April 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 | Novartis Pharmaceuticals Corp | FDA approval of the drug to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g | Vanrafia | Solid dose manufacture |
| Aenova Holding GmbH | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Almac Group Ltd | Vertex Pharmaceuticals (Europe) Ltd | EMA expanded indications of the drug in a combination regimen with ivacaftor for the treatment of people with cystic fibrosis (CF) expanded to include all patients ages 2 years and older who have at least one non-class I mutation in the cystic fibrosis conductance regulator (CFTR) gene | Kaftrio | Solid dose manufacture & packaging |
| AstraZeneca Plc | Merck & Co Inc | FDA expanded indications of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test | Keytruda | Biologic API |
| Avid Bioservices Inc | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Bachem Holding AG | Theratechnologies Inc | FDA expanded indications of the drug for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy | Egrifta WR | Biologic API |
| Bachem Holding AG | Alzinova AB | Positive Phase I final results to evaluate safety, tolerability and immunogenicity of drug in subjects with early alzheimer's disease | ALZ-101 | Biologic API |
| Biogen Inc | Swedish Orphan Biovitrum AB | NICE recommended the drug as an option for treating and preventing bleeding episodes in people 2 years and over with haemophilia A (congenital factor VIII deficiency), only if they have a factor VIII activity level of less than 1% (severe haemophilia A), the company provides it according to the commercial arrangement | Altuvoct | Biologic API; Parenteral manufacture & packaging |
| Biogen Inc | Janssen Biotech Inc | FDA expanded indications of the drug for the treatment of adult patients with moderately to severely active Crohn’s disease | Tremfya | Biologic API |
| Biogen Inc | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| Biogen Inc | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| BioSpring GmbH | Genzyme Corp | FDA approval of the drug for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors | Qfitlia | Biologic API |
| Boehringer Ingelheim Fremont, 6701 & 6397 Kaiser Drive, Fremont, California, United States | Merck & Co Inc | FDA expanded indications of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Amgen Europe BV | NICE recommended the drug with chemotherapy can be used as an option to treat Philadelphiachromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adults, if the leukaemia is minimal residual disease-negative, it is used at the start of consolidation treatment and the company provides it according to the commercial arrangement |
Blincyto | Parenteral manufacture & packaging |
| Boehringer Ingelheim Pharma GmbH & Co KG | AstraZeneca AB | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy and in combination with chemotherapy is indicated for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck & Co Inc | FDA expanded indications of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test | Keytruda | Biologic API |
| Catalent Germany Schorndorf GmbH | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Evotec SE | UCB SA | NICE recommended the drug as an option for treating seizures associated with Lennox–Gastaut syndrome (LGS), as an add-on to other antiseizure medicines, for people 2 years and over. It is recommended only if the frequency of drop seizures is checked every 6 months, and fenfluramine is stopped if the frequency is not reduced by at least 30% compared with the 6 months before starting treatment and the company provides it according to the commercial arrangement | Fintepla | Small mol API |
| Fareva SA | Cubist Pharmaceuticals LLC | FDA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates in pediatric patients <12 years of age and weighing ≥35 kg | Sivextro | Solid dose manufacture |
| FUJIFILM Diosynth Biotechnologies USA Inc | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| FUJIFILM Diosynth Biotechnologies USA Inc | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| Gilead Alberta ULC | Janssen Products LP | FDA expanded indications of the drug in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adults and pediatric patients weighing at least 25 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) | Prezcobix | Small mol API |
| IBERFAR Industria Farmaceutica SA | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Jubilant HollisterStier LLC | Theratechnologies Inc | FDA expanded indications of the drug for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy | Egrifta WR | Parenteral manufacture & packaging |
| Lonza Biologics Inc | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and in combination with Yervoy, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Opdivo | Biologic API |
| Lonza Biologics Plc | Amgen Europe BV | NICE recommended the drug with chemotherapy can be used as an option to treat Philadelphiachromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adults, if the leukaemia is minimal residual disease-negative, it is used at the start of consolidation treatment and the company provides it according to the commercial arrangement |
Blincyto | Biologic API |
| Lonza Biologics Plc | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Lonza Group Ltd | Alzamend Neuro Inc | Trial planned - Phase I to assess the safety and effects of a crystalized form of drug, when compared to commonly used lithium carbonate in healthy volunteers | AL-001 | Small mol API |
