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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
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
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
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Biotechnology
COVID-19 vaccine developer Novavax has provided an update on the Phase III program for NVX-CoV2373, a stable, prefusion protein made using the firm’s nanoparticle technology. 28 October 2020
Biotechnology
US biopharma firm Apellis Pharmaceuticals and Swedish Orphan Biovitrum (also known as Sobi) have announced a strategic collaboration to accelerate the advancement of systemic pegcetacoplan, a targeted C3 therapy, for the treatment of multiple rare diseases with high unmet need, impacting more than 275,000 patients globally. 28 October 2020
Biotechnology
A further boost for antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has come in the form of Priority Review designation from the US regulator. 28 October 2020
Biotechnology
US biotech Moderna today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started the rolling review process of mRNA-1273, the company’s vaccine candidate against COVID-19. 27 October 2020
Biotechnology
Sweden-based biotech firm BioInvent International and USA-based CASI Pharmaceuticals today announced an exclusive licensing agreement for the development and commercialization of novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. 27 October 2020
Biotechnology
Chinese biotech firm CStone Pharmaceuticals (HKEX: 2616) has signed an agreement to out-license ex-Greater China rights for two key late-stage immuno-oncology assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx. 27 October 2020
Biotechnology
Boston-based Catabasis Pharmaceuticals has announced that the Phase III PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy (DMD) did not meet its primary endpoint. 27 October 2020
Biotechnology
People involved in the ongoing Phase III program for AstraZeneca’s COVID-19 vaccine candidate say it produces a robust immune response in the elderly. 27 October 2020
Biotechnology
Oncology specialist Spectrum Pharmaceuticals has announced that the US Food and Drug Administration (FDA) is deferring its action on the company’s Biologics License Application (BLA) for Rolontis (eflapegrastim). 26 October 2020
Biotechnology
Israel’s BiondVax Pharmaceuticals has announced top-line data from the company’s pivotal, Phase III trial of M-001 as a standalone universal flu vaccine candidate. 26 October 2020
Biotechnology
Canada-based biotech firm Medicago, a subsidiary of Mitsubishi Tanabe Pharma, has reached an agreement with the Canadian government to develop its COVID-19 candidate. 26 October 2020
Biotechnology
Privately-held UK regenerative medicine company Rexgenero today announced that the Independent Data Monitoring Committee (IDMC) for its REX-001 Phase III clinical trial recently met to review patient safety and tolerability data from the initial 22 subjects. 26 October 2020
Biotechnology
Germany’s largest drugmaker Bayer today revealed it is taking a hefty punt on expanding its cell and gene therapy portfolio, with the acquisition of privately-held US biotech Asklepios BioPharmaceutical (also known as AskBio). 26 October 2020
Biotechnology
London-based cell therapy specialist Quell Therapeutics has kicked off a new collaboration with the Sheffield Institute for Translational Neuroscience (SITraN), an international center of excellence within the University of Sheffield. 26 October 2020
Biotechnology
Moving at a slower pace than other regulators which have already approved resumption of the AZD1222 studies, the Food and Drug Administration on Friday authorized the restart in the USA, following the resumption of trials in other countries in recent weeks. 24 October 2020
Biotechnology
US biopharma Ultragenyx Pharmaceutical and Solid Biosciences, a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, have announced a strategic collaboration and license agreement. 23 October 2020
Biotechnology
Leverkusen-based Bayer has won a positive reimbursement decision in the UK for Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in prostate cancer. 23 October 2020
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has reversed a draft rejection of Keytruda (pembrolizumab) and now recommends the monotherapy for the first-line treatment of adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). 23 October 2020
Biotechnology
French biotech Nicox SA has announced a novel drug candidate, NCX 1728, which the ophthalmology specialist intends to take into the clinic. 23 October 2020
Biotechnology
UK-based 4D pharma, which is leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome - and Longevity Acquisition Corp today announce the proposed merger of the two companies. 22 October 2020
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