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South Africa’s Competition Commission Investigates J&J for MDR-TB Drug Pricing and Evergreening
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The Competition Commission of South Africa has announced an investigation into Johnson & Johnson (J&J; NYSE: JNJ) concerning allegations of profiteering on the multidrug-resistant tuberculosis (MDR-TB) drug Sirturo (bedaquiline) and employing evergreening practices to extend its patent until 2027. Investigation Details and Pricing ConcernsThe government currently pays ZAR 5,400 (USD…
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Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
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China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD). Study Design and OutcomesThe Phase III study was a double-blind,…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled…
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Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
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BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
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China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
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