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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
All news
Biotechnology
Phase III tests of a leading COVID-19 vaccine candidate have been halted after a participant fell ill, pausing progress in the multi-site international study. 9 September 2020
Biotechnology
The US Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab, marketed by Roche (ROG: SIX) under the trade name Tecentriq, and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease. 9 September 2020
Biotechnology
Spero Therapeutics has announced positive top-line results from the Phase III ADAPT-PO study of the oral antibiotic candidate tebipenem HBr. 8 September 2020
Biotechnology
Leading drugmakers working on vaccines for the novel coronavirus have come together to pledge that they will: “uphold the integrity of the scientific process” as they do so. 8 September 2020
Biotechnology
French pharma major Sanofi will present new results from a Phase III study of Dupixent (dupilumab) at the 2020 virtual congress of the European Respiratory Society (ERS). 8 September 2020
Biotechnology
Austrian respiratory and ophthalmology specialist Marinomed Biotech has submitted for approval for its nasal spray Carragelose in a first group of EU countries. 8 September 2020
Biotechnology
Talazoparib is another drug from the substance class of PARP inhibitors, which also includes olaparib and rucaparib, for example, to have been approved this year for the treatment of breast cancer. 7 September 2020
Biotechnology
A new precision medicine company, IcanoMAB, has been founded in Polling, Germany. 7 September 2020
Biotechnology
The German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase II/III clinical trial in Germany of BNT162b2. 7 September 2020
Biotechnology
Leading global plasma-derived medicines maker Grifols has entered into a transaction to acquire the remaining equity of US biotech Alkahest. 7 September 2020
Biotechnology
Destiny Pharma has entered into a collaboration in COVID-19 with fellow UK-based biotech SporeGen. 7 September 2020
Biotechnology
Australian biotech CSL Limited today revealed it has signed a heads of agreement (HoA) with the Australian government for the supply of 51 million doses of the University of Queensland’s (UQ) COVID-19 vaccine candidate (V451), and a separate HoA with UK-based AstraZeneca to manufacture the Oxford University candidate (AZD1222), should clinical trials of both prove successful. 7 September 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 7 September 2020
Biotechnology
US drugmaker AbbVie and I-Mab signed a broad, global agreement for the development and commercialization of lemzoparlimab, an innovative anti-CD47 monoclonal antibody internally discovered and developed by the Chinese biopharma for the treatment of multiple cancers. 4 September 2020
Biotechnology
Kite today announced that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Yescarta (axicabtagene ciloleucel). 4 September 2020
Biotechnology
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
Biotechnology
RedHill Biopharma announced that opaganib (trade name Yeliva) has been selected for $300,000 grant funding from the Pennsylvania state COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program, which will support the rapid further development of novel COVID-19 therapies. 4 September 2020
Biotechnology
Californian monoclonal antibody (Mab) specialist Xencor has entered a strategic collaboration with the University of Texas MD Anderson Cancer Center to study investigational treatments for patients with a variety of cancer types. 4 September 2020
Biotechnology
Chinese biotech InxMed (Nanjing) says that it has completed its Series A+ financing of 130 million renminbi (~$19 million), which was led by Ennovation Ventures and China Growth Capital and followed by InnoMed Capital and Grand Yangtze Capital 4 September 2020
Biotechnology
Gilead Sciences’ CAR-T subsidiary Kite and HiFiBiO Therapeutics have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML). 3 September 2020
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