September 2024 — CDMO Opportunities And Threats Report
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 |
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| AbbVie Inc | Merck Sharp & Dohme BV | EMA approval of the drug in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity (see section 5.1 of the SmPC) | Winrevair | Biologic API |
| Aenova Holding GmbH | Basilea Pharmaceutica Ltd | EMA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis; in adults and in paediatric patients from 6 years of age for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate; in patients from 1 year of age and older for the treatment of invasive aspergillosis; in patients from 1 year of age and older for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Solid dose manufacture |
| AGC Biologics Inc | NEC Bio BV | Trial planned - Phase I/II to assess safety and tolerability of drug, at the dose level of 10^7 CFU , in addition to programmed cell death protein 1 (PD-1) inhibitor therapy | VXMNEO | Biologic API |
| AGC Biologics Inc | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Biologic API |
| AGC Biologics Inc | Samsung Bioepis Co Ltd | EMA expanded indication of the drug for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies; for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies | Eksunbi | Biologic API |
| Aldevron LLC | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Biologic API |
| Allergopharma GmbH & Co KG | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Almac Group Ltd | Basilea Pharmaceutica Ltd | EMA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis; in adults and in paediatric patients from 6 years of age for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate; in patients from 1 year of age and older for the treatment of invasive aspergillosis; in patients from 1 year of age and older for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Solid dose manufacture & packaging |
| AstraZeneca Plc | Merck Sharp & Dohme BV | EMA expanded indication of the drug in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults | Keytruda | Biologic API |
| AstraZeneca Plc | Merck Sharp & Dohme Ltd | NICE recommended the drug with platinum- and fluoropyrimidine-based chemotherapy, within its marketing authorisation, as an option for untreated locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more or metastatic carcinoma of the oesophagus in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 10 or more. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Avara Pharmaceutical Services Inc | Astellas Pharma Europe BV | EMA expanded indication of the for drug prolonged release tablets for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years | Betamiga | Solid dose manufacture |
| Biogen Inc | Janssen Biotech Inc | FDA expanded indication of the drug for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed | Tremfya | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie UK Ltd | UK MHRA expanded indication of the drug for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy | Skyrizi | Biologic API, Parenteral manufacture |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme BV | EMA expanded indication of the drug in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | Merck Sharp & Dohme Ltd | NICE recommended the drug with platinum- and fluoropyrimidine-based chemotherapy, within its marketing authorisation, as an option for untreated locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more or metastatic carcinoma of the oesophagus in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 10 or more. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Biologic API |
| Boehringer Ingelheim Pharma GmbH & Co KG | AbbVie Inc | NICE recommended the drug as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if a tumour necrosis factor (TNF)-alpha inhibitor, has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and the company provides it according to the commercial arrangement | Skyrizi | Biologic API, Parenteral manufacture |
| Bushu Pharmaceuticals Ltd | Accord Healthcare SLU | NICE recommended the drug within its marketing authorisation, as an option for treating prostate cancer in adults with advanced hormone-sensitive prostate cancer, alongside radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer and as neoadjuvant treatment before radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer | Orgovyx | Solid dose manufacture |
| Catalent Anagni Srl | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Catalent CTS LLC | Travere Therapeutics Inc | FDA expanded indication of the drug indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression | Filspari | Solid dose manufacture |
| Catalent CTS LLC | BeiGene Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating marginal zone lymphoma in adults who have had at least 1 anti‑CD20-based treatment. It is only recommended if the company provides it according to the commercial arrangement | Brukinsa | Solid dose manufacture |
| Catalent Inc | PharmAust Ltd | Positive Phase I Interim results of the drug for the treatment of amyotrophic lateral sclerosis (ALS) | monepantel | Solid dose manufacture |
| Catalent Inc | Pierre Fabre Medicament SA | EMA expanded indication of the drug in combination with Mektovi (binimetinib) is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation | Braftovi | Solid dose manufacture |
| Catalent Indiana LLC | Sanofi-Aventis US LLC | FDA expanded indication of the drug as as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) | Dupixent | Biologic API |
| Catalent Indiana LLC | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent is indicated as adjuvant treatment after surgery for adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements; and in combination with platinum-containing chemotherapy is indicated as neoadjuvant treatment, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| Catalent Indiana LLC | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Challenge Bioproducts Co Ltd | MediWound Ltd | FDA expanded indication of the drug for the treatment of eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns | NexoBrid | Biologic API |
| Charles River Laboratories International Inc | CRISPR Therapeutics AG | NICE recommended the drug with managed access as an option for treating transfusion-dependent beta-thalassaemia in people 12 years and over. when a haematopoietic stem cell transplant (HSCT) is suitable, but a human leukocyte antigen-matched related haematopoietic stem cell donor is not available only if the conditions in the managed access agreement for exa‑cel are followed | Casgevy | Biologic API |
