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26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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Biotechnology
Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission. 28 April 2021
Biotechnology
The US Food and Drug Administration has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788), Japan’s largest drugmaker Takeda Pharmaceutical announced today. 28 April 2021
Biotechnology
Privately-held Pyxis Oncology has announced the targets of its three antibody-drug conjugate (ADC) candidates along with additional details and preclinical data supporting the potential of its ADC platform. 27 April 2021
Biotechnology
USA-based LogicBio Therapeutics has announced a strategic collaboration and option agreement with China-based CANbridge Pharmaceuticals leveraging LogicBio’s gene editing and gene delivery platforms. 27 April 2021
Biotechnology
As anticipated, the European Union launched a legal action against AstraZeneca in the Belgian courts on Friday, alleging the British firm failed to live up to its contractual obligations on vaccine supplies. 27 April 2021
Biotechnology
Responding to the rapid increase in COVID-19 cases in India, US biotech Gilead Sciences says it is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. 27 April 2021
Biotechnology
Samsung Biologics and US biotech TG Therapeutics have announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. 27 April 2021
Biotechnology
GlaxoSmithKline has gained European Commission conditional marketing authorization for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. 26 April 2021
Biotechnology
Krakow, Poland-based oncology specialist Ryvu Therapeutics today announced that Vatnak Vat-Ho has joined the company as chief business officer. 26 April 2021
Biotechnology
Health Canada has begun the review of the rolling submission for Medicago’s plant-derived COVID-19 vaccine candidate in combination with GlaxoSmithKline’s pandemic adjuvant. 26 April 2021
Biotechnology
US clinical-stage biotech Pieris Pharmaceuticals’ shares edged up 4% to $2.37 in early trading today after it announced an exclusive product license agreement with Boston Pharmaceuticals to develop PRS-342, a 4-1BB/GPC3 pre-clinical immuno-oncology Anticalin-antibody bispecific fusion protein. 26 April 2021
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on uniQure’s hemophilia B gene therapy program after determining that Dutch gene therapy company had satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial of AMT-061. 26 April 2021
Biotechnology
Large-scale research undertaken by the University of Oxford, published as two pre-prints, shows a significant fall in COVID-19 infections after a single vaccine dose. 26 April 2021
Biotechnology
US biotech Inovio Pharmaceuticals saw its shares crash nearly 25% to $6.85 by close of trading on Friday, after it revealed that the US government had pulled the plug on funding for its Phase III trial of COVID-19 vaccine candidate INO-4800. 26 April 2021
Biotechnology
Having a treatment that, the data show, can save the lives of babies and children facing an otherwise grim outlook is an excellent starting point for ensuring swift reimbursement for a product, but by no means is it a guarantee. 26 April 2021
Biotechnology
Notable news last week included Australia’s Kazia Therapeutics entering a licensing deal with Germany’s Evotec for worldwide rights to cancer candidate EVT801. French vaccine specialist Valneva has started Phase III evaluation of its COVID-19 candidate VLA200 in the UK. US biotech bluebird bio gave an update on its genetic disease portfolio last Tuesday and said it was withdrawing its beta thalassemia drug Zynteglo from the German market due to failed price negotiations. GlaxoSmithKline was granted US Food and Drug Administration approval for its checkpoint blocker Jemperli. Also, on Friday the FDA lifted its pause on the use of Johnson & Johnson’s COVID-19 Vaccine Janssen. 25 April 2021
Biotechnology
On Friday, Swiss antibody-drug conjugate specialist ADC Therapeutics saw its shares gain almost 5% to $24.40 after-hours, as it revealed that the US Food and Drug Administration has granted accelerated approval for Zynlonta (loncastuximab tesirine-lpyl). 24 April 2021
Biotechnology
Following its April meeting, the European Medicines Agency’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the European Union. 24 April 2021
Biotechnology
Indian drugmaker Zydus Cadila has received restricted emergency use approval (EUA) from the Drug Controller General of India (DCGI) for the use of Virafin (pegylated interferon alpha-2b) in treating moderate COVID-19 infection in adults. 23 April 2021
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human US (CHMP) recommended eight medicines for approval at its April 2021 meeting, five of which were novel drugs. 23 April 2021
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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
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
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