| Lonza Group Ltd | Pfizer Inc | EMA approval of the drug as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy | Tivdak | Biologic API |
| Lonza Group Ltd | Daiichi Sankyo Europe GmbH | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment | Enhertu | Biologic API |
| Lonza Group Ltd | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Lonza Group Ltd | Vaxcyte Inc | Positive Phase II top-line results to evaluate the safety, tolerability and immunogenicity following the primary three-dose immunization series of drug in healthy infants | VAX-24 | Biologic API |
| Lyocontract GmbH | Gilead Sciences Ltd | UK MHRA expanded indications of the drug for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease | Hepcludex | Parenteral manufacture & packaging |
| NorthX Biologics Matfors AB | NEOGAP Therapeutics AB | Positive Phase I/II Interim results to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed, extensive small cell lung cancer after platinum-based first-line chemotherapy | Personal Tumor Trained Lymphocytes | Biologic API |
| Novo Nordisk AS | AstraZeneca AB | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy and in combination with chemotherapy is indicated for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Novo Nordisk AS | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Yervoy | Parenteral manufacture & packaging |
| Novo Nordisk AS | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Biologic API |
| Novo Nordisk AS | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| Organon & Co | Merck & Co Inc | FDA expanded indications of the drug in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test | Keytruda | Parenteral manufacture & packaging |
| Patheon France SAS | Theramex HQ UK Ltd | UK MHRA expanded indications of the drug in adult women of reproductive age for symptomatic treatment of endometriosis, in women with a history of previous medical or surgical treatment for their endometriosis | Yselty | Solid dose manufacture & packaging |
| Patheon Ltd | Cubist Pharmaceuticals LLC | FDA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates in pediatric patients <12 years of age and weighing ≥35 kg | Sivextro | Solid dose manufacture & packaging |
| Patheon NV | Exelixis Inc | FDA expanded indications of the drug for the treatment of Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET) | Cabometyx | Solid dose manufacture & packaging |
| Patheon NV | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Parenteral manufacture |
| Patheon NV | Janssen Products LP | FDA expanded indications of the drug in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adults and pediatric patients weighing at least 25 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) | Prezcobix | Small mol API; Solid dose manufacture & packaging |
| Patheon UK Ltd | Cubist Pharmaceuticals LLC | FDA expanded indications of the drug for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates in pediatric patients <12 years of age and weighing ≥35 kg | Sivextro | Solid dose manufacture & packaging |
| PCI Pharma Services | UCB SA | NICE recommended the drug as an option for treating seizures associated with Lennox–Gastaut syndrome (LGS), as an add-on to other antiseizure medicines, for people 2 years and over. It is recommended only if the frequency of drop seizures is checked every 6 months, and fenfluramine is stopped if the frequency is not reduced by at least 30% compared with the 6 months before starting treatment and the company provides it according to the commercial arrangement | Fintepla | Non-sterile liquid manufacture and packaging |
| PCI Pharma Services | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| PCI Pharma Services | Janssen Biotech Inc | FDA expanded indications of the drug for the treatment of adult patients with moderately to severely active Crohn’s disease | Tremfya | Parenteral packaging |
| PCI Pharma Services | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Parenteral packaging |
| Pfizer Inc | Ocular Therapeutix Inc | FDA expanded indications of the drug for use in pediatric patients for the treatment of pain following ophthalmic surgery, ocular inflammation following ophthalmic surgery and for use in pediatric patients aged 2 years and older for the treatment of ocular itching associated with allergic conjunctivitis | Dextenza | Small mol API; Sterile liquid packaging |
| Porton Pharma Solutions Ltd | Janssen Products LP | FDA expanded indications of the drug in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adults and pediatric patients weighing at least 25 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) | Prezcobix | Small mol API |
| PYRAMID Laboratories Inc | Novo Nordisk Inc | FDA expanded indications of the drug to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR greater than or equal to 30 mL/min/1.73 m2 | Rivfloza | Parenteral manufacture |
| Rechon Life Science AB | Swedish Orphan Biovitrum AB | NICE recommended the drug as an option for treating and preventing bleeding episodes in people 2 years and over with haemophilia A (congenital factor VIII deficiency), only if they have a factor VIII activity level of less than 1% (severe haemophilia A), the company provides it according to the commercial arrangement | Altuvoct | Parenteral packaging |