| Delpharm SAS | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Divi's Laboratories Ltd | Basilea Pharmaceutica Ltd | EMA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis; in adults and in paediatric patients from 6 years of age for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate; in patients from 1 year of age and older for the treatment of invasive aspergillosis; in patients from 1 year of age and older for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Small mol API |
| EuroAPI SAS | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Excella GmbH & Co KG | Accord Healthcare SLU | NICE recommended the drug within its marketing authorisation, as an option for treating prostate cancer in adults with advanced hormone-sensitive prostate cancer, alongside radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer and as neoadjuvant treatment before radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer | Orgovyx | Small mol API |
| Exelead Inc | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture |
| Hovione FarmaCiencia SA | Basilea Pharmaceutica Ltd | EMA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis; in adults and in paediatric patients from 6 years of age for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate; in patients from 1 year of age and older for the treatment of invasive aspergillosis; in patients from 1 year of age and older for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Small mol API |
| Jetpharma SA | Pierre Fabre Medicament SA | EMA expanded indication of the drug in combination with Mektovi (binimetinib) is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation | Braftovi | Small mol API |
| Laboratorios Farmaceuticos Rovi SA | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Biologic API, Parenteral manufacture & packaging |
| Lek Pharmaceuticals dd | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Lonza Group Ltd | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Biologic API |
| Lonza Group Ltd | Astellas Pharma Europe Ltd | EMA expanded indication of the drug in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy | Padcev | Biologic API |
| Mibe GmbH Arzneimittel | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| National Resilience Inc | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Biologic API |
| Novartis AG | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| NUVISAN Pharma Holding GmbH | Celltrion Europe Ltd | EMA approval of the drug for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies; alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate; for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies; for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) | Steqeyma | Parenteral manufacture |
| Organon & Co | Merck Sharp & Dohme BV | EMA expanded indication of the drug in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults | Keytruda | Parenteral packaging |
| Organon & Co | Merck Sharp & Dohme Ltd | NICE recommended the drug with platinum- and fluoropyrimidine-based chemotherapy, within its marketing authorisation, as an option for untreated locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more or metastatic carcinoma of the oesophagus in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 10 or more. Drug is only recommended if the company provides it according to the commercial arrangement | Keytruda | Parenteral packaging |
| Patheon NV | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Patheon NV | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Patheon NV | Merck Sharp & Dohme BV | EMA approval of the drug in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity (see section 5.1 of the SmPC) | Winrevair | Parenteral manufacture |
| Patheon NV | Pierre Fabre Ltd | NICE recommended the drug as an option for treating the symptoms of overactive bladder syndrome in adults. It is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects. If people with the condition and their healthcare professional consider the drug to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. This recommendation is not intended to affect treatment with 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 healthcare professional consider it appropriate to stop | Obgemsa | Solid dose manufacture & packaging |
| Patheon NV | Theramex Ireland Ltd | NICE recommended the drug as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age only if it is intended to be used for longer-term treatment (normally for more than 6 months and not for people who need short-term treatment, for example, before planned surgery) the following dosage is used with hormonal add-back therapy (ABT) 200 mg once daily, without hormonal ABT: 200 mg once daily for 6 months, then 100 mg once daily. This recommendation is not intended to affect treatment with 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 healthcare professional consider it appropriate to stop | Yselty | Solid dose manufacture & packaging |
| PCI Pharma Services | Janssen Biotech Inc | FDA expanded indication of the drug for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed | Tremfya | Parenteral packaging |
| PCI Pharma Services | Eisai Ltd | UK MHRA approval of the drug for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers | Leqembi | Parenteral packaging |
| PCI Pharma Services | Taiho Pharmaceutical Co Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least 1 line of systemic treatment in adults. Drug is only recommended if the company provides it according to the commercial arrangement | Lytgobi | Solid dose packaging |
| PCI Pharma Services | BeiGene Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating marginal zone lymphoma in adults who have had at least 1 anti‑CD20-based treatment. It is only recommended if the company provides it according to the commercial arrangement | Brukinsa | Solid dose packaging |
| PCI Pharma Services | Accord Healthcare SLU | NICE recommended the drug within its marketing authorisation, as an option for treating prostate cancer in adults with advanced hormone-sensitive prostate cancer, alongside radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer and as neoadjuvant treatment before radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer | Orgovyx | Solid dose packaging |
