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News

Biden and biotech: Science first

January 20, 2021

Via: FierceBiotech

The November election now seems such a long time ago: It has, in fact, been less than three months, but that time has been filled with political and scientific catastrophes that will shape President Joe Biden’s term in office. The […]


Cell and Gene Therapy, FDA, Industry, Regulations

FDA Lifts Partial Clinical Hold on PRS-343 Phase 1 Studies

January 19, 2021

Via: BioSpace

Pieris, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the previously announced partial clinical […]


Cell and Gene Therapy, Industry, News

Ixaka (formerly Rexgenero) Launches as an Integrated Cell and Gene Therapy Company

January 18, 2021

Via: BioSpace

Ixaka Ltd, an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The Company’s shareholders have funded the business with over £40 million in financing. Previously Rexgenero Ltd, a UK-based […]


Industry, Vaccines

World on the brink of ‘catastrophic moral failure’ due to unfair vaccine rollouts, WHO chief says

January 18, 2021

Via: CNBC

The head of the World Health Organization said Monday the equitable distribution of coronavirus vaccines is at “serious risk.” Warning of a “catastrophic moral failure,” WHO’s Director-General Tedros Adhanom Ghebreyesus said “the recent emergence of rapidly-spreading variants makes the rapid […]


Cell and Gene Therapy, Industry

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

January 13, 2021

Via: Drugs.com

Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. […]


News

Clash Over FDA’s Top Lawyer Appointees Causes Further Discord Between Agency and HHS

January 12, 2021

Via: BioSpace

The U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations. As reported in POLITCO, the […]


News

Machine Learning for Better Bioprocess Data Analysis

January 12, 2021

Via: Genetic Engineering and Biotechnology News

Use of artificial intelligence (AI) in bioprocessing is set to increase. According to a Deloitte survey, biopharma is undergoing a “digital transformation” with 58% of executives quizzed identifying the adoption of innovative technologies, AI, and automation as a top priority. […]


Clinical Trials, Research and Development

New COVID-19 Mutation Could Mess Up Tests, Trigger False Negatives

January 11, 2021

Via: BioSpace

Concern has been building about the new SARS-CoV-2 strain discovered last month in the U.K., and on Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests. The […]


Industry, Vaccines

Governor explains how West Virginia became a top state for Covid vaccine administration

January 11, 2021

Via: CNBC

West Virginia Gov. Jim Justice on Monday touted the state’s coronavirus vaccine distribution strategy, particularly its emphasis on ensuring elderly residents were granted the highest priority. “We don’t have vaccines in a warehouse sitting on a shelf,” Justice said on […]


Clinical Trials, Research and Development

The Health Research Authority launches fast-track service for non-COVID-19 research

January 7, 2021

Via: Pharma Times

The Health Research Authority (HRA) has launched a new service offered to pharmaceutical companies and research organisations which will accelerate the ethics review stage of clinical trials approval. The HRA will offer the new swift review to global trials and […]


Industry, Vaccines

Allergic Reactions to COVID Vaccines Are Rare, Resolved on Site: CDC

January 6, 2021

Via: Drugs.com

Cases of anaphylactic shock caused by COVID-19 vaccines are very rare, based on numbers from the first week and a half of vaccinations in the United States, federal public health officials said Wednesday. There have been 21 cases of anaphylaxis […]


Clinical Trials, Manufacturing, Research and Development

Tech Can Solve Stem Cell Sector’s Manufacturing Challenges

January 5, 2021

Via: Genetic Engineering and Biotechnology News

Transplanted stem cells have been used as regenerative therapies for decades. In cancer, for example, they can restore the body’s ability to create the red blood cells, white blood cells, and platelets after chemotherapy. But stem cells have wider therapeutic […]