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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Biotechnology
Research news last week featured US CRIPR genome-editing company Caribou Biosciences announcing positive early data on its Hodgkin lymphoma candidate vispacabtagene regedleucel (vispa-cell). US biotech start-up Braveheart Bio raised $185 million to support development of its cardiomyopathy candidate BHB-1893. Eli Lilly last week said it would move its obesity candidate eloralintide into Phase III following positive Phase II results. Lilly also inked a deal with the US government to reduce patient costs for obesity drugs including Zepbound and orforglipron. 9 November 2025
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
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Pharmaceutical
The US Department of Health and Human Services (HHS) has warned that more than 32,000 of its staff could be furloughed if Congress fails to avert a federal government shutdown this week, raising the risk of disruption across public health and medical research. 30 September 2025
Pharmaceutical
China-Belgium biotech Full-Life Technologies has raised $77 million through a mix of $50 million series C equity and $27 million debt financing. The cash will accelerate its radiopharmaceutical pipeline and fund completion of a manufacturing plant in Gembloux, Belgium. Total financing since its 2021 launch now approaches $200 million. 30 September 2025
Biotechnology
San Diego, USA-based biotech AnaptysBio saw its shares climb by 10.4% to $25.70 in pre-market trading, following its announcement to split into two separate publicly traded companies, each poised for strong, sustainable growth. 30 September 2025
Biotechnology
US drugmaker AbbVie has announced plans to launch Elahere (mirvetuximab soravtansine-gynx) in the UK at a list price equal to the USA. 30 September 2025
Biotechnology
US biotech Star Therapeutics, which is developing best-in-class antibodies for bleeding disorders and other diseases, today announced an oversubscribed $125 million Series D financing. 30 September 2025
Biotechnology
Privately-held French biotech focused on providing immuno-therapeutics Biomunex Pharmaceuticals today announced a capital increase and the investment from new shareholders in equity, actively supporting its growth trajectory and accelerating the development of its portfolio, particularly its MAIT engagers. 30 September 2025
Pharmaceutical
Shares in Enanta Pharmaceuticals, a US biotech creating small molecule drugs for viral infections and immunological diseases, closed 92% higher Monday. 30 September 2025
Biotechnology
US obesity firm Metsera has presented new data that demonstrates why pharma giant Pfizer is paying up to $7.3 billion to buy the company in an acquisition announced last week. 30 September 2025
Biotechnology
Shares of US clinical-stage biotech Dogwood Therapeutics soared a massive 43% to $7.91 yesterday, on the news it has secured a royalty free, global license to develop Serpin Pharma’s intravenous (IV) formulation of SP16 to manage cancer related pain (CRP) including a broad range of chemotherapy induced neuropathy symptoms. 30 September 2025
Biotechnology
US eye disease specialist Kala Bio saw its shares close down almost 90% at $2.04 yesterday, after it revealed disappointing trial results for its KPI-012. 30 September 2025
Pharmaceutical
President Donald Trump has called on US industries to put America first, and the biopharmaceutical sector is answering that call with major actions to demonstrate its commitment to American patients and workers. 30 September 2025
Biotechnology
Boston, USA-based biotech Cue Biopharma has announced the appointment of Dr Usman Azam as its new president and chief executive (CEO), supporting the company’s advancement of its first-in-class tolerogenic drug candidate CUE-401 for autoimmune diseases, among other priorities. 30 September 2025
Biotechnology
Japanese drugmaker Eisai and US biotech major Biogen have presented new clinical data from a post-hoc sub-group analysis of the Clarity AD, open-label extension (OLE) study. 30 September 2025
Pharmaceutical
For years, rare diseases were seen as a safe harbor for biotech and pharma: small patient populations, little competition, and robust pricing that payers accepted. That era is ending. The orphan drug market is becoming more crowded, contested, and expensive, as payers and regulators demand more evidence and large pharma reshapes the economics. 30 September 2025
Pharmaceutical
US health technology body ICER will review the comparative clinical effectiveness and value of four COVID-19 vaccines: Pfizer and BioNTech’s Comirnaty, Moderna’s Spikevax and mNexspike, and Novavax’s Nuvaxovid. The study will assess both short- and long-term effects of infection, with findings due for discussion in June 2026. 30 September 2025
Pharmaceutical
Since my first job in healthcare over 25 years ago to my current role within Gilead UK&I, I have seen time and time again that women still face real and lasting barriers to fair access to healthcare. Listening closely to colleagues, advocates and patients has deepened my understanding of the scale, complexity and deep-rooted nature of these inequities and has only reinforced my belief in how much work still lies ahead to address them. 30 September 2025
Biotechnology
Danish pharma major Novo Nordisk has announced two updates in a single day on filings to the US Food and Drug Administration (FDA). 29 September 2025
Biotechnology
With US President Donald Trump pushing pharma to put America first and reduce US drug prices, which are much higher than anywhere else in the developed world, domestic and other drugmakers have been attracted to a new scheme to sell their medicines direct to consumers/patients, thus avoiding the substantial margins taken by middlemen. 29 September 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Tremfya (guselkumab) to treat children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). 29 September 2025
Pharmaceutical
Dutch clinical Contract Research Organization (CRO) Julius Clinical today announced the appointment of Bassem Saleh as its new chief executive (CEO). 29 September 2025
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