Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy,...
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
Simcere has announced a partnership with Vivoryon whereby it will leverage the potential of innovative N3pE amyloid-targeting agents to treat Alzheimer’s disease (AD) in Greater China.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a ‘strong body of evidence’ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual...
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
Catalent is to acquire German company, RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies.
Iksuda Therapeutics, a developer of a new generation of antibody drug conjugates (ADCs), has expanded its research collaboration and license agreement with LegoChem Biosciences Inc (LCB).
Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Coriolis Pharma has announced a 7,800-meter-square expansion to a building situated in Munich, Germany, where the company is headquartered, that will host formulation development for advanced therapeutic medicine products (ATMPs).
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
Sorrento Technologies, a biotech firm developing novel treatments for COVID-19 and aggressive cancers such as melanoma, has received FDA clearance to start a research collaboration together with Mayo Clinic.
In recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including COVID-19 vaccines.
These organizations hope to connect with attendees at the event, sharing clinical research ideas and innovations in sessions and the virtual exhibit hall.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
Whether working in the pharmaceutical industry or in academia or government, the skills required to achieve, maintain and grow a career are vastly different today than they were 30 years ago. A session at DIA 2021 will put the spotlight on the skills...
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
A lesson learnt from the COVID-19 pandemic was that human ingenuity prevailed and resolved an issue that challenged the world; the crisis also reinforced faith in the power of science, said Dr Albert Bourla, CEO of Pfizer, in a keynote interview during...
Co-administration of Novavax’s COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. “The findings suggest simultaneous vaccination may be a viable immunization strategy,”...
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
Evonik says it is working with Stanford University, California on a technology to deliver mRNA to tissues and organs that goes beyond the capabilities of lipid nanoparticles (LNPs).
The G7 wants to see a 100-day response to future pandemics, including vaccines ready for deployment at scale in this time. ‘The three best weapons we have are diagnostics, therapeutics and vaccines’ says a report from the summit.
Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as...
Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.
Shoreline Biosciences and BeiGene have announced an exclusive worldwide strategic collaboration to develop and commercialize a portfolio of natural killer (NK) based cell therapeutics.
The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.
Dutch biotech, Byondis, today announced positive topline results from a Phase 3 study, which it says confirms the safety and efficacy of its antibody drug conjugate (ADC) - SYD985 - as a treatment for patients with pretreated HER2-positive locally advanced...
The Alzheimer’s Association has welcomed the FDA’s approval of aducanumab for Alzheimer’s disease, calling it ‘the beginning of a completely new future for Alzheimer’s treatments’.
Biogen pledges to share future insights about Aduhelm (aducanumab-avwa) with the scientific community as it collects more data from real-world use of the treatment, after the drug was approved by the FDA yesterday.
The virtual clinical development firm’s analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
