR | Solid dose packaging |
| Catalent Inc | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Celltrion Inc | Teva Pharmaceutical Industries Ltd | NICE approval for preventing migraine in adults | Ajovy | Biologic API |
| Centre for Probe Development and Commercialization | POINT Biopharma Global Inc | Trial planned - Phase II for local radiorecurrent prostate cancer | PNT-2002 | Parenteral manufacture |
| Corden Pharma International GmbH | Lupin Ltd | FDA expanded indications for the treatment of bacterial vaginosis and trichomoniasis in patients 12 years of age and older. | Solosec | Small mol API |
| CoreRx Inc | Aimmune Therapeutics Inc | NICE approval for treating peanut allergy in children aged 4 to 17. | Palforzia | Solid dose |
| Dalton Pharma Services | University of Saskatchewan | Trial planned - Phase I/II to access the safety and immunogenicity of two dosing levels (10 and 25 µg S1 protein tested in parallel) administered once in healthy adults ≥18 of age who have received 2 doses at least 6 months earlier. | COVID-19 Vaccine** | Parenteral manufacture and packaging |
| Dalton Pharma Services | Oncovir Inc | Trial planned - Phase I for cutaneous melanoma stage 2 and 3 | Hiltonol | Biologic API, parenteral manufacture and packaging |
| Divi's Laboratories Ltd | Merck & Co Inc | FDA expanded indication as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure | Delstrigo | Small mol API |
| Divi's Laboratories Ltd | Merck & Co Inc | FDA expanded indication in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine | Pifeltro | Small mol API |
| Emergent BioSolutions Inc | Serb SAS | EMA approval for reducing toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity | Voraxaze | Biologic dose & packaging |
| Emergent BioSolutions Inc | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Biologic API & parenteral manufacture |
| Esteve Huayi Pharmaceutical Co Ltd | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Small mol API |
| Fareva SA | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture |
| Flamma SpA | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Small mol API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Ascendis Pharma AS | EMA approval for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD) | Lonapegsomatropin | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Biologic API |
| GlaxoSmithKline Plc | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Parenteral manufacture & packaging |
| Hikma Pharmaceuticals Plc | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture |
| Hovione FarmaCiencia SA | Merck & Co Inc | FDA expanded indication as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure | Delstrigo | Solid dose |
| Hovione FarmaCiencia SA | Merck & Co Inc | FDA expanded indication in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine | Pifeltro | Solid dose |
| Isotopia Molecular Imaging Ltd | POINT Biopharma Global Inc | Trial planned - Phase II for local radiorecurrent prostate cancer | PNT-2002 | Biologic API |
| ITM Isotopen Technologien Munchen AG | POINT Biopharma Global Inc | Trial planned - Phase II for local radiorecurrent prostate cancer | PNT-2002 | Biologic API |
| Jubilant HollisterStier LLC | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Parenteral manufacture & packaging |
| Jubilant HollisterStier LLC | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture & packaging |
| Kaneka Eurogentec SA | Serb SAS | EMA approval for reducing toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity | Voraxaze | Biologic API |
| Konapharma AG | Johnson & Johnson | NICE approval for treating relapsing–remitting multiple sclerosis | Ponvory | Solid dose packaging |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Biologic API, parenteral manufacture and packaging |
| Laurus Labs Ltd | Merck & Co Inc | FDA expanded indication as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure | Delstrigo | Small mol API |
| Lonza Group Ltd | AstraZeneca Plc | NICE approval for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection | Tagrisso | Small mol API |
| Lonza Group Ltd | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Biologic API |
| Lonza Group Ltd | Ascendis Pharma AS | EMA approval for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD) | Lonapegsomatropin | Biologic API |
| Mabion SA | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Biologic API |
| Merck KGaA | AstraZeneca Plc | FDA expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction | Xigduo XR | Small mol API |
| National Resilience Inc | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Biologic API |
| Novasep Holding SAS | Pfizer Inc | EMA approval for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 | Paxlovid** | Small mol API |
| Organon & Co | Merck & Co Inc | NICE approval with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer; adjuvant treatment of completely resected stage 3 melanoma | Keytruda | Parenteral packaging |
| Organon & Co | Merck & Co Inc | EMA expanded indication for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions | Keytruda | Parenteral packaging |
| Par Sterile Products LLC | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Parenteral manufacture |
| Patheon NV | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Patheon NV | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture & packaging |
| Patheon NV | Johnson & Johnson | NICE approval for treating relapsing–remitting multiple sclerosis | Ponvory | Small mol API, solid dose & packaging |
| PCI Pharma Services | Pfizer Inc | EMA approval for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 | Paxlovid** | Solid dose packaging |
| PCI Pharma Services | Aimmune Therapeutics Inc | NICE approval for treating peanut allergy in children aged 4 to 17. | Palforzia | Solid dose packaging |
| PCI Pharma Services | Johnson & Johnson | NICE approval in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable | Darzalex | Parenteral packaging |
| PCI Pharma Services | Taiho Pharmaceutical Co Ltd | FDA expanded indication in adults as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting | Teysuno | Solid dose |
| PCI Pharma Services | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral packaging |
