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.
US biotech firm Moderna saw its shares rocket more than 25% to $83.42 in morning trading, having hit $88.50 pre-market, after the company released new data showing that all 45 evaluated volunteers in a study of its coronavirus vaccine candidate had developed antibodies that would help protect them from COVID-19 infection. 18 May 2020
An investment of £138 million ($167 million) from the UK government will help boost vaccines manufacturing capacity, as well as establish a “virtual VMIC” in the country. 18 May 2020
Daiichi Sankyo and partner AstraZeneca today announced that their Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy designation (BTD) in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy. 18 May 2020
The US Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. 16 May 2020
On Friday, the US Food and Drug Administration granted accelerated approval to Rubraca (rucaparib) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 16 May 2020
Shares in San Diego-based Sorrento Therapeutics jumped over 200% on Friday, after the firm announced positive data from its COVID-19 antibody program. 15 May 2020
The US Food and Drug Administration has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). 15 May 2020
US biotech Humanigen has announced that the first COVID-19 patient has been dosed in its trial of lenzilumab, the company’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. 15 May 2020
Chugai Pharmaceutical saw its shares close up a modest 1% today as it revealed the signing of a license agreement with US major Eli Lilly that could lead to the creation of an antibody against COVID-19. 15 May 2020
Paris-based Sanofi has been forced to walk back claims that the USA would be entitled to the largest order of its investigational COVID-19 vaccine, should it be successfully developed. 15 May 2020
The European Commission (EC) has extended the current conditional marketing authorization of Adcetris (brentuximab vedotin) to include adults with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with cyclophosphamide, doxorubicin, prednisone (CDP). 14 May 2020
Boehringer Ingelheim has acquired Northern Biologics, a wholly-owned subsidiary of Canada-based Northern LP, the German family-owned pharma major announced today. 14 May 2020
Biotech holding company Roivant Sciences has announced several updates from its BREATHE trial evaluating intravenous gimsilumab’s impact on mortality in COVID-19 patients with lung injury or acute respiratory distress syndrome. 14 May 2020
A weight management trial testing a 2.4 mg subcutaneous (SC) formulation of Novo Nordisk’s semaglutide has met its primary endpoint, raising the prospect of new market opportunities for the Danish firm. 14 May 2020
Ahead of featuring the data at the American Society of Clinical Oncology (ASCO) meeting later this month, results from the Phase III CheckMate-9LA trial, which demonstrated a statistically-significant and clinically-meaningful survival benefit with Opdivo (nivolumab) plus Yervoy (ipilimumab), given concomitantly with two cycles of chemotherapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC), have been released. 14 May 2020
While targeted therapies have delivered on their promise to make oncology more personalized, the addition of immunotherapy agents without first testing for patients who are most likely to benefit may limit the success of triplet combinations in melanoma. 14 May 2020
Shares in bluebird bio were hit and those in Bristol-Myers Squibb were holding up after the news that they received a Refusal to File letter from the US Food and Drug Administration (FDA) relating to their CAR-T therapy, idecabtagene vicleucel (ide-cel; bb2121). 13 May 2020
Boehringer Ingelheim has entered into a collaboration and licensing agreement with CDR-Life to research and develop antibody fragment-based therapeutics for geographic atrophy (GA). 13 May 2020
The USA-based not-for-profit Sabin Vaccine Institute (Sabin) and its partner, Italian biotech ReiThera, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised the first two options, valued at $20 million under the 2019 contract to advance the development of vaccines against Ebola Sudan and Marburg viruses through Phase II clinical trials. 13 May 2020
UK cell and gene therapy developer Oxford Biomedica today announced the successful outcome of its recent UK Medicines & Healthcare products Regulatory Agency (MHRA) inspection, resulting in the issue of a Certificate of GMP compliance for the first two GMP manufacturing suites and supporting area such as warehouse, cold chain facilities and QC laboratories, in its new Oxbox manufacturing facility. 13 May 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