Complete response letters (CRLs) were issued by the FDA recently for two biosimilar...
Zepatier for the Treatment of Chronic Hepatitis C GT1 and GT4 Infection
Zepatier is a once-daily, oral selective combination of nonstructural 5A (NS5A) replication complex inhibitor elbasvir (50mg) and non-structural 3/4A protease inhibitor grazoprevir (100mg).
Afinitor Disperz (everolimus) for the Treatment of TSC-Associated Partial-Onset Seizures
Afinitor Disperz® (everolimus) is indicated for the treatment of tuberous sclerosis complex (TSC) associated partial-onset seizures in adult and paediatric patients.
Rubraca (rucaparib) for the Treatment of Advanced Ovarian Cancer
Poly adenosine diphosphate ribose polymerase (PARP) inhibitor Rubraca® (rucaparib) is indicated for the treatment of breast cancer susceptibility gene (BRCA) mutation-linked advanced ovarian cancer.
May’s top news stories
Abivax unveiled new data that may suggest its clinical candidate ABX464 could be a safe, functional cure for human immunodeficiency virus (HIV), as well as a method to treat inflammatory diseases; and Cancer Research UK and Experimental Cancer Medicine Centres (ECMC) Network joint venture (JV) Combinations Alliance started the SeluDex trial, a Phase I clinical study to evaluate selumetinib in combination with dexamethasone for treating leukaemia.
Parsabiv™ (etelcalcetide) for the Treatment of Secondary Hyperparathyroidism (SHPT)
Parsabiv™ (etelcalcetide) is an intravenous injectable calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) that were previously treated with haemodialysis.
US biosimilar setbacks highlight difficulty of cost-effective development
Complete response letters (CRLs) were issued by the FDA recently for two biosimilar versions of Roche’s Rituxan—first to Celltrion and Teva on April 9 for Truxima and then to the Sandoz division of Novartis on May 3 for Rixathon, over two months ahead of its Prescription Drug User Fee Act (PDUFA) date, effectively stalling rituximab biosimilar development in the US.
POINT trial may increase clopidogrel use in secondary ischemic stroke prevention
Aspirin is still the standard of care (SoC) in the US for patients with non-cardioembolic acute ischemic stroke (AIS) and transient ischemic attack (TIA) to reduce the risk of recurrence. Another antiplatelet drug, clopidogrel, which is sold by Sanofi under the brand name Plavix, is routinely prescribed in combination with aspirin in China.
FDA approves first non-opioid treatment for opioid withdrawal
The US Food and Drug Administration (FDA) has announced its approval of Lucemyra (lofexidine hydrochloride), the first non-opioid medication intended for the reduction of withdrawal symptoms associated with opioid use disorder (OUD) in adults, enabling patients’ discontinuation of opioid treatments.
Barriers impede biosimilar market entry into the US
Back in 2010, the FDA implemented the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act (ACA), which created an abbreviated pathway for biosimilar drug approval.
Ocrevus (ocrelizumab) for the Treatment of Multiple Sclerosis
Ocrevus (ocrelizumab) is a humanised monoclonal antibody indicated for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
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