Expert Advice 28 Jul 2023 What you need to know about the EU HTA regulation before deadline By Anke van Engen, senior principal, EMEA value & payer evidence, IQVIA, and Dima Samaha, senior principal, EMEA value & payer evidence, IQVIA The European Union (EU) comprises 27 member states (MS) with varying laws, processes and regulatory standards. This variation has led to a complex data landscape for health technologies and drug therapeutics developers, […] July 28, 2023 - 7 minutesmins - By External Contributor Share WhatsApp Twitter Linkedin Email
In Depth 27 Jul 2023 Cell and gene therapy manufacturing: trends, advancements and challenges Cell and gene therapy manufacturing has been a pertinent topic for a while now, largely due to the fact it is such a complicated process, involving a number of moving parts and excessive costs. As such, figuring out how to make these types of therapies scalable, less time consuming and cost-effective is still an ongoing […] July 27, 2023 - 7 minutesmins - By Willow Shah-Neville Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2023 Recbio shingles vaccine clinical trial approved Jiangsu Recbio Technology Co., Ltd. has received notice of acceptance from China’s National Medical Products Administration (NMPA) to start a clinical trial for its self-developed novel adjuvanted recombinant shingles vaccine, REC610. Within 60 days from the date of acceptance, the company may carry out clinical trials in accordance with the submitted plan if no negative […] July 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2023 Epsilogen completes first clinical trial of IgE antibody to treat cancer Epsilogen, a producer of immunoglobulin E (IgE) antibodies to treat cancer, has published the final phase I data from the first ever clinical trial of an IgE antibody therapeutic. The results were published in Nature Communications. MOv18 IgE is Epsilogen’s lead IgE antibody drug candidate and binds to anti-folate receptor (FRα), a well validated target […] July 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2023 Medicxi announces $400M fund for life science companies Medicxi, a European life sciences investment firm, has launched its $400 million Medicxi IV fund. The new fund will support companies with clear product visions to deliver transformative therapies for patients. Medicxi’s investments have resulted in the development of several marketed and late-stage development drugs, including Daratumumab (Genmab/Johnson & Johnson), Blincyto (Amgen), Alunbrig (Takeda), Voquezna […] July 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 26 Jul 2023 Diabetes drug could promote healthy aging A research team from the School of Public Health, LKS Faculty of Medicine of the University of Hong Kong (HKUMed), has provided genetic evidence that metformin might promote healthy aging using a cohort study of more than 300,000 participants of European descent (UK Biobank). The proof-of-concept work supports further clinical research into the drug repositioning […] July 26, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
In Depth 26 Jul 2023 Antibody drug conjugates: BiVictriX drives a new era in cancer medicine The first-ever antibody-drug conjugate (ADC) to be approved, gemtuzumab ozogamicin, raised hope for a new class of drugs to treat cancer. But the drug was then withdrawn following a black box warning after patients experienced adverse side effects, and there had been fatalities. But this didn’t discourage biopharmas looking to create safer alternatives from expediting […] July 26, 2023 - 7 minutesmins - By Roohi Mariam Peter Share WhatsApp Twitter Linkedin Email
News and Trends 25 Jul 2023 Triastek sees positive results from printed oral treatment for ulcerative colitis Triastek, Inc. has completed its first in human study of its third 3D printing drug product, T21, designed to treat moderate to severe ulcerative colitis (UC). Imaging results from the study confirmed that T21 tablets are precisely delivered and released to the target site – the colon – for the drug release. The administration of […] July 25, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 25 Jul 2023 Can the microbiome help the fight against infections? Animals and humans coexist with a vast array of microorganisms known as the microbiome, forming a relationship that can range from mutually beneficial to pathogenic. To safeguard against harmful pathogens and maintain the presence of beneficial microorganisms, animals have evolved various defenses.One is small antimicrobial peptides (AMPs), small peptides that combat invading microbes. AMPs are […] July 25, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 25 Jul 2023 Molecure raises $12M and gets FDA clearance for pulmonary sarcoidosis trial Molecure S.A. has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application to conduct phase II clinical testing of OATD-01. The announcement follows the company closing a secondary public offering and entering into subscription agreements for all 2,776,000 H-shares offered by way of private placement, within the […] July 25, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 25 Jul 2023 Roche and Alnylam to work on RNAi therapeutic to treat hypertension Roche has announced a partnership with Alnylam to develop and commercialize zilebesiran, an investigational RNAi therapeutic currently in phase 2 for the treatment of hypertension. Hypertension affects more than 1.2 billion adults worldwide and is the main, independent, preventable risk factor for death and disability, with approximately 80% of the adults with hypertension worldwide not […] July 25, 2023 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 25 Jul 2023 Crescendo Biologics raises $32M and expands cancer trial Crescendo Biologics Ltd, a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, has announced that it plans to augment the ongoing phase 1b clinical trial of CB307 through the addition of a new pembrolizumab (anti-PD-1) combination expansion cohort. Additional financing of $32 million has been secured with the support of all major […] July 25, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email