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Biotechnology
28 March 2025 The interleukin-2 (IL-2) therapies market in the USA is poised for major growth, projected to reach $4 billion by 2034, according to research from DelveInsight.
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Biotechnology
Japanese drugmaker Ono Pharmaceutical today revealed that it has entered into a drug discovery collaboration agreement with fellow Japan-based Reborna Biosciences to generate ribonucleic acid (RNA)-targeting novel small molecule in the field of central nervous system. 31 March 2025
Biotechnology
US pharma major Eli Lilly has unveiled new Phase II data showing that its RNA-based therapy lepodisiran produced significant and lasting reductions in levels of lipoprotein(a), a known genetic risk factor for cardiovascular disease. 31 March 2025
Biotechnology
Australian medicines regulator, the Therapeutic Goods Administration (TGA), has granted approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. 31 March 2025
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for Evrysdi Tablets 5mg, a new formulation of the spinal muscular atrophy (SMA) treatment risdiplam. 31 March 2025
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the USA for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). 31 March 2025
Biotechnology
Cambridge, USA-based Anthos Therapeutics presented two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. 31 March 2025
Pharmaceutical
Novartis announced late Friday that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. 31 March 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. 31 March 2025
Generics
The Danish Medicines Agency's new analysis shows that generic prescribing will not necessarily lead to financial savings or increased patient safety. 31 March 2025
Biotechnology
Brii Biosciences has reported promising interim results from its Phase II ENSURE study of elebsiran, a hepatitis B therapeutic, in combination with pegylated interferon, reinforcing its strategy to identify patients more likely to benefit from curative therapies. 31 March 2025
Pharmaceutical
The US government is reclaiming over $11 billion in unspent public health funds originally allocated during the COVID-19 emergency, a move that has drawn sharp criticism from lawmakers and public health advocates who warn it will weaken the country’s ability to respond to future health threats and disrupt essential care services. 31 March 2025
Pharmaceutical
Pharma trade group Medicines Australia has welcomed the government’s announcement of an increase in its investment in the health the nation. 31 March 2025
Pharmaceutical
Novo Nordisk has reported new Phase IIIb data showing its GLP-1 drug semaglutide, in both oral and injectable forms, led to significant health benefits in adults with type 2 diabetes facing cardiovascular complications. 31 March 2025
Pharmaceutical
Last week’s deal-making news included US biotech Alumis signing a licensing agreement with Japan’s Kaken Pharma for its dermatology candidate ESK-001 in Japan. On the regulatory front, US biotech Exelixis gained Food and Drug Administration (FDA) approval for its Cabometyx as a treatment for advanced neuroendocrine tumors. Among research news, Wave Life Sciences released positive Phase II data on its investigational Duchenne muscular dystrophy drug WVE-N531, while Equillium reported disappointing Phase III results for its graft-versus-host disease candidate itolizumab. 30 March 2025
Biotechnology
US gene therapy company bluebird bio has confirmed receipt of an unsolicited non-binding written proposal from Ayrmid Pharma to acquire the company for up to $110.5 million 29 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three biosimilars for approval at its March 2025 meeting. 28 March 2025
Pharmaceutical
Cardiovascular-focused Milestone Pharmaceuticals was trading more than 60% lower early in trading on Friday, with its share price worth less than $0.90. 28 March 2025
Pharmaceutical
Danish pharma major Novo Nordisk has taken another step in its strategy to maintain dominance in the obesity space by adding complementary mechanisms to pair with its blockbuster bGLP-1 franchise. 28 March 2025
Biotechnology
Japan’s Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. 28 March 2025
Pharmaceutical
German life sciences and pharma company Merck KGaA today revealed it has exercised its option with China’s Abbisko Therapeutics for commercialization of pimicotinib in the US and rest of world. 28 March 2025
All news
Biotechnology
Japanese drugmaker Ono Pharmaceutical today revealed that it has entered into a drug discovery collaboration agreement with fellow Japan-based Reborna Biosciences to generate ribonucleic acid (RNA)-targeting novel small molecule in the field of central nervous system. 31 March 2025
Biotechnology
US pharma major Eli Lilly has unveiled new Phase II data showing that its RNA-based therapy lepodisiran produced significant and lasting reductions in levels of lipoprotein(a), a known genetic risk factor for cardiovascular disease. 31 March 2025
Biotechnology
Australian medicines regulator, the Therapeutic Goods Administration (TGA), has granted approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. 31 March 2025
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for Evrysdi Tablets 5mg, a new formulation of the spinal muscular atrophy (SMA) treatment risdiplam. 31 March 2025
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the USA for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). 31 March 2025
Biotechnology
Cambridge, USA-based Anthos Therapeutics presented two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. 31 March 2025
Pharmaceutical
Novartis announced late Friday that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. 31 March 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. 31 March 2025
Generics
The Danish Medicines Agency's new analysis shows that generic prescribing will not necessarily lead to financial savings or increased patient safety. 31 March 2025
Biotechnology
Brii Biosciences has reported promising interim results from its Phase II ENSURE study of elebsiran, a hepatitis B therapeutic, in combination with pegylated interferon, reinforcing its strategy to identify patients more likely to benefit from curative therapies. 31 March 2025
Pharmaceutical
The US government is reclaiming over $11 billion in unspent public health funds originally allocated during the COVID-19 emergency, a move that has drawn sharp criticism from lawmakers and public health advocates who warn it will weaken the country’s ability to respond to future health threats and disrupt essential care services. 31 March 2025
Pharmaceutical
Pharma trade group Medicines Australia has welcomed the government’s announcement of an increase in its investment in the health the nation. 31 March 2025
Pharmaceutical
Novo Nordisk has reported new Phase IIIb data showing its GLP-1 drug semaglutide, in both oral and injectable forms, led to significant health benefits in adults with type 2 diabetes facing cardiovascular complications. 31 March 2025
Pharmaceutical
Last week’s deal-making news included US biotech Alumis signing a licensing agreement with Japan’s Kaken Pharma for its dermatology candidate ESK-001 in Japan. On the regulatory front, US biotech Exelixis gained Food and Drug Administration (FDA) approval for its Cabometyx as a treatment for advanced neuroendocrine tumors. Among research news, Wave Life Sciences released positive Phase II data on its investigational Duchenne muscular dystrophy drug WVE-N531, while Equillium reported disappointing Phase III results for its graft-versus-host disease candidate itolizumab. 30 March 2025
Biotechnology
US gene therapy company bluebird bio has confirmed receipt of an unsolicited non-binding written proposal from Ayrmid Pharma to acquire the company for up to $110.5 million 29 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three biosimilars for approval at its March 2025 meeting. 28 March 2025
Pharmaceutical
Cardiovascular-focused Milestone Pharmaceuticals was trading more than 60% lower early in trading on Friday, with its share price worth less than $0.90. 28 March 2025
Pharmaceutical
Danish pharma major Novo Nordisk has taken another step in its strategy to maintain dominance in the obesity space by adding complementary mechanisms to pair with its blockbuster bGLP-1 franchise. 28 March 2025
Biotechnology
Japan’s Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. 28 March 2025
Pharmaceutical
German life sciences and pharma company Merck KGaA today revealed it has exercised its option with China’s Abbisko Therapeutics for commercialization of pimicotinib in the US and rest of world. 28 March 2025
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