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Astellas Pharma Partners with Kelonia Therapeutics to Advance CAR-T Cell Therapies
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Astellas Pharma Inc. (TYO: 4503) has announced a strategic research collaboration and licensing agreement with U.S.-based biotech company Kelonia Therapeutics. The partnership, established through Astellas’ subsidiary Xyphos Biosciences, will leverage Kelonia’s proprietary in vivo gene placement system (iGPS) to engineer advanced lentiviral particles for targeted genetic delivery, in conjunction with…
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Denali Therapeutics Faces Setback as ALS Trial Fails to Meet Primary Endpoint
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Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its RIPK1-targeted small-molecule drug for amyotrophic lateral sclerosis (ALS). The drug, developed in partnership with France-based Sanofi Inc. (NASDAQ: SNY), failed to meet the primary endpoint in the Phase II HIMALAYA study, which assessed the change…
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China’s NMPA Releases 77th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 77th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking another step in ensuring the quality and consistency of generic medications in the country. This batch includes 62 new specifications and 30 modified specifications for generic drugs, with…
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GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
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The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart (dutasteride) has been given the green light to resume import, sales, and use in China, effective from September 1, 2023. This follows a previous suspension due to an unsuccessful overseas site inspection by the NMPA…
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National Health Commission Notification Signals New Poliovirus Containment Measures
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The National Health Commission (NHC) has issued a notification announcing the establishment of the National Authority for Containment (NAC), a new body dedicated to poliovirus management. This initiative comes in response to the significant global progress made since the World Health Organization (WHO) launched its polio eradication campaign in 1988,…
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China’s NHC Approves 2023 Large Medical Equipment Configuration Licenses, Targets Cancer Treatment
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The National Health Commission (NHC) has granted approval for the Class A large medical equipment configuration licenses for the year 2023. This includes the installation of heavy ion proton radiation therapy systems in 21 hospitals and high-end radiation therapy equipment in 17 hospitals. In March 2023, the NHC issued the…
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Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of…
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US Lawmakers Call for Sanctions Against WuXi AppTec and WuXi Biologics Over National Security Concerns
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US politicians have intensified their opposition to China’s biotech industry, with Congressmen and Senators sending a letter to the White House Administration, directly calling for sanctions against WuXi AppTec (SHA: 603259) and its affiliate WuXi Biologics (HKG: 2269). As reported by Reuters, the letter was signed by four lawmakers: Congressmen…
