January 20, 2021
Via: FierceBiotechThe 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
January 19, 2021
Via: BioSpacePieris, 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
January 18, 2021
Via: BioSpaceIxaka 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 […]
January 18, 2021
Via: CNBCThe 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
January 13, 2021
Via: Drugs.comHarpoon 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. […]
January 12, 2021
Via: BioSpaceThe 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 […]
January 12, 2021
Via: Genetic Engineering and Biotechnology NewsUse 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
January 11, 2021
Via: BioSpaceConcern 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 […]
January 11, 2021
Via: CNBCWest 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
January 7, 2021
Via: Pharma TimesThe 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 […]
January 6, 2021
Via: Drugs.comCases 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
January 5, 2021
Via: Genetic Engineering and Biotechnology NewsTransplanted 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 […]