Latest Pharma and Biotech News
Pharmaceutical
6 November 2025 Arena BioWorks, a privately funded biomedical research institute that aimed to overhaul the traditional drug discovery model, has closed its doors less than two years after its $500 million launch. The decision follows what its founding investor group called “dramatic changes” in biotech market conditions, with no clear recovery in sight.
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Pharmaceutical
The last week or so has seen an escalation of the bidding war for US obesity-focused Metsera, with counter bids and law suits galore, but now that battle is over. 8 November 2025
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer’s extension to the licence of the Abrysvo (respiratory syncytial virus vaccine (bivalent, recombinant) to include the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18-59 years of age who are at increased risk for lower respiratory tract disease caused by RSV. 8 November 2025
Pharmaceutical
Biopharma company Pelthos Therapeutics has acquired the US commercialization rights to Xepi (ozenoxacin) Cream, 1%, from Biofrontera and Ferrer Internacional. 7 November 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). 7 November 2025
Biotechnology
Danish biotech Genmab reported a 25% rise in its total revenue to $1.02 billion during the third quarter of 2025, ahead of analysts’ expectations for $966 million. 7 November 2025
Pharmaceutical
German pharma major Bayer announced new Phase III investigational data from the pivotal FINE-ONE trial showing that Kerendia (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001). 7 November 2025
Pharmaceutical
US pharma major Eli Lilly has partnered with chipmaker NVIDIA to develop an AI supercomputer for pharmaceutical research, a collaboration that GlobalData says could transform how medicines are discovered and developed. The project will accelerate molecular simulations, protein analysis, and large-scale AI model training to shorten the R&D cycle. 7 November 2025
Pharmaceutical
Healthcare giant Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. 7 November 2025
Pharmaceutical
US pharma major Eli Lilly has announced an agreement with the US government to expand access to its obesity medicines and reduce patient costs. 7 November 2025
Pharmaceutical
Danish pharma major Novo Nordisk has presented new post-hoc analyses from the Phase III REDEFINE 1 trial evaluating CagriSema (cagrilintide/semaglutide), an investigational injectable combination treatment for overweight or obese adults, and effects on well-known cardiovascular (CV) risk factors, including hypertension and systemic inflammation. 7 November 2025
Pharmaceutical
Danish diabetes and obesity drug giant Novo Nordisk has agreed with the US Administration to lower drug prices beginning in 2026 and expand patient access and affordability for its GLP-1 semaglutide medicines, including Wegovy and Ozempic, in the USA. 7 November 2025
Pharmaceutical
The global endometrial cancer market is on course for steady expansion, projected to reach nearly $39 billion by 2030. Growth is being fueled by rising incidence rates linked to aging populations, obesity, and metabolic conditions, alongside expanding use of targeted and immuno-oncology therapies in key regions, particularly the USA. 7 November 2025
Pharmaceutical
The USA’s Centers for Medicare & Medicaid Services (CMS) is tackling high drug prices and protecting the American taxpayers through a landmark Innovation Center initiative designed to lower prescription drug spending in Medicaid, improve health outcomes by increasing access to critical medications, and strengthen the Medicaid program overall. 7 November 2025
Pharmaceutical
Belgian biopharma company UCB has announced a leadership reshuffle, effective January 1, 2026, as part of a plan to reinforce cross-functional collaboration and sustain growth. 7 November 2025
Pharmaceutical
The Russian government has proposed a new mechanism for subsidization of works for development of new drugs, reports The Pharma Letter’s local correspondent. 7 November 2025
Pharmaceutical
Eli Lilly is preparing to start Phase III trials of its experimental obesity therapy eloralintide by year-end, following Phase II results that showed weight reductions of up to 20% over 48 weeks. The once-weekly injection was well-tolerated, strengthening confidence in Lilly’s expanding obesity portfolio. 7 November 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca closed Thursday’s trading 3% higher, as investors digested its third quarter financial results. 6 November 2025
Biosimilars
South Korea’s Samsung Bioepis. has signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of Pyzchiva, a biosimilar to J&J’s Stelara (ustekinumab), in Europe. The terms of the agreement remain confidential. 6 November 2025
Biotechnology
US biopharma company Ultragenyx Pharmaceutical today announced the sale, for $400 million, of an additional 25% of the company’s royalty interest from Kyowa Kirin on the future sales of Crysvita (burosumab) in the USA and Canada to OMERS, one of Canada’s largest defined benefit pension plans. 6 November 2025
