March 2024 – CDMO Opportunities And Threats Report
Source: Outsourced Pharma
By GlobalData
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 |
||||
| Ajinomoto Bio-Pharma Services | Ipsen SA | FDA expanded indication of the drug in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Onivyde | Parenteral manufacture & packaging |
| Alcami Corp | Karus Therapeutics Ltd | Trial planned - Phase II/II Ito evaluate the efficacy and safety of drug in subjects with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency) | CVL-237 | Small mol API |
| Almac Group Ltd | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Solid dose packaging |
| Almac Group Ltd | Pfizer Inc | EMA approval of the drug to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent | Velsipity | Solid dose manufacture |
| Almac Group Ltd | Pfizer Inc | NICE recommended the drug, within its marketing authorization, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when: conventional or biological treatments cannot be tolerated or the condition has not responded well enough, or lost response to treatment. The drug is only recommended if the company provides it according to the commercial arrangement. If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements | Velsipity | Solid dose manufacture |
| AMPAC Fine Chemicals LLC | Pfizer Inc | EMA approval of the drug to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent | Velsipity | Small mol API |
| AMPAC Fine Chemicals LLC | Pfizer Inc | NICE recommended the drug, within its marketing authorization, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when: conventional or biological treatments cannot be tolerated or the condition has not responded well enough, or lost response to treatment. The drug is only recommended if the company provides it according to the commercial arrangement. If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements | Velsipity | Small mol API |
| AstraZeneca Plc | Merck & Co Inc | UK MHRA expanded indication of the drug in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1; in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Biologic API |
| Biogen Inc | Johnson & Johnson | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody | Tecvayli | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | UK MHRA expanded indication of the drug in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1; in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Biologic API |
| Cambrex Corp | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Small mol API |
| Cambrex Corp | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Solid dose manufacture & packaging |
| Catalent Anagni Srl | Ono Pharmaceutical Co Ltd | FDA expanded indication of the drug as a single agent is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma | Opdivo | Parenteral manufacture & packaging |
| Catalent Belgium SA | Novo Nordisk AS | FDA expanded indication of the drug in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight; in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, adults with overweight in the presence of at least one weight-related comorbid condition | Wegovy | Parenteral manufacture & packaging |
| Catalent CTS LLC | BeiGene Ltd | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory Follicular Lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy | Brukinsa | Solid dose manufacture |
| Catalent Gosselies SA | Iovance Biotherapeutics Inc | FDA approval of the drug for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor | Amtagvi | Biologic API |
| Catalent Inc | PharmAust Ltd | Positive Phase I/II top-line results of the drug for the treatment of Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS) | Monepantel | Solid dose manufacture |
| Catalent Inc | Incannex Healthcare Ltd | Positive Phase II top-line results of the drug for the treatment of generalized anxiety disorder(GAD) | Psilocybin | Solid dose manufacture |
| Catalent Inc | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Solid dose manufacture |
| Catalent Indiana LLC | Novo Nordisk AS | FDA expanded indication of the drug in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight; in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, adults with overweight in the presence of at least one weight-related comorbid condition | Wegovy | Parenteral packaging |
| Catalent Indiana LLC | Regeneron Pharmaceuticals Inc | UK MHRA expanded indication of the drug in combination with platinum-based chemotherapy for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC | Libtayo | Parenteral manufacture & packaging |
| Chime Biologics Ltd | EOC Pharma Ltd | Positive Phase I Interim results of the drug in combination with Paclitaxel chemotherapy for the treatment of Metastatic Breast Cancer | Eftilagimod alfa | Parenteral manufacture |
| Dalton Pharma Services | GLyPharma Therapeutic Inc | Positive Phase III top-line results of the drug once-weekly in adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF) | Apraglutide | Parenteral manufacture |