| Pfizer Inc | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture |
| Pharmaceutical Manufacturing Research Services Inc | Cingulate Therapeutics LLC | Trial planned - Phase III for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). | Dexmethylphenidate hydrochloride | Solid dose |
| QPharma AB | Taiho Pharmaceutical Co Ltd | FDA expanded indication in adults as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting | Teysuno | Solid dose & packaging |
| Recipharm AB | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Samsung Biologics Co Ltd | Checkpoint Therapeutics Inc | Positive phase III topline results to evaluate the safety and efficacy of its anti-PD-L1 antibody in patients with metastatic cutaneous squamous cell carcinoma | Cosibelimab | Biologic API |
| Samsung Biologics Co Ltd | Johnson & Johnson | NICE approval in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable | Darzalex | Biologic API |
| Samsung Biologics Co Ltd | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Sandoz International GmbH | H. Lundbeck AS | EMA approval for the prophylaxis of migraine in adults who have at least 4 migraine days per month | Vyepti | Biologic API |
| Sanofi | Moderna Inc | FDA expanded indication for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | Spikevax** | Parenteral manufacture and packaging |
| Siegfried Holding AG | Takeda Pharmaceutical Co Ltd | FDA expanded indications for routine prophylaxis to reduce the frequency of bleeding episodes in adults diagnosed with severe Type 3 von Willebrand Disease receiving on-demand therapy. | Vonvendi | Parenteral manufacture |
| Siegfried Holding AG | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Parenteral manufacture & packaging |
| SK Bioscience Ltd | Novavax Inc | UK MHRA approval for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Nuvaxovid** | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Johnson & Johnson | NICE approval in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable | Darzalex | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Ascendis Pharma AS | EMA approval for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD) | Lonapegsomatropin | Parenteral manufacture and packaging |
| Xellia Pharmaceuticals ApS | Gilead Sciences Inc | FDA expanded indication FDA expanded indication for the treatment of COVID-19 for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg | Veklury** | Parenteral manufacture |
POTENTIALLY NEGATIVE |
||||
| AbbVie Inc | AstraZeneca Plc | NICE rejection for treating BRCA mutation-positive HER2-negative metastatic breast cancer after chemotherapy | Lynparza | Solid dose & packaging |
| Amgen Inc | Eli Lilly and Co | FDA limits the use of drug in combination with etesevimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Bamlanivimab** | Biologic API |
| Amgen Inc | Shanghai Junshi Bioscience Co Ltd | FDA limits the use of drug in combination with bamlanivimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Etesevimab** | Biologic API |
| Baxter Biopharma Solutions | Johnson & Johnson | NICE rejection with bortezomib, melphalan and prednisone for untreated multiple myeloma | Darzalex | Parenteral manufacture |
| Biogen Inc | Johnson & Johnson | NICE rejection with bortezomib, melphalan and prednisone for untreated multiple myeloma | Darzalex | Biologic API |
| Catalent Inc | Regeneron Pharmaceuticals Inc | FDA limits the use of drug to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Ronapreve** | Parenteral manufacture & packaging |
| DPT Laboratories Ltd | Pfizer Inc | EMA Withdrawal/Discontinuation of the marketing authorisation for the product at the marketing holder's request | Staquis | Semi-solid non-sterile manufacture |
| Emergent BioSolutions Inc | Regeneron Pharmaceuticals Inc | FDA limits the use of drug to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Ronapreve** | Parenteral packaging |
| FUJIFILM Diosynth Biotechnologies USA Inc | Eli Lilly and Co | FDA limits the use of drug in combination with etesevimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Bamlanivimab** | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Shanghai Junshi Bioscience Co Ltd | FDA limits the use of drug in combination with bamlanivimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Etesevimab** | Biologic API |
| Jetpharma SA | AstraZeneca Plc | NICE rejection for treating BRCA mutation-positive HER2-negative metastatic breast cancer after chemotherapy | Lynparza | Small mol API |
| Jubilant HollisterStier LLC | Eli Lilly and Co | FDA limits the use of drug in combination with etesevimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Bamlanivimab** | Parenteral manufacture |
| Lonza Group Ltd | AstraZeneca Plc | NICE rejection for treating BRCA mutation-positive HER2-negative metastatic breast cancer after chemotherapy | Lynparza | Small mol API |
| Lonza Group Ltd | Shanghai Junshi Bioscience Co Ltd | FDA limits the use of drug in combination with bamlanivimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Etesevimab** | Biologic API |
| Patheon NV | AstraZeneca Plc | NICE rejection for treating BRCA mutation-positive HER2-negative metastatic breast cancer after chemotherapy | Lynparza | Solid dose & packaging |
| PCI Pharma Services | Johnson & Johnson | NICE rejection with bortezomib, melphalan and prednisone for untreated multiple myeloma | Darzalex | Parenteral packaging |
| Samsung Biologics Co Ltd | Johnson & Johnson | NICE rejection with bortezomib, melphalan and prednisone for untreated multiple myeloma | Darzalex | Biologic API |
| Samsung Biologics Co Ltd | Eli Lilly and Co | FDA limits the use of drug in combination with etesevimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Bamlanivimab** | Biologic API |
| Samsung Biologics Co Ltd | Shanghai Junshi Bioscience Co Ltd | FDA limits the use of drug in combination with bamlanivimab to treat COVID-19 to only when the patient is likely to have been infected with or exposed to Omicron variant that is susceptible to these treatments | Etesevimab** | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Johnson & Johnson | NICE rejection with bortezomib, melphalan and prednisone for untreated multiple myeloma | Darzalex | Parenteral 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