The FDA has given accelerated approval for QALSODY™ (tofersen) to treat SOD1-ALS, marking a significant scientific advancement as it is the first treatment to target a genetic cause of ALS.
Biogen Inc. (Nasdaq – BIIB) has announced that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mutation. This approval is based on a reduction in plasma neurofilament light chain (NFL) observed in patients […]
FDA Approval of RNAimmune’s Investigational New Drug Application for the RV-1730 COVID-19 Booster Vaccine Phase I Trial
The United States Food & Drug Administration (FDA) has given the go-ahead for the company’s Investigational New Drug (IND) application of a Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate. RNAimmune is a biopharmaceutical company that specialises in the discovery and development of mRNA-based therapeutics and vaccines. It is a non-wholly owned […]
Kiromic Biopharma Has Received Authorization from The FDA To Commence A Phase 1 Clinical Trial to Evaluate Deltacel In the Treatment of Non-Small Cell Lung Cancer
In order to create cell therapies with a focus on immuno-oncology, Kiromic Bio Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to launch a Phase 1 clinical trial to assess Deltacel. The company’s allogeneic, non-engineered, over-the-counter Gamma Delta T-cell (GDT) therapy is called […]
Presentations- Advancements in Gene Therapy and AAV Vector Technology: Insights from the Penn GTP
Introduction: The Gene Therapy Program (GTP) at the Perelman School of Medicine at the University of Pennsylvania is making significant contributions to the field of gene therapy. Led by James M. Wilson, MD, PhD, the program focuses on advancing genetic medicines and exploring the potential of adeno-associated virus (AAV) vector technology. The GTP’s innovative research […]
IMPT-314: Advancing the Treatment Landscape for Aggressive B-cell Lymphoma
ImmPACT Bio USA, Inc. has achieved a major milestone in the realm of relapsed/refractory aggressive B-cell lymphoma treatment, as the FDA grants fast track designation to their groundbreaking CD19/CD20 CAR T-cell therapy, IMPT-314. In a pivotal investigator-led phase 1 study at UCLA, IMPT-314 showcased exceptional efficacy and safety outcomes, with no instances of cytokine release […]
Gilead Sciences: Upgraded Outlook and Promising Growth Path
Gilead Sciences (NASDAQ:GILD) recently received an upgrade from BMO Capital analysts, who raised their price target for the stock from $90 to $100 per share and changed their rating to Outperform from Market Perform. The analysts highlighted three key factors that contributed to this upgrade: Gilead’s outstanding cell therapy franchise, the strengthening solid tumor oncology […]
With FDA Submission For Sickle Cell Gene Therapy, Bluebird Bio Can Potentially Have 3 Approved Products By 2023
Bluebird Bio Inc, a prominent biotechnology company traded on the NASDAQ under the ticker BLUE, has recently submitted a comprehensive Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its groundbreaking gene therapy known as lovotibeglogene autotemcel, or lovo-cel, to be used in patients aged 12 and older who […]
Amgen and TScan Therapeutics Team Up to Identify Novel Targets in Crohn’s Disease
Amgen and TScan Therapeutics, Inc. recently announced a multi-year agreement to identify the antigens recognized by T cells in patients with Crohn’s disease using TScan’s unique target identification technology, TargetScan. Article Summary Based on the targets identified by TScan, Amgen will consider a range of treatment approaches and will have all global commercial and […]
Bristol Myers Squibb Boosts Cell Therapy Capabilities by Introducing New U.S. Viral Vector Manufacturing Facility
Following the execution of an agreement with Novartis, Bristol Myers Squibb recently announced the expansion of its global cell therapy manufacturing network to enable in-house viral vector production through a U.S.-based manufacturing facility and its operations in Libertyville, Illinois. Article Summary The laboratory and its operations are capable of producing viral vectors for the […]
Takeda Receives Top Honors in the Social Impact Category for the 2023 ISPE Facility of the Year Awards
Takeda has announced that the firm won first place in the Social Impact category of the 2023 Facility of the Year Awards (FOYA) from the International Society for Pharmaceutical Engineering (ISPE). At its production facility for plasma-derived therapies in Lessines, Belgium, Takeda was commended for accelerating the transition to sustainable facility design, which aims to […]
ThermoFisher Scientific & Pfizer Collaborate to Expand Localized Access to Next Generation Sequencing-Based Testing for Cancer Patients in International Markets
Pfizer and Thermo Fisher Scientific Inc. recently disclosed that they have entered into a partnership arrangement to assist with improving local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in over 30 nations across Latin America, Africa, the Middle East, and Asia where advanced genomic testing has previously been restricted or […]
Pharma.Aero adds five new associate partners
Excerpt Cross-pharmaceutical industry collaboration platform Pharma.Aero has further expanded its global network of life science and medtech stakeholders by adding HAZGO, Topa Thermal, SmartCAE, Nippon Express and Air Cargo Logistics as associate partners. Article Summary Frank Van Gelder, secretary general of Pharma.Aero, observed of the group’s partners: “All of them are concentrating on specific […]
