Pharmaceutical News
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Swiss pharma giant Novartis has announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum). 13 November 2025
Pharmaceutical
Swiss pharma giant Roche could be among the best-placed drugmakers to tackle two of today’s biggest challenges in global healthcare, according to Teresa Graham, chief executive of its Pharmaceuticals division. 12 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
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US pharma major Bristol Myers Squibb—in collaboration with Johnson & Johnson—has announced the decision to stop the Phase III Librexia ACS trial evaluating the efficacy and safety of milvexian when added to the standard of care, of conventional antiplatelet therapy, for patients after a recent acute coronary syndrome (ACS) event. 14 November 2025
Pharmaceutical
TandemAI has announced that it has secured a $22 million Series A extension to further develop its drug discovery platform, which combines advanced AI, physics-based computational methods, and wet lab capabilities. 14 November 2025
Pharmaceutical
The race to find a new treatment for hair loss hotted up last month with two mega funding rounds for Pelage Pharmaceuticals and Veradermics. The deals also demonstrated biopharma’s growing interest in consumer-focused prescription products. 14 November 2025
Pharmaceutical
Merck & Co has struck a $9.2 billion deal to acquire biotechnology company Cidara Therapeutics in a move that bolsters the US pharma giant’s respiratory portfolio and pipeline as it braces for the 2028 loss of patent exclusivity for its mega blockbuster cancer drug Keytruda (pembrolizumab). 14 November 2025
Pharmaceutical
Ireland-based Avadel Pharmaceuticals today announced that it has received an unsolicited proposal from Denmark’s Lundbeck to acquire Avadel, whose shares shot up 21.7% to $19.24 in pre-market activity. 14 November 2025
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Pharmaceutical
12 November 2025 Japanese drugmaker Shionogi has announce the launch of a new formulation of the anti-influenza virus drug Xofluza (baloxavir marboxil) Granules 2%.
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.
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Pharmaceutical
Peru is emerging as one of Latin America’s most proactive countries in strengthening its regulatory system for pharmaceuticals and health products, according to a recent study published in the Peruvian journal Science, Policy and Pharmaceutical Regulation. 12 November 2025
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
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
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Pharmaceutical
Neurvati Neurosciences, the neuroscience development platform of Blackstone Life Sciences, has announced the appointment of Carlos Martin as chief commercial officer (CCO). 14 November 2025
Pharmaceutical
UK-based specialty CNS-focused pharma company CNX Therapeutics has appointed Kevan Leggett as chairman to support its growth strategy, effective November 3, 2025. 13 November 2025
Pharmaceutical
The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) today announced that Dr Richard Pazdur, has been appointed director of the Center for Drug Evaluation and Research (CDER). Dr Pazdur is a 26-year veteran of the FDA and the founding director of its Oncology Center of Excellence. 12 November 2025
Pharmaceutical
US immunology specialist Celldex has appointed Teri Lawver as senior vice president, chief commercial officer. 11 November 2025
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