Saturday, October 1, 2022


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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Latest Biotech Industry News

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

ImprimisRx Launches Fortisite ™ (Tobramycin 1.5% + Vancomycin 5%) Compounded Antibiotic Formulation

Fortisite includes a patent-pending compounded combination of Tobramycin 1.5% and Vancomycin 5%.

Neogen Launches New Genomic Management Technology

Neogen notes the Encompass™ platform advances how beef and dairy producers are able to sort and apply genomic data to herd selection and management.

MP Biomedicals Launches New Line of Well-characterized Antibodies, antigens, & ELISA Kits to Advance SARS-CoV-2 Research

MP Biomedicals' extensive line of SARS-CoV-2 research products are fully validated to ensure quality and performance to help advance COVID-19 research.

Yourgene Health Receives HSA approval for IONA Nx NIPT Workflow in Singapore

Rob Henke, PhD, Vice President of Sales, Asia Pacific, Yourgene Health, said: “By expanding into Singapore’s market, we are able to provide more laboratories access to our technology and, ultimately, offer more patients NIPT as a first call over higher-risk procedures.

CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas

“The RMAT designation is an important milestone for the CTX130 program that recognizes the transformative potential of our cell therapy in patients with T-cell lymphomas based upon encouraging clinical data to date,” said Phuong Khanh (P.K.) Morrow, M.D., FACP, Chief Medical Officer of CRISPR Therapeutics. "We continue to work with a sense of urgency to bring our broad portfolio of allogeneic cell therapies to patients in need.”

BioAlberta Recognizes Alberta Innovators and Entrepreneurs at Annual Health and Life Sciences Showcase & Awards Ceremony

“Our life sciences sector is expanding quickly, and the 2022 award recipients showcase Alberta's growing ability to accelerate and develop new technologies that are both sustainable and scalable to produce real-world solutions with a global impact,” said Robb Stoddard, President and CEO of BioAlberta.

CNBX Pharmaceuticals Announces New Patent Granted in Australia

CNBX Pharmaceuticals said the notice relates to the Company's patent titled: System and Method for High Throughput Screening of Cancer Cells. The term of the patent granted is set for 20 years starting May 2016 and until May 2036.

Advanced Instruments Introduces Solentim VIPS PRO, A High Efficiency Single Cell Seeder to Optimize Cell Line Development Workflows

VIPS PRO delivers powerful and efficient seeding technology and definitive proof of monoclonality for workflow productivity and confidence.

Nykode Therapeutics Announces Positive Results from the Phase 1/2 Open Label, Dose Escalation Trial of its T Cell Focused SARS-CoV-2 Vaccine Candidate

Nykode Therapeutics reports the T cell responses were analyzed by ex vivo ELISpot up until day 35. VB10.2210 induced broad and strong T cell responses, dominated by killer CD8 T cells, against both Spike- and non-Spike antigens. It was safe and well-tolerated at all three dose levels.

Sciwind Biosciences and SynerK Enter into Research Partnership to Discover and Develop Novel siRNA Therapeutics

Sciwind Biosciences notes the partnership will bring together the expertise of the two companies in the discovery and development of innovative therapies against important human diseases.

First Approval of TAAV Synthetic DNA Material for Use in Clinical Trial

Synthetic DNA material to be used in upcoming approved Huntington's disease study in France may be key to scaling gene therapy production

Noteworthy Views & Opinions from Our Experts

The Promise of a Scientific Informatics Platform: By Michael Swartz, SVP Enterprise Product Strategy at Dotmatics

The promise of a platform is to enable global collaboration, workflow support, consistent regulatory compliance, and optimal decision making. There is an underlying assumption that “one platform” will enable these things. But how, and what is it precisely? Read on to learn more.

Avoiding the Pervious Pitfalls of a Drug Launch

George Litos and Ken Edwards provide their expert views on how digital transformation can help mRNA companies overcome sales, marketing, and supply chain challenges for a therapeutic launch. A must read.

How AI is Democratizing Biotechnology Publishing By Neeraj Sanghani Business Head of Products at Paperpal

Neeraj Sanghani, Business Head of Products at Paperpal, CACTUS, discusses this linguistic injustice and how it can be addressed.

