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Therapeutic areas

(NAS = New Active Substance)

 

Anaesthesia

Anaesthetic sedative NAS

Local anaesthesia

 

Cardiovascular

Acute ischaemic stroke NAS

Cardioplegia

Cardiovascular disease prophylaxis

Dyslipidaemia NASs

 

CNS

Abuse deterrence

Breakthrough pain

Central neuroprotectant NAS

Hypnotics

Mania NAS

Migraine

Multiple sclerosis NASs
and biosimilar

Novel antidepressant NAS

Opioid dependence

Parkinson’s disease NAS

Parkinson’s disease new formulation

Schizophrenia NAS

Sensory neuropathy NAS

Strong analgesics

 

Dermatology

Antihistamines

Atopic dermatitis NAS

Hereditary angio-oedema NAS

Pruritus NAS

Psoriasis NASs

Topical steroid bioequivalence

 

 

Endocrinology

Acromegaly

Familial adenomatous polyposis

Male hypogonadism

PTH

Topical postmenopausal therapy

Type 2 Diabetes – NASs & combination therapy

 

Gastroenterology

Chronic anal fissure NAS

Faecal incontinence

Gastric acid suppression

Gastric antisecretory agent NAS

GLP-1 analogue NAS

 

Haematology

Anaemia - NASs & Biosimilars

Autoimmune Haemolytic anaemia NAS

Heparin-induced thrombocytopenia NAS

Paroxysmal Nocturnal Haemoglobinuria NAS

 

Infections

Antifungal agents

Broad spectrum antifungals

Generic antibacterial agents

Herpes simplex NAS

 

Oncology

Acute leukaemias; lymphoblastic / myeloid NASs

Early breast cancer

Hepatobiliary cancers

Malignant melanoma NAS

Malignant pleural mesothelioma NAS

Multiple myeloma

Prostate cancer NAS

Tumour suppression

 

 

Regulatory Challenges

Complex generics

Liposomal biosimilars

Modified release products

Therapeutic equivalence /
non-inferiority studies

Topical product development

 

Respiratory

Asthma NAS/combinations

COPD NAS/combinations

Large molecule inhalation for serious pulmonary disease

 

Other

Anaphylaxis

Drooling

Electrolye imbalance NAS

Herbals

Hyperhidrosis

Hyperphosphataemia NAS

Immune nephropathies NAS

Induction of labour

Macular Degeneration NAS

Poisoning

Rheumatoid arthritis NAS

Vaccines

Vitamin D