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.
Adding to existing trials in older children, Pfizer and BioNTech have initiated a study of their coronavirus vaccine in children aged 6-12. 26 March 2021
As if there were not enough problems facing the manufacture and distribution of vaccines to fight the novel the novel coronavirus pandemic, there is a new warning that a shortage of viral vectors will have a further impact on two leaders in the field. 25 March 2021
US biotech Vertex Pharmaceuticals has announced that the Australian Therapeutic Goods Administration (TGA) has approved the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis (CF). 25 March 2021
Swiss biotech Basilea Pharmaceutica has announced positive results of a pre-planned interim analysis in cohort 2 of the Phase II study FIDES-01 (Fibroblast growth factor Inhibition with DErazantinib in Solid tumors), which is assessing the anti-tumor efficacy of the orally-administered fibroblast growth factor receptor (FGFR) inhibitor, derazantinib, in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA), a form of bile duct cancer. 25 March 2021
A joint statement from the UK government and the European Union signals the latest attempt to draw a line under a long-running dispute over vaccine supplies in Europe. 25 March 2021
In the ongoing controversy over COVID-19 vaccine supplies, the India government has put a temporary hold on all major exports of the AstraZeneca coronavirus shot made by the Serum Institute of India, to meet domestic demand as infections rise, according to sources cited by India’s Economic Times and other local media. 25 March 2021
Positive top-line results from the primary analysis of AstraZeneca’s USA-based Phase III trial confirm the safety and efficacy of its coronavirus vaccine. 25 March 2021
Abu Dhabi’s Mubadala Investment Company is to invest £800 million ($1.1 billion), alongside £200 million from the British government, in UK life sciences as part of a partnership announced on Thursday. 24 March 2021
XOMA Corp has purchased the potential future milestones and royalties associated with existing licenses relating to two clinical-stage drug candidates that were obtained in Viracta Therapeutics’ merger with US drug developer Sunesis Pharmaceuticals. 24 March 2021
Swiss pharma giant Novartis has announced a positive result of its Phase III study with the radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer. 23 March 2021
Japanese drugmaker Chugai Pharmaceutical has obtained approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent Polivy (polatuzumab vedotin [genetical recombination]) intravenous infusion 30mg and 140mg [generic combination with bendamustine and rituximab (BR therapy) for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). 23 March 2021
Taisho Pharmaceutical has submitted an application for approval to manufacture and market the anti-TNFα Nanobody therapeutic ozoralizumab to the Ministry of Health, Labor and Welfare (MHLW) for the planned indication of rheumatoid arthritis (RA), which is to-date inadequately managed by the current available treatments. 23 March 2021
The US Food and Drug Administration has approved a label update for Merck & Co’s blockbuster checkpoint blocker, targeting advanced esophageal or gastroesophageal (GEJ) cancer. 23 March 2021
Californian aging specialist CohBar is using mitochondrial science to treat diseases, but chief executive Steven Engle doesn’t rule out offering a “cure for ageing” at some point. 23 March 2021
US oral peptides specialist Chiasma’s shares were up 13% at $3.89 pre-market today, after the company announced the presentation of new positive clinical data from its MPOWERED Phase III trial of Mycapssa (octreotide) at the Endocrine Society’s annual meeting, ENDO 2021, being held virtually March 20-23, 2021. 23 March 2021
Top-line data from a trial testing an antibody cocktail in non-hospitalized people with the novel coronavirus show a reduction in the risk of hospitalization or death by 70%. 23 March 2021
The odds for and against betting on Provention Bio’s teplizumab, which is being studied in the prevention of type 1 diabetes (T1D) among at-risk patients, have been assessed. 22 March 2021
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
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024