Biotechnology
Swiss inflammatory diseases specialist MoonLake Immunotherapeutics has announced the pricing of a $75 million underwritten offering. 6 November 2025
All news
Pharmaceutical
The last week or so has seen an escalation of the bidding war for US obesity-focused Metsera, with counter bids and law suits galore, but now that battle is over. 8 November 2025
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer’s extension to the licence of the Abrysvo (respiratory syncytial virus vaccine (bivalent, recombinant) to include the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18-59 years of age who are at increased risk for lower respiratory tract disease caused by RSV. 8 November 2025
Pharmaceutical
Biopharma company Pelthos Therapeutics has acquired the US commercialization rights to Xepi (ozenoxacin) Cream, 1%, from Biofrontera and Ferrer Internacional. 7 November 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). 7 November 2025
Biotechnology
Danish biotech Genmab reported a 25% rise in its total revenue to $1.02 billion during the third quarter of 2025, ahead of analysts’ expectations for $966 million. 7 November 2025
Pharmaceutical
German pharma major Bayer announced new Phase III investigational data from the pivotal FINE-ONE trial showing that Kerendia (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001). 7 November 2025
Pharmaceutical
US pharma major Eli Lilly has partnered with chipmaker NVIDIA to develop an AI supercomputer for pharmaceutical research, a collaboration that GlobalData says could transform how medicines are discovered and developed. The project will accelerate molecular simulations, protein analysis, and large-scale AI model training to shorten the R&D cycle. 7 November 2025
Pharmaceutical
Healthcare giant Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. 7 November 2025
Pharmaceutical
US pharma major Eli Lilly has announced an agreement with the US government to expand access to its obesity medicines and reduce patient costs. 7 November 2025
Pharmaceutical
Danish pharma major Novo Nordisk has presented new post-hoc analyses from the Phase III REDEFINE 1 trial evaluating CagriSema (cagrilintide/semaglutide), an investigational injectable combination treatment for overweight or obese adults, and effects on well-known cardiovascular (CV) risk factors, including hypertension and systemic inflammation. 7 November 2025
Pharmaceutical
Danish diabetes and obesity drug giant Novo Nordisk has agreed with the US Administration to lower drug prices beginning in 2026 and expand patient access and affordability for its GLP-1 semaglutide medicines, including Wegovy and Ozempic, in the USA. 7 November 2025
Pharmaceutical
The global endometrial cancer market is on course for steady expansion, projected to reach nearly $39 billion by 2030. Growth is being fueled by rising incidence rates linked to aging populations, obesity, and metabolic conditions, alongside expanding use of targeted and immuno-oncology therapies in key regions, particularly the USA. 7 November 2025
Pharmaceutical
The USA’s Centers for Medicare & Medicaid Services (CMS) is tackling high drug prices and protecting the American taxpayers through a landmark Innovation Center initiative designed to lower prescription drug spending in Medicaid, improve health outcomes by increasing access to critical medications, and strengthen the Medicaid program overall. 7 November 2025
Pharmaceutical
Belgian biopharma company UCB has announced a leadership reshuffle, effective January 1, 2026, as part of a plan to reinforce cross-functional collaboration and sustain growth. 7 November 2025
Pharmaceutical
The Russian government has proposed a new mechanism for subsidization of works for development of new drugs, reports The Pharma Letter’s local correspondent. 7 November 2025
Pharmaceutical
Eli Lilly is preparing to start Phase III trials of its experimental obesity therapy eloralintide by year-end, following Phase II results that showed weight reductions of up to 20% over 48 weeks. The once-weekly injection was well-tolerated, strengthening confidence in Lilly’s expanding obesity portfolio. 7 November 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca closed Thursday’s trading 3% higher, as investors digested its third quarter financial results. 6 November 2025
Biosimilars
South Korea’s Samsung Bioepis. has signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of Pyzchiva, a biosimilar to J&J’s Stelara (ustekinumab), in Europe. The terms of the agreement remain confidential. 6 November 2025
Biotechnology
US biopharma company Ultragenyx Pharmaceutical today announced the sale, for $400 million, of an additional 25% of the company’s royalty interest from Kyowa Kirin on the future sales of Crysvita (burosumab) in the USA and Canada to OMERS, one of Canada’s largest defined benefit pension plans. 6 November 2025
Biotechnology
Swiss inflammatory diseases specialist MoonLake Immunotherapeutics has announced the pricing of a $75 million underwritten offering. 6 November 2025
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