-
ArkBio Partners with SDODT to Boost ADHD Treatment Marketing and Commercialization
•
Shanghai Ark Biopharmaceutical Co., Ltd (ArkBio), a Chinese biopharmaceutical company, has entered into a partnership with SDODT, a domestic innovator in digital therapeutics technology. The collaboration aims to enhance the marketing and commercialization efforts for products targeting Attention Deficit Hyperactivity Disorder (ADHD) treatment. ADHD is a prevalent chronic neurodevelopmental disorder…
-
Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
•
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand,…
-
BMS’s Yervoy-Opdivo Combo on Track for Breakthrough Therapy Designation in China for CRC
•
The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive…
-
Beijing Tinavi Medical Technologies to Form Radiotherapy Equipment JV with IM INNO and Celestial Oncology
•
Beijing Tinavi Medical Technologies Co., Ltd (SHA: 688277) has announced its intention to establish a joint venture (JV) with IM INNO and Celestial Oncology Inc. The new entity is to be capitalized with RMB 30.7 million (USD 4.4 million) for registration purposes. The joint venture is intended to concentrate its…
-
Pfizer’s RSV Vaccine Demonstrates Durable Efficacy with Abrysvo Phase III Results
•
Pfizer Inc. (NYSE: PFE) last week reported the outcomes of a Phase III trial for its respiratory syncytial virus (RSV) bivalent vaccine, Abrysvo, in adults aged 60 and above following the second RSV season. The vaccine’s efficacy against RSV-associated lower respiratory tract disease (LRTD) experienced a decline from 88.9% in…
-
Biden’s Executive Order May Restrict Data Access for China-Based Life Science Firms in the US
•
US President Joe Biden last week issued an Executive Order titled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern,” which may present new challenges for China-based life science companies operating in the United States. The order is designed to curb the…
-
Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
•
The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
-
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
•
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
