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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
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Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
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Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
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Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease vaccine candidate, VLA15, has demonstrated immunogenicity and safety as a booster shot in individuals aged between 5 and 17 years. The primary scheme resulted in seroconversion rates of 94.6% to 95.3% for all serotypes of…
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European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for a pediatric indication for its vaccine Ervebo, expanding its use as an active immunization for individuals aged 1 year or older against Ebola virus disease (EVD) caused by Zaire ebolavirus. This life-threatening condition has been…
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Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study for CU-40102 (external einasteride spray) in androgenic alopecia in China has successfully reached its primary endpoint. Study Design and Patient EnrollmentThe multi-center, randomized, double-blind, placebo-controlled Phase III regulatory study was designed to assess the efficacy…
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AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food and Drug Administration (FDA) for an indication extension of its complement inhibitor Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. The FDA has requested modifications to the drug’s…
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Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
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China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its recombinant hexavalent norovirus vaccine. This development marks a significant step forward in addressing the global health challenge posed by norovirus, which is…
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Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
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Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
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Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
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Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
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Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
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Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
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Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
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Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review status for its dexmethylphenidate hydrochloride sustained release capsules, which are being developed for potential pediatric use. The molecule is intended to treat attention deficit hyperactivity disorder (ADHD) in children. Phase III Clinical Study and EfficacyThe…
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Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
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US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents…
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CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
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Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
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Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
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China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical studies for PaiEnJiaBin, a Category 1 chemical drug co-developed with the Shanghai Institute of Materia Medica. PaiEnJiaBin is a next-generation KCNQ potassium channel agonist, with no similar products approved globally, and is being developed to…
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MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, in minors aged between 9 and 15 years old. The results indicate that the immunogenicity generated by the vaccine persisted for 10 years after the third and final…
