Therapeutic Areas
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"Specialty drugs, rare/orphan drugs, and biologics are changing the healthcare system."
The regulatory hurdle for specialty drugs is decreasing, driven by new expedited access pathways like breakthrough status in the US and adaptive pathways in the EMA.
The payer hurdle is increasing in that reimbursement authorities are requiring higher patient values; driven by escalating costs and budgetary pressures
Allergy and Asthma:
allergic asthma, allergies, chronic urticaria
Anti-Infectives:
antibiotics (community and nosocomial-acquired, resistant infections), antifungals, hepatitis B and C, human immunodeficiency virus infection, influenza, vaccinations
Autoimmune:
ankylosing spondylitis, Crohn’s disease, psoriasis, rheumatoid arthritis, solid organ transplantation, systemic lupus erythematosus
Blood Products/Hematology:
anticoagulation, deep vein thrombosis, dialysis/hemofiltration, hemodynamic monitoring, hemophilia A and B (with and without inhibitors), von Willebrand disease
Cardiovascular:
atherosclerosis, atrial fibrillation and cardioversion, dyslipidemia, heart failure, hypertension, pulmonary embolism, stents, stroke, thrombocytopenia, valve repair
Dermatology:
acne vulgaris, actinic keratosis, botulinum toxin injections, cosmetic dermal fillers, head lice, rosacea
Diabetes and Endocrinology:
acromegaly, continuous glucose monitoring, Cushing’s disease, pediatric growth hormone deficiency, type 1 & 2 diabetes mellitus
Gastroenterology:
chronic idiopathic constipation, diverticulitis, gastroesophageal reflux disease, irritable bowel syndrome, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), obesity, opioid-induced constipation, paralytic ileus
Men’s Health:
benign prostatic hyperplasia, erectile dysfunction
Neurology and Pain:
agitation in Alzheimer’s dementia, diabetic peripheral neuropathy, epilepsy, fibromyalgia, insomnia, migraine, multiple sclerosis, narcolepsy, neuropathic pain, Parkinson disease, postherpetic neuralgia, substance use/abuse
Oncology:
angiogenesis, bladder, breast (HER2+/-, triple negative, resistant), colorectal, glioblastoma, hepatic, melanoma, multiple myeloma/ myeloproliferative neoplasms, non-small cell lung cancer, ovarian, prostate, renal, and lymphoma/leukemia; chemotherapy-induced nausea, chemotherapy-induced neutropenia
Ophthalmology:
chronic dry eye, diabetic retinopathy, glaucoma, macular degeneration, ocular allergies
Psychiatry:
major depressive disorder, schizophrenia/ schizoaffective disorder; suicidal ideation
Rare Diseases:
Alagille syndrome, biliary atresia, Morquio A syndrome
Respiratory/Pulmonary Medicine:
acute respiratory distress syndrome, chronic obstructive pulmonary disease, neonatal respiratory distress syndrome, surfactant aerosol replacement
Urology:
overactive bladder, stress and urge urinary incontinence, urinary tract infections
Women’s Health:
bacterial vaginosis, contraception, endometrial hyperplasia, hormone replacement therapy, hypoactive sexual desire disorder, menopause, osteoporosis