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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
The European Medicines Agency’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, AZD1222, which is being developed by AstraZeneca in collaboration with the University of Oxford. 1 October 2020
Biotechnology
Californian biopharma Olema Oncology has announced the closing of a $85 million Series C financing. 1 October 2020
Biotechnology
Speaking at the Financial Times’ US Pharma and Biotech Conference yesterday, Moderna Therapeutics’ chief executive Stéphane Bancel stated that the company will not be able to apply for emergency use authorization (EUA) in the USA for its COVID-19 vaccine candidate mRNA-1273 before November 25 at the earliest, reflecting the minimum amount of time needed to accumulate enough safety data. 1 October 2020
Biotechnology
Novartis Gene Therapies (formerly AveXis, that was acquired by Swiss pharma giant Novartis) today announced new interim data from the ongoing Phase III STR1VE-EU clinical trial for Zolgensma (onasemnogene abeparvovec) that demonstrated patients with spinal muscular atrophy (SMA) Type 1 continued to experience significant therapeutic benefit. 1 October 2020
Biotechnology
US biotech Locus Biosciences has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) product that will target Escherichia coli (E. coli) bacteria causing recurrent urinary tract infections (UTIs). 1 October 2020
Biotechnology
US biotech Regeneron Pharmaceuticals has announced the first data from a descriptive analysis of a seamless Phase I/II/III trial of its investigational antibody cocktail REGN-COV2, showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. 30 September 2020
Biotechnology
Taiwanese drugmaker TaiGen Biotechnology has announced that it has signed an exclusive licensing agreement with Luminarie Canada to develop and commercialize Taigexyn (nemonoxacin) in Canada, Australia and New Zealand. 30 September 2020
Biotechnology
Dr Daniel Vasella, former chairman and chief executive of Swiss pharma giant Novartis, has been appointed the new and independent chairman of the board of Swiss biotech Numab Therapeutics. 30 September 2020
Biotechnology
News of a collaborations with US pharma giant Pfizer sent the shares of Hong Kong-listed biotech CStone Pharmaceutical up as much as 39.6% to HK$12.98, the highest since early October last year. 30 September 2020
Biotechnology
Danish biotech firm Ascendis Pharma, which uses its innovative TransCon technologies to address unmet medical needs, has announced positive preliminary six-month results from the open-label extension (OLE) portion of PaTH Forward, a global Phase II trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism (HP). 30 September 2020
Biotechnology
Health Canada has approved Reblozyl (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia. 29 September 2020
Biotechnology
US biotech firm Orgenesis has entered into a definitive agreement to acquire all outstanding stock of US regenerative medicines company Koligo Therapeutics for an aggregate of $15 million, subject to final closing conditions, with expected completion before year-end. 29 September 2020
Biotechnology
David Nicholson, the former executive vice president and chief R&D officer at Allergan, has been named chairman of the board of directors at UK-based Exscientia. 29 September 2020
Biotechnology
US pharma giant Pfizer has announced today that the US Food and Drug Administration (FDA) has approved Xeljanz (tofacitinib) to treat children and adolescents aged two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). 29 September 2020
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company known as Sobi, and specializes on the production of drugs for the treatment of orphan diseases is considering expanding into the Russian market this year, according to Russian media reports. 29 September 2020
Biotechnology
The Russian government will revise plans for the purchase of some of the most expensive drugs for state needs this year due to the lack of funds in the state budget, according to some sources close to the federal government and local media, reports The Pharma Letter’s local correspondent. 29 September 2020
Biotechnology
The US Food and Drug Administration says it has additional questions about the planned Phase II/III trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial. 28 September 2020
Biotechnology
Chinese company Innovent Biologics today announced the results of a Phase III, open label, randomized study in China. 28 September 2020
Biotechnology
New two-year data from Part 1 of the pivotal FIREFISH study of Evrysdi (risdiplam) in infants aged two-even months with symptomatic Type 1 spinal muscular atrophy (SMA) showed that they continued to improve and achieve motor milestones. 28 September 2020
Biotechnology
Johnson & Johnson has released an interim analysis from the ongoing Phase I/IIa clinical trial of COVID-19 vaccine candidate JNJ-78436735. 28 September 2020
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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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