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CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
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China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its Support Anti-tumor drugs R&D for Kids (SPARK) project within one month. This initiative marks a significant step forward in promoting the development of pediatric antitumor drugs. Project BackgroundThe SPARK project is a pilot effort in…
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Jointown Pharmaceutical Partners with Shandong DYNE to Boost Pediatric Drug Distribution
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Jointown Pharmaceutical Group Co., Ltd (SHA: 600998), China’s largest private pharmaceutical distributor, has partnered with Shandong DYNE Marine Biopharmaceutical Co., Ltd., a state-owned firm specializing in pediatric medications. The collaboration aims to integrate Jointown’s nationwide logistics network with DYNE’s R&D expertise in pediatric drugs. Jointown’s Distribution EdgeJointown operates a logistics…
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Zhaoke Ophthalmology’s NVK002 ANDA Accepted for Review by China’s NMPA
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the National Medical Products Administration (NMPA) has accepted for review the Abbreviated New Drug Application (ANDA) for NVK002, an atropine external use eye solution aimed at pediatric myopia progression. NVK002: A Novel Ophthalmic…
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Johnson & Johnson Submits sBLA to FDA for Simponi in Pediatric Ulcerative Colitis
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US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for its drug Simponi (golimumab), seeking approval to treat children aged two years and older with moderately to severely active ulcerative colitis…
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Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
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US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. This approval expands their indications to include specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and…
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MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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Yunnan Province Increases Pediatric Medical Service Prices for Children Under 6
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The Yunnan Provincial Healthcare Security Administration and the Health Commission of Yunnan Province have issued a notification to implement a policy that allows for increased pricing on certain pediatric medical services for children under the age of 6 in public medical institutions, effective from October 10, 2024. This policy aims…
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NHC Releases Updated List of Pediatric Drugs for Research and Development Incentives
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The National Health Commission (NHC) has issued a notification regarding the fifth batch of pediatric drugs encouraged for research and development. The list includes 15 varieties, encompassing systemic anti-infective drugs, respiratory system medications, anti-tumor drugs, and immune modulators. This edition features 25 specifications and 8 dosage forms, and is notable…
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Takeda Prepares to File Dengue Fever Vaccine for US Approval, Expanding Global Regulatory Reach
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Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly preparing to submit its dengue fever vaccine for regulatory approval in the United States, according to the Nikkei Asian Review. At this juncture, specifics regarding the timing of the filing or the anticipated decision date…
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Servier’s Voranigo Receives FDA Nod for IDH Inhibitor as Brain Tumor Treatment
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The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade…
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Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
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Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Misses Late-Stage Trial Endpoints
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Pfizer Inc. (NYSE: PFE) has announced that a late-stage clinical trial for its investigational gene therapy, fordadistrogene movaparvovec, in children aged 4 to 7 with Duchenne muscular dystrophy (DMD) failed to meet its primary endpoint of improving motor function. Additionally, secondary endpoints related to motor function showed no significant improvement…
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AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
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RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
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RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has secured marketing approval from the National Medical Products Administration (NMPA) for pitolisant, its in-licensed drug candidate. The histamine 3 (H3) receptor antagonist/inverse agonist is now approved for treating excessive daytime sleepiness (EDS) or cataplexy in…
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Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
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Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
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Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
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This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year. In…
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Wanbangde Pharmaceutical’s Huperzine A Earns FDA Rare Pediatric Disease Designation for HIE Treatment
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced that its subsidiary, Wanbangde Pharmaceutical Group, has received a rare pediatric disease (RPD) designation from the US Food and Drug Administration (FDA) for its drug huperzine A. This designation is for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE), a…
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Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical trial for its antimalarial drug Coartem (artemether + lumefantrine) in infants with uncomplicated Plasmodium falciparum malaria. The trial data indicates that the tablet formulation meets pharmacokinetic (PK), efficacy, and safety requirements, achieving the primary PK…
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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
