15 April 2025 Shares in Johnson & Johnson were 1% lower in the early stages of Tuesday’s trading after the US health conglomerate presented its first-quarter 2025 financial results.
Kallyope’s latest obesity drug trial results show modest weight-loss effects that lag behind competing therapies in the increasingly competitive obesity treatment market. 28 February 2025
Neurocrine Biosciences has announced positive results from its Phase IV KINECT-PRO study, showing that Ingrezza (valbenazine) provided meaningful and sustained benefits for patients with tardive dyskinesia (TD). 28 February 2025
Rare Disease Day, held annually on 28th February, raises awareness of people living with rare diseases across the world, their families, and their carers. The key aims of the campaign are to achieve equitable access to diagnosis, treatment, and social opportunity for those affected by rare diseases. 28 February 2025
Berlin, Germany-based radioisotopes specialist Eckert & Ziegler today announced a comprehensive strategic partnership with the USA’s Bicycle Therapeutics, which is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology. 27 February 2025
The government of Ukraine plans to increase public procurements of drugs this year and to make them more affordable for local population despite the current tough business environment in the country and the ongoing war with Russia, reports The Pharma Letter’s local correspondent. 27 February 2025
A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage lst. 27 February 2025
French biotech start-up studio Argobio and non-profit biomedical research center the Institut Pasteur have announced the launch of Enodia Therapeutics. 26 February 2025
US pharma major Eli Lilly plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical manufacturing sites in the USA, involving new investment of $27 billion. 26 February 2025
Danish dermatology specialist LEO Pharma has announced results showing a strong performance in 2024, with both sales growth and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) margin ahead of the initial outlook for the year. 26 February 2025
Neurodevelopmental disorders company GRIN Therapeutics, an affiliate of the Blackstone Life Sciences portfolio company Neurvati Neurosciences, has announced a major milestone. 26 February 2025
Chicago, USA-based Emalex Biosciences announced positive top-line data from its Phase III registrational study of ecopipam, a novel dopamine-1 receptor antagonist, in subjects with Tourette syndrome. 26 February 2025
Cardiovascular diseases specialist Kiniksa Pharmaceuticals International has announced updates to its pipeline alongside fourth quarter and full year 2024 financial results. 26 February 2025
Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically-significant and clinically-meaningful improvement in the primary endpoint of progression-free survival (PFS). 26 February 2025
Privately-held BridGene Biosciences has announced a strategic collaboration and licensing agreement with Japan’s Takeda (TYO: 4502). The new deal expands on their initial 2021 partnership, valued at around $500 million, centered on chemoproteomics-based approaches to address "undruggable" targets. 26 February 2025
Israel-headquartered Teva Pharmaceutical Industries’ US subsidiary and France’s Medincell announced that the supplemental New Drug Application (sNDA) for Uzedy (risperidone) extended-release injectable suspension for the maintenance treatment of bipolar-I (BP-I) in adults has been accepted for filing by the US Food and Drug Administration (FDA). 26 February 2025
The US Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase Ib multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. 25 February 2025
Dutch specialty pharma firm Norgine Pharmaceuticals has entered into a definitive agreement to acquire Theravia, a French pharmaceutical company specializing in cutting-edge treatments for patients with rare and debilitating conditions from Mérieux Equity Partners. 16 April 2025
German biotech HepaRegeniX has raised 21.5 million euros ($23 million) in new funding to support the clinical development of its lead candidate, HRX-215, a first-in-class treatment aimed at enhancing liver regeneration. 15 April 2025
Danish pharma major Novo Nordisk says that it has become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside its authorized supply chain in the USA. 15 April 2025
Cambridge, USA-based biotech Oak Hill Bio, which is focused on acquiring and developing life-changing rare disease therapeutics, has entered into an exclusive license agreement with Roche to obtain global rights for rugonersen (RO7248824). 15 April 2025
Shares in Johnson & Johnson were 1% lower in the early stages of Tuesday’s trading after the US health conglomerate presented its first-quarter 2025 financial results. 15 April 2025
New research from consultancy Vital Transformation has shown the effects of US policy the Inflation Reduction Act’s (IRA) drug pricing provisions on biopharmaceutical investment, research and development (R&D). 15 April 2025
US pharma major Bristol Myers Squibb yesterday disclosed that its Phase III ODYSSEY-HCM trial of Camzyos (mavacamten) did not meet its primary endpoints for treating non-obstructive hypertrophic cardiomyopathy (nHCM). 15 April 2025
Japan’s RaQualia Pharma has announced the termination of the license agreement regarding a retinoic acid receptor agonist (tamibarotene/TM-411/SY-1425, between the USA’s Syros Pharmaceuticals and TMRC Co, a consolidated subsidiary of RaQualia. 14 April 2025
US pharma giant Pfizer has announced that it is discontinuing development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. 14 April 2025
The Dutch Healthcare Authority (NZa) has published a report entitled From patent to competition – Analysis of expenditure and use of seven expensive medicines in hospital treatments. 14 April 2025
Japanese biotech Prism BioLab has entered a strategic partnership with AI drug discovery company Elix to accelerate the development of small molecule therapies for difficult-to-treat diseases. 14 April 2025
New regulations for running clinical trials in the UK have now been signed into law, the Medicines & Healthcare products Regulatory Agency (MHRA) announced on Friday. 14 April 2025
According to the country’s trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. 14 April 2025
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
The obesity drug market has experienced a seismic shift in recent years, with Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Mounjaro (tirzepatide) revolutionizing the way the condition is treated. 11 April 2025
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025