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Biotechnology News Magazine, Jacksonville, FL (2023)

12/7/22: Modernization of Clinical Trials Amidst the Pandemic. This article, written by Kolabtree’s freelance scientist ...

12/07/2022

Modernization Of Clinical Trials Amidst The Pandemic - Reports Biotechnology News Magazine

12/7/22: 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. Read at https://biomag1.com/modernization-of-clinical-trials-amidst-the-pandemic/ Kolabtree

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

12/05/2022

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

Dr. Eftekhari weighs in on the promise of personalized medicine. Read at https://biomag1.com/the-pros-and-cons-of-personalized-medicine-by-dr-pierre-eftekhari-ceo-of-inoviem-scientific-bcell-design/

11/22/2022

QleanAir Partnership To Support Work Of Two Faculty Members Aiming To Reduce Occurrences Of Contamination In Compounding Pharmacies With AI - Reports Biotechnology News Magazine

A partnership with QleanAir, along with previous grant support from the Eshelman Institute for Innovation (EII), will drive their work forward.

He writes: "Pharmaceutical companies are weathering rapid changes in drug development driven by upstream issues, downstr...

11/22/2022

Strategies To Keep Pace Amid Rapid Changes In Drug Development - By Jeff Souza, President And CEO Of BioBridges - Reports Biotechnology News Magazine

He writes: "Pharmaceutical companies are weathering rapid changes in drug development driven by upstream issues, downstream issues, and recently, the management and acceleration of programs during a worldwide pandemic." Read his expert views and vision. https://biomag1.com/strategies-to-keep-pace-amid-rapid-changes-in-drug-development-by-jeff-souza-president-and-ceo-of-biobridges/

Pharmaceutical companies are weathering rapid changes in drug development driven by upstream issues, downstream issues, and recently, the management and acceleration of programs during a worldwide pandemic. Read on.

A must buy book! The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medi...

11/20/2022

The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia

A must buy book! The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia authored by Dr Frank J Veith - It was pre-launched at the recent 49th annual
VEITHsymposium held in NYC. You can PRE-ORDER the book at

The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia

11/10/2022

Iovance Biotherapeutics Announces Updated Clinical Data For Lifileucel In Advanced Melanoma At Society For Immunotherapy Of Cancer (SITC) Annual Meeting - Reports Biotechnology News Magazine

Amod Sarnaik, M.D., Professor of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center, presenting author and lead C-144-01 trial investigator, stated, “We are excited to present the comprehensive clinical data on behalf of the C-144-01 investigators. The trial demonstrated a robust an...

11/10/2022

Seagen Announces U.S. FDA Approval Of New Indication For ADCETRIS® (brentuximab Vedotin) For Children With Previously Untreated High Risk Hodgkin Lymphoma - Reports Biotechnology News Magazine

“ADCETRIS is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “We want to...

11/10/2022

CG Oncology Presents New Phase 2 Data With CG0070 In Combination With KEYTRUDA® (pembrolizumab) In Non-Muscle Invasive Bladder Cancer Unresponsive To Bacillus Calmette-Guérin - Reports Biotechnology News Magazine

CG Oncology Presents New Phase 2 Data With CG0070 In Combination With KEYTRUDA® (pembrolizumab) In Non-Muscle Invasive Bladder Cancer Unresponsive To Bacillus Calmette-Guérin - Reports Biotechnology News Magazine

“We’re excited to present these results, which continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “We are seeing continued positive results for CG0070 in...

11/09/2022

Guided Therapeutics Provides Update Of Significant Progress In Chinese Clinical Study For Marketing Approval Of The LuViva Advanced Cervical Scan - Reports Biotechnology News Magazine

According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thu...

11/09/2022

Nektar And Collaborators Announce Publication In Blood Advances Of Preclinical Data Demonstrating NKTR-255, A Novel Polymer-conjugated Human IL-15, Improves Efficacy Of CD19-targeted CAR-T Cell Immunotherapy - Reports Biotechnology News Magazine

Nektar And Collaborators Announce Publication In Blood Advances Of Preclinical Data Demonstrating NKTR-255, A Novel Polymer-conjugated Human IL-15, Improves Efficacy Of CD19-targeted CAR-T Cell Immunotherapy - Reports Biotechnology News Magazine

The data from this publication demonstrate that NKTR-255 not only enhanced in vivo proliferation and accumulation of T and NK cells in non-human primates, but also demonstrated enhanced in vivo antitumor efficacy of human CD19 CAR-T in lymphoma-bearing immunodeficient mice.

