March 2025 — CDMO Opportunities And Threats Report
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 | AstraZeneca UK Ltd | NICE recommended the drug, within its marketing authorisation, as an option for treating HER2-negative locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had an anthracycline and a taxane as neoadjuvant or adjuvant treatment, or for metastatic disease, unless these are not suitable, and endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable. Drug is only recommended if the company provides it according to the commercial arrangement | Lynparza | Solid dose manufacture |
| AGC Biologics Inc | 4TEEN4 Pharmaceuticals GmbH | Trial planned - Phase I/II to evaluate safety, tolerability and pharmacokinetics of drug in patients with cardiogenic shock and elevated circulating dipeptidyl peptidase 3 (cdpp3) concentrations | Procizumab | Biologic API |
| Ajinomoto Bio-Pharma Services | Servier Laboratories Ltd | UK MHRA expanded indications of the drug in combination with oxaliplatin, 5‑fluorouracil and leucovorin for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas | Onivyde | Parenteral manufacture & packaging |
| Almac Group Ltd | Alexion Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive | Soliris | Parenteral manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults | Keytruda | Biologic API |
| Baccinex SA | OSE Immunotherapeutics SA | Positive Phase II top-line results for the treatment of Pancreatic Cancer | OSE-2101 | Parenteral manufacture |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults | Keytruda | Biologic API |
| BSP Pharmaceuticals SpA | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Biologic API; Parenteral manufacture & packaging |
| Catalent Inc | CSL Ltd | EMA approval of the drug for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Kostaive | Biologic API |
| Catalent Inc | Emalex Biosciences Inc | Positive Phase III top-line results for the treatment of patients with Tourette syndrome | Ecopipam hydrochloride | Solid dose manufacture |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating moderate to severe house dust mite allergic rhinitis in people 12 to 65 years that is diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test or specific immunoglobulin E [IgE]) and persistent despite use of symptom-relieving medicine |
Acarizax | Solid dose manufacture & packaging |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello Inc | FDA expanded indications of the drug to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged five through 11, in addition to patients aged 12 through 65 | Odactra | Solid dose manufacture & packaging |
| Celonic AG | Lindis Biotech GmbH | EMA expanded indications of the drug for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy | Korjuny | Parenteral manufacture & packaging |
| Cenexi SAS | Egetis Therapeutics AB | EMA approval of the drug or the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth | Emcitate | Solid dose manufacture & packaging |
| Charles River Laboratories International Inc | Vertex Pharmaceuticals (Europe) Ltd | NICE recommended the drug with managed access as an option for treating sickle cell disease (SCD) in people 12 years and over who have recurrent vaso-occlusive crises (VOCs) and a βS/βS, βS/β+ or βS/β0 genotype and when haematopoietic stem cell transplant (HSCT) is suitable, but a human leukocyte antigen-matched related haematopoietic stem cell donor is not available. It is only recommended for people who have had at least 2 VOCs (as defined in section 3.4) per year during the 2 previous years and if the conditions in the managed access agreement for exa‑cel are followed | Casgevy | Biologic API |
| Curia Global Inc | Indivior Inc | FDA expanded indications of the drug for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine | Sublocade | Parenteral manufacture |
| Delpharm SAS | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Parenteral manufacture & packaging |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | NICE recommended the drug, within its marketing authorisation, as an option for the adjuvant treatment of stage 1b to 3a non‑small‑cell lung cancer (NSCLC) after complete tumour resection. It is for adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or EGFR exon 21 (L858R) substitution mutations. It is only recommended if drug is stopped at 3 years, or earlier if there is disease recurrence or unacceptable toxicity and the company provides it according to the commercial arrangement | Tagrisso | Small mol API |
| Dottikon Exclusive Synthesis AG | AstraZeneca UK Ltd | NICE recommended the drug, within its marketing authorisation, as an option for treating HER2-negative locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had an anthracycline and a taxane as neoadjuvant or adjuvant treatment, or for metastatic disease, unless these are not suitable, and endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable. Drug is only recommended if the company provides it according to the commercial arrangement | Lynparza | Small mol API |
| Fareva SA | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Parenteral manufacture & packaging |
