A licensing deal between XOMA Corporation and Affimed Therapeutics is starting to bear fruit, with progress in three innate cell engager (ICE) programs. 16 April 2021
The European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody. 16 April 2021
The approval of a Food and Drug Administration (FDA) emergency use authorization (EUA) for AstraZeneca’s COVID-19 vaccine AZD1222, now dubbed Vaxzevria, will boost confidence and use of the vaccine globally. 16 April 2021
For biotech companies, the prospect of receiving non-dilutive, non-recourse funding to advance their assets even through the early stages of clinical development may sound too good to be true. 16 April 2021
California, USA-based biotech BioAge Labs has entered into an exclusive worldwide license agreement with Amgen to develop and commercialize Amgen’s clinical-stage APJ agonist, BGE-105 previously (named AMG 986 by Amgen) to ameliorate muscle aging. 15 April 2021
Cambridge, UK-based biotech Alchemab Therapeutics today announced the completion of a £60 million ($82 million) Series A financing round. 15 April 2021
The National Institute for Care and Health Excellence’s (NICE) has recommended Ultomiris (ravulizumab) for use in the National Health Service (NHS) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 15 April 2021
UK endocrine diseases specialist Diurnal Group has withdrawn its application for maintenance of orphan designation in Europe for Efmody (hydrocortisone modified-release hard capsules), a drug formerly known as Chronocort. 15 April 2021
US pharma giant Merck & Co today announced it will discontinue the development of MK-7110 (formerly known as CD24Fc) for the treatment of hospitalized patients with COVID-19. 15 April 2021
PTC Therapeutics has announced new data showing continued improvements in motor milestones in infants with type 1 spinal muscular atrophy (SMA) after two years of treatment with Evrysdi (risdiplam). 15 April 2021
UK pharma major GlaxoSmithKline today announced that, following a recommendation by the Independent Data Monitoring Committee, it has taken the decision to stop enrolling patients in the Phase II INDUCE-3 trial, including discontinuing treatment with feladilimab. 15 April 2021
China’s SciNeuro Pharmaceuticals has entered into an exclusive license agreement with US pharma major Eli Lilly for the development and commercialization of alpha-synuclein targeted antibody therapies in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. 15 April 2021
Pfizer and BioNTech’s Comirnaty (tozinameran) is forecast to have peak sales of $24.8 billion by 2021, which is only its second year on the market. 15 April 2021
US biotech Tango Therapeutics has signed a deal with BCTG Acquisition, a special-purpose acquisition company, or SPAC, sponsored by San Diego's Boxer Capital, to go public through a reverse merger. 14 April 2021
The Indian government has decided to fast-track vaccine approvals that have already been authorized by one of four foreign drug regulators or the World Health Organization, clearing the way for the emergency approval for COVID-19 vaccines amid a huge surge in infections and deaths. 14 April 2021
London-listed blood disease specialist Hemogenyx Pharmaceuticals (LSE: HEMO) has provided an update on the development of its lead product candidate, a CDX bispecific antibody. 14 April 2021
Following swiftly on approval for metastatic triple-negative breast cancer (mTNBC), the US Food and Drug Administration has also granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. 14 April 2021
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