11/09/2022

Grant Awarded To Develop Genetically Engineered Stem Cell Products To Fight Gastroesophageal Cancer - Reports Biotechnology News Magazine

The DeGregorio Family Foundation with support from the Torrey Coast Foundation Gastro Esophageal Investigator Network Initiative (GEMINI) has awarded $250,000 to Saar Gill, MD, PhD, of the University of Pennsylvania, to improve immunotherapy in gastroesophageal cancer by using the tools of genetic e...

11/09/2022

Immutep Granted New Patents In Japan And South Korea For First-in-Class LAG-3 Candidate, Eftilagimod Alpha In Chemo-Immunotherapy Combination - Reports Biotechnology News Magazine

Immutep CEO Marc Voigt, commented: “We continue to invest in building a moat around efti, which is a very unique biomolecule. These new patents are notable because this family of patents protects a component of the triple combination therapy being evaluated in our INSIGHT-003 clinical trial.

11/09/2022

Revolo Biotherapeutics Announces That The Last Patient In Its Phase 2a Trial Of ‘1104 In Eosinophilic Esophagitis Has Completed The Study - Reports Biotechnology News Magazine

“The last patient out marks a key milestone in our Phase 2a trial in EoE, and we are looking forward to announcing topline data early next year,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics. “’1104 has the unique ability to reset the immune system ahead of th...

11/08/2022

Schreiner MediPharm & SCHOTT Pharma Debut Prefilled Syringes With RFID-Labels - Reports Biotechnology News Magazine

Previously, the ongoing partnership between Schreiner MediPharm and SCHOTT Pharma had been focused primarily on equipping COC syringes with analog functional labels. With this latest effort, the two pharmaceutical packaging experts are digitizing prefilled syringes.

11/08/2022

NeuroSigma Announces That Enrollment Commences In Two Large, Double-Blind Trials Of ETNS For Pediatric ADHD - Reports Biotechnology News Magazine

Ian Cook, M.D., NeuroSigma’s Chief Medical Officer. “The data generated will significantly expand the evidence base for eTNS as a treatment for pediatric ADHD and, we believe, demonstrate the value of eTNS as a non-pharmaceutical alternative for treating this common condition. We are also excite...

Biologic drugs have increasingly delivered treatments for cancer and rare diseases and continue to prove effective in ot...

11/08/2022

The Promise & Pressures Of Biologics R&D By Christian Olsen, Dotmatics - Reports Biotechnology News Magazine

Biologic drugs have increasingly delivered treatments for cancer and rare diseases and continue to prove effective in other wide-ranging areas, from neurological and metabolic disorders to respiratory and cardiovascular diseases. But along with the incredible potential biologics offer, there is also great pressure to discover and deliver novel treatments quickly and cost-effectively. Read what he has to say.

Biologic drugs have increasingly delivered treatments for cancer and rare diseases and continue to prove effective in other wide-ranging areas, from neurological and metabolic disorders to respiratory and cardiovascular diseases. But along with the incredible potential biologics offer, there is also...

He brings to LumaBridge extensive experience in strategic planning, program development, team building, operations, and ...

11/08/2022

LumaBridge Welcomes Dr Alexander Stojadinovic As Chief Medical Officer - Reports Biotechnology News Magazine

He brings to LumaBridge extensive experience in strategic planning, program development, team building, operations, and research and development.

Dr Alexander Stojadinovic brings to LumaBridge his extensive experience in strategic planning, program development, team building, operations, and research and development.

11/08/2022

Cantargia's CAN10 Demonstrates Positive Activity In Systemic Sclerosis Models In New Data - Reports Biotechnology News Magazine

Across the models, which mimic difficult-to-treat forms of the disease, CAN10 reduced both pathological inflammation and fibrosis in skin and lung tissue, factors associated with clinical severity in humans. CAN10 also normalized a number of biomarkers closely associated with the human disease. The....

11/02/2022

CTCs Isolated By The Parsortix System From Metastatic Breast Cancer Patients Can Be Analysed By Multiple Downstream Techniques - Reports Biotechnology News Magazine

This research highlights the ability to perform multiple downstream analyses on CTCs enriched using the Parsortix system.

