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.
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 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
Johnson & Johnson has announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients given Darzalex (daratumumab)-subcutaneous (SC) therapy alongside bortezomib, lenalidomide and dexamethasone (VRd). 11 April 2025
US biotech giant Amgen today announced a significant breakthrough with its global Phase III DeLLphi-304 clinical trial evaluating Imdelltra (tarlatamab-dlle). 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
US biopharma company Palatin Technologies is at risk of being removed from the NYSE American exchange after failing to meet minimum stockholders' equity requirements. 11 April 2025
US biotech Oncolytics Biotech has entered into a funding agreement with institutional investor Alumni Capital, providing access to up to $20 million in equity financing over the next 15 months. 11 April 2025
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Australian biotech Opthea is cutting around two-thirds of its workforce, as the company moves to curb spending following the collapse of its lead program for age-related macular degeneration (AMD). 11 April 2025
Swiss pharma giant Novartis has announced a planned $23 billion investment over five years in US-based infrastructure, ensuring all key Novartis medicines for US patients will be made in the USA. 11 April 2025
US biotech Imbria Pharmaceuticals has raised $57.5 million in a series B financing round to fund a new mid-stage trial of its only pipeline drug, ninerafaxstat, for a form of heart muscle disease with limited treatment options. 11 April 2025
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
US biotech Atossa Therapeutics has entered into a research collaboration with China-backed Nona Biosciences, aiming to identify next-generation antibody therapies for breast cancer using Nona’s proprietary platform technology. 10 April 2025
US clinical-stage biotech Imbria Pharmaceuticals, which is focused on cardiometabolic diseases with high unmet need, says it has closed a $57.5 million Seres B financing. 10 April 2025
Pain is good. Or finding non-opioid ways to manage it is good, if Latigo Biotherapeutics’ $150 million March fundraise is anything to go by. 10 April 2025
US biotech ImmunityBio has secured $75 million through a direct offering with a single institutional investor, according to a statement released Tuesday. 10 April 2025
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 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
US pharma major Eli Lilly has announced a deal with San Diego-based Organovo Holdings, a biotech focused on developing novel treatment approaches in inflammatory bowel disease (IBD). 25 February 2025
Ryvu Therapeutics saw its shares tumble nearly 13% to 22.70 zloty by close of trading today, as the Polish oncology-focused biotech company announced a strategic reorganization that will extend Ryvu’s cash runway to second-half 2026 to focus on driving the RVU120 clinical program and the early pipeline to key data inflection points. 25 February 2025
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) for a new indication. 25 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
Danish pharma major Novo Nordisk has announced the appointment of Sebnem Avsar Tuna as the new general manager (GM) of its UK affiliate. 25 February 2025
Boston, USA-based biotech Nimbus Therapeutics today revealed that, along with partner Eli Lilly, it has achieved a significant pre-clinical milestone in their research collaboration targeting AMP-activated protein kinase (AMPK) for the treatment of cardiometabolic diseases. 25 February 2025
UK-based Swarm Oncology, a biotech developing T-cell therapies to achieve long-term remission in advanced solid cancers, has announced a strategic partnership with cell and gene therapy-focused contract development and manufacturing organization Cellex Cell Professionals. 25 February 2025
US biotech Regeneron Pharmaceuticals says that its investigational gene therapy DB-OTO showed clinically-meaningful hearing improvements in nearly all children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene. 25 February 2025
Florida, USA-based Summit Therapeutics saw its share rise 6.2% to $23.50 pre-market on the news of a clinical trial collaboration with Pfizer to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of the US pharma giant’s antibody drug conjugates (ADCs) across multiple solid tumor settings. 25 February 2025
The US Food and Drug Administration (FDA) has approved label changes for Sublocade (buprenorphine extended-release), including a rapid initiation protocol and alternative injection sites. 25 February 2025
The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. 25 February 2025
South Korean firm Celltrion announced that the European Commission (EC) has granted marketing authorization for Avtozma (CT-P47), a biosimilar referencing RoActemra (tocilizumab), which is marketed by Swiss pharma giant Roche. 25 February 2025
In this episode, we’ll take a look at the role of Japanese pharmaceutical groups in the UK, with Jackie Davis, general manager at Astellas Pharma. 24 February 2025
US CNS-focused biopharma firm Axsome Therapeutics today announced that the EMERGE Phase III trial of Symbravo (MoSEIC meloxicam and rizatriptan) in patients experiencing inadequate response to oral CGRP inhibitors met its primary endpoint. 24 February 2025
US pharma giant Pfizer has ended all development and commercialization activities relating to fidanacogene elaparvovec, a hemophilia B gene therapy marketed as Beqvez in the USA and Durveqtix in Europe. 24 February 2025
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A vertically-integrated, clinical-stage biotech company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.