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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
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
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
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Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for brensocatib (formerly known as INS1007) for the treatment of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbations, says the drug’s developer, US rare-diseases focussed biopharma Insmed. 8 June 2020
Biotechnology
The European Medicines Agency (EMA) has received Gilead Sciences’ application for conditional marketing authorization (CMA) of remdesivir for the treatment of COVID-19. 8 June 2020
Biotechnology
Staidson has partnered with Spanish full-service contract research organization (CRO) Pivotal to assess Staidson´s investigational product BDB-001, a monoclonal anti-C5a antibody, in a Europe-based clinical trial in progressive severe COVID-19 patients caused by SARS-CoV-2. 8 June 2020
Biotechnology
Cell and gene therapy specialist Oxford Biomedica has inked a new five-year collaboration deal with the not-for-profit Vaccines Manufacturing and Innovation Centre (VMIC). 8 June 2020
Biotechnology
The European medicines regulator has granted approval for the first adjuvanted quadrivalent influenza vaccine (aQIV), developed by Seqirus, the vaccine unit of Australian biotech firm CSL. 8 June 2020
Biotechnology
Positive Phase III results from the ILLUMINATE-A study of lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1), were presented by US RNAi specialist Alnylam Pharmaceuticals at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) International Congress on Sunday. 8 June 2020
Biotechnology
Legend Biotech has announced the pricing of its initial public offering of 18,425,000 American depositary shares (ADSs), each representing two ordinary shares, at a public offering price of $23.00 per ADS, for total gross proceeds of around $423.8 million. 8 June 2020
Biotechnology
Japan’s largest drugmaker Takeda Pharmaceutical has announced findings from two new interim analyses of data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE) at the 2020 European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress. 8 June 2020
Biotechnology
As researchers around the world scramble to repurpose existing drugs to find a solution to the current coronavirus pandemic, Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor currently approved for certain hematological malignancies, was seen to reduce markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease, according to a study published in Science Immunology. 6 June 2020
Biotechnology
US drugmaker AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center are collaborating to develop a new antibody to prevent and treat COVID-19. 5 June 2020
Biotechnology
Having risen 14% pre-market, shares of US biotech firm Novavax were still up 4.6% at $46.73 by mid-morning, after the vaccine developer announced it has been awarded a contract by the US Department of Defense (DoD) for the manufacturing of NVX CoV2373, Novavax’ COVID-19 vaccine candidate. 5 June 2020
Biotechnology
A COVID-19 vaccine candidate hatched at the University of Queensland is at the heart of a new collaboration with CSL Ltd and CEPI, the Coalition for Epidemic Preparedness Innovations. 5 June 2020
Biotechnology
Hopes for a COVID-19 vaccine as soon as September 2020 have been raised further, as British drugmaker AstraZeneca announced plans to have in place manufacturing capacity for two billion doses. 5 June 2020
Biotechnology
Slightly more than a month after the US Food and Drug Administration approved the product, the European Commission (EC) has also granted marketing authorization for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM), says US healthcare giant Johnson & Johnson. 5 June 2020
Biotechnology
The UK's AstraZeneca has upped its involvement in RNA-based therapies, inking a new collaboration deal with Accent Therapeutics. 4 June 2020
Biotechnology
Privately-held German firm Immatics Biotechnologies today announced that Cedrik Britten has been appointed as chief medical officer (CMO) effective June 1, 2020. 4 June 2020
Biotechnology
South Korean LegoChem Biosciences has entered a worldwide license agreement with Newcastle, UK-based Iksuda Therapeutics for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors. 4 June 2020
Biotechnology
Canada-based biotech FSD Pharma saw its shares skyrocket 127% to C$9.65 by close of trading Wednesday, after it revealed that the US Food and Drug Administration had given the company permission to submit an Investigational New Drug Application (IND) for the use of its lead candidate FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus. 4 June 2020
Biotechnology
The European Commission (EC) has approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy, says privately-held French drugmaker Pierre Fabre. 4 June 2020
Biotechnology
Pharma giant Novartis has announced full positive results from the Phase III PREVENT trial of Cosentyx (secukinumab) in axial spondyloarthritis. 4 June 2020
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