| Pharma Packaging Solutions | Eisai Ltd | UK MHRA approval of the drug for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers | Leqembi | Parenteral packaging |
| Polymun Scientific Immunbiologische Forschung GmbH | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture |
| Recipharm AB | RedHill Biopharma Ltd | FDA expanded indication of the drug as an empirically-prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection | Talicia | Solid dose manufacture & packaging |
| Recipharm AB | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Rentschler Biopharma SE | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Biologic API |
| Rentschler Biopharma SE | AbbVie Inc | EMA expanded indication of the drug as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy | Tepkinly | Biologic API |
| Roslin Cell Therapies Ltd | CRISPR Therapeutics AG | NICE recommended the drug with managed access as an option for treating transfusion-dependent beta-thalassaemia in people 12 years and over. when a haematopoietic stem cell transplant (HSCT) is suitable, but a human leukocyte antigen-matched related haematopoietic stem cell donor is not available only if the conditions in the managed access agreement for exa‑cel are followed | Casgevy | Biologic API |
| Samsung Biologics Co Ltd | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Sanofi | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Sharp Packaging Services | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent is indicated as adjuvant treatment after surgery for adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements; and in combination with platinum-containing chemotherapy is indicated as neoadjuvant treatment, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral packaging |
| Siegfried Holding AG | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Moderna Inc | FDA expanded indication of a drug indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Spikevax | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Astellas Pharma Europe Ltd | EMA expanded indication of the drug in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy | Padcev | Parenteral manufacture & packaging |
| Simtra BioPharma Solutions | Basilea Pharmaceutica Ltd | EMA expanded indication of the drug in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis; in adults and in paediatric patients from 6 years of age for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate; in patients from 1 year of age and older for the treatment of invasive aspergillosis; in patients from 1 year of age and older for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate | Cresemba | Solid dose manufacture & packaging |
| Sumitomo Chemical Co Ltd | Astellas Pharma Europe BV | EMA expanded indication of the for drug prolonged release tablets for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years | Betamiga | Small mol API |
| Syngene International Ltd | PharmAust Ltd | Positive Phase I Interim results of the drug for the treatment of amyotrophic lateral sclerosis (ALS) | monepantel | Small mol API |
| The Biovac Institute | Pfizer Inc | FDA expanded indication of the drug for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older | Comirnaty | Parenteral manufacture |
| Vetter Pharma-Fertigung GmbH & Co KG | AstraZeneca Pharmaceuticals LP | FDA expanded indication of the drug as a single agent is indicated as adjuvant treatment after surgery for adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements; and in combination with platinum-containing chemotherapy is indicated as neoadjuvant treatment, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | Imfinzi | Parenteral manufacture & packaging |
| WuXi XDC Cayman Inc | BeiGene Ltd | NICE recommended the drug within its marketing authorisation, as an option for treating marginal zone lymphoma in adults who have had at least 1 anti‑CD20-based treatment. It is only recommended if the company provides it according to the commercial arrangement | Brukinsa | Small mol API |
POTENTIALLY NEGATIVE |
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| Rottendorf Pharma GmbH | Boehringer Ingelheim International GmbH | NICE is unable to make a recommendation about the use in the NHS of drug for treating type 2 diabetes in people aged 10 to 17 years. This is because Boehringer Ingelheim has confirmed that it does not intend to make an evidence submission for the appraisal. Boehringer Ingelheim's view, which it has corroborated in consultation with healthcare professionals and other relevant decision makers, is that an appraisal will not add value | Jardiance | Solid dose manufacture & packaging |
| Fabbrica Italiana Sintetici SpA | Boehringer Ingelheim International GmbH | NICE is unable to make a recommendation about the use in the NHS of drug for treating type 2 diabetes in people aged 10 to 17 years. This is because Boehringer Ingelheim has confirmed that it does not intend to make an evidence submission for the appraisal. Boehringer Ingelheim's view, which it has corroborated in consultation with healthcare professionals and other relevant decision makers, is that an appraisal will not add value | Jardiance | Small mol API |
| Hikma Pharmaceuticals Plc | Boehringer Ingelheim International GmbH | NICE is unable to make a recommendation about the use in the NHS of drug for treating type 2 diabetes in people aged 10 to 17 years. This is because Boehringer Ingelheim has confirmed that it does not intend to make an evidence submission for the appraisal. Boehringer Ingelheim's view, which it has corroborated in consultation with healthcare professionals and other relevant decision makers, is that an appraisal will not add value | Jardiance | Solid dose packaging |
| Praxis Packaging Solutions | Boehringer Ingelheim International GmbH | NICE is unable to make a recommendation about the use in the NHS of drug for treating type 2 diabetes in people aged 10 to 17 years. This is because Boehringer Ingelheim has confirmed that it does not intend to make an evidence submission for the appraisal. Boehringer Ingelheim's view, which it has corroborated in consultation with healthcare professionals and other relevant decision makers, is that an appraisal will not add value | Jardiance | Solid dose packaging |
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