Biotech | May 29, 2022
USFDA approves two Opdivo-based regimens
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
HK inno.N Corporation will be responsible for the manufacture and supply of Tegoprazan, while Dr. Reddy's will handle local clinical development, registration, marketing and sales
It is the first hospital in the country to achieve the significant milestone of completing over 2600 robotic surgeries for treating patients with prostate, kidney and urinary bladder cancer
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Daewoong delivered KRW 1.055 trillion in sales, KRW 95.5 billion in operating profit and KRW 40.5 billion in net profit.
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
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