| Dottikon Exclusive Synthesis AG | AstraZeneca Plc | FDA expanded indication of the drug in combination with pemetrexed and platinum-based chemotherapy is indicated for the firstline treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | Tagrisso | Small mol API |
| Esteve Pharmaceuticals SA | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Small mol API |
| Esteve Quimica SA | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | Small mol API |
| Esteve Quimica SA | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Small mol API |
| Evonik Industries AG | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | Small mol API |
| Excella GmbH & Co KG | Pfizer Inc | FDA expanded indication of the drug for the treatment of adult with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer; in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) | Talzenna | Solid dose manufacture & packaging |
| Excella GmbH & Co KG | Pfizer Inc | NICE recommended the drug, within its marketing authorization, for treating HER2-negative, locally advanced, or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had: an anthracycline or a taxane, or both, unless these treatments are not suitable, and endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable. The drug is only recommended if the company provides it according to the commercial arrangement | Talzenna | Solid dose manufacture & packaging |
| Fareva SA | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture |
| Flamma SpA | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Small mol API |
| Hikma Pharmaceuticals Plc | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture |
| Hovione FarmaCiencia SA | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Small mol API |
| Hubei Haosun Pharmaceutical Co Ltd | Ipsen SA | FDA expanded indication of the drug in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Onivyde | Small mol API |
| Ivers-Lee AG | Alvotech SA | FDA approval of the drug for the treatment of Ankylosing Spondylitis (Bekhterev's Disease), Anterior Uveitis, Axial Spondyloarthritis, Crohn's Disease (Regional Enteritis), Hidradenitis Suppurativa, Intermediate Uveitis, Non-infectious Uveitis, Plaque Psoriasis (Psoriasis Vulgaris), Polyarticular Juvenile Idiopathic Arthritis (PJIA), Posterior Uveitis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis | Simlandi | Parenteral packaging |
| Jubilant HollisterStier LLC | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture & packaging |
| Lonza Group Ltd | Shanghai Junshi Biosciences Co Ltd | Trial planned - Phase II to investigate the efficacy and safety of the therapeutic regimen of the drug and JS004 plus etoposide and platinum chemotherapy in limited-stage SCLC | Tifcemalimab | Biologic API |
| Lonza Group Ltd | Surrozen Inc | Trial planned - Phase I to assess the safety and the way the body absorbs, distributes, and eliminates the drug | SZN-043 | Biologic API, Parenteral manufacture |
| Lonza Group Ltd | Iovance Biotherapeutics Inc | FDA approval of the drug for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor | Amtagvi | Biologic API |
| Lonza Group Ltd | Ono Pharmaceutical Co Ltd | FDA expanded indication of the drug as a single agent is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma | Opdivo | Biologic API |
| Lonza Group Ltd | AstraZeneca Plc | FDA expanded indication of the drug in combination with pemetrexed and platinum-based chemotherapy is indicated for the firstline treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | Tagrisso | Small mol API |
| Organon & Co | Merck & Co Inc | UK MHRA expanded indication of the drug in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1; in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults | Keytruda | Parenteral packaging |
| Patheon NV | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture & packaging |
| Patheon NV | Johnson & Johnson | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody | Tecvayli | Parenteral manufacture & packaging |
| Patheon NV | Novo Nordisk AS | FDA expanded indication of the drug in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight; in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, adults with overweight in the presence of at least one weight-related comorbid condition | Wegovy | Parenteral packaging |
| Patheon NV | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Solid dose manufacture |
| PCI Pharma Services | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | Solid dose packaging |
| PCI Pharma Services | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral packaging |
| PCI Pharma Services | Johnson & Johnson | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody | Tecvayli | Parenteral packaging |
| PCI Pharma Services | BeiGene Ltd | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory Follicular Lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy | Brukinsa | Solid dose packaging |
| PCI Pharma Services | Pfizer Inc | EMA approval of the drug to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent | Velsipity | Solid dose manufacture & packaging |
