Guest Column | May 8, 2025

April 2025 — CDMO Opportunities And Threats Report

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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

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