| Farmhispania SA | Boehringer Ingelheim International GmbH | UK MHRA approval of the drug in adults and children aged ≥10 years for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise in patients insufficiently controlled on their maximally tolerated dose of metformin alone, in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products, and in patients already being treated with the combination of empagliflozin and metformin as separate tablets | Synjardy | Solid dose manufacture & packaging |
| Forge Biologics Inc | Solid Biosciences Inc | Positive Phase I/II Interim results for the treatment of Duchenne muscular dystrophy (Duchenne) | SGT-003 | Biologic API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim Ltd | UK MHRA expanded indications of the drug for the treatment of generalised pustular psoriasis flares in adults and adolescents aged ≥12 years as monotherapy | Spevigo | Parenteral packaging |
| Hubei Haosun Pharmaceutical Co Ltd | Servier Laboratories Ltd | UK MHRA expanded indications of the drug in combination with oxaliplatin, 5‑fluorouracil and leucovorin for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas | Onivyde | Small mol API |
| Kymos Pharma Services SL | Celltrion Healthcare Hungary Kft | EMA approval of the drug for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV) | Eydenzelt | Parenteral manufacture |
| Kymos Pharma Services SL | Celltrion Inc | FDA approval | Osenvelt | Parenteral manufacture |
| Kymos Pharma Services SL | Celltrion Inc | FDA expanded indications of the drug for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment | Omlyclo | Parenteral manufacture |
| Lonza Biologics Inc | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Opdivo | Biologic API |
| Lonza Group Ltd | AstraZeneca UK Ltd | NICE recommended the drug, within its marketing authorisation, as an option for the adjuvant treatment of stage 1b to 3a non‑small‑cell lung cancer (NSCLC) after complete tumour resection. It is for adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or EGFR exon 21 (L858R) substitution mutations. It is only recommended if drug is stopped at 3 years, or earlier if there is disease recurrence or unacceptable toxicity and the company provides it according to the commercial arrangement | Tagrisso | Small mol API |
| Lonza Group Ltd | Vertex Pharmaceuticals (Europe) Ltd | NICE recommended the drug with managed access as an option for treating sickle cell disease (SCD) in people 12 years and over who have recurrent vaso-occlusive crises (VOCs) and a βS/βS, βS/β+ or βS/β0 genotype and when haematopoietic stem cell transplant (HSCT) is suitable, but a human leukocyte antigen-matched related haematopoietic stem cell donor is not available. It is only recommended for people who have had at least 2 VOCs (as defined in section 3.4) per year during the 2 previous years and if the conditions in the managed access agreement for exa‑cel are followed | Casgevy | Biologic API |
| Lonza Group Ltd | AstraZeneca UK Ltd | NICE recommended the drug, within its marketing authorisation, as an option for treating HER2-negative locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had an anthracycline and a taxane as neoadjuvant or adjuvant treatment, or for metastatic disease, unless these are not suitable, and endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable. Drug is only recommended if the company provides it according to the commercial arrangement | Lynparza | Small mol API |
| Lonza Group Ltd | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Biologic API |
| Lonza Group Ltd | Trevi Therapeutics Inc | Positive Phase II top-line results for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) | nalbuphine hydrochloride ER | Solid dose manufacture |
| Lonza Group Ltd | Alexion Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive | Soliris | Biologic API |
| MIAS Pharma Ltd | CSL Ltd | EMA approval of the drug for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older | Kostaive | Parenteral manufacture & packaging |
| Midas Pharma GmbH | Celltrion Healthcare Hungary Kft | EMA approval of the drug for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV) | Eydenzelt | Parenteral manufacture & packaging |
| Midas Pharma GmbH | Celltrion Inc | FDA approval | Osenvelt | Parenteral manufacture & packaging |
| Midas Pharma GmbH | Celltrion Inc | FDA expanded indications of the drug for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment | Omlyclo | Parenteral manufacture |
| NorthX Biologics Matfors AB | LipUm AB | Positive Phase I top-line results for the treatment of inflammatory diseases with a novel mode of action | SOL-116 | Biologic API; Parenteral manufacture |
| Novo Nordisk AS | AstraZeneca AB | NICE recommended the drug with etoposide and either carboplatin or cisplatin, as an option for untreated extensive-stage small-cell lung cancer in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the company provides durvalumab according to the commercial arrangement | Imfinzi | Parenteral manufacture & packaging |
| Novo Nordisk AS | Geron Corp | EMA approval of the drug as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy | Rytelo | Parenteral manufacture |