Telehealth Post Pandemic Concerns By Mark Kestner Chief Innovation Officer for MediGuru

The expression “desperate times call for desperate measures” aptly explains developments in the field of telehealth during the COVID-19 pandemic. In order to serve those forced to stay in place by the pandemic, healthcare regulators made a number of concessions that loosened controls related to patient privacy and data security in an effort to boost accessibility. In essence, telehealth practices that were a concern prior to Covid were, for the sake of serving patients, deemed acceptable.


NeuShen Therapeutics Closes Pre-A Financing with ~ $20M

NeuShen Therapeutics notes closure of pre-A financing round led by LAMPAM Capital.

NIH Awards Contract to AN2 Therapeutics Valued Up to $17.8 Million

AN2 Therapeutics said the base period contract is $4.3 million with additional options that, if exercised, will total $17.8 million to support preclinical, Phase 1 studies and other activities to enable advancement of epetraborole into a pivotal Phase 2/3 clinical trial for acute systemic melioidosis.

careviso Raises Over $17 million in Series B Funding

Recently rebranded careviso is scaling its technology and offerings to remove the administrative barriers associated with prior authorizations and financial transparency for diagnostic testing. Technology provides enhanced outcomes and transparency for patients and physicians alike.

Clinical Trials, Studies, Data

Avidity Biosciences Announces the Phase 1/2 FORTITUDE™ Trial of AOC 1020 in Adults with Facioscapulohumeral Muscular Dystrophy

AOC 1020 is Avidity's second siRNA antibody oligonucleotide conjugate (AOC™) entering Phase 1/2 studies.

Bristol Myers Squibb and ConcertAI Advance Novel Oncology Accelerated Digital Clinical Trial Solution

ConcertAI is a leader in Real-World Evidence (RWE) and AI technology solutions for life sciences and healthcare. Our mission is to accelerate insights and outcomes for patients through leading real-world data, AI technologies, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies.

1st Patient Dosed in Phase 1b Clinical trial of KBA1412 in Patients with Advanced Solid Tumors

"KBA1412 has remarkable properties identified in preclinical studies including efficacy as monotherapy mediated by two anti-cancer mechanisms (cell-mediated cytotoxicity and enhanced immune cell infiltration into tumors), synergy with PD-1 blockade, and a very favorable preclinical safety profile not seen previously with anti-CD9 antibodies" said Timothy M. Wright, MD, Kling Bio co-founder and interim CEO.

C4 Therapeutics Receives Study May Proceed Letter from U.S. FDA to Initiate Phase 1/2 Clinical Trial of CFT1946, an Orally Bioavailable BiDAC™ Degrader, in BRAF-V600 Mutant Solid Cancers

CFT1946 is an orally bioavailable BiDAC degrader designed to be potent and selective against BRAF-V600 mutant targets. In pre-clinical studies, CFT1946 is active in vivo and in vitro in models with BRAF-V600E-driven disease and in the escape mutant BRAF models. C4T is advancing CFT1946 to the clinic to study treatment for BRAF-V600 mutant solid tumors including lung, colorectal or melanoma.

EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 PAVIA Clinical Trial of EYP-1901 for the Treatment of Non-Proliferative Diabetic Retinopathy

The 12-month, randomized, controlled Phase 2 PAVIA clinical trial of EYP-1901 for NPDR is expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg), or to the control group receiving a sham injection.

SpringWorks Therapeutics Announces Dosing of 1st Patient in Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.

More Articles from the Experts

FDA Updates

AVA6000 Receives Orphan Drug Designation from the FDA

AVA6000 is a form of the generic chemotherapy doxorubicin that has been modified using the pre|CISION technology so that it is activated predominantly in the tumour with the aim of sparing healthy tissue from exposure and improving the safety, tolerability and efficacy of the drug.

FDA Approves Konvomep ™ (omeprazole and sodium bicarbonate for oral suspension)

It is expected that Konvomep™ will become commercially available in pharmacies nationwide in Q1 2023.

Immuneering Announces Submission of IND Application to the FDA for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations

The IND application supports a Phase 1/2a clinical trial of IMM-1-104, an oral once daily small molecule in development for the treatment of advanced RAS mutant solid tumors.

Market Reports

Executives on the Move

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Robert Bitterman Appointed New Executive Chairman at Phio Pharmaceuticals

As Executive Chairman, Robert Bitterman will assume the duties of principal executive officer and principal financial officer and will lead all aspects of the Company's operations.

Health / Lifestyle Articles

Articles of Interest