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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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China-based MicroPort NeuroTech Limited (HKG: 2172) has announced its commitment to invest RMB 200 million (USD 27.46 million) to jointly establish an investment fund aimed at fostering the development of the brain science and brain-Inspired Intelligence industry, aligning with MicroPort NeuroTech’s strategic future direction. Collaboration with Other InvestorsJoining MicroPort NeuroTech…
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US-based Candid Therapeutics Inc. is fulfilling its ambition to become a leader in advancing T-cell engagers (TCEs) for B-cell depletion to treat autoimmune diseases, with the signing of Chinese firms Nona Biosciences and EpimAb Biotherapeutics, Inc., as well as compatriot firm Ab Studio, Inc., in a single day to strengthen…
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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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China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its existing license agreement with Costa Rican partner SteinCares, which was initially struck in March of this year. Under the revised accord, SteinCares will gain exclusive rights to distribute and market the new biosimilar in Brazil…
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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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Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0 has received CE certification. This marks a significant advancement in the Swiss company’s polymerase chain reaction (PCR) technology. Optimizing Laboratory Efficiency with cobas 6800/8800 Systems 2.0The new cobas 6800/8800 Systems 2.0 update represents a major…
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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…
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Quantum Hi-Tech (China) Biotechnology Co., Ltd, known as ChemPartner (SHE: 300149), is poised to raise a significant amount of capital through a private share placement. The company plans to issue 149,389,197 shares at a price of RMB 6.23 per share, which is expected to yield over RMB 930 million (USD…
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US pharmaceutical company AbbVie (NYSE: ABBV) has reached an agreement to acquire Swiss pharmaceutical giant Roche’s (SWX: ROG) peptide discovery spinout, Nimble Therapeutics, in a deal initially valued at USD 200 million in cash. This strategic acquisition is aimed at strengthening AbbVie’s immunology product pipeline. Acquisition Highlights and Nimble’s Lead…