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Biotechnology
US gene therapy biotech Tern Therapeutics has announced its launch and closing of a $15 million financing. 28 August 2024
Biotechnology
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
Pharmaceutical
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024
Pharmaceutical
Spending on hospital medicine in Denmark increased by just under 6% in the first half of 2024, compared to the first six months of the year in 2023. 27 August 2024
Pharmaceutical
Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have agreed to merge, with the goal of focusing on the development of Trappsol Cyclo (hydroxypropyl beta cyclodextrin). 23 August 2024
Biotechnology
BridgeBio Pharma (Nasdaq: BBIO) has announced the formation of a new joint venture, GondolaBio, in collaboration with a syndicate of prominent investors. 22 August 2024
Biotechnology
Avidity Biosciences (Nasdaq: RNA) has successfully closed its previously announced public offering, raising approximately $345.1 million. 19 August 2024
Biotechnology
USA-based biotech Tiziana Life Sciences today announced the appointment of Ivor Elrifi as its chief executive (CEO), effective immediately. 19 August 2024
Biotechnology
Last week’s research news included US biotech Avidity Biosciences releasing strong early-stage trial results for its Duchenne muscular dystrophy (DMD) candidate delpacibart zotadirsen (AOC 1044). On the regulatory front, the US Food and Drug Administration (FDA) approved Ascendis Pharma’s hypoparathyroidism drug Yorvipath. The FDA also granted approval for Gilead Sciences’ seladelpar, now trade-named Livdelzi, for the treatment of the rare liver disease PCB. Also of significant importance, the US Centers for Medicare and Medicaid Services (CMS) last week selected 10 drugs for the first cycle of negotiations for pricing under the Inflation Reduction Act (IRA). 18 August 2024
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has announced that the US medicines regulator will consider vimseltinib under the Priority Review scheme. 16 August 2024
Pharmaceutical
US rare diseases focused biotech Quince Therapeutics today announced the online publication of data in The Lancet Neurology from its Phase III ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem clinical trial evaluating the safety and efficacy of its lead asset, EryDex. 15 August 2024
Pharmaceutical
Th US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare liver disease, said Gilead Sciences 15 August 2024
Biotechnology
Japanese drugmaker Chugai Pharmaceutical has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for gene therapy delandistrogene moxeparvovec, for the treatment of Duchenne muscular dystrophy (DMD). 15 August 2024
Pharmaceutical
Swiss drugmaker Santhera Pharmaceuticals today announced the closing of two financing agreements that provided the company with gross funding totaling around 69 million francs ($80.2 million). 13 August 2024
Pharmaceutical
In a major boost to the domestic pharmaceutical industry, the Indian government has approved the manufacture of eight orphan drugs. 12 August 2024
Biotechnology
Avidity Biosciences saw is shares close up more than 12% at $46.95, after it announced positive AOC 1044 5mg/kg data demonstrated unsurpassed delivery of phosphorodiamidate morpholino oligomers (PMO) concentrations to skeletal muscle in Duchenne muscular dystrophy (DMD) patients. 10 August 2024
Pharmaceutical
US biopharma Apellis Pharmaceuticals and partner Swedish Orphan Biovitrum have announced positive topline results from the Phase III VALIANT study. 9 August 2024
Biotechnology
Australian biotech Neuren Pharmaceuticals today announced top-line results from its Phase II clinical trial of NNZ-2591. 9 August 2024
Biotechnology
US gene therapy biotech Tern Therapeutics has announced its launch and closing of a $15 million financing. 28 August 2024
Biotechnology
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
Pharmaceutical
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024
Pharmaceutical
Spending on hospital medicine in Denmark increased by just under 6% in the first half of 2024, compared to the first six months of the year in 2023. 27 August 2024
Pharmaceutical
Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have agreed to merge, with the goal of focusing on the development of Trappsol Cyclo (hydroxypropyl beta cyclodextrin). 23 August 2024
Biotechnology
BridgeBio Pharma (Nasdaq: BBIO) has announced the formation of a new joint venture, GondolaBio, in collaboration with a syndicate of prominent investors. 22 August 2024
Biotechnology
Avidity Biosciences (Nasdaq: RNA) has successfully closed its previously announced public offering, raising approximately $345.1 million. 19 August 2024
Biotechnology
USA-based biotech Tiziana Life Sciences today announced the appointment of Ivor Elrifi as its chief executive (CEO), effective immediately. 19 August 2024
Biotechnology
Last week’s research news included US biotech Avidity Biosciences releasing strong early-stage trial results for its Duchenne muscular dystrophy (DMD) candidate delpacibart zotadirsen (AOC 1044). On the regulatory front, the US Food and Drug Administration (FDA) approved Ascendis Pharma’s hypoparathyroidism drug Yorvipath. The FDA also granted approval for Gilead Sciences’ seladelpar, now trade-named Livdelzi, for the treatment of the rare liver disease PCB. Also of significant importance, the US Centers for Medicare and Medicaid Services (CMS) last week selected 10 drugs for the first cycle of negotiations for pricing under the Inflation Reduction Act (IRA). 18 August 2024
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has announced that the US medicines regulator will consider vimseltinib under the Priority Review scheme. 16 August 2024
Pharmaceutical
US rare diseases focused biotech Quince Therapeutics today announced the online publication of data in The Lancet Neurology from its Phase III ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem clinical trial evaluating the safety and efficacy of its lead asset, EryDex. 15 August 2024
Pharmaceutical
Th US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare liver disease, said Gilead Sciences 15 August 2024
Biotechnology
Japanese drugmaker Chugai Pharmaceutical has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for gene therapy delandistrogene moxeparvovec, for the treatment of Duchenne muscular dystrophy (DMD). 15 August 2024
Pharmaceutical
Swiss drugmaker Santhera Pharmaceuticals today announced the closing of two financing agreements that provided the company with gross funding totaling around 69 million francs ($80.2 million). 13 August 2024
Pharmaceutical
In a major boost to the domestic pharmaceutical industry, the Indian government has approved the manufacture of eight orphan drugs. 12 August 2024
Biotechnology
Avidity Biosciences saw is shares close up more than 12% at $46.95, after it announced positive AOC 1044 5mg/kg data demonstrated unsurpassed delivery of phosphorodiamidate morpholino oligomers (PMO) concentrations to skeletal muscle in Duchenne muscular dystrophy (DMD) patients. 10 August 2024
Pharmaceutical
US biopharma Apellis Pharmaceuticals and partner Swedish Orphan Biovitrum have announced positive topline results from the Phase III VALIANT study. 9 August 2024
Biotechnology
Australian biotech Neuren Pharmaceuticals today announced top-line results from its Phase II clinical trial of NNZ-2591. 9 August 2024
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