Category: Industry

July 25, 2024

The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization serve up unique challenges for incorporating AI into processes? According to Siegfried Schmitt, vice-president, […]

July 24, 2024

The study results offer hope for patients who wish to avoid the burden of frequent Factor VIII injections. But some questions about the treatment remain. As with other gene therapies that hold out the promise of one-time solution for a […]

July 22, 2024

At the start of 2024, optimism had returned to biotech. Investor cash flowed back toward drug companies and initial public offerings, a useful barometer of the sector’s health, picked up in a sign of the market’s strengthening. But IPOs have […]

July 18, 2024

You’re far less likely to develop Long COVID now than you were in the midst of the pandemic, promising new data shows. Changes in strains of SARS-CoV-2, the virus that causes COVID-19, are playing a role in the lowered risk, […]

July 16, 2024

Affecting approximately one in every 40,000 people, FA is a neurodegenerative movement disorder and the most common form of inherited ataxia. The typical age of disease onset is between ten and 15 years, with initial symptoms including unsteady posture, frequent […]

July 15, 2024

Friedreich’s ataxia is known as a neurodegenerative disorder, as the progressive nerve damage it causes affects a person’s coordination and ability to walk or speak. But the most common reason people die from the condition is a type of cardiomyopathy […]

July 12, 2024

Affecting approximately 70,000 people in Europe and the US, Huntington’s is an inherited neurodegenerative disorder that causes nerve cells in the brain to decay over time. Patients can experience motor symptoms such as chorea, as well as behavioural abnormalities and […]

July 10, 2024

Flagship’s robust funding round highlights a general recovery in biotech investment. A number of venture capital firms brought in fresh cash this year, including Foresite Capital, Sands Capital, Scion Life Sciences and a life sciences arm of Goldman Sachs. Arch […]

July 10, 2024

The Dutch biotech said a higher dose of the gene therapy slowed progression by 80% compared to a matched control group, measured using the Unified Huntington’s Disease Rating Scale (cUHDRS), 24 months after it was dosed, in a pair of […]

July 8, 2024

Genezen, a gene therapy contract development and manufacturing organization (CDMO), and uniQure, a gene therapy company, announced on July 1, 2024 that they have entered into an agreement under which Genezen will acquire uniQure’s commercial gene therapy operations in Lexington, […]

July 4, 2024

The award from the Biomedical Advanced Research and Development Authority (BARDA) will be used to accelerate the development of pandemic flu vaccines, according to Moderna, and specifically “support late-stage development for an mRNA-based vaccine to enable the licensure of a […]

July 3, 2024

The Series B – led by Forbion and joined by other investors, including Syncona, Oxford Science Enterprises, and Oxford University Innovation – takes the total raised by Beacon since its formation last year to $290 million, making it a rising […]

July 1, 2024

Like many of its cell therapy peers, Artiva reshuffled its strategy hoping to ride a recent wave of investor interest in autoimmune disease research. The company is one of a number of biotechs to emerge in recent years to develop […]

June 28, 2024

The agency’s positive opinion, which specifically applies to adults with severe or moderately severe haemophilia B without a history of factor IX (FIX) inhibitors, reverses its previous decision to reject the therapy. Affecting more than 2,000 people in the UK, […]

June 24, 2024

The new data from Vertex’s phase 1/2 trial of VX-880, presented at the American Diabetes Association (ADA) annual congress in Florida, suggest that the therapy can restore the physiological activity of the insulin-producing islet cells of the pancreas and restore glucose […]

June 20, 2024

The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness. The agency on Thursday made the therapy, called […]

June 14, 2024

COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday. It’s a turnaround for the agency: […]

June 13, 2024

The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar […]

June 10, 2024

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness. Drugmaker GSK’s Arexvy vaccine, […]

June 6, 2024

A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled […]