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.
The National Institute for Health and Care Excellence (NICE) has recommended Adcetris (brentuximab vedotin) with cyclophosphamide, doxorubicin and prednisone (CHP), for untreated systemic anaplastic large cell lymphoma (sALCL) in adults, within a final appraisal document (FAD). 9 July 2020
Wisconsin, USA-based diagnostics company Promega is launching a new test for microsatellite instability (MSI) in the UK, which could help identify candidates for cancer immunotherapy. 9 July 2020
US cancer-focused biotech start-up Foghorn Therapeutics, formed in 2016, has announced it first major collaboration, signing a deal with US giant pharma Merck & Co. 9 July 2020
Canadian biotech firm Zymeworks saw its share gain 5% in after-hours trading yesterday, after announcing it has signed a new license deal with long-time partner, Merck & Co to develop additional multispecific antibody therapeutic candidates using Zymeworks’ Azymetric and EFECT platforms. 9 July 2020
In a rare setback for immuno-oncology leader Keytruda (pembrolizumab), the US regulator on Wednesday rejected a bid for accelerated approval in liver cancer. 8 July 2020
Evive Biotech, a Shanghai-based biologics firm formerly known as Generon Biomed, has announced positive Phase III results for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients. 8 July 2020
Medicines regulator Health Canada has approved Sarclisa (isatuximab for injection) in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. 8 July 2020
Belgian drugmaker UCB and privately-held Swiss firm Ferring have signed a co-promotion agreement to commercialize the prefilled syringe formulation of Cimzia (certolizumab pegol) in the USA for the treatment of Crohn's disease (CD). 8 July 2020
Dutch biopharma Kiadis Pharma's shares kick off today, leaping 58% to 2.22 euros by early afternoon, after it announced an exclusive license deal for its previously undisclosed K-NK004 program with French pharma major Sanofi. 8 July 2020
Anglo-Swedish drugmaker AstraZeneca and US pharma giant Merck & Co have announced that Lynparza (olaparib) has been approved in the European Union (EU) for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. 8 July 2020
Switzerland-based biotech firm Numab Therapeutics has entered into a research collaboration and worldwide licensing agreement with German family-owned pharma Boehringer Ingelheim. 7 July 2020
Immuno-oncology start-up Vor Biopharma, which is pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, today announced it has raised $110 million in a Series B financing. 7 July 2020
US biotech firm Regeneron Pharmaceuticals saw its shares rise 4.6% on Monday and gain a further 3.6% to $650.03 by mid-morning today, after it announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron's investigational double antibody cocktail for the treatment and prevention of COVID-19, as well as a lucrative deal with the US government. 7 July 2020
The European Investment Bank (EIB) and CureVac, a clinical-stage German biotech company developing a new class of transformative medicines based on optimised mRNA, entered into a 75 million-euros ($84 million) loan agreement to support the company’s ongoing development of vaccines against infectious diseases, including its vaccine candidate CVnCoV aimed at preventing SARS-CoV-2 infections. 7 July 2020
Shares in Immunomedics were lifted 8% on Monday, after the antibody-drug conjugate (ADC) specialist posted positive data from the Phase III ASCENT study of Trodelvy (sacituzumab govitecan-hziy). 7 July 2020
Emergent BioSolutions has announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, part of US healthcare giant Johnson & Johnson, for large-scale drug substance manufacturing for J&J’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac technology. 7 July 2020
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