Pharmaceutical
Artificial Intelligence (AI) has rapidly evolved from a promising technology to a core enabler of innovation in the pharmaceutical industry. Today, AI is estimated to generate between $350 billion and $410 billion in annual value for pharmaceutical companies. 29 May 2025
Pharmaceutical
US pharma major Eli Lilly has announced a definitive agreement to acquire SiteOne Therapeutics, a private biotechnology company developing small molecule inhibitors of sodium channels to treat pain and other neuronal hyperexcitability disorders. 28 May 2025
Biotechnology
Biotech major Biogen and fellow Cambridge, USA-based City Therapeutics, today announced a strategic collaboration to develop select novel RNA interference (RNAi)-based therapies. 27 May 2025
Recent news
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
Japanese drugmaker Sumitomo Pharma and Denmark’s Novo Nordisk have entered into a co-promotion agreement in Japan for Ozempic (semaglutide) Subcutaneous Injection 2mg, a once-weekly subcutaneous GLP-1 receptor agonist indicated for the treatment of type 2 diabetes. 30 May 2025
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In Brief
Biosimilars
23 May 2025 At its May meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for three biosimilar medicines:
Biotechnology
12 May 2025 The Indian subsidiary of UK pharma major AstraZeneca has announced a Central Drugs Standard Control Organization (CDSCO) approval to import for sale and distribution of trastuzumab deruxtecan concentrate for solution for infusion 100mg for an additional indication, according to a Healthcare Radius report.
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30 May 2025 3 June 2025 Chicago, IL, McCormick Place
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16 September 2025 18 September 2025 Basel, Switzerland, Hall 1.0, Messe Basel
15 September 2025 16 September 2025 Paris, France, Maison de la Chimie
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Biotechnology
Lupus is a rare autoimmune disease characterized by chronic inflammation. It presents in four main forms: systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), drug-induced lupus, and neonatal lupus. SLE is the most common, accounting for approximately 70% of cases. Unlike CLE, which affects only the skin, SLE can involve the skin, joints, connective tissue, and internal organs.1 28 May 2025
Pharmaceutical
This week, Dr Kimberly Smith, Senior Vice President, Chief Scientific Officer, Head of Research & Development at ViiV Healthcare, provides an Expert View on how, through a deep understanding of the HIV community, the company has led the way in changing the HIV treatment and prevention paradigm. 23 May 2025
Generics
The share of generics in the Russian pharmaceutical market is steadily growing despite the efforts of the local state to create conditions for the production of original drugs, The Pharma Letter’s local correspondent reports. 22 May 2025
Pharmaceutical
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Biotechnology
Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece. 19 May 2025
Generics
Representatives of Russian patent unions have sent an appeal to the Russian Scientific Center for Expertise of Medical Products to provide a protocol for the compliance of Lantesens, a drug for the treatment for spinal muscular atrophy (SMA), which is produced by the Russian drugmaker Generium, a copy of the original drug Spinraza (nusinersen) from US biotech Biogen (Nasdaq: BIIB), reports The Pharma Letter’s local correspondent. 14 May 2025
Pharmaceutical
A Feature on M&A, VC investment, licensing and partnerships in the radiopharmaceuticals arena. 9 May 2025
One to Watch Companies
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.
One to watch
Aphaia Pharma is a clinical-stage biopharmaceutical company with headquarters in Switzerland, Canada and Puerto Rico.
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.
Boardroom
Pharmaceutical
US biotech Hillstar Bio has appointed Maude Tessier as chief operating officer and Shiva Krupa as vice president of program management, reinforcing its leadership bench ahead of a planned clinical entry for its lead autoimmune program in 2026. 29 May 2025
Biotechnology
Swedish biotech Hansa Biopharma (Nasdaq Stockholm: HNSA) is preparing to reduce its headcount by around one-fifth as part of a restructuring plan aimed at sharpening operational focus and reducing costs. The proposed layoffs, subject to mandatory consultations with trade unions in Sweden, are expected to generate annual savings of between 40 million and 50 million Swedish kronor ($4.2 million to $5.3 million). The company, headquartered in Lund, said the restructuring will involve notifying the Swedish Public Employment Service and following local labor regulations before final decisions are made. 27 May 2025
Pharmaceutical
Danish privately-held drugmaker MC2 Therapeutics today announced the appointment of Trine Ahlgreen as chief executive (CEO). 27 May 2025
Biotechnology
UK biotech Nucleome Therapeutics has appointed Bhavna Hunjan as chief business officer, a move that strengthens its leadership as it advances its pipeline of antibody therapies for inflammatory diseases. Ms Hunjan, who starts immediately, will oversee business development, strategic partnerships, and financing efforts. She joins from C4X Discovery where she played a central role in securing licensing deals and supporting capital raising. Her previous experience spans roles at Lehman Brothers, Nomura International, PwC, and Cancer Research UK. 27 May 2025
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