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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
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
Biotechnology
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
Biotechnology
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
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
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Biotechnology
US biotech Gilead Sciences and Danish diabetes giant Novo Nordisk today announced encouraging results from a Phase II proof-of-concept trial of a cocktail of their liver disease candidates, under a 2019 collaboration. 16 November 2020
Biotechnology
Seed Therapeutics, a BeyondSpring spin-off focused on discovering and developing “molecular glues” to degrade disease-causing protein previously believed to be undruggable, has entered into a research collaboration and license agreement with Eli Lilly to discover and develop new chemical entities (NCEs) that could produce therapeutic benefit through targeted protein degradation (TPD). 14 November 2020
Biotechnology
On Friday, the Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab), in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. 14 November 2020
Biotechnology
Japan’s largest drugmaker Takeda Pharmaceutical today announced the final results from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE), showing that Takhzyro (lanadelumab-flyo) helped prevent and reduce the frequency of hereditary angioedema (HAE) attacks long term in patients 12 years of age and older who received treatment for a mean (standard deviation) duration of 29.6 (8.2) months. 13 November 2020
Biotechnology
Russia has agreed terms for South Korean biotech GL Rapha to produce 150 million doses per year of its home-grown coronavirus vaccine, Sputnik V. 13 November 2020
Biotechnology
Tokyo’s Taiho Pharmaceutical and Texas, USA-based Lung Therapeutics have agreed an exclusive license agreement for the latter’s LTI-01, for the territory of Japan. 13 November 2020
Biotechnology
The UK National Institute of Health and Care Excellence (NICE) has issued a positive final appraisal document (FAD) for the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 12 November 2020
Biotechnology
French pharma major Sanofi has announced that the UK National Institute for Health and Care Excellence (NICE) has recommended Cablivi (caplacizumab) with plasma exchange and immunosuppression, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults and in young people aged from 12 years who weigh at least 40 kg. 12 November 2020
Biotechnology
The UK's National Institute of Health and Care Excellence (NICE) has published guidance recommending Venclyxto (venetoclax) plus obinutuzumab for all front-line English patients with chronic lymphocytic leukemia (CLL). 12 November 2020
Biotechnology
Belgian drugmaker UCB has announced the acquisition of Handl Therapeutics along with a new collaboration with Lacerta Therapeutics. 12 November 2020
Biotechnology
The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalized with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. 12 November 2020
Biotechnology
Analysts’ third quarter revenue forecasts were right on the money for Merck KGaA, the German drugmaker reporting sales of 4.4 billion euros ($5.2 billion), an increase of 9.7%. 12 November 2020
Biotechnology
Australian regenerative medicine company Mesoblast is continuing with a Phase III trial of remestemcel-L in people with moderate to severe acute respiratory distress syndrome (ARDS). 11 November 2020
Biotechnology
Five Prime Therapeutics on Tuesday announced positive top-line results from the global, randomized, double-blind placebo-controlled Phase II FIGHT trial, with the news sending the shares roaring up 364% to $24.80 in heavy volume after-hours. 11 November 2020
Biotechnology
In timely fashion, a deal has been announced for the European Commission (EC) to be supplied with 200 million doses of the Pfizer and BioNTech mRNA-based vaccine candidate against COVID-19. 11 November 2020
Biotechnology
The US Department of Health and Human Services on Tuesday announced plans to allocate initial doses of Eli Lilly's investigational monoclonal antibody therapeutic, bamlanivimab, which received emergency use authorization from the US Food and Drug Administration November 9 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. 11 November 2020
Biotechnology
Brazilian health regulator Anvisa has brought a halt to a trial of a coronavirus vaccine being developed by Sinovac. 11 November 2020
Biotechnology
Japanese drug major Eisai and USA-based Merck & Co have announced positive top-line results from the Phase III CLEAR/KEYNOTE-581 trial. 11 November 2020
Biotechnology
UK biotech Tiziana Life Sciences is collaborating with Parexel Biotech, a division of global clinical research organization (CRO), Parexel International (IRL), to conduct a global Phase Ib/II trial with enteric-coated capsules of formulated foralumab, the only fully human anti-CD3 monoclonal antibody (MAb) - as a therapy for patients with moderate to severe Crohn’s disease (CD). 11 November 2020
Biotechnology
Suspiciously soon after Pfizer and BioNTech announced positive Phase III data for their COVID-19 vaccine, Russia’s PR machine whirred to life. 11 November 2020
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