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.
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
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
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
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
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
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
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
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
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
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
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
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
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
In a second collaboration announced by Vertex Pharmaceuticals this week, the US firm says it has entered into a strategic research collaboration and licensing agreement with Obsidian Therapeutics, focused on the discovery of novel therapies that regulate gene editing for the treatment of serious diseases. 23 April 2021
Horizon Therapeutics has announced new data on Uplinza (inebilizumab-cdon) were presented at the American Academy of Neurology’s 73rd Annual Meeting being held virtually April 17-22, 2021 (AAN 2021). 23 April 2021
The US Food and Drug Administration has approved Jemperli (dostarlimab-gxly), a checkpoint blocker developed by UK drugmaker GlaxoSmithKline. 23 April 2021
US biotech major Biogen today reported first quarter 2021 financial results which, though well below 2020 comparisons, beat analysts’ expectations. 22 April 2021
US pharma major Bristol Myers Squibb is expanding its global manufacturing footprint by investing in a new cell therapy manufacturing site in the Netherlands. 22 April 2021
Anavo Therapeutics, a Netherlands-based company that is aiming to unlock the full therapeutic potential of human phosphatase biology, debuted today with a 20 million euros (~$24 million) seed financing from M Ventures, INKEF, Taiho Ventures, and Bioqube Ventures. 22 April 2021
Guernsey and Switzerland based Pureos Bioventure has announces the final closing of its first fund BB Pureos Bioventures LP with a committed capital of $205 million. 22 April 2021
Swiss pharma giant Roche today released first-quarter 2021 financials, showing that group sales rose 3% (-1% in in francs) to 14.9 billion Swiss francs ($16.2 billion), propelling the firm’s shares up 2.3% to 332.20 francs in early afternoon trading. 21 April 2021
Shares of Swiss gene-editing specialist CRISPR Therapeutics traded up as much as 9.1% at $125.48 yesterday, after it announced amendments to its existing collaboration with USA-based Vertex Pharmaceutical. 21 April 2021
A nasal spray designed to block the novel coronavirus, from Austrian drug developer Marinomed Biotech, has been shown to inactivate new, rapidly spreading variants. 21 April 2021
bluebird bio today announced business and program updates across its severe genetic disease portfolio, which pushed the US biotech firm’s shares down more than 2% to $27.40 by late-morning trading. 20 April 2021
At its meeting on Tuesday, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) decided that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. 20 April 2021
There was good news today for Eli Lilly and Company (NYSE: LLY) and Incyte (Nasdaq: INCY) today, as they released positive results from a second Phase III trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2mg and 4mg in adults with severe alopecia areata (AA). 20 April 2021
The US Food and Drug Administration has accepted two supplemental Biologics License Application (sBLA) submissions for Padcev (enfortumab vedotin-ejfv) for review as part of the Real-Time Oncology Review (RTOR) pilot program. 20 April 2021
Shares of German biotech Evotec were up 2.3% at 34.39 euros by late afternoon today after it said it has initiated the construction of its J.POD 2 EU biologics manufacturing facility at Evotec's Campus Curie in Toulouse, France. 20 April 2021
Ocular diseases focussed genomics medicines company SparingVision has entered into a definitive agreement to acquire fellow French biotech firm GAMUT Therapeutics, which has unique gene-independent approach to treat the later stages of rod-cone dystrophies such as retinitis pigmentosa (RP). 20 April 2021
Japanese drugmaker Eisai, one of an increasingly small number of major players still working in the Alzheimer’s space, has published results from a Phase IIb trial of lecanemab. 20 April 2021
The National Institute for Health and Care Excellence (NICE) has recommended Enhertu (trastuzumab deruxtecan) for use within the Cancer Drugs Fund (CDF) to treat HER2 positive unresectable or metastatic breast cancer in English adults who have received two or more prior anti-HER2 based therapies. 20 April 2021