Pharmaceutical
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. 6 November 2025
Biotechnology
California-based Azalea Therapeutics, a biotech promising to redefine precision genomic medicines in vivo, has announced its official launch and completion of $82 million in seed and Series A financing to advance its proprietary enveloped delivery vehicle (EDV) technology. 5 November 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Belgium drugmaker UCB’s Kygevvi (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. 4 November 2025
Pharmaceutical
The rulebook for rare disease treatments will be overhauled to make it quicker and easier to get these therapies tested, manufactured and approved in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced in a new paper supporting the ambitions of the government's life sciences strategy. 3 November 2025
Pharmaceutical
US pharma giant Pfizer revealed on Friday that it has filed a lawsuit against Metsera, its board of directors, and Denmark’s Novo Nordisk in the Delaware Court of Chancery. 1 November 2025
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A biopharma company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology.
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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
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Pharmaceutical
1 November 2025 The US Food and Drug Administration (FDA) on Friday posted an update to let industry know that the agency can still accept submissions for fiscal year 2026 that do not require a fee payment and for which FDA review work is covered by available carryover user fee funding.
Pharmaceutical
28 October 2025 French pharma major Sanofi this morning revealed that it has successfully priced its offering of $3 billion of notes across 5 tranches:
Conferences
17 October 2025 21 October 2025 Berlin, Germany, Messe Berlin
9 December 2025 11 December 2025 London, UK, Savoy Place
3 December 2025 5 December 2025 Sydney, Australia, University of Sydney
25 November 2025 27 November 2025 Greater Noida, India, India Expo Centre
24 November 2025 25 November 2025 London, UK, Kensington Conference & Events Centre
18 November 2025 19 November 2025 Vienna, Austria, Hotel Savoyen
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Pharmaceutical
The pharmaceutical industry is experiencing a seismic shift in regulatory transparency as the US Food and Drug Administration (FDA) implements its most ambitious disclosure initiative to date. 3 November 2025
Generics
India’s GLP-1 drug market is poised for explosive growth, outpacing global trends and positioning domestic pharma giants to challenge multinational dominance. 3 November 2025
Pharmaceutical
Pharmacovigilance (PV) is a crucial process used by pharmaceutical companies, healthcare professionals and regulators in identifying, evaluating and preventing adverse drug reactions. 3 November 2025
Pharmaceutical
In the last week on the regulatory front, the European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), completed its 27-30 October session and decided to issue a targeted professional communication on injectable forms of tranexamic acid, signalling increased risk-management attention across the EU. 3 November 2025
Pharmaceutical
Sales of drugs against dementia are steadily growing in Russia these days, as the number of patients who suffer from the disease is also growing, The Pharma Letter’s local correspondent reports. 29 October 2025
Pharmaceutical
The European Medicines Agency (EMA) and its Committee for Medicinal Products for Human Use (CHMP) set the pace in Europe, with the CHMP issuing strong recommendations — one for the first-ever treatment for non-cystic fibrosis bronchiectasis and another confirming a suspension for a sickle-cell-disease medicine. 29 October 2025
Pharmaceutical
Russia is facing a sharp growth of drug price these days due to a record inflation and the ever-deteriorating business environment, reports The Pharma Letter’s local correspondent. 28 October 2025
One to Watch Companies
One to watch
A privately-held French biotech advancing a clinical pipeline of gamma delta T-cell-focused antibodies for cancer and autoimmune diseases.
One to watch
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
One to watch
Privately-held GAIA is focused on the development of evidence-based, safe and accessible AI-powered digital therapeutics (DTx) that help patients restore and maintain their mental and physical health.
One to watch
Exsilio Therapeutics is developing genomic medicines that can be delivered in lipid nanoparticles to durably and safely treat a broad range of diseases, including genetic diseases, cancer, and autoimmune conditions.
Boardroom
Pharmaceutical
Belgian biopharma company UCB (Euronext: UCB) has announced a leadership reshuffle, effective January 1, 2026, as part of a plan to reinforce cross-functional collaboration and sustain growth. The move will see Fiona du Monceau become executive vice president and chief commercial officer, while Emmanuel Caeymaex will transition to head of patient evidence. 7 November 2025
Biotechnology
US mRNA-based therapeutics company Strand Therapeutics has announced the promotion of Prashant Nambiar to chief scientific officer and appointment of Ethan Cash as senior vice president, head of portfolio management and program development. 6 November 2025
Pharmaceutical
UK biotech Slingshot Therapeutics, part of the Syncona Accelerator, has expanded its senior team with the appointments of John Isaac as chief scientific officer and Bobby Soni as chief business officer. The move supports the company’s strategy to advance early-stage academic research into drug candidates ready for clinical development. 4 November 2025
Biotechnology
SOTIO Biotech, a Czech clinical-stage biopharma owned by PPF Group, today announced the promotion of Dr Vivi Boura, an accomplished oncologist with extensive experience leading the clinical development of novel cancer therapies, to chief medical officer (CMO). 4 November 2025
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