| Novo Nordisk AS | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with Opdivo for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Yervoy | Parenteral manufacture & packaging |
| Novo Nordisk AS | AstraZeneca UK Ltd | UK MHRA expanded indication of the drug for the treatment of Refractory (or Resistant) Disease or Relapsed Disease | Fasenra | Parenteral manufacture & packaging |
| Novo Nordisk AS | AstraZeneca UK Ltd | FDA expanded indications of the drug for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Healthcare Hungary Kft | EMA approval of the drug for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV) | Eydenzelt | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Galderma SA | EMA approval of the drug for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy and moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy | Nemluvio | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | FDA approval | Osenvelt | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Inc | FDA expanded indications of the drug for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment | Omlyclo | Parenteral manufacture & packaging |
| Organon & Co | Merck Sharp & Dohme (UK) Ltd | UK MHRA expanded indications of the drug in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults | Keytruda | Parenteral manufacture & packaging |
| Patheon France SAS | Boehringer Ingelheim International GmbH | UK MHRA approval of the drug in adults and children aged ≥10 years for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise in patients insufficiently controlled on their maximally tolerated dose of metformin alone, in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products, and in patients already being treated with the combination of empagliflozin and metformin as separate tablets | Synjardy | Solid dose manufacture & packaging |
| Patheon Italia SpA | Alexion Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive | Soliris | Parenteral manufacture & packaging |
| Patheon NV | Geron Corp | EMA approval of the drug as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy | Rytelo | Parenteral manufacture |
| Patheon NV | Gilead Sciences Inc | FDA expanded indications of the drug for the treatment of HIV-1 infection in pediatric patients weighing at least 25 to less than 35 kg for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) and for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg to less than 35 kg for the treatment of HIV-1 infection as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL | Odefsey | Solid dose manufacture & packaging |
| Patheon NV | Alexion Pharmaceuticals Inc | FDA expanded indications of the drug for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive | Soliris | Parenteral packaging |
| Patheon NV | Candel Therapeutics Inc | Positive Phase II final results for the treatment of pancreatic ductal adenocarcinoma | CAN-2409 | Biologic API |
| Patheon Puerto Rico Inc | Boehringer Ingelheim International GmbH | UK MHRA approval of the drug in adults and children aged ≥10 years for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise in patients insufficiently controlled on their maximally tolerated dose of metformin alone, in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products, and in patients already being treated with the combination of empagliflozin and metformin as separate tablets | Synjardy | Solid dose manufacture |
| PCI Pharma Services | Gilead Sciences Ireland UC | EMA approval of the drug for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA | Seladelpar | Solid dose manufacture |
| Piramal Pharma Solutions Inc | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Biologic API |
| Renaissance Lakewood LLC | ARS Pharmaceuticals Inc | FDA expanded indications of the drug in patients 4 years of age and older, who weigh 15 kg to less than 30 kg, for emergency treatment of type I allergic reactions, including anaphylaxis | Neffy | Non-sterile liquid manufacture |
| Roslin Cell Therapies Ltd | Vertex Pharmaceuticals (Europe) Ltd | NICE recommended the drug with managed access as an option for treating sickle cell disease (SCD) in people 12 years and over who have recurrent vaso-occlusive crises (VOCs) and a βS/βS, βS/β+ or βS/β0 genotype and when haematopoietic stem cell transplant (HSCT) is suitable, but a human leukocyte antigen-matched related haematopoietic stem cell donor is not available. It is only recommended for people who have had at least 2 VOCs (as defined in section 3.4) per year during the 2 previous years and if the conditions in the managed access agreement for exa‑cel are followed | Casgevy | Biologic API |
| Rottendorf Pharma GmbH | BridgeBio Pharma Inc | EMA approval of the drug for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) | Beyonttra | Solid dose manufacture |
