Tag: biotech

September 21, 2023

On Sept. 20, 2023, Alexion, AstraZeneca’s rare disease group, completed the purchase and license agreement for a portfolio of preclinical rare disease gene therapy programs and enabling technologies from Pfizer. The acquisition cost AstraZeneca up to $1 billion, with the […]

September 21, 2023

Like many biotechnology companies, Seraxis has an ambitious aim. The company wants to transform the lives of millions of diabetics who must take insulin every day to control their blood sugar levels. Its approach: use a stem cell line generated […]

September 20, 2023

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA […]

September 20, 2023

Taysha is now retrenching and focusing on another experimental drug, TSHA-102, for a rare neurological disorder called Rett Syndrome. The company now expects to reduce operating expenses enough to extend its cash runway into the fourth quarter of 2025. While […]

September 19, 2023

In recent years, cancer researchers have hailed the arrival of chimeric antigen receptor T cell (CAR T) therapy, which has delivered promising results, transforming the fight against various forms of cancer. The process involves modifying patients’ T-cells to target cancer […]

September 18, 2023

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have […]

September 18, 2023

On Sept. 15, 2023, FDA announced the publication of a draft guidance to assist sponsors of biosimilars and interchangeable biosimilars develop draft labeling. The labeling recommendations are only for prescribing information, “except for certain recommendations in section V, FDA-Approved Patient […]

September 18, 2023

Millions of eligible people in England can now book their vaccine via the NHS website, the NHS app, or by calling 119 for free if they do not have access online. From this week, people aged 65 and over, pregnant […]

September 13, 2023

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]

September 13, 2023

Advisers to the Food and Drug Administration on Wednesday endorsed Alnylam Pharmaceuticals’ drug Onpattro for a rare heart condition, despite questions from agency scientists over the degree of benefit offered by the RNA-based therapy. The advisory committee’s 9-3 vote sets […]

September 8, 2023

Artificial intelligence tools have drawn the interest of many drugmakers hoping to use it to unearth new therapeutic targets. Launched in 2015, Verge has raised over $100 million from a variety of investors, including the asset management firm Blackrock and […]

September 8, 2023

Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the […]

September 7, 2023

New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. The U.S. Centers […]

September 7, 2023

Seagen is the biotech sector’s leading developer of antibody-drug conjugates, which deliver cell-killing toxins to diseased cells by attaching them to an antibody that seeks out proteins on tumor cells. Its first, Adcetris, is on track to become a blockbuster […]

September 5, 2023

Success in the clinic would boost the RNA editing field as well as Wave. Broadly speaking, the technology is designed to edit specific sites in an RNA transcript without making permanent changes to a person’s genome. It’s an approach that’s […]

September 5, 2023

The funding will boost the University of Nottingham spinout’s development of bone regeneration treatment TherageniX, a company developing a dry powder gene therapy for bone graft augmentation, and the institution from which it emerged, the University of Nottingham, have been […]

September 5, 2023

FEATUREDThe investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the […]

August 29, 2023

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme Faron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukaemia […]

August 29, 2023

The Food and Drug Administration on Monday approved wider use of a drug important to Bristol Myers Squibb’s future, clearing the medicine for people newly diagnosed with a cancer-like disease of the bone marrow. Called Reblozyl, the drug has been […]

August 28, 2023

Estimates hold that around half a million people in the U.S. have Parkinson’s, though, due to underdiagnosis or misdiagnosis, some believe the true number is much higher. The disease causes nerve cells in the part of the brain that controls […]