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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 US Food and Drug Administration (FDA) has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). 3 August 2020
Biotechnology
Despite gaining 1.9% pre-market, AbbVie shares were down 2% at $94.14 mid-morning after it announced financial results for the second quarter ended June 30, 2020. 31 July 2020
Biotechnology
Pfizer and BioNTech have received a third major order in a month for their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval. 31 July 2020
Biotechnology
Genomic medicine company Sangamo Therapeutics closed 15% higher on Thursday. 31 July 2020
Biotechnology
The US Food and Drug Administration has granted accelerated approval for the combination of Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. 31 July 2020
Biotechnology
The US Food and Drug Administration has approved an expanded indication for Stelara (ustekinumab) as a treatment for pediatric patients (six-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO). 31 July 2020
Biotechnology
US biotech Gilead Sciences announced its results for the second quarter of 2020 late Thursday, sending shares in the company plummeting. 31 July 2020
Biotechnology
A positive reimbursement decision has paved the way for Bavencio (avelumab) plus Inlyta (axitinib) to be made available for people with kidney cancer in the UK. 31 July 2020
Biotechnology
In between headline-grabbing updates for its world-leading COVID-19 vaccine program, BioNTech provided news from its work in oncology on Friday. 31 July 2020
Biotechnology
US pharma major Bristol-Myers Squibb and partner bluebird bio today announced the submission of their Biologics License Application (BLA) to the US Food and Drug Administration for idecabtagene vicleucel (ide-cel; bb2121). 30 July 2020
Biotechnology
Tagrisso (osimertinib) has been granted Breakthrough Therapy designation (BTD) in the USA for 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 with curative intent. 30 July 2020
Biotechnology
Results published in the New England Journal of Medicine (NEJM) indicate that a new kind of immunization could help protect premature babies from respiratory syncytial viruses (RSV). 30 July 2020
Biotechnology
Israel-based Teva Pharmaceutical Industries announced that its partner, Otsuka Pharmaceutical, has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for Ajovy (fremanezumab) injection for the preventive treatment of migraine. 30 July 2020
Biotechnology
Since the novel coronavirus pandemic outbreak, and with no available vaccines or treatment, many dozens of existing medicines have been trialled in the setting, so far with few successes. 29 July 2020
Biotechnology
Shares of Belgium’s largest drugmaker UCB were barely moved in early trading, despite the announcement of a potentially massive licensing deal for its Alzheimer’s candidate. 29 July 2020
Biotechnology
The Alliance for Regenerative Medicine (ARM) has called for pan-European action to fast-track the use of real world evidence (RWE) for advanced therapy medicinal products (ATMPs) to help ensure patient access to transformative therapies. 29 July 2020
Biotechnology
Infectious diseases specialist Nabriva Therapeutics has won European approval for Xenleta (lefamulin), for the treatment of community-acquired pneumonia (CAP) in adults. 29 July 2020
Biotechnology
US biotech giant Amgen late Tuesday announced financial results for the second quarter of 2020, which, although better than analysts’ expectations, pushed the firm’s shares down 1.5% to $251.50 in after-hours trading. 29 July 2020
Biotechnology
Cancer Research UK, the University of Southampton and London-based biotech Touchlight Genetics, today (July 29) announced a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC). 29 July 2020
Biotechnology
AbbVie’s aspiring blockbuster Rinvoq (upadacitinib) is on course for a second indication following the presentation of pivotal Phase III results in atopic dermatitis (AD). 28 July 2020
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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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