| PCI Pharma Services | Pfizer Inc | NICE recommended the drug, within its marketing authorization, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when: conventional or biological treatments cannot be tolerated or the condition has not responded well enough, or lost response to treatment. The drug is only recommended if the company provides it according to the commercial arrangement. If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements | Velsipity | Solid dose manufacture & packaging |
| Pfizer Inc | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture |
| Porton Pharma Solutions Ltd | Pfizer Inc | EMA approval of the drug to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent | Velsipity | Small mol API |
| Porton Pharma Solutions Ltd | Pfizer Inc | NICE recommended the drug, within its marketing authorization, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when: conventional or biological treatments cannot be tolerated or the condition has not responded well enough, or lost response to treatment. The drug is only recommended if the company provides it according to the commercial arrangement. If people with the condition and their clinicians consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements | Velsipity | Small mol API |
| Recipharm AB | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Solid dose manufacture & packaging |
| Rentschler Biopharma SE | Genmab AS | NICE recommended the drug as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults after 2 or more systemic treatments, only if: they have had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and the company provides the drug according to the commercial arrangement, This recommendation is not intended to affect treatment with the drug that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop | Tepkinly | Biologic API |
| Rottendorf Pharma GmbH | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | Solid dose manufacture |
| Samsung Biologics Co Ltd | Ono Pharmaceutical Co Ltd | FDA expanded indication of the drug as a single agent is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma | Opdivo | Biologic API |
| ScinoPharm Taiwan Ltd | Ipsen SA | FDA expanded indication of the drug in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Onivyde | Small mol API |
| Sharp Packaging Services | Shionogi & Co Ltd | FDA expanded indication of the drug for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications | Xofluza | Solid dose packaging |
| Simtra BioPharma Solutions | Ipsen SA | FDA expanded indication of the drug in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Onivyde | Parenteral packaging |
| Syngene International Ltd | PharmAust Ltd | Positive Phase I/II top-line results of the drug for the treatment of Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS) | Monepantel | Small mol API |
| Takeda Pharmaceutical Co Ltd | Ipsen SA | FDA expanded indication of the drug in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Onivyde | Parenteral manufacture |
| Takeda Pharmaceutical Co Ltd | F. Hoffmann-La Roche Ltd | FDA expanded indication of the drug for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy | Xolair | Parenteral manufacture & packaging |
| Uquifa SA | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | Small mol API |
| Vetter Pharma-Fertigung GmbH & Co KG | Ono Pharmaceutical Co Ltd | FDA expanded indication of the drug as a single agent is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | F. Hoffmann-La Roche Ltd | FDA expanded indication of the drug for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy | Xolair | Parenteral manufacture |
| WuXi AppTec Co Ltd | Immutep Ltd | Positive Phase I Interim results of the drug in combination with Paclitaxel chemotherapy for the treatment of Metastatic Breast Cancer | Eftilagimod alfa | Parenteral manufacture |
| WuXi AppTec Co Ltd | Iovance Biotherapeutics Inc | FDA approval of the drug for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor | Amtagvi | Parenteral manufacture |
| WuXi STA (Shanghai) Co Ltd | Vertex Pharmaceuticals Inc | UK MHRA expanded indication of the drug for the treatment of infants aged ≥1 month, toddlers and children weighing 3kg to <25kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene; In a combination of a drug regimen with tezacaftor/elexacaftor was indicated for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene | Kalydeco | Small mol API |
| WuXi XDC Cayman Inc | BeiGene Ltd | FDA expanded indication of the drug for the treatment of adult patients with relapsed or refractory Follicular Lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy | Brukinsa | Small mol API |
| Xellia Pharmaceuticals ApS | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of COVID-19 for pediatric patients from birth to less than 28 days of age weighing at least 1.5 kg to less than 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death | Veklury | Parenteral manufacture |
| Yuhan Chemical Inc | Gilead Sciences Inc | FDA expanded indication of the drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg, 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 known or suspected substitutions associated with resistance to drug | Biktarvy | 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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