Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
There is a healthy appetite for continued investment in gene therapy, in new modalities and more indications, says an industry insider as he reflected on the prospects for the US gene therapy sector next year.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
As of January 1, 2022, Biogen will cut the price of its Alzheimer’s drug Aduhelm (aducanumab-avwa) in half: saying too many patients are not currently being offered the choice of the drug due to financial considerations.
The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.
A booster shot of Moderna’s COVID-19 vaccine increases neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels, according to data released by the company today.
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimer’s drug application, following the agency’s recommendation to refuse authorization of the drug in the EU.
Australia company, Inventia Life Science, which is focused on advanced 3D cell cultures for research and clinical purposes, has just closed a US$25M Series B funding round, led by Blackbird Ventures.
The Parkinson’s Progression Markers Initiative, built using Evidation Health’s research platform, aims to triple enrollment and recruit online participants.
Lonza has signed a licensing agreement with clinical-stage biopharma, Zhejiang Doer Biologics, whereby the Hangzhou, China based biopharma company will develop multi-specific biotherapeutics using the Swiss CDMO’s XS Pichia.
A single booster dose of Sanofi and GSK’s recombinant adjuvanted COVID-19 vaccine candidate delivered ‘consistently strong immune responses’, according to data released by the companies.
SGS, the Swiss-based testing, inspection and certification company, has acquired Quay Pharma, a UK based pharmaceutical industry targeted contract development and manufacturing organization (CDMO).
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
Samsung Biologics will manufacture AstraZeneca’s COVID-19 long-lasting antibody combination (AZD7442) and cancer immunotherapy product from next year under an expanded partnership.
Moderna and the Australian government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
Oxford Biomedica plc has announced an extended commercial supply agreement with Novartis for the manufacture of lentiviral vectors for several Novartis CAR-T products.
Moderna released what it deemed to be positive interim data from the phase 1 study of its quadrivalent flu vaccine, mRNA-1010, on Friday. But the markets were left underwhelmed.
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.
Taiwan based contract manufacturer, Bora Pharmaceuticals, in partnership with Taishin Healthcare Limited, is ready to spend millions to expand its footprint in the CDMO sector.
Cincinnati Children's Hospital Medical Center and research service provider CTI Clinical Trial & Consulting Services will form a company to provide cell and gene therapy manufacturing services to the biotech and pharmaceutical industries.
Catalent is reporting that the technology transfer for the manufacture of BrainStorm Cell Therapeutics’ autologous cellular therapy at its facility in Houston, Texas has been finalized.
Two doses of the Pfizer/BioNTech vaccine ‘may not be sufficient’ to protect against infection with the Omicron variant; but three doses of the vaccine neutralize the variant, according to a preliminary laboratory study released by the companies.
PDC*line Pharma, a clinical stage biotech company developing cancer vaccines, has completed its Series B2 round of financing, raising a total of €17.5m (US$20.3m) with Belgian and South-Korean investors.
Fujifilm Irvine Scientific, Inc, is to build a new bioprocessing center in China, with the goal of ensuring local cell culture media optimization support for vaccines, advanced therapies, and biotherapeutic drug development.
Trince, a spin-off of Ghent University (UGent) that is focused on advancing cell-based science and therapeutics by facilitating the delivery of molecules into cells, both in vitro and ex vivo, has raised €4m (US$4.5m) from investors.
The European Commission has extended the marketing authorisation for Actemra/RoActemra (tocilizumab) to include the treatment of severe COVID-19 in adults.
Medicago and GSK’s plant-based COVID-19 vaccine candidate has reported an overall efficacy rate of 71% in Phase 3 trials: with the final regulatory submission for the vaccine to be filed with Health Canada shortly.
Australia’s Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharm’s subsidiary Pharmorage.
The European Medicines Agency (EMA) has started a rolling review of VLA2001, Valneva’s COVID-19 vaccine candidate, with the company set to supply up to 60 million doses to the European Union.
Genezen, a cell and gene therapy focused CDMO, has just opened a new process development and analytical lab, a build that represents the first phase of a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility in Indianapolis.
The Oxford-GSK Institute of Molecular and Computational Medicine has been created via a five-year collaboration between GlaxoSmithKline and the University of Oxford.
Several contract development and manufacturing organization (CDMO) supported biopharma projects have been flagged in the past month. We take a closer look.
EverImmune, a biotech based near Paris, and specialized in the development of live biotherapeutic products in the field of microbiota oncology, has raised €5m (US$5.7m) in a Series A funding round from undisclosed private investors.
The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.
Chinook Therapeutics, Inc. has announced the formation of SanReno Therapeutics - a joint venture with an investor syndicate led by Frazier Healthcare Partners and Pivotal bioVenture Partners China - to develop, manufacture and commercialize kidney disease...
As capital project delivery ramps back up to pre-pandemic levels over the coming months and years, the smaller biopharma players are looking outside their own resources for strategic manufacturing and research support, confirms a new market outlook from...
Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize...
A new report reveals that “speed-to-market” has jumped up from a lower-ranking business driver before the pandemic to the top priority today for biopharma companies, overtaking cost-based considerations by a healthy margin.
Ncardia, a human-induced pluripotent stem cell-based (iPSC) technology company, has secured more than US$60m in capital through a strategic partnership with Kiniciti, a US based investor with a focus on the global cell and gene therapy ecosystem.