11/02/2022

Basilea Pharmaceutica Announces Sale Of Preclinical Oncology Program To Twentyeight-Seven Therapeutics - Reports Biotechnology News Magazine

Under the terms of the agreement, Basilea Pharmaceuticawill receive an upfront payment of CHF 1 million and potential near-term milestone payments of CHF 2 million.

11/02/2022

Ascletis Announces U.S. IND Filing Of Oral 3CLpro Inhibitor ASC11 For COVID-19 - Reports Biotechnology News Magazine

ASC11 is an in-house discovered oral small molecule drug candidate, targeting 3-chymotrypsin like protease (3CLpro)

11/02/2022

CSL Enters Licensing Agreement With Arcturus Therapeutics For Next Generation MRNA Vaccine Technology - Reports Biotechnology News Magazine

CSL Seqirus is a global leader in influenza prevention and has a longstanding heritage in influenza vaccines.

11/01/2022

Quantum Science Partnership Puts Academic Expertise At The Heart Of Cutting-edge Nanomaterials Research - Reports Biotechnology News Magazine

The joint project, funded by Innovate UK, will see the team at Quantum Science work alongside academic experts on a postdoc level that will ensure the company can continue to push the boundary of what is possible in quantum dot devices.

10/28/2022

ScienceMedia Joins Forces With Leading Advocate For Life Sciences In California - Reports Biotechnology News Magazine

ScienceMedia is headquartered in San Diego, CA. Their commitment to their California community of life science and pharma organizations that share the same goal of supporting innovative science and positive impacts on patients' lives.

Marketing authorization in the European Economic Area anticipated in H1 2023

10/28/2022

Pharming Group Announces European Medicines Agency (EMA) Validates Its Marketing Authorization Application Under Accelerated Assessment For Leniolisib - Reports Biotechnology News Magazine

Marketing authorization in the European Economic Area anticipated in H1 2023

The MAA is supported by positive data from a Phase II/III study of leniolisib, announced on February 2, 2022, which met its co-primary endpoints of reduction in lymph node size and increase in percentage of naïve B cells in patients with APDS. Furthermore, safety data from the study showed that len...

In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. cru...

10/27/2022

Urovant Sciences Announces Publication Of Pharmacokinetic Data On GEMTESA® (Vibegron 75mg) Administered As An Intact Or Crushed Tablet - Reports Biotechnology News Magazine

In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. crushed and mixed with applesauce.

In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. crushed and mixed with applesauce. The results suggest that crushing and administering vibegron with applesauce may be an appropriate consideration for patients with overactive bladde...

10/27/2022

Ardigen Supports JUMP-CP Consortium Scaling Up Image-based Drug Discovery With The World’s Largest Public Cell Painting Dataset - Reports Biotechnology News Magazine

Ardigen’s primary scope of research within the JUMP-CP Consortium is aimed at improving the predictive power of the JUMP-CP data by expanding the applicability domain of machine learning models that predict assay activity based on Cell Painting images.

10/27/2022

NDA For New Second-Line Indication Of CAR T-Cell Therapy Product YIKAIDA (Axicabtagene Ciloleucel Injection) Approved For CDE Review - Reports Biotechnology News Magazine

"The NDA for new second-line indication of YIKAIDA was recently approved by the CDE of NMPA for review, which inspired the staff at Fosun Kite." Huang Hai, CEO of Fosun Kite, said, "As a high-tech biomedical enterprise, we will strive to benefit more patients through our practical pioneering and inn...

10/26/2022

ACTO Recognized As “Life Sciences Commercial Analytics And AI Trailblazer” By Everest Group - Reports Biotechnology News Magazine

Path Khanna, CEO ACTO. "This is an important acknowledgment of ACTO's investments in analytics and AI, which include our recently launched AI-powered conversational assistant that helps pharma reps learn in the flow of work and our deep analytics that tie training to field rep performance."

10/26/2022

4D Molecular Therapeutics Interim Clinical Data From The On-going Phase 1/2 Clinical Trial Of 4D-710 For Cystic Fibrosis Lung Disease To Be Presented At NACFC 2022 - Reports Biotechnology News Magazine

4D Molecular Therapeutics Interim Clinical Data From The On-going Phase 1/2 Clinical Trial Of 4D-710 For Cystic Fibrosis Lung Disease To Be Presented At NACFC 2022 - Reports Biotechnology News Magazine

4D Molecular Therapeutics advises the presentation will include a summary of 4D-710 safety, tolerability, delivery and CFTR transgene expression in patients with cystic fibrosis who have been enrolled on cohort 1 of the dose exploration portion of the clinical trial (n=3; 1E15 vg).

