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Pharmaceutical
The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 14 June 2025
Pharmaceutical
The International Finance Facility for Immunization (IFFIm) has announced the settlement of its £300 million ($407 million), three-year 4.25% fixed-rate bond that was announced on June 3. 14 June 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group. 13 June 2025
Biotechnology
US immunology specialist Celldex was trading 5% higher midday Friday, following on from 10% gains on Thursday. 13 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Pharmaceutical
Germany’s Merck KGaA has presented detailed results from cohort B of the global Phase II WILLOW study of enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). 13 June 2025
Pharmaceutical
Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organization (CMO) specializing in sterile manufacture of injectable drug products, has appointed Angelika Rublack as senior business development manager to support its expanding global client base and drive growth across several territories. 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Pharmaceutical
UK pharma major GSK today revealed that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India’s Bharat Biotech International (BBIL). 13 June 2025
Pharmaceutical
Novo Nordisk late Thursday announced that it will advance subcutaneous (SC) and oral amycretin into Phase III development in weight management based on completed clinical studies and feedback received from regulatory authorities. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Biotechnology
Belgium’s largest drugmaker UCB has announced plans for a significant investment in a new, state-of-the-art biologics manufacturing facility in the USA. 13 June 2025
Pharmaceutical
The Russian pharmaceutical market is showing positive dynamics these days, despite the ever-tightening sanctions regime and the growing isolation of Russia in the international arena, reports The Pharma Letter’s local correspondent. 13 June 2025
Pharmaceutical
Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal hemoglobinuria (PNH) market and adding momentum to the oral drug’s expanding presence across rare blood and kidney disorders. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Biotechnology
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Pharmaceutical
Research services company IQVIA has unveiled new AI agents built using NVIDIA technology that are designed to enhance workflows and accelerate insights for life sciences. 12 June 2025
All news
Pharmaceutical
The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 14 June 2025
Pharmaceutical
The International Finance Facility for Immunization (IFFIm) has announced the settlement of its £300 million ($407 million), three-year 4.25% fixed-rate bond that was announced on June 3. 14 June 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group. 13 June 2025
Biotechnology
US immunology specialist Celldex was trading 5% higher midday Friday, following on from 10% gains on Thursday. 13 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Pharmaceutical
Germany’s Merck KGaA has presented detailed results from cohort B of the global Phase II WILLOW study of enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). 13 June 2025
Pharmaceutical
Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organization (CMO) specializing in sterile manufacture of injectable drug products, has appointed Angelika Rublack as senior business development manager to support its expanding global client base and drive growth across several territories. 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Pharmaceutical
UK pharma major GSK today revealed that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India’s Bharat Biotech International (BBIL). 13 June 2025
Pharmaceutical
Novo Nordisk late Thursday announced that it will advance subcutaneous (SC) and oral amycretin into Phase III development in weight management based on completed clinical studies and feedback received from regulatory authorities. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Biotechnology
Belgium’s largest drugmaker UCB has announced plans for a significant investment in a new, state-of-the-art biologics manufacturing facility in the USA. 13 June 2025
Pharmaceutical
The Russian pharmaceutical market is showing positive dynamics these days, despite the ever-tightening sanctions regime and the growing isolation of Russia in the international arena, reports The Pharma Letter’s local correspondent. 13 June 2025
Pharmaceutical
Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal hemoglobinuria (PNH) market and adding momentum to the oral drug’s expanding presence across rare blood and kidney disorders. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Biotechnology
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Pharmaceutical
Research services company IQVIA has unveiled new AI agents built using NVIDIA technology that are designed to enhance workflows and accelerate insights for life sciences. 12 June 2025
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