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Biotechnology News Magazine

Biotechnology News Magazine

Biotechnology News Magazine is one of the industry’s leading sources for biotech industry news!

Biotechnology News Magazine reports the latest biotech, pharma, FDA updates, biotechnology clinical trials, biotechnology mergers, biotechnology acquisitions, biotechnology funding, articles of interest and other important news.

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We hope you find value in Biotechnology News Magazine’s overall purpose and objectives. BiotechnologyNews Magazine is the authoritative voice of biotechnology, bridging the industry to healthcare professionals, academia, government, venture capitalists, and the general public.

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Latest Biotech Industry News

TransCure bioServices Offers BioVolume 3D Imaging for Insightful Preclinical Oncology Research

BioVolume reconstructs tumors from 3D, RGB, and thermal imaging. The solution is non-invasive, using a machine learning algorithm to automatically calculate subcutaneous tumor length, height, and width.

Deciphex Completes Validation Activities Enabling Veterinary Consultant Pathologists to Perform CLP Peer Review Digitally Using Patholytix

GLP and non-GLP studies can now be digitally peer reviewed by consultant pathologists for CROs and Pharma companies leading to faster study review and reduced backlogs with Drug candidates brought to clinical trials sooner advises Deciphex.

Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA Nephropathy

Kinpeygo is the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease.

Mergers/Acquisitions/Funding

InDevR Raises $9 Mil in Series B Financing

Kathy Rowlen, CEO at InDevR, said: “I am grateful for the opportunity to continue our successful partnership with Adjuvant Capital, and to work with the talented team at bioMérieux. The expertise at bioMérieux, combined with our innovation engine, will ensure that our CQA/QC tools are backed by a trusted partner who understands the needs of the highly regulated pharma industry.”

ISA Pharmaceuticals and Cancer Focus Fund Announce $5 Million Investment to Support First-in-Human Trial of ISA’s Novel Immunotherapy ISA103 in Uveal Melanoma

ISA103 immunotherapy targets PRAME (PReferentially expressed Antigen in MElanoma), a cancer testis antigen that is overexpressed in various solid and liquid cancers. It plays a crucial role in tumor survival and spread. ISA103 was developed using the company’s proprietary Synthetic Long Peptide (SLP®) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein.

iOnctura Awarded EUR17.5 Mil Funding from the EIC Accelerator for Clinical Development of Novel Pancreatic Cancer Therapy

On 8 December 2022 iOnctura announced the first patient was dosed in a Phase Ib clinical trial of IOA-289 in metastatic pancreatic cancer.

Clinical Trials, Studies, Data

Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma

"The CARTITUDE-4 study represents the first Phase 3 program in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma," said Jordan Schecter, M.D., Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, LLC. "We look forward to the presentation of the data from the CARTITUDE-4 study at a future medical meeting."

Decibel Therapeutics Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Lead Gene Therapy Candidate DB-OTO

The CTA authorization for DB-OTO provides approval for the Company to expand its planned Phase 1/2 clinical trial to the U.K. in patients two years of age and younger

Agenus Presents Clinical Data Demonstrating Durable Responses of Botensilimab/Balstilimab Combination in Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI

Overall response rate (ORR) of 23% and disease control rate (DCR) of 76% in expanded cohort of 70 heavily pre-treated patients; data suggest superior benefit compared to what has been reported for standard of care and other investigational therapies reports Agenus.

Iantrek Reports: 12-month Clinical Results of a Novel Micro-interventional Bio-stenting Procedure Published in the British Journal of Ophthalmology

"We are encouraged by the results of this study and the potential of this new approach to improve the lives of millions of people living with glaucoma worldwide," said Dr. Sean Ianchulev, Founder, Chairman, and CEO of Iantrek, as well as Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai and Director of Ophthalmic Innovation and Technology at the New York Eye and Ear Infirmary of Mount Sinai.

CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, "We are very pleased to receive regulatory approval to expand STAR-T into Canada and are now working closely with our partners at the Population Health Research Institute to onboard up to 7 Canadian sites as soon as possible.

REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients

RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.

Views from Our Experts

Modernization of Clinical Trials Amidst the Pandemic

This article, written by Kolabtree's freelance scientist Aditi Kandlur, elaborates on how the pandemic has brought about an evolution in clinical trials.

The Pros and Cons of Personalized Medicine By Dr. Pierre Eftekhari, CEO of Inoviem Scientific & Bcell Design

Dr. Pierre Eftekhari, CEO of Inoviem Scientific & Bcell Design, weighs in on the promise of personalized medicine.

FDA Updates

ImmPACT Bio Announces FDA Clearance of IND for Novel Bispecific CAR to Treat Aggressive B-cell Lymphoma

Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas.

DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the Treatment of Advanced, Recurrent or Metastatic Endometrial Carcinoma with HER2 Overexpression

DualityBio is currently evaluating DB-1303 in an ongoing Phase I/IIa clinical trial for preliminary safety and efficacy in advanced/metastatic solid tumors with Her2 expression, including both HER2 positive and HER2 low patients.  

Neurelis Announces Filing of Its Investigational New Drug Application for NRL-1049, a Rho Kinase (Rock) Inhibitor with Potential to Treat Cerebral Cavernous Malformations

"We are excited that the preclinical studies have shown that NRL-1049 is safe and efficacious in animal models," said Enrique Carrazana, M.D., Neurelis Chief Medical Officer. "Based on the significance of these data, Neurelis is developing further studies in humans to assess the safety of NRL-1049 in the treatment of chronic and acute conditions that affect the functioning of the blood-brain barrier. If successfully developed and approved, NRL-1049 has the potential to provide relief to people suffering from CCMs."

Market Reports

Executives on the Move

BerGenBio Announces the Establishment of Oncology Scientific Advisory Board

"We are very proud and honored to have assembled a group of leading international NSCLC experts to guide us as we investigate bemcentinib in 1st line NSCLC STK11m in combination with today's standard of care," said Cristina Oliva, M.D., Chief Medical Officer of BerGenBio. "Their expertise will play an integral role in our evaluation of bemcentinib and its potential to provide significant benefits to patients who today face a particularly poor prognosis."

Nicole Hijnen Appointed President of the Board of Freya Pharma Solutions

In addition to bringing a wealth of experience from the healthtech industry at Philips, Dr. Nicole Hijnen has held a number of senior management and scientific positions worldwide. She obtained vast commercialization experience in the medical device industry and has a deep understanding of the EU and US markets.