Category: Research and Development

April 25, 2024

Patients eligible for the therapy will be aged 12 years and older and have somatostatin receptor (SSTR)-positive gastroenteropancreatic NETs, including foregut, midgut and hindgut NETs. The FDA’s decision was supported by positive results from the NETTER-P trial, which evaluated Lutathera […]

April 10, 2024

The enrollment pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but […]

April 10, 2024

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in certain groups, including older adults, infants and those with certain underlying chronic […]

April 8, 2024

Exclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness. But the drug caused serious […]

April 5, 2024

The studies will be funded by the Blood Biomarker Challenge, a multi-million-pound award given by Alzheimer’s Research UK, Alzheimer’s Society, the National Institute for Health and Care Research and Gates Ventures. Affecting more than 944,000 people in the UK, dementia […]

March 21, 2024

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]

March 12, 2024

For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his team treat about 500 people with the rare, fatal disorder that rapidly erodes nerve cells. Friday, though, was particularly difficult. […]

March 11, 2024

As the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative […]

March 11, 2024

Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company […]

March 6, 2024

Affecting an estimated one in 10,000 infants globally, SMA is a rare, genetic neuromuscular disease and a leading genetic cause of infant death. Caused by the lack of a functional SMN1 gene, the most severe forms of SMA result in […]

March 5, 2024

The study results represent the first human data from Apogee, which last year became one of the rare preclinical biopharmaceutical companies to succeed in a tough market for initial public offerings. After launching in late 2022, Apogee raised $300 million […]

February 20, 2024

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]

February 20, 2024

Innovative Trials has announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity. The Retention Patch Program is designed to engage directly with children and young […]

February 7, 2024

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in […]

January 23, 2024

Testing a person’s blood for a protein called phosphorylated tau could provide a means of large-scale screening for Alzheimer’s disease (AD), according to a new study. The immunoassay – which has been developed by California biotech ALZpath – focuses on […]

December 28, 2023

Treatment with the cardiac myosin inhibitor significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited disorder in which the heart muscle becomes thickened and can obstruct blood flow. It is one of the most common reasons […]

December 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples. As the chief scientific officer of large-molecule bioanalysis, Dr. Tom Zhang leverages his expertise to promote ever-evolving automation technologies. He […]

November 21, 2023

Evinova will aim to better meet the needs of healthcare professionals, regulators and patients. The new healthtech business aims to bring to market established and scaled digital technology solutions which are already used globally by AZ, to pharmaceutical, biotechnology and […]

November 20, 2023

In biopharma manufacturing, there is a fine line between being data rich and information poor. Sites are filled with disparate systems, increasing the potential for siloed data. But since data is so key, biopharma companies must find better ways to […]

November 17, 2023

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]