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Merck Initiates Phase 3 Clinical trial for PCSK9 Inhibitor MK-0616
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Merck Initiates Phase 3 Clinical trial for PCSK9 Inhibitor MK-0616
29 August 2023
Merck has today made public the launch of the company's Phase 3 clinical trials, labeled as CORALreef, for MK-0616, a potential oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.
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Positive Results of Phase III Clinical Trials for Bavarian's Chikungunya Virus Vaccine PXVX0317
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Positive Results of Phase III Clinical Trials for Bavarian's Chikungunya Virus Vaccine PXVX0317
10 August 2023
On August 8, 2023, Bavarian Nordic announced positive top-line results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of its Chikungunya virus candidate vaccine, CHIKV VLP (PXVX0317), in adults and adolescents aged 12 to 64.
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Vistagen's new drug, Fasedienol, reaches Phase 3 clinical trial endpoint, alleviating social anxiety disorder
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Vistagen's new drug, Fasedienol, reaches Phase 3 clinical trial endpoint, alleviating social anxiety disorder
10 August 2023
On August 8, 2023, Vistagen announced the positive top-line results of the PALISADE-2 Phase 3 clinical trial, which assessed the efficacy and safety of its investigational fasedienol (PH94B, Aloradine) nasal spray in adult patients with social anxiety disorder (SAD).
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AstraZeneca has agreed to pay Bristol-Myers Squibb $510 million to resolve patent disputes
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AstraZeneca has agreed to pay Bristol-Myers Squibb $510 million to resolve patent disputes
4 August 2023
On August 1, 2023, AstraZeneca has reached an agreement to pay $510 million to BMS to resolve patent lawsuit over its PD-L1 mAb Imfinzi (Durvalumab) and CTLA-4 mAb Imjudo (Tremelimumab).
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The oral TNF-α drug MYMD-1 of MyMD Pharmaceuticals has reached phase 2 clinical end points
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The oral TNF-α drug MYMD-1 of MyMD Pharmaceuticals has reached phase 2 clinical end points
3 August 2023
On August 1, 2023, MyMD Pharmaceuticals announced that the oral Tumor Necrosis Factor-α (TNF-α) inhibitor MYMD-1 achieved statistically significant positive results in a Phase 2 randomized clinical trial (NCT05283486).
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Sumitomo Dainippon Pharma/Otsuka Pharmaceutical announced that two Phase III studies of Ulotaront did not meet the primary endpoints
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Sumitomo Dainippon Pharma/Otsuka Pharmaceutical announced that two Phase III studies of Ulotaront did not meet the primary endpoints
3 August 2023
On July 31, 2023, Sumitomo Dainippon Pharma and Otsuka Pharmaceutical jointly announced that their two Phase III studies, DIAMOND 1 and DIAMOND 2, for ulotaront (SEP-363856) in the treatment of acute schizophrenia did not meet the primary endpoints.
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Astellas files NDA in China for CLDN18.2-targeted new drug Zolbetuximab
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Astellas files NDA in China for CLDN18.2-targeted new drug Zolbetuximab
3 August 2023
On August 1, 2023, the official website of the Chinese Drug Evaluation Center (CDE) shows that the new drug application (NDA) for Zolbetuximab injection developed by Astellas has been accepted for review.
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GSK's PD-1 inhibitor Dostarlimab combined with chemotherapy for the treatment of dMMR endometrial cancer receives FDA approval
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GSK's PD-1 inhibitor Dostarlimab combined with chemotherapy for the treatment of dMMR endometrial cancer receives FDA approval
3 August 2023
Dostarlimab is the first immunotherapy approved by the FDA to be used in combination with chemotherapy for the first-line treatment of this patient population.
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Checkpoint announces latest clinical trial data for PD-L1 inhibitor cosibelimab
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Checkpoint announces latest clinical trial data for PD-L1 inhibitor cosibelimab
2 August 2023
Checkpoint Therapeutics announced the long-term data obtained in its key study on the PD-L1 inhibitor cosibelimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC).
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Astellas and PeptiDream enter into collaboration to develop next-generation Protein Degradation Drugs
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Astellas and PeptiDream enter into collaboration to develop next-generation Protein Degradation Drugs
28 July 2023
On July 26, 2023, Astellas and PeptiDream announced that they have entered into a research collaboration and licensing agreement to discover innovative protein degradation drugs for two targets selected by Astellas.
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FDA approves Tarsus new drug Xdemvy for the treatment of demodex blepharitis
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FDA approves Tarsus new drug Xdemvy for the treatment of demodex blepharitis
28 July 2023
On July 26, 2023, Tarsus Pharmaceuticals announced that the U.S. FDA has approved Xdemvy (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis.
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Boehringer Ingelheim & Eli Lilly's SGLT2 inhibitor Empagliflozin obtains new indication approval in the European Union
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Boehringer Ingelheim & Eli Lilly's SGLT2 inhibitor Empagliflozin obtains new indication approval in the European Union
27 July 2023
Empagliflozin is the first Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor to statistically significantly reduce the risk of hospitalization for any cause compared to a placebo in patients with CKD.
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