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Cell and Gene Therapy, Industry, News

Biogen, ViGeneron Enter Gene Therapy Collaboration

January 5, 2021

Via: Contract Pharma

ViGeneron GmbH, a gene therapy company, has announced a global collaboration and licensing agreement with Biogen Inc. to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use ViGeneron’s […]


News

Recipharm and Moderna Finalize Bioprocess Agreement

January 4, 2021

Via: Genetic Engineering and Biotechnology News

Moderna and Recipharm (STO: RECI-B) reached an agreement to support formulation and fill-finish a part of the Moderna COVID-19 vaccine supply outside of the U.S. The activity will be performed in Recipharm’s drug product manufacturing facility located in France. Subject […]


FDA, Regulations

FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

January 4, 2021

Via: BioSpace

Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the […]


Mergers and Acquisitions

Thermo Fisher Scientific Acquires Programmable Dye Platform Pioneer Phitonex

December 31, 2020

Via: BioSpace

Thermo Fisher Scientific, the world leader in serving science, today announced it has completed the acquisition of Phitonex, Inc., a Durham, North Carolina-based company that has pioneered a spectral dye platform for high-resolution biology applications designed to accelerate research and […]


Clinical Trials, Research and Development

ImmVira Announces Series C Financing with Leading Specialist Investors

December 31, 2020

Via: BioSpace

ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing. The Company’s rapidly advancing […]


FDA, Regulations

FDA In Brief: FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries

December 29, 2020

Via: BioSpace

“Providing women with access to safe medical devices to meet their health care needs is a top priority for the FDA. Today, we’ve taken two important steps on laparoscopic power morcellators as a result of listening to and acting on […]


Industry, Vaccines

Novavax announces initiation of PREVENT-19 pivotal Phase 3 efficacy trial of COVID-19 vaccine in the United States and Mexico

December 28, 2020

Via: World Pharma News

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, […]


Industry, Pharma

Algernon Pharmaceuticals Announces Acceleration of Expiry Date of Warrants

December 24, 2020

Via: BioSpace

Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company announces that the Company has elected to exercise its acceleration right under the warrant indenture (the “Indenture”) governing the common share […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Breast Cancer Metastasis Promoted by Regulatory RNAs

December 23, 2020

Via: Genetic Engineering and Biotechnology News

A wide variety of cancer types have been linked to the misregulation of long noncoding RNA (lncRNA) genes. Now, a team from Cold Spring Harbor Laboratory (CSHL) showed that a particular lncRNA plays a role in mammary tumor cell proliferation, […]


Cell and Gene Therapy, Industry

Immune Cell Gene Expression Revealed in 3D Maps

December 22, 2020

Via: Genetic Engineering and Biotechnology News

To understand how genes affect human health, researchers need to go beyond variants in the DNA sequence, and dive into the switches, or enhancers, that control when and where a gene is expressed in the body. Now, researchers at La […]


FDA, Industry, Regulations, Vaccines

Moderna Wins FDA Authorization for COVID-19 Vax

December 21, 2020

Via: Contract Pharma

Moderna, Inc. received authorization from the U.S. FDA for the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The vaccine is now authorized for distribution and use under an Emergency Use Authorization […]


Clinical Trials, Research and Development

SARS-CoV-2’s Spike Protein Can Enter the Brain in Mice

December 21, 2020

Via: Genetic Engineering and Biotechnology News

The COVID-19 symptoms on the center stage are those associated with pneumonia and respiratory distress. But there are also a host of symptoms that relate to the central nervous system. Although it is unclear whether or not the SARS-CoV-2 virus […]