Tags : ONO

Biotech

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab)

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure […]Read More

Regulatory

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L

Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for […]Read More

Insights+

PharmaShots’ Most Read News of 2019

The year 2019 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements and gaining approvals. Our team has compiled a list of 20 most read life sciences news on PharmaShots in 2019. 1. Celltrion Signed an Exclusive Co-Marketing Agreement with Juno in Australia Juno provided sales […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (December 23-27, 2019)

1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005 Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US 2. Immunomedics Reports the US FDA’s Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer Published: Dec 26, 2019 | Tags: Acceptance, BLA, FDA, Immunomedics, […]Read More

Biotech

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab)

Shots: The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in approved items of the manufacturing and marketing approval The application is based on Part 1 of P-III CheckMate -227 study assessing the combination therapy vs […]Read More

Pharma

Bayer Signs a Clinical Collaboration Agreement with BMS and Ono

Shots: Bayer, BMS and Ono collaborate to evaluate the combination of Bayer’s Stivarga (regorafenib) with BMS & Ono’s Opdivo (nivolumab) vs regorafenib in patients with micro-satellite stable mCRC The collaboration follows safety data of regorafenib as 3L monothx. in P-III CORRECT study and the efficacy data of P-I REGONIVO study evaluating the combination of regorafenib […]Read More

Pharma

ONO Signs a Research Collaboration with Repare Therapeutics for its

Shots: Repare to receive $15M upfront, $160M milestones and royalties on sales of product from ONO. Repare to get exclusive development and commercialization rights for Repare’s Polθ Inhibitor Program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries Repare will retain development and commercialization rights (ex- ONO’s territory) for Polθ Inhibitor Program in […]Read More