Month: June 2020

Biosimilars Regulatory

Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for

Shots: CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019 The CHMP’s opinion is based on data evaluating the PK, efficacy and safety between CT-P13 SC to CT-P13 IV […]Read More

Pharma Regulatory

AstraZeneca and MSD’s Selumetinib Receive MHLW’s Orphan Drug Designation for

Shots: The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs The P-I/II SPRINT Stratum 1 study demonstrated a reduction in the size of tumors with 66% ORR in children. AstraZeneca and MSD are co-developing and co-commercializing selumetinib which received the US FDA’s approval […]Read More

Biotech COVID-19

Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First

Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV. The company anticipate initiating the clinical studies in July’2020 The DCGI’s approval is based on preclinical data demonstrating safety and immune response. The SARS-CoV-2 strain was isolated in NIV & transferred to […]Read More

MedTech

Abbott Integrates its CGM Technology with Tandem’s Insulin Delivery System

Shots: The companies collaborated to develop & commercialize integrated diabetes solutions that combine Abbott’s FreeStyle Libre CGM technology with Tandem’s t:slim X2 pump to improve diabetes management In Oct’2019, the two companies collaborated to their technologies for monitoring glucose without fingersticks while the current agreement covers the technical development of device integration and its commercial […]Read More

Biosimilars Regulatory

Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Receives CHMP’s Positive Opinion to

Shots: The CHMP has recommended the approval of Aybintio in the EU to treat mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. The EC will review the CHMP’s positive opinion to grant marketing authorization for the therapy The MAA is based on analytical, PK, clinical data, pharmacology, and […]Read More

Biosimilars Regulatory

Kyowa Kirin’s FKB327 (biosimilar, adalimumab) Receives the MMA Approval in

Shots: FKB327 (biosimilar, adalimumab) is an injectable medication that involves inhibition of Tumor Necrosis Factor (TNF) blocks the inhibition of activity, thereby reducing inflammation and other disease symptoms including RA, plaque psoriasis, Crohn’s disease, and ulcerative colitis In 2018, Fujifilm signed an agreement with Mylan to commercialize biosimilar adalimumab in EU and will expand it […]Read More