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
Swiss pharma major Novartis has secured a positive reimbursement decision in the UK for Cosentyx (secukinumab) as an option for certain people with active non-radiographic axial spondyloarthritis. 17 June 2021
The Russia Ministry of Health of the Russian Federation has approved pathogenetic therapy of cytokine release syndrome in patients with moderate to severe new coronavirus infection (COVID-19) as an additional indication to be included in the olokizumab SmPC. 17 June 2021
Positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation have been published in that the New England Journal of Medicine. 17 June 2021
The US government has purchased an additional 200 million doses of the coronavirus vaccine developed by Moderna, in case boosters are needed. 17 June 2021
In an environment with continued pricing pressure biopharma executives are asking themselves: Can we discover and develop new medicines that improve patient outcomes whilst solving access challenges? 17 June 2021
Having scored a historic first last week, with accelerated US regulatory approval for the use of its Aduhelm (aducanumab) as the first treatment in nearly two decades to address an underlying cause of Alzheimer's disease, yesterday US biotech major Biogen (Nasdaq: BIIB) also added to the list of failures in the search for such treatments. 17 June 2021
The US Food and Drug Administration approved Cambridge, Massachusetts-based Blueprint Medicines’ Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis (AdvSM). 17 June 2021
German vaccines developer CureVac saw its shares halve in value overnight, after the firm announced its coronavirus vaccine had failed late-stage testing. 17 June 2021
US biotech Regeneron Pharmaceuticals’ shares were up 2.4% at $40.16 in early trading today, as new results of a large UK clinical trial showed the company’s antibody cocktail improved survival in hospitalized COVID-19 patients. 16 June 2021
In a second cardiometabolic deal signed this month, Danish diabetes care giant Novo Nordisk has now entered into a collaboration with privately-held US biotech Lumen Bioscience. 16 June 2021
Japanese pharma major Daiichi Sankyo has pulled the plug on development of an inhaled formulation of nafamostat, dubbed DS-2319, as a treatment for COVID-19. 16 June 2021
Vyepti (eptinezumab-jjmr) met both co-primary endpoints of the RELIEF study, published today in the Journal of the American Medical Association (JAMA), showing early benefit for time to headache pain freedom, and time to the absence of most bothersome symptoms (MBS), compared to placebo, said Danish CNS specialist Lundbeck. 16 June 2021
Swiss-American biotech CRISPR Therapeutics and USA-based Capsida Biotherapeutics have entered into a strategic partnership to research, develop, manufacture and commercialize in vivo gene editing therapies delivered with engineered AAV vectors for the treatment of familial amyotrophic lateral sclerosis (ALS) and Friedreich’s ataxia. 15 June 2021
Biogen’s near-billion dollar bet on Nightstar Therapeutics looks set to lose spectacularly, following the failure of the Phase III STAR study of lead candidate timrepigene emparvovec. 15 June 2021
Advanced therapy trade group The Alliance for Regenerative Medicine (ARM) has highlighted the passage of a new piece of legislation designed to accelerate patient access in Germany. 15 June 2021
New data from Public Health England (PHE) have demonstrated that COVID-19 Vaccine AstraZeneca offers high levels of protection against the Delta variant (B.1.617.2; formerly the ‘Indian’ variant). 15 June 2021
Biotech funder and incubator Flagship Pioneering has raised an additional $2.2 billion, augmenting the capital base for its Fund VII, which was reopened in April. 15 June 2021
Independent private equity firm Jeito Capital, which is dedicated to biotech and biopharma, today announced that it has become a key investor as part of a $67 million Series B financing round in Alentis Therapeutics. 15 June 2021
UK pharma major GlaxoSmithKline has entered into a collaboration with Belgian biotech iTeos Therapeutics to co-develop and co-commercialize EOS-448, an anti-TIGIT monoclonal antibody (MAb) currently in Phase I development as a potential treatment for patients with cancer. 14 June 2021
South Korea’s Celltrion group saw its shares close up nearly 6% at 281,000 won today, after it announced top-line efficacy and safety data from the global Phase III clinical trial of an COVID-19 treatment candidate. 14 June 2021