Hemlibra® (emicizumab-kxwh) is an antibody indicated to reduce the frequency of bleeding episodes...
- Varubi IV’s second-try FDA approval provides CINV patients with a new option
- The future of orphan drugs in Europe
- Innovative trial design: where regulators and payers divide
- Ignyta’s Entrectinib is a game-changer for NTRK/ROS1/ALK fusion-positive solid tumors
- Termination of REMS for erythropoiesis-stimulating agents marks end of an era for FDA
Sartorius Lab Instrument’s Cubis® Balance Range Meets the Cleanability Requirements of the Pharmaceutical Industry
Balances in Satorius Lan Instrument's Cubis® product range have been designed for the demanding pharmaceutical environment, which is regulated by good manufacturing practices (GMP) and good laboratory practices (GLP).
Sublocade™ for the Treatment of Opioid Use Disorder
Sublocade™ (buprenorphine extended-release) is a partial agonist indicated for the treatment of moderate-to-severe opioid use disorder (OUD) in adults.
Hemlibra® (emicizumab-kxwh) for the Treatment of Haemophilia A with Inhibitors
Hemlibra® (emicizumab-kxwh) is an antibody indicated to reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
Varubi IV’s second-try FDA approval provides CINV patients with a new option
The treatment of chemotherapy-induced nausea and vomiting (CINV) has improved significantly over the past two decades. The current standard of care is a three-drug regimen consisting of a neurokinin-1 receptor (NK1) receptor antagonist, a 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, and a corticosteroid—dexamethasone.
Innovative trial design: where regulators and payers divide
There is an increasing movement in the pharmaceutical industry away from traditional trial design as more dynamic and innovative design approaches offer new ways to demonstrate clinical effectiveness. Although these innovative trial designs have been accepted, and in some cases encouraged, by regulators, the same cannot be said for increasingly powerful payers.
Calquence (acalabrutinib) for the Treatment of Mantle Cell Lymphoma
Calquence® (acalabrutinib) is a bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL).
Zilretta (triamcinolone acetonide extended-release injectable suspension) for the Treatment of Osteoarthritis Knee Pain
Zilretta™ (triamcinolone acetonide extended-release injectable suspension) is a US Food and Drug Administration (FDA) approved extended-release intra-articular therapy indicated for the treatment of osteoarthritis knee pain.
Ignyta’s Entrectinib is a game-changer for NTRK/ROS1/ALK fusion-positive solid tumors
San Diego, California-based biotech firm Ignyta is attracting attention for its orally available central nervous system (CNS) active tyrosine kinase inhibitor, entrectinib.
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