| Rottendorf Pharma GmbH | Exelixis Inc | FDA expanded indications of the drug for the treatment of Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET) | Cabometyx | Solid dose manufacture |
| ROVI Pharma Industrial Services SA | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose manufacture & packaging |
| Samsung Biologics Co Ltd | AstraZeneca AB | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy and in combination with chemotherapy is indicated for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and in combination with Yervoy, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Opdivo | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indications of the drug as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) | Opdivo + Yervoy | Biologic API |
| Samsung Biologics Co Ltd | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Yervoy | Biologic API, Parenteral manufacture |
| Samsung Biologics Co Ltd | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Biologic API |
| Sharp Packaging Services LLC | AstraZeneca AB | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy and in combination with chemotherapy is indicated for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral packaging |
| Simtra US LLC | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with nivolumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Yervoy | Parenteral manufacture |
| Simtra US LLC | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Parenteral manufacture & packaging |
| Simtra US LLC | Janssen-Cilag International NV | EMA expanded indications of the drug for the treatment of moderately to severely active Crohn’s disease in pediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy | Stelara | Parenteral manufacture |
| Unigen Co Ltd | Sanofi Winthrop Industrie SA | EMA expanded indications of the drug for active immunization for the prevention of influenza disease in adults and children from 9 years of age and older | Supemtek | Biologic API |
| Vetter Pharma-Fertigung GmbH & Co KG | Swedish Orphan Biovitrum AB | NICE recommended the drug as an option for treating and preventing bleeding episodes in people 2 years and over with haemophilia A (congenital factor VIII deficiency), only if they have a factor VIII activity level of less than 1% (severe haemophilia A), the company provides it according to the commercial arrangement | Altuvoct | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca AB | EMA expanded indications of the drug as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy and in combination with chemotherapy is indicated for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Bristol-Myers Squibb Co | FDA expanded indications of the drug in combination with Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and in combination with Yervoy, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | Opdivo | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Genzyme Corp | FDA approval of the drug for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors | Qfitlia | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | Argenx SE | FDA expanded indications of the drug for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo | Parenteral manufacture & packaging |
| Vetter Pharma-Fertigung GmbH & Co KG | Janssen-Cilag International NV | EMA expanded indications of the drug in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma | Darzalex | Parenteral manufacture & packaging |
| Wasdell Packaging Group | Rad Neurim Pharmaceuticals Eec Ltd | EMA expanded indications of the drug treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient | Slenyto | Solid dose packaging |
| Yuhan Chemical Inc | Janssen Products LP | FDA expanded indications of the drug in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adults and pediatric patients weighing at least 25 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) | Prezcobix | Small mol API |
POTENTIALLY NEGATIVE |
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| Ajinomoto Bio-Pharma Services | Servier Laboratories Ltd | NICE is unable to make a recommendation on drug plus oxaliplatin, 5-fluorouracil and leucovorin for untreated metastatic pancreatic cancer in adults. This is because the company did not provide an evidence submission | Onivyde | Parenteral manufacture & packaging |
| Hubei Haosun Pharmaceutical Co Ltd | Servier Laboratories Ltd | NICE is unable to make a recommendation on drug plus oxaliplatin, 5-fluorouracil and leucovorin for untreated metastatic pancreatic cancer in adults. This is because the company did not provide an evidence submission | Onivyde | Small mol API |
| Patheon Biologics LLC | Astellas Pharma Inc | NICE not recommended the drug with fluoropyrimidine- and platinum-based chemotherapy, within its marketing authorisation, for untreated, locally advanced, unresectable or metastatic, claudin-18.2-positive, HER2-negative, gastric or gastro-oesophageal junction adenocarcinoma in adults | Vyloy | Biologic API |
| ScinoPharm Taiwan Ltd | Servier Laboratories Ltd | NICE is unable to make a recommendation on drug plus oxaliplatin, 5-fluorouracil and leucovorin for untreated metastatic pancreatic cancer in adults. This is because the company did not provide an evidence submission | Onivyde | Small mol API |
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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