10/26/2022

Darrin Paschal Appointed New CCO Of Growcentia - 25 Year Industry Veteran - Reports Biotechnology News Magazine

Darrin Paschal will bring his strategic leadership and technical know-how to Growcentia as the company continues to expand

10/25/2022

Clinical Research Opportunities In China And The Path To USFDA Approval - Whitepaper - Reports Biotechnology News Magazine

The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.

10/25/2022

Lonza Expands Global Process Development Team And Laboratory Spaces For Cell And Gene Development - Reports Biotechnology News Magazine

Lonza advises the expansions further strengthen its global process development service offering by adding capabilities and capacity to its existing laboratories, which are among the largest in the industry.

10/25/2022

Cellevolve Bio Receives FDA Clearance Of IND Application And Orphan Drug Designation For CE-VST01-JC For The Treatment Of Progressive Multifocal Leukoencephalopathy - Reports Biotechnology News Magazine

Cellevolve Bio Receives FDA Clearance Of IND Application And Orphan Drug Designation For CE-VST01-JC For The Treatment Of Progressive Multifocal Leukoencephalopathy - Reports Biotechnology News Magazine

The safety and efficacy of CE-VST01-JC will be evaluated in ASCEND-JC, a global, multi-center, randomized, double-blind, placebo-controlled Phase 2 study that will enroll up to 60 patients across the US, Canada, and EU. The first patient enrolled is anticipated in the first half of 2023.

10/25/2022

AgroSpheres Raises $22 Million Series B - Reports Biotechnology News Magazine

AgroSpheres notes the round was led by Lewis & Clark AgriFood and Ospraie Ag Science.

10/25/2022

Veracyte Reports New Data Suggest Decipher GRID-Derived Genomic Signature Can Help Identify Men With Prostate Cancer Who Should Receive High-Dose Radiotherapy - Medical Device News Magazine

“This study demonstrates how gene-expression signatures can help identify the men who are most likely to benefit from more radiation, and help inform physician and patient decisions regarding their radiation treatment after surgery,” said Elai Davicioni, Ph.D., medical director for Veracyte Urol...

The data show that using Turn Biotechnologies Epigenetic Reprogramming of Aging (ERA™) technology and its eTurna™ delive...

10/24/2022

T-cells Treated By Turn Biotechnologies Show Increased Cancer-killing Effectiveness - Reports Biotechnology News Magazine

The data show that using Turn Biotechnologies Epigenetic Reprogramming of Aging (ERA™) technology and its eTurna™ delivery platform in the manufacture of T cells can produce and deliver more effective therapies more efficiently. The findings promise to help reduce the cost of T-cell therapies and make them more accessible to cancer patients.

The data show that using Turn Biotechnologies Epigenetic Reprogramming of Aging (ERA™) technology and its eTurna™ delivery platform in the manufacture of T cells can produce and deliver more effective therapies more efficiently. The findings promise to help reduce the cost of T-cell therapies an...

10/24/2022

DeCODE Genetics Publishes Multiomics Study Of Nonalcoholic Fatty Liver Disease - Reports Biotechnology News Magazine

deCODE genetics highlights sequence variants that associate with NAFLD were identified, including rare, protective loss-of-function variants that point to potential drug targets. Plasma proteomic analyses provided further insight into the pathogenesis of NAFL.

The Revolution Circulating Free Total Nucleic Acid (cfTNA) Kit™ and cfDNA Reference Standard products are designed to ad...

10/24/2022

NRichDX Launches Two New Products For Liquid Biopsy Applications - Reports Biotechnology News Magazine

The Revolution Circulating Free Total Nucleic Acid (cfTNA) Kit™ and cfDNA Reference Standard products are designed to advance liquid biopsy application development.

Both products are designed for use with the nRichDX Revolution Sample Prep System™.

10/24/2022

Veracyte Data Presented At ATA Annual Meeting Provide New Insights Into Molecular Underpinnings Of Thyroid Cancer - Reports Biotechnology News Magazine

In one study, Veracyte researchers reviewed over 300 pathology reports from the training sets used to develop the company’s market-leading Afirma Genomic Sequencing Classifier.