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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
A Feature on recent investment activity in Asia-Pacific. 7 April 2023
Generics
The Russian government plans to take additional measures to further increase the share of domestic drugs in the local market, as pressure from the West on the country and its pharmaceutical sector is growing. 7 April 2023
Biotechnology
Noting that sometimes such collaborations will lead to success and result in approved drugs, but in many cases, they will be terminated for scientific or business reasons, Poland’s oncology specialist Ryvu Therapeutics late Thursday announced that its accord with Belgium’s Galapagos in inflammatory disorders entered into in April 2020 had been terminated. 7 April 2023
Pharmaceutical
The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma. 7 April 2023
Pharmaceutical
Family-owned Italian drugmaker Chiesi Farmaceutici says that its worldwide growth continues. 6 April 2023
Biotechnology
The UK’s BioIndustry Association (BIA) has published research suggesting that the country’s medicines evaluation body is basing its methods and processes for evaluating drugs for rare diseases on outdated evidence. 6 April 2023
Biotechnology
US biotechnology company Bicycle Therapeutics , which pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, has announced the appointment of Dr Santiago Arroyo as chief development officer, effective March 31. 6 April 2023
Biotechnology
French clinical-stage biotech Abivax has appointed Marc de Garidel as chief executive (CEO) and interim board chairman of the company, effective May 5, 2023. 6 April 2023
Pharmaceutical
There have been huge changes in the way highly regulated markets operate in recent years – caused by new regulations, technologies and demands. 6 April 2023
Biotechnology
Having received accelerated approval from US Food and Drug Administration (FDA) in January this year for their Alzheimer’s disease drug Leqembi (lecanemab), Japan’s Eisai and US biotech Biogen are now awaiting authorizations in the important markets of the European Union and Japan to solidify the drug’s position as the top-selling drug for Alzheimer's in the upcoming years. 6 April 2023
Biotechnology
San Diegan protein degrader company Biotheryx has agreed terms for a research collaboration with Incyte. 6 April 2023
Pharmaceutical
In what is being seen as a double blow to UK pharma major AstraZeneca's non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib mesylate), the Indian Patent Office has granted a patent to the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, for its nano-formulation of drug osimertinib mesylate. 6 April 2023
Biotechnology
TheUK's National Institute for Health and Care Excellence (NICE) has recommended the provision of Lynparza (olaparib) for National Health Service (NHS) patients with forms of early-stage breast cancer and prostate cancer in England and Wales. 6 April 2023
Biotechnology
Vienna, Austria-based start-up Proxygen today revealed entering a multi-year research collaboration and license agreement with US pharma giant Merck & Co, known as MSD outside the USA and Canada, to jointly identify and develop molecular glue degraders against multiple undisclosed therapeutic targets. 5 April 2023
Pharmaceutical
US immunology focussed biotech Immunic saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC). 5 April 2023
Biotechnology
A number of changes in how the US Food and Drug Administration (FDA) perceives rigorous trial design have been noted in a report on the evolving FDA approval processes for biotech companies in Asia Pacific, Europe, and the USA, including typical impediments to success. 5 April 2023
Pharmaceutical
UK-based iron deficiency specialist Shield Therapeutics today revealed that Andy Hurley will be joining the firm’s executive team as chief commercial officer (CCO), effective April 10, 2023. 5 April 2023
Biotechnology
American antiviral specialist Arbutus Biopharma and Genevant Sciences have filed a patent infringement case against the developers of Comirnaty, in the US District Court for New Jersey. 5 April 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the use of Germany-headquartered clinical-stage biotech InflaRx Gohibic (vilobelimab) injection. 5 April 2023
Biotechnology
Positive high-level results from a planned interim analysis of the DUO-O Phase III trial have been presented by Anglo-Swedish drugmaker AstraZeneca, which was subsequently trading 2% higher by lunchtime Wednesday. 5 April 2023
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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
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Pharmaceutical
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
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