Shots: The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs, […]Read More
Shots: The P-lll IM-UNITI LTE study involves assessing of Stelara (SC, 90mg, q8w/q12w) vs PBO as maintenance therapy in 1,281 patients with moderate to severe CD. All patients completing 44wks. were eligible to enter the LTE program, continuing their current regimen ~252wks. 50%+ patients were randomized to q8w dosing and continued to receive this dosage […]Read More
Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More
Shots: The EC’s approval is based on P-III CADMUS Jr study assessing Stelara (SC) in 44 pediatric patients with mod. to sev. PsO aged 6–11 yrs. from 9 countries. The study follows its prior P-III CADMUS study The P-III CADMUS Jr study results: @12wks. improvement in psoriasis and HrQOL; patients achieved PGA 0/1 (77.3%); PASI […]Read More
Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]Read More
Shots: The approval is based on P-III UNIFI studies (UNIFI-I & -M) assessing Stelara induction (6mg/kg, IV, for 8wks.) and maintenance therapy (90mg, SC, for 44wks.) vs PBO in patients with mod. to sev. UC with inadequate response to conventional therapies The P-III UNIFI-I & M study results: the achievement of clinical remission (19% @ […]Read More
Shots: The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies Induction study results: Clinical response achievement […]Read More
Shots: Neuclone plans for the onset of P-I clinical study for NeuLara, a Stelara’s biosimilar evaluating NeuLara vs the US & EU score of Stelara in healthy candidates in Australia under CTN scheme of TGA in H2’19 NeuLara is developed utilizing NeuMAX technology & Right from the Start development approach, analytically tested with X-ray crystallography […]Read More
Shots: The submission is based on P-III UNIFI study (had two part one induction and second maintenance) results assessing Stelara vs PBO (130 mg, 6 mg/kg) in 961 patients in ratio (1:1:1) with moderately to severely active UC for a duration of 1 year P-III UNIFI study results: clinical remission (15.6%, 15.5% vs 15.3%); endoscopic […]Read More
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