Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. PharmaShots is keeping a track of all of the important updates in the Lifesciences sector, where […]Read More
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
Shots: The approval is based on P-III FeDeriCa study which involves assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab, IV) & Herceptin (trastuzumab, IV) + CT in 500 patients with HER2+ve early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings evaluated PK, efficacy, and safety The study met its […]Read More
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
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
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
Shots: Gilead will price its COVID-19 treatment at $390/ vial in the US and other developed countries, with a 5days treatment course of 6 vials costing $2340/ patient while the price for private insurance companies will be $520/ vial Pricing the remdesivir at low value ensures the broad and equitable access for the therapy during […]Read More
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
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
Shots: The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with […]Read More
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