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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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Sciwind Biosciences Co., Ltd has received a significant boost as the National Medical Products Administration (NMPA) has accepted its filing for review of another indication for ecnoglutide. The Chinese biopharmaceutical company is now seeking NMPA’s approval for the use of its drug in long-term weight management for adult patients, complementing…
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China-based Everest Medicines (HKG: 1952) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Velsipity (etrasimod), a treatment for moderate to severe active ulcerative colitis (UC). Velsipity’s Mechanism and Licensing BackgroundVelsipity is a once-daily, oral medication that functions as…
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN2350 in the patient-centered rare disease drug development pilot program, known as the Care Plan. The public has until December 23 to provide feedback on the notice. ALXN2350: A Potential Treatment for…
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to terminate the clinical development of vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, following recent disappointing data from Phase III trials. Discontinuation of Vibostolimab TrialsThe Phase III KeyVibe-003 and KeyVibe-007 studies, which were assessing…
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for its in-house developed VUM02 for injection, receiving approval from the National Medical Products Administration (NMPA) in China to study the treatment of decompensated cirrhosis and obtaining Orphan Drug Designation (ODD) from the Food and Drug…
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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 (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed with the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) has received a complete response letter (CRL). The application sought approval for the treatment of patients…
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Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its innovative drug GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%). The Chinese company is seeking approval for the drug to treat Demodex blepharitis, a condition…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
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The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel)…
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its DTcP vaccine, designed for infants and young children under the age of 2. Quality Consistency and Market GapThe DTcP vaccine, a component…
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The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) co-developed by China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) and the UK pharmaceutical major GSK (NYSE: GSK). This PRIME designation follows Breakthrough Therapy Designations (BTDs) received in the United States…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The CHMP recommends conditional approval for adult patients with von Hippel-Lindau (VHL) disease…
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Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), the German pharmaceutical company announced last week. ATTR-CM and the Impact of AcoramidisATTR-CM is a rare disease…
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine product, neffy (epinephrine nasal spray) 2 mg, have been submitted by its licensing partners in China, Japan, and Australia. Neffy’s Role in Treating Type I Allergic ReactionsNeffy is indicated for the emergency treatment of Type…