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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
Sun Pharma has announced that its Japanese subsidiary had launched Ilumya (tildrakizumab) subcutaneous injection 100mg Syringe in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. 24 September 2020
Biotechnology
Shares in AC Immune were 44% lower after two hours of trading on Wednesday. 23 September 2020
Biotechnology
California, USA-based Nutcracker Therapeutics, a company developing and producing mRNA therapeutics, today announced not only a financing deal but also a new senior executive. 23 September 2020
Biotechnology
Shares of US biotech firm Vaccinex tanked more than 60% pre-market on Tuesday, after the company revealed that the mid-stage SIGNAL trial of its pepinemab failed to meet pre-specified co-primary endpoints. 23 September 2020
Biotechnology
Novartis Gene Therapies, the new name for AveXis - which Swiss pharm giant Novartis acquired in an $8.7 billion deal in 2018, has recently received feedback from the US Food and Drug Administration following its review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA). 23 September 2020
Biotechnology
Denmark’s Genmab saw its shares drop over a tenth after it emerged the firm was locked in a legal battle over royalties for cancer drug daratumumab. 23 September 2020
Biotechnology
The US Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for its interleukin (IL)-17 inhibitor bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 September 2020
Biotechnology
Australian oncology-focussed biotech Kazia Therapeutics has entered into a collaboration with Dana-Farber Cancer Institute (DFCI) in the USA, to investigate the use of Kazia's investigational new drug, paxalisib (formerly GDC-0084), in primary central nervous system (CNS) lymphoma, a potential new indication for the drug. 22 September 2020
Biotechnology
The US Food and Drug Administration has accepted and granted Priority Review for Bristol Myers Squibb and bluebird bio’s Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121). 22 September 2020
Biotechnology
Swiss biopharma Santhera Pharmaceuticals and its partner ReveraGen Biopharma have highlighted the publication of long-term clinical data on the safety, tolerability and efficacy of vamorolone in patients with Duchenne muscular dystrophy (DMD). 22 September 2020
Biotechnology
Coronavirus vaccine research in Australia has been supported by a grant from the Medical Research Future Fund (MRFF), worth over $2 million. 22 September 2020
Biotechnology
South Korean contract development and manufacturing organization Samsung Biologics has signed a long-term supply agreement, valued at around $330.8 million, with UK pharma major AstraZeneca. 22 September 2020
Biotechnology
Swiss antibody-drug conjugate specialist ADC Therapeutics has submitted to the US regulator for approval to market loncastuximab tesirine as a third-line option. 22 September 2020
Biotechnology
Shares in Legend Biotech fell by nearly 16% in the first four hours of trading on Monday. 21 September 2020
Biotechnology
Combo therapies featuring an immunotherapy and a tyrosine kinase inhibitor (TKI) are all the rage at this year’s annual congress of the European Society of Medical Oncology (ESMO). 21 September 2020
Biotechnology
Chinese biopharma Innovent Biologics and US drugmaker Eli Lilly have jointly announced that biomarker results from the ORIENT-11 study were released in a mini oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. 21 September 2020
Biotechnology
Health Canada has approved Inrebic (fedratinib), a new once-daily oral medication used to treat adults with an enlarged spleen and associated symptoms caused by intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. 21 September 2020
Biotechnology
The Johnson & Johnson unit Janssen has announced interim results from the CHRYSALIS study, evaluating amivantamab in combination with the third-generation EGFR tyrosine kinase inhibitor lazertinib in patients with non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. 21 September 2020
Biotechnology
A late-breaking paper discussed at the annual congress of ESMO 2020 shows positive data for an investigational antibody-drug conjugate (ADC) developed by Seattle Genetics and Genmab. 21 September 2020
Biotechnology
Seqirus, a subsidiary of Australia’s CSL Limited, today announced new real-world evidence (RWE) that demonstrated an MF59 adjuvanted, trivalent influenza vaccine (aTIV) was more effective than a standard-dose non-adjuvanted trivalent seasonal vaccine in preventing influenza-related medical office visits and hospitalizations in adults 65 years and older during the 2017/18 US flu season. 21 September 2020
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