Primary overall survival (OS) analysis results of the Phase III ZUMA-7 study have been released by US biotech major Gilead Sciences’ subsidiary Kite. 22 March 2023
Australian Health Technology Assessment (HTA) Review Terms of Reference were released today, and will continue to advocate for bold policy reform to speed up access to innovative medicines. 22 March 2023
Positive data for a new kind of cancer med, targeting the CLDN18.2 biomarker, will be presented at the March Plenary Series of the American Society of Clinical Oncology (ASCO). 22 March 2023
Even as the World Trade Organization (WTO) members continue to remain divided on the waiver of intellectual property (IP) rights for Covid-related vaccine technologies, India, South Africa, and other developing countries have resuscitated their campaign to extend the temporary waiver of IP for Covid vaccines to coronavirus drugs at the WTO. 22 March 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said today it will introduce a series of new measures, with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK. 21 March 2023
US psychiatric and neurological conditions specialist Karuna Therapeutics has announced top-line results from its Phase III EMERGENT-3 trial of its lead investigational therapy, KarXT (xanomeline-trospium) in schizophrenia. 21 March 2023
Sandoz, the soon to be spun-out generics and biosimilars unit of Swiss pharma giant Novartis, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration 21 March 2023
Zydus Lifesciences today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s Xeljanz from the US Food and Drug Administration (FDA). 21 March 2023
Drugmakers have welcomed the European Commission’s commitment to a “competitiveness check,” related to the legislative environment in the region. 21 March 2023
Just a couple of years ago, shares in US biotech Sangamo Therapeutics were worth more than $13, but the latest dose of bad news on the company has led them to drop below $2. 21 March 2023
US biotech major Gilead Sciences has exercised its option to exclusively license Nurix Therapeutics’ investigational targeted protein degrader molecule NX 0479, with the news sending the latter’s share price up 6.5% to $9.60 by late afternoon on Monday. 21 March 2023
Patient Voice Aotearoa’s Dr Malcolm Mulholland appeared before the Health Select Committee to voice opposition to parts of the Therapeutic Products Bill on behalf of patients in New Zealand. 21 March 2023
A novel combination medicine designed to help people with chronic refractory gout has demonstrated a high level of efficacy in a Phase III study. 21 March 2023
A few eyebrows might have been raised late last year at the size of the deal when Japanese drugmaker Takeda acquired a selective allosteric tyrosine kinase 2 (TYK2) inhibitor from privately-held US drug discovery company Nimbus Therapeutics. 20 March 2023
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024