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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
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
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
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
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
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
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Biotechnology
US healthcare giant Johnson & Johnson’s subsidiary Janssen says that the European Commission has granted marketing authorization for Tremfya (guselkumab), alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. 1 December 2020
Biotechnology
Privately-held Scottish biotech ILC Therapeutics has secured an investment from Medical Incubator Japan, a Tokyo-based fund specializing in healthcare. 1 December 2020
Biotechnology
Canadian biotech Zymeworks today revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for zanidatamab (formerly known as ZW25) in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC). 30 November 2020
Biotechnology
Modern today announced that the primary efficacy analysis of the Phase III study of its COVID-19 vaccine candidate mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. 30 November 2020
Biotechnology
Sanofi has won a broader European label for Dupixent (dupilumab), adding treatment of children between 6 and 11 with severe atopic dermatitis. 30 November 2020
Biotechnology
Thousands of Australians with debilitating back and joint pain will have access to a life changing treatment option through the Pharmaceutical Benefits Scheme (PBS) which would otherwise cost tens of thousands of dollars. 30 November 2020
Biotechnology
Vertex Pharmaceuticals on Friday announced that the European Commission has granted approval of the label extension for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor). 30 November 2020
Biotechnology
Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to manufacture and market Cabometyx (cabozantinib) as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy. 28 November 2020
Biotechnology
US drugmaker AbbVie and Eisai on Friday announced approval of an additional indication of Humira (adalimumab), a fully human anti-TNFalpha monoclonal antibody, for the treatment of pyoderma gangrenosum (PG). 28 November 2020
Biotechnology
US CNS specialists Biogen and Sage Therapeutics have announced a global collaboration to develop and commercialize potential breakthrough therapies in depression and movement disorders. 27 November 2020
Biotechnology
The Russian Direct Investment Fund (RDIF) has bolstered manufacturing capacity for the supply of Sputnik V, Russia’s home-grown coronavirus vaccine. 27 November 2020
Biotechnology
The US Food and Drug has approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. 27 November 2020
Biotechnology
It has been a long and confusing week for investors and patients trying to work out what is going on with the COVID-19 vaccine being developed by the University of Oxford and Anglo-Swedish drugmaker AstraZeneca. 27 November 2020
Biotechnology
Germany’s Merck KGaA has announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. 26 November 2020
Biotechnology
Israel’s RedHill Biopharma yesterday announced partnerships with two leading, USA-based manufacturers for large-scale manufacturing of opaganib (trade name Yeliva). 26 November 2020
Biotechnology
The US Food and Drug Administration has granted accelerated approval for Danyelza (naxitamab) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). 26 November 2020
Biotechnology
The US Food and Drug Administration has completed its internal review of the Baseline-Controlled Study results of omaveloxolone for the treatment of patients with Friedreich’s ataxia (FA) and concluded that the results do not strengthen the results of Part 2 of the MOXIe study. 26 November 2020
Biotechnology
British artificial intelligence specialist InstaDeep and German biotech firm BioNTech have deepened ties, embarking on a multi-year project to develop new technologies. 25 November 2020
Biotechnology
Messenger RNA specialist Moderna has agreed to supply 80 million doses of its COVID-19 vaccine to the European Commission, with an option for a further 80 million. 25 November 2020
Biotechnology
Privately-held Chinese company Gmax Biopharm has announced that the first patient has received its humanized monoclonal antibody, GMA301, as part of investigations around the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). 24 November 2020
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