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Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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Pharmaceutical
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
Biosimilars
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
Shares in US biotech major Amgen were 11% lower early on Tuesday. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Pharmaceutical
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
All news
Pharmaceutical
An Expert View from the global consulting firm CRA's Steve Kelly, Mike Hodder and Owen Jones. 15 March 2023
Biotechnology
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals yesterday announced that its Qinlock (ripretinib) has been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line gastrointestinal stromal tumor (GIST) patients intolerant to sunitinib. 15 March 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday announced it has amended the emergency use authorization (EUA) for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, co-developed by US pharma giant Pfizer and Germany’s BioNTech. 15 March 2023
Biotechnology
UK-based company that uses artificial intelligence (AI) in drug discovery Exscientia saw its shares edge up 2.8% to $6.86 in morning trading today, despite announcing that US pharma major Bristol Myers Squibb would not be taking up an option under an agreement with Celgene. 15 March 2023
Pharmaceutical
US healthcare giant Johnson & Johnson has recently presented positive results from A DUE analyses of Opsynvi (macitentan and tadalafil), providing insight into the drug’s ability to reduce pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH). 15 March 2023
Pharmaceutical
In a major change towards placing all drug manufacturing responsibilities in the hands of a single licensing authority, the Indian government has proposed that the country's apex drug regulatory body, the CDSCO, (Central Drugs Standard Control Organization), be empowered to regulate the manufacture of drugs and medical devices, instead of state drug regulators as is the current practice. 14 March 2023
Generics
Attempts to curb drug shortages in Germany may not be sufficient to prevent a crisis, the government has been warned. 14 March 2023
Pharmaceutical
Russia may face a shortage of rare disease drug Cuprenil (penicillamine), according to government procurement statistics data and the statistics of the commercial retail, reports The Pharma Letter’s local correspondent. 14 March 2023
Pharmaceutical
Sales of Russian drugs grew in 2022 due to an increase of advertising budgets and a decline of the share of foreign drugs, reports The Pharma Letter’s local correspondent. 14 March 2023
Pharmaceutical
To achieve its goal of being a leader in medical dermatology, Denmark’s LEO Pharm today announced – in early 2023 - a significant shift in R&D to a research model, which aims at driving the early-stage pipeline with externally sourced innovation. 14 March 2023
Pharmaceutical
UK pharma major GSK has announced positive headline results from a Phase III trial of its MenABCWY combination vaccine candidate. 14 March 2023
Pharmaceutical
Japan’s largest drugmaker Takeda has revealed that its dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003), is now approved by Brazil’s National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from four to 60 years of age. 14 March 2023
Biotechnology
Given the large market potential and high unmet need for new respiratory syncytial virus (RSV) therapies, drug developers have been focused on new vaccine and monoclonal antibody (MAb) development. 14 March 2023
Pharmaceutical
The Lancet has published detailed results from the Phase III SKYLIGHT 1 study of fezolinetant. 14 March 2023
Pharmaceutical
In June 2021, the US Food and Drug Administration (FDA) approved Novo Nordisk’s (NOV: N) type 2 diabetes drug Wegovy (semaglutide) injection for chronic weight management in overweight or obese adults with at least one weight-related condition.1 This is just one example of the potential for existing drugs to offer new uses – also known as drug repurposing. 14 March 2023
Biotechnology
US biotech Moderna has failed to dodge a patent lawsuit relating to its COVID-19 vaccine. 13 March 2023
Biotechnology
The Phase I trial of XMT-2056 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, US clinical-stage biotech Mersana Therapeutics, whose shares fell over 2% to $4.6 in pre-market trading today 13 March 2023
Pharmaceutical
Exenatide, a GLP-1 agonist sold under the brand names Byetta and Bydureon by AstraZeneca (LSE: AZN) as a type 2 diabetes drug, could be useful in another indication, a trial has found. 13 March 2023
Pharmaceutical
March is Wilson’s Disease Awareness Month – an opportunity to raise awareness and explore progress within the management and treatment of this rare condition. 13 March 2023
Pharmaceutical
Two American firms have agreed terms for the joint commercialization of the novel attention deficit/hyperactivity disorder (ADHD) candidate CTx-1301 (dexmethylphenidate). 13 March 2023
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