Shots: The approval is based on P-III NEURO-TTR study trial assessing Tegsedi vs PBO in 172 patients in ratio (2:1) with hATTR amyloidosis with symptoms of polyneuropathy The study resulted […]readmore
Tags : receives
Shots: Hemlibra’s approval is based on results of P-III HAVEN 3 study assessing Hemlibra qw or q2w vs no prophylaxis and HAVEN 4 study assessing Hemlibra q4w, in patients aged […]readmore
Shots: Novo Nordisk’s Tresiba has received an approval for indication expansion by Health Canada for the treatment of pediatric patients (>2 years of age) with Type 1 diabetes The expanded […]readmore
Shots: The approval is based on results of ongoing P-III CONVERT study conducted at 18 countries with 125 sites assessing Arikayce + guideline-based therapy (GBT) vs GBT alone with refractory […]readmore
Regulatory
Paratek Pharmaceuticals’ Nuzyra (omadacycline) Receives FDA Approval for Community-Acquired Bacterial
Shots: The approval is based on multiple trial study assessing Nuzyra and resulted in safe, efficacious and well tolerated results Nuzyra (omadacycline) is a qd IV PO tetracycline class antibacterial […]readmore
Shots: The approval is based on the results of P-II EMPOWER-CSCC-1 study and P-I study 1423 (two advanced CSCC expansion cohorts) assessing Libtayo in patients with mCSCC, locally advanced CSCC […]readmore
Shots: The approval is based on P-III ARCHER 1050 study assessing Vizimpro 45mg vs Gefitinib 250mg in a ratio (1:1) in patients with unresectable, mNSCLC harboring EGFR, exon 19 deletion […]readmore
Shots: The approval is based on DUO (NCT02004522) & DYNAMO (NCT01882803) study results assessing Copiktra (25msg bid) vs ofatumumab or rituximab and to either CT or radioimmunotherapy in 319 adults […]readmore
Shots: • CHMP approval is based on two P-III trials i.e. DRIVE-AHEAD and DRIVE-FORWARD assessing (Delstrigo vs efavirenz (EFV)/emtricitabine (FTC)/TDF) and (Pifeltro vs darunavir +ritonavir +FTC/TDF/abacavir (ABC)/3TC)) for 48 wks., […]readmore
Biosimilars
Regulatory
Biocon and Mylan Fulphila (pegfilgrastim, Neulasta biosimilar) Receives CHMP (EMA)
Shots: Post FDA approval in H1’18, CHMP has recommended Fulphila based on its biosimilarity data assessing Fulphila vs Neulasta (Amgen’s biosimilar) in patients with Neutropenia and demonstrated non-inferiority data in […]readmore