Category : Regulatory

Sandoz’s Zessly (infliximab) Receives EU Approval for Gastroenterological, Rheumatological And

Vartika Singh May 24, 2018

Shots: The approval is based on non-inferiority and P-III REFLECTIONS B537-02 study results assessing Zessly vs reference drug and demonstrated meeting 1EPs with safety, efficacy and quality Zessly is 3rd EC approval in 12 mos. and 6th biosimilar approval for Sandoz Zessly (infliximab) is a mAb, blocks the action of tumor necrosis factor (TNF)-alpha in […]Read More

Regulatory

BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in

Vartika Singh May 24, 2018

Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase-pqpz, 20mg qd or 40mg qd) in patients in ratio (2:1) with high level of phenylalanine (Phe) The P-III PRISM-2 study resulted in maintaining blood Phe level vs PBO in patients Palynziq (pegvaliase-pqpz, SC) is an enzyme substitution therapy of phenylalanine hydroxylase (PAH) […]Read More

Regulatory

AstraZeneca’s Lokelma Receives FDA’s Approval for Patients with Hyperkalaemia in

Vartika Singh May 18, 2018

Shots: The approval is based on five studies assessing Lokelma vs PBO in patients with hyperkalaemia The study resulted in onset of action was at 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, 92% of patients achieved normal potassium level in 48 hrs. and was effective […]Read More

Regulatory

Amgen’s Aimovig (erenumab-aooe) Receives FDA’s Approval for Prevention of Migraine

Vartika Singh May 17, 2018

Shots: The approval is based on P-IIIb LIBERTY (NCT03096834) study results assessing Aimovig (140mg) vs PBO for duration of 12 weeks The study resulted in 50% reduction of monthly migraine days sustained up to 15 months with the use of acute migraine drugs Aimovig (erenumab-aooe) is a novel drug used for targeting Calcitonin Gene-Related Peptide […]Read More

Regulatory

Helsinn’s (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced

Vartika Singh April 20, 2018

Shots: The approval is based on two clinical studies results assessing Akynzeo (NEPA) vs Palonosetron in patients with CINV across 80 centers in 11 countries The two clinical studies Trial 1 (NCT#02557035) & Trial 2 (NCT # 02517021) indicated benefits & side effect of Akynzeo in 440 & 404 patients respectively Akynzeo is a combination […]Read More

Regulatory

Roche’s Hemlibra Receives FDA’s Breakthrough Therapy Designation for Hemophilia A

Tuba Khan April 17, 2018

Shots: The FDA’s BT designation is based on P-III HAVEN 3 study assessing Hemlibra vs no prophylaxis in 152 patients in ratio (2:2:1) with hemophilia A + prior treated with factor VIII therapy aged>12years The P-III HAVEN 3 study results: reduction in treated bleeds; superior to prior factor VIII prophylaxis; no thrombotic microangiopathy; no new […]Read More

Regulatory

Mylan and Biocon’s Semglee Receives EU Approval for Patients with

Vartika Singh March 28, 2018

Shots: The approval is based on CHMP (EMA) recommendation, reviewed by EU for diabetic patients In 2009, Mylan and Biocon globally collaborated to jointly develop multiple generic biologic compounds Semglee is a prefilled 100unit/ml 3ml disposable pen, approved in Australia by TGA and in EU including Norway, Iceland and Liechtenstein for patients with diabetes with […]Read More

Biosimilars Regulatory

Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation

Vartika Singh March 23, 2018

Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, toxicology data with efficacy, safety and immunogenicity in patients ABP 980 (trastuzumab) is a recombinant DNA-derived mIgG1 kappa Ab indicated for HER2-overexpressing early BC, adjuvant […]Read More

Regulatory

Proteostasis’ PTI-428 Receives FDA’s Breakthrough Therapy Designation for Cystic Fibrosis

Tuba Khan March 12, 2018

Shots: The FDA’s BT designation is based on P-II study results assessing PTI-428 (50 mg, qd) vs PBO in 24 CF with F508del mutation on background treatment with Orkambi for 28 days The P-II study results: improvement in forced expiratory volume in 1 second (ppFEV1) 5.2%; increase in nasal mucosal CFTR protein Proteostasis’ PTI-428 is […]Read More

Regulatory Uncategorized

Rigel Pharmaceuticals’ Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for

Vartika Singh March 6, 2018

Shots: The approval is based on three FIT studies results assessing Tavalisse (100/150mg, bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1 The FIT studies result: FIT-1 (NCT02076399) stable platelets response (SPR) (18% vs 0%); FIT-2 (NCT02076412) SPR (16% vs 4%); FIT-3 (23%) Tavalisse (fostamatinib disodium hexahydrate, PO) is a spleen tyrosine […]Read More

Takeda Signs an Exclusive License Agreement with Ovid for Soticlestat to Treat Dravet Syndrome and Lennox-Gastaut Syndrome

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

UCB Collaborates with Microsoft to Accelerate Drug Discovery and Development

Biocon Biologics and Viatris Receive CHMP’s Positive Opinion for Abevmy (biosimilar, bevacizumab)

Samsung Bioepis Initiates P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

Category : Regulatory

Sandoz’s Zessly (infliximab) Receives EU Approval for Gastroenterological, Rheumatological And

BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in

AstraZeneca’s Lokelma Receives FDA’s Approval for Patients with Hyperkalaemia in

Amgen’s Aimovig (erenumab-aooe) Receives FDA’s Approval for Prevention of Migraine

Helsinn’s (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced

Roche’s Hemlibra Receives FDA’s Breakthrough Therapy Designation for Hemophilia A

Mylan and Biocon’s Semglee Receives EU Approval for Patients with

Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation

Proteostasis’ PTI-428 Receives FDA’s Breakthrough Therapy Designation for Cystic Fibrosis

Rigel Pharmaceuticals’ Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for

Latest Posts

Insights+ Key Biosimilars Events of February 2021

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Category : Regulatory

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