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.
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
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
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
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
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
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
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
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
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
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
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
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
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
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
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
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
US biopharma Unum Therapeutics has completed the acquisition of Kiq, a privately-held biotech focused on the discovery and development of precision kinase inhibitors. 6 July 2020
Cambridge, USA-based Dragonfly Therapeutics today announced a new research collaboration with Bristol-Myers Squibb to discover and develop Dragonfly's novel immunotherapies for multiple sclerosis and neuro-inflammation targets. 6 July 2020
Swiss oncology-focused drug discovery firm ADC Therapeutics today announced that the US Food and Drug Administration has lifted the partial clinical hold on the pivotal Phase II clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL). 6 July 2020
UK-based drug discovery and development company Mission Therapeutics, which is focused on selectively inhibiting deubiquitylating enzymes (DUBs), today announced that it has raised $15 million in equity investment. 6 July 2020
Swiss biotech Idorsia today announced positive top-line results of the second pivotal Phase III study investigating 10mg and 25mg doses of its dual orexin receptor antagonist, daridorexant, in 924 adult and elderly patients (39.3% ≥ 65 years) with insomnia. 6 July 2020
The specialist HIV company ViiV Healthcare, which is majority owned by GlaxoSmithKline, has announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. 3 July 2020
CSL Behring has announced that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options, for Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa). 3 July 2020
The US Phase III trial of rheumatoid arthritis drug Kevzara (sarilumab) in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo). 3 July 2020
The US Food and Drug Administration has approved a randomized, double-blind, placebo-controlled Phase III clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated acute respiratory distress syndrome (ARDS). 2 July 2020
Hopes for an effective vaccine against the novel coronavirus have been boosted by positive Phase I/II data from the BNT162 mRNA-based vaccine program. 2 July 2020
US clinical-stage immuno-oncology firm EpicentRx has entered into a licensing agreement for RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα with ongoing Phase III trial in small cell lung cancer (SCLC), with China-owned SciClone Pharmaceuticals International. 1 July 2020
Germany’s Merck KGaA and US drug giant Pfizer have received US approval to market Bavencio (avelumab) for the maintenance treatment of locally-advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. 1 July 2020
Swedish immuno-oncology firm BioInvent and New York pharma major Pfizer have extended their ongoing collaboration, through to the end of the year. 1 July 2020
In a therapy sector that has seen little success so far, Akero Therapeutics late yesterday announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase IIa BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with non-alcoholic steatohepatitis (NASH). 1 July 2020
Ever deal-thirsty Japanese pharma giant Takeda has today entered into a collaboration with USA-based Carmine Therapeutics to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine's REGENT technology, based on red blood cell extracellular vesicles. 30 June 2020
The long-running feud between US biopharma Vertex Pharmaceuticals and budget holders for the National Health Service (NHS) in England seems well and truly over. 30 June 2020
As Gilead Sciences revealed the price of remdesivir, its potential antiviral treatment for COVID-19, the US government announced that it has got its hands on another huge batch of the drug. 30 June 2020