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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
All news
Biotechnology
Intercept Pharmaceuticals has received a complete response letter from the Food and Drug Administration regarding its New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to non-alcoholic steatohepatitis (NASH). 30 June 2020
Biotechnology
A second patient in the ASPIRO clinical trial investigating AT132 (the investigational gene therapy product candidate) for X-linked myotubular myopathy (XLMTM) has tragically passed away, Audentes Therapeutics has revealed. 30 June 2020
Biotechnology
Roche has been granted US approval for Phesgo (pertuzumab/trastuzumab/hyaluronidase) plus chemo, for the treatment of early and metastatic HER2-positive breast cancer. 30 June 2020
Biotechnology
US biotech Heron Therapeutics was one of a number of companies to announce on Monday that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA). 30 June 2020
Biotechnology
On Monday, the US Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. 30 June 2020
Biotechnology
Efforts to broaden the use of IL-1 blocker rilonacept have been met with Phase III success, lifting shares in Bermuda-incorporated Californian firm Kiniksa Pharmaceuticals. 30 June 2020
Biotechnology
Russian President Vladimir Putin has approved the proposal of the Ministry of Health to establish a special state fund that will focus on the purchases of some of the most expensive drugs for the needs of Russian patents, primarily children for years to come, according to recent statements by the press-service of the Russian Presidential Administration. 30 June 2020
Biotechnology
Japan’s Ono Pharmaceutical has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country. 29 June 2020
Biotechnology
Shares in US biotech Vaxart were gaining further on Monday following Friday’s 28% leap. 29 June 2020
Biotechnology
The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica). 29 June 2020
Biotechnology
A private placement has raised $250 million for German precision medicines specialist BioNTech, a company focused on immunotherapies for cancer and infectious diseases. 29 June 2020
Biotechnology
The European Commission (EC) on Friday approved Reblozyl (luspatercept), developed by Celgene, which is now part of US pharma major Bristol-Myers Squibb under a $74 billion buy-out that completed in November 2019, and Acceleron Pharma. 27 June 2020
Biotechnology
Johnson & Johnson has axed its late-stage LOTUS study of Stelara (ustekinumab) in systemic lupus erythematosus (SLE), due to lack of efficacy. A second, China-based Phase III trial will now not go ahead. 26 June 2020
Biotechnology
The US regulator has rebuffed a submission for abicipar pegol, a novel, investigational therapy for neovascular (wet) age-related macular degeneration (nAMD). 26 June 2020
Biotechnology
Swiss pharma giant Novartis late yesterday revealed that it has reached settlements with the US Department of Justice (DoJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the company and its subsidiaries. 26 June 2020
Biotechnology
VistaGen Therapeutics, a US biotech with a pipeline focused on antidepressants, and EverInsight Therapeutics have entered into a strategic licensing and collaboration agreement for the clinical development and commercialization of PH94B, VistaGen's novel, rapid-onset neurosteroid drug candidate for multiple anxiety-related disorders, in Greater China, South Korea and Southeast Asia. 26 June 2020
Biotechnology
Japanese firm Sosei Group has announced an exclusive discovery collaboration and option-to-license agreement by its Sosei Heptares unit with US pharma major AbbVie (NYSE: ABBV) to discover, develop and commercialize novel medicines that modulate G protein-coupled receptor (GPCR) targets of interest to AbbVie. 25 June 2020
Biotechnology
American biotech firm Regeneron Pharmaceuticals is the subject of a legal action from the US government, alleging kickbacks were paid to a charity to illegally promote sales of Eylea (aflibercept). 25 June 2020
Biotechnology
Late Wednesday Dutch biotech uniQure announced a licensing deal with CSL Behring, a subsidiary of Australia’s CSL Limited, providing the firm with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B. 25 June 2020
Biotechnology
The US regulator has granted another approval to New Jersey’s Merck & Co, for Keytruda (pembrolizumab). 25 June 2020
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