| Rottendorf Pharma GmbH | Gilead Sciences Inc | FDA expanded indications of the drug for the treatment of HIV-1 infection in pediatric patients weighing at least 25 to less than 35 kg for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) and for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg to less than 35 kg for the treatment of HIV-1 infection as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL | Odefsey | Solid dose manufacture & packaging |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with Opdivo for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Yervoy | Biologic API; Parenteral manufacture |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Pharma EEIG | EMA expanded indications of the drug in combination with ipilimumab for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Opdivo + Yervoy | Biologic API |
| ScinoPharm Taiwan Ltd | Servier Laboratories Ltd | UK MHRA expanded indications of the drug in combination with oxaliplatin, 5‑fluorouracil and leucovorin for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas | Onivyde | Small mol API |
| Sharp Packaging Services | AstraZeneca AB | NICE recommended the drug with etoposide and either carboplatin or cisplatin, as an option for untreated extensive-stage small-cell lung cancer in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the company provides durvalumab according to the commercial arrangement | Imfinzi | Parenteral packaging |
| Sharp Packaging Services | AstraZeneca UK Ltd | FDA expanded indications of the drug for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral packaging |
| Sharp Packaging Services | Beigene USA Inc | FDA expanded indications of the drug in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) | Tevimbra | Parenteral packaging |
| Simtra BioPharma Solutions | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with Opdivo for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Yervoy | Parenteral manufacture |
| Simtra BioPharma Solutions | Seagen Inc | FDA expanded indications of the drug in combination with lenalidomide and a rituximab is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy | Adcetris | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca AB | NICE recommended the drug with etoposide and either carboplatin or cisplatin, as an option for untreated extensive-stage small-cell lung cancer in adults, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the company provides durvalumab according to the commercial arrangement | Imfinzi | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Galderma SA | EMA approval of the drug for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy and moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy | Nemluvio | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Pharma EEIG | EMA expanded indication of the drug in combination with ipilimumab for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca UK Ltd | FDA expanded indications of the drug for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | Imfinzi | Parenteral manufacture & packaging |
| Vistin Pharma AS | Boehringer Ingelheim International GmbH | UK MHRA approval of the drug in adults and children aged ≥10 years for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise in patients insufficiently controlled on their maximally tolerated dose of metformin alone, in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products, and in patients already being treated with the combination of empagliflozin and metformin as separate tablets | Synjardy | Solid dose manufacture & packaging |
| W. R. Grace & Co | Emalex Biosciences Inc | Positive Phase III top-line results for the treatment of patients with Tourette syndrome | Ecopipam hydrochloride | Small mol API |
| WuXi AppTec Co Ltd | Sound Pharmaceuticals Inc | Trial planned - Phase III to evaluate the safety of open-label drug 400 mg BID treatment in adults with Menieres Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use | ebselen | Small mol API |
| WuXi Biologics Cayman Inc | Apogee Therapeutics Inc | Positive Phase I Interim results for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE) | APG990 | Parenteral manufacture |
| Zhejiang Raybow Pharmaceutical Co Ltd | Novartis UK Ltd | UK MHRA expanded indications of the drug in combination with aromatase inhibitors (AI) for the traetment of women and men diagnosed with HR+/HER2- early breast cancer (eBC) at high risk of recurrence | Kisqali | Small mol API |
POTENTIALLY NEGATIVE |
||||
| Almac Group Ltd | Amryt Pharmaceuticals DAC | EMA withdrawal/discontinuation at the MAH's request | Mycapssa | Solid dose packaging |
| Catalent U.K. Swindon Zydis Ltd | ALK-Abello Ltd | NICE rejection for the drug within its marketing authorisation, for treating house dust mite allergic asthma in adults that is diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test or specific IgE) and associated with mild to severe house dust mite allergic rhinitis and not well controlled by inhaled corticosteroids | Acarizax | Solid dose manufacture & packaging |
| NextPharma Technologies Holding Ltd | Amryt Pharmaceuticals DAC | EMA withdrawal/discontinuation at the MAH's request | Mycapssa | Solid dose manufacture & packaging |
| PCI Pharma Services | Amryt Pharmaceuticals DAC | EMA withdrawal/discontinuation at the MAH's request | Mycapssa | Solid dose manufacture |
Notes:
Source: GlobalData, Pharma Intelligence Center ©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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