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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
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
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
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
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Biotechnology
US privately-held immunotherapy company ImmunityBio has appointed Fabio Benedetti as chief strategy officer, effective January 4, 2021. 31 December 2020
Biotechnology
US biotech Regeneron Pharmaceuticals yesterday announced encouraging initial data from an ongoing Phase I/II/III clinical trial of its antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. 30 December 2020
Biotechnology
The COVID-19 vaccine developed by AstraZeneca and the University of Oxford has been given regulatory approval for emergency supply by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 December 2020
Biotechnology
Pfizer and BioNTech late yesterday announced they will supply an additional 100 million doses of Comirnaty (BNT162b2), the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. 30 December 2020
Biotechnology
USA-based biotech Actinium Pharmaceuticals saw its shares tank 22.5% to $8.31 by midday Tuesday, despite the company reporting encouraging developments for its bone marrow transplant candidate. 30 December 2020
Biotechnology
Swedish company Alligator Bioscience has appointed Christina Reimer as chief medical officer. 29 December 2020
Biotechnology
Myovant Sciences has entered into a development and commercialization agreement on relugolix - a gonadotropin-releasing hormone (GnRH) receptor antagonist, in oncology and women’s health – in the USA and Canada. 29 December 2020
Biotechnology
Registration of Russia’s first gene therapy drug Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA), may be delayed by one and a half years as, in order to assess the quality of the drug, the Russian Ministry of Health has demanded from the Swiss pharma giant Novartis up to 40 vials with a total price of up to $88 million, reports The Pharma Letter’s local correspondent. 29 December 2020
Biotechnology
US clinical-stage biotech Novavax closed down almost 10% at $116.85 yesterday, despite announcing initiation of PREVENT-19, its pivotal Phase III study in the USA and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the company’s COVID-19 vaccine candidate. 29 December 2020
Biotechnology
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers announced on Monday. 29 December 2020
Biotechnology
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
Biotechnology
UK government officials confirmed on Sunday that the Medicines and Healthcare products Regulatory Agency (MHRA) would imminently approve the Oxford COVID-19 vaccine, adding that the announcement could come as soon as Tuesday, according to the Financial Times. 28 December 2020
Biotechnology
British scientists are trialling a new drug that could prevent people who have been exposed to the novel coronavirus from going on to develop COVID-19, which experts say could save many lives, the UK Guardian newspaper reported today (December 26). 26 December 2020
Biotechnology
US pharma major Bristol Myers Squibb yesterday announced a disappointing update on its CheckMate -548, a Phase III trial evaluating the addition of Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus placebo plus the standard of care in patients with newly diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation following surgical resection of the tumor. 24 December 2020
Biotechnology
A2 Biotherapeutics has entered into an agreement with pharma giant Merck & Co, whereby A2 will continue research and pre-clinical development of its undisclosed Tmod cell therapy candidate. 24 December 2020
Biotechnology
US biotech Moderna says that medicines regulator Health Canada has authorized its vaccine against COVID-19, mRNA-1273, for the immunization of people 18 years of age and older under an Interim Order. 24 December 2020
Biotechnology
US pharma giant Merck & Co has entered into an agreement with the US Department of the Health and Human Services (HHS) and the Department of Defense (DoD) to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) on approval or Emergency Use Authorization (EUA) from the US Food and Drug Administration. 23 December 2020
Biotechnology
US pharma giant Pfizer and German partner BioNTech have signed a second deal with the US government to supply an additional 100 million doses of BNT162b2, their COVID-19 vaccine, from production facilities in the USA. 23 December 2020
Biotechnology
Privately-held US biotech Skyhawk Therapeutics and Vertex Pharmaceuticals have signed a strategic research collaboration and licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases. 23 December 2020
Biotechnology
The European Commission has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection for the treatment of early and metastatic HER2-positive breast cancer. 23 December 2020
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