LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic. Read More
Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma. Read More
BEIJING – During the market downturn caused by COVID-19 disruptions, biotech and med-tech companies continue to attract investors at a time when medical solutions are needed more than ever. Qiming Venture Partners said that it has established a new $1.1 billion fund to target early stage health care and technology investments, the latest good news sector for biopharma and med-tech startups. Read More
Less than a year after backing Tscan Therapeutics Inc.'s $48 million series B round, Novartis AG is tapping the Waltham, Mass.-based company to discover and develop new T-cell receptor (TCR)-engineered T-cell therapies for up to three new solid tumor targets. The collaboration includes an up-front technology access fee and research funding totaling $30 million, as well as potential clinical, regulatory and sales-based milestone payments that could total hundreds of millions of dollars, Tscan said. Read More
The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers. Read More
Nearly 40 years on, the generic drug market is often lauded as an American success story. But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries. Read More
The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product. Read More
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.” Read More
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ansun, Arvinas, Cytodyn, Gensight, Ico, Mallinckrodt, Oragenics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen. