Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced that the FDA cleared the company to proceed with a Phase 3 clinical trial using the investigational EV drug ExoFlo to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19.
AbbVie terminated the company’s collaboration agreement with BioArctic in the development of alpha-synuclein antibodies for Parkinson’s disease and other movement disorders.
TScan Therapeutics secured clearance from the U.S. Food and Drug Administration for the company’s investigational new drug application to assess TSC-100 in treating patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).
Is Your Quality Management System Ready for Fast Tracked Pandemic Related Drug Approvals?Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutics, Current Goods and Manufacturing Practice (CGMP), Data, Fast Track, FDA, Investigational New Drug (INDs) submissions, IQVIA, Manufacturing, Medicines, New Drug Applications, New Drug Approvals, R&D, Virtual, Warning Letters
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
Based in South San Francisco, Lyell Pharmaceuticals filed for an initial public offering (IPO) with plans to raise $150 million. The preclinical biotech raked in $493 million in a Series C round on March 12, 2020.
ImmunoGen shares fell after the company announced the slashing of 220 employees as part of an effort to reduce ongoing expenses while recovering from an FDA rejection of an ovarian cancer drug.
Merck Acquires Immune DesignAcquisitions, Business, Cancer, Cellular immunotherapy, Cellular immunotherapy, Chronic Diseases, Collaborations, Health Technology, Immune Cells, Immune System, Immunizations, Intratumoral TLR4 agonists, Investigational New Drug (INDs) submissions, Oncology, Sarcomas, Shares, Synovial sarcoma, T-Cells
Shares of Immune Design skyrocketed after Merck announced the acquisition of the Seattle-based oncology company for $300 million in cash.
2018 was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown.
A Record Year: A Look at the Biotech IPOs for Q4 2018Adenovirus, Allergic Conjunctivitis, Autoimmune Disorders, Biologics, Biopsies, Biotech, Blood Tests, Business, Cancer, Crohn's Disease, Diagnostics, DNA, Gene Therapy, Genetic Code, Immune Diseases, Initial Public Offering (IPO), Investigational New Drug (INDs) submissions, Ischemic Stroke, Messenger RNA (mRNA) Therapeutics, Ocular Itch, Respiratory, Shares, Thymoma, Vascular DIsease
The Nasdaq indicated that there was a record amount of biotech initial public offerings (IPOs) in 2018, totaling around $8.2 billion raised, breaking 2014’s record of $6.5 billion.
The long-awaited and massively hyped initial public offering (IPO) of Moderna Therapeutics hit the market.