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Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
Biotechnology
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
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
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
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
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Biotechnology
Hutchmed says that the first commercial sale in China of Orpathys (savolitinib), the Chinese firm's oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, occurred on July 12, 2021. 13 July 2021
Biotechnology
Shares in New Jersey, USA-based Celldex Therapeutics leapt by a quarter on Monday, after the firm announced positive results from an ongoing Phase Ib trial of CDX-0159. 13 July 2021
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. 13 July 2021
Biotechnology
The University of Texas MD Anderson Cancer Center and Hummingbird Bioscience have announced the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, the Texas biotech’s VISTA antagonist antibody. 12 July 2021
Biotechnology
England’s health technology assessor, the National Institute for Health and Care Excellence (NICE), has dealt a blow to Orchard Therapeutics’ reimbursement goals for atidarsagene autotemcel. 12 July 2021
Biotechnology
Data from two Phase II studies investigating bemcentinib in hospitalized COVID-19 patients have been presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) by Norwegian biotech BerGenBio. 12 July 2021
Biotechnology
Prothena Corp shares were up nearly 6% at $62.70 in pre-market New York trading, as the Ireland-headquartered biotech announced a definitive purchase agreement with Danish diabetes care giant Novo Nordisk. 12 July 2021
Biotechnology
French vaccines developer Valneva has been awarded Breakthrough Therapy designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA). 12 July 2021
Biotechnology
Belgian cell therapy company Bone Therapeutics, which is addressing unmet medical needs in orthopedics and other diseases, has appointed Anne Leselbaum as chief medical officer (CMO), effective August 23, 2021. 12 July 2021
Biotechnology
The controversy over the approval of Alzheimer’s med Aduhelm (aducanumab) has deepened, as the acting head of the US Food and Drug Administration called for an investigation into her agency’s own actions. 12 July 2021
Biotechnology
The US Food and Drug Administration has granted Padcev (enfortumab vedotin-ejfv) regular approval, in addition to approving a new indication for adult patients with locally-advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. 10 July 2021
Biotechnology
Japanese drug major Chugai Pharmaceuticals has entered into an option and license agreement with Chinese biotech Alebund Pharmaceuticals (Hong Kong), regarding Chugai’s EOS789, an investigational agent under development for hyperphosphatemia. 10 July 2021
Biotechnology
The USA's Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of a host of therapies for atopic dermatitis (AD). 9 July 2021
Biotechnology
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) held its July meeting this past week, and today reported on safety issues with a leukemia drug and four COVID-19 vaccines. 9 July 2021
Biotechnology
Based on the observed large differences in overall survival in pre-specified subgroups, the US Food and Drug Administration has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation, Swedish biotech Oncopeptides revealed on Thursday, sending the firm’s shares tumbling as much as 23%. 9 July 2021
Biotechnology
Shares of both Biogen and Eisai were up following the news that the US Food and Drug Administration had amended the labelling for their Aduhelm (aducanumab-avwa), which, somewhat controversially, in June became the first treatment in two decades to gain approval in the treatment of Alzheimer’s disease. 9 July 2021
Biotechnology
Men with particularly aggressive prostate cancers can be treated more effectively by combining an existing targeted medicine, abiraterone, with a new experimental drug to block two of cancer’s growth signals at once, a major new trial shows. 9 July 2021
Biotechnology
AstraZeneca has been granted Priority Review for its Biologics License Application (BLA) for tezepelumab, developed in collaboration with Amgen. 8 July 2021
Biotechnology
Shares of UK and USA-based clinical stage biotech F-star Therapeutics were up 11% at $8.15 pre-market, as it revealed it has entered into an exclusive licensing agreement with AstraZeneca,, under which the Anglo-Swedish pharma major will receive global rights to research, develop and commercialize next generation Stimulator of Interferon Genes (STING) inhibitor compounds. 8 July 2021
Biotechnology
Sino-American biotech BeiGene said yesterday that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy. 8 July 2021
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