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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
Impressive data for another immuno-oncology / tyrosine kinase inhibitor (TKI) combo add up to yet more competition in the first-line kidney cancer setting. 21 September 2020
Biotechnology
Eli Lilly’s Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25% compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer. 21 September 2020
Biotechnology
Shares of Swiss biotech Relief Therapeutics (SWX: RLF) were up more than 7% at 0.54 Swiss francs by early afternoon, after it announced the completion of the partnership agreement with USA-based NeuroRx for the commercialization of RLF-100 (aviptadil) worldwide. 21 September 2020
Biotechnology
Swiss drugmaker Roche has presented detailed results from the Phase III IMpassion031 study of Tecentriq (atezolizumab), at the European Society for Medical Oncology (ESMO) virtual congress. 21 September 2020
Biotechnology
New overall survival (OS) Phase III data, showing that Trodelvy (sacituzumab govitecan-hziy) significantly reduced the risk of death for people with triple-negative breast cancer (TNBC) by 52%, with a mean OS of 12.1 months compares to 6.7 months for standard single-agent chemotherapy, were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. 21 September 2020
Biotechnology
Results from a pre-specified exploratory analysis of the positive ADAURA Phase III trial showed that UK pharma major AstraZeneca’s blockbuster cancer drug Tagrisso (osimertinib) demonstrated a clinically-meaningful improvement in central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumor resection. 21 September 2020
Biotechnology
Netherlands-based Scenic Biotech has entered into a multi-year strategic collaboration with Genentech, a subsidiary of Swiss pharma giant Roche, to discover, develop and commercialize novel therapeutics that target genetic modifiers. 21 September 2020
Biotechnology
A new immuno-oncology combination from Bristol Myers Squibb and Exelixis could make a real difference in kidney cancer, the firms outlined on Saturday. 19 September 2020
Biotechnology
Co-development partners Astellas Pharma and Seattle Genetics have announced that a Phase III trial of Padcev (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy. 18 September 2020
Biotechnology
Updated results from the PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit in patients with unresectable, stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT). 18 September 2020
Biotechnology
Today Akcea Therapeutics announced that Waylivra (volanesorsen), the first and only for the ultra-rare and life-threatening condition familial chylomicronemia syndrome (FCS), is to become available on the NHS in England. 18 September 2020
Biotechnology
Results from the Phase III JAVELIN Bladder 100 study have been published in The New England Journal of Medicine with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of Bavencio (avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. 18 September 2020
Biotechnology
French pharma major Sanofi has announced positive results from the pivotal Phase II trial for the PD-1 inhibitor Libtayo (cemiplimab) in locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy. 18 September 2020
Biotechnology
Investors reacted negatively to a slower timeline for COVID-19 vaccine development, announced by US biotech Moderna. 18 September 2020
Biotechnology
The Phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra/RoActemra (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). 18 September 2020
Biotechnology
Chinese biotech company Hutchison China MediTech, commonly-known as Chi-Med, today announced that its New Drug Application (NDA) for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors (NET) has been accepted for review by the China National Medical Products Administration (NMPA). 17 September 2020
Biotechnology
German biotech BioNTech has signed a share purchase agreement with Novartisto acquire the Swiss pharma giant’s good manufacturing practices (GMP) certified manufacturing facility in Marburg, Germany. 17 September 2020
Biotechnology
US drugmaker Eli Lilly and biotech major Amgen have announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for the former company’s potential COVID-19 therapies. 17 September 2020
Biotechnology
Moderna has revealed it has entered into a new strategic research collaboration and licensing agreement with Vertex Pharmaceuticals aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). 17 September 2020
Biotechnology
Moderna has announced a collaboration with Italian family-controlled Chiesi Farmaceutici aimed at the discovery and development of mRNA therapeutics for the treatment of pulmonary arterial hypertension (PAH), a rare disease with an incidence of 2-5 per million adults. 17 September 2020
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