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Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
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China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia…
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Apeloa Pharmaceutical Expands Global Footprint with Apeloa Europe GmbH in Germany
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China-based contract development and manufacturing organization (CDMO) Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced an investment of USD 2 million to establish a wholly owned subsidiary, Apeloa Europe GmbH, in Germany. This strategic move is aimed at deepening the company’s globalization strategy, expanding its global market presence, and enhancing…
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AbbVie Acquires Mitokinin, Advancing PINK1 Activator for Parkinson’s Disease
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AbbVie (NYSE: ABBV) has announced the acquisition of US-based biotechnology company Mitokinin, exercising an exclusive right obtained in 2021. The acquisition was contingent upon the successful completion of pre-clinical studies on Mitokinin’s lead program, a potential first-in-class PINK1 activator for the treatment of Parkinson’s disease (PD). Details of the AcquisitionAbbVie…
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Shanghai BDgene’s BD112 Earns Orphan Drug Designation from US FDA for Huntington’s Disease
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Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has announced that its drug candidate BD112, which utilizes virus-like particle (VLP) delivery technology for in vivo gene editing, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). This follows a previous ODD granted by…
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AstraZeneca Alum Yu Yuping Appointed Vice-President at Merck KGaA’s China Unit
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Yu Yuping, a seasoned professional with a distinguished career at AstraZeneca (AZ, NASDAQ: AZN), has reportedly taken on a new role at German pharmaceutical giant Merck KGaA (ETR: MRK). He has been appointed as the vice-president of Merck’s China medicine and health business, where he will lead the Cardiovascular, Metabolic,…
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AffaMed Technologies Secures Exclusive Rights to SIFI’s Intraocular Lens Products in Greater China
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AffaMed Technologies, a joint venture between China’s AffaMed Therapeutics and Italy-based SIFI S.p.A., has announced a significant licensing agreement with the SIFI Group. This deal grants AffaMed exclusive rights to manufacture, develop, and commercialize SIFI’s range of intraocular lens (IOL) products in the Greater China region. The financial details of…
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Simcere Pharmaceutical Secures Exclusive Rights to AnDiCon’s Anti-Influenza Candidate ADC189
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced a strategic collaboration agreement with domestic firm AnDiCon Bio. The collaboration centers on AnDiCon’s pipeline candidate, ADC189, with Simcere now holding exclusive commercialization rights for the drug in China. ADC189: A Novel Anti-Influenza TreatmentADC189 is an innovative anti-influenza polymerase acidic protein (PA)…
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J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial
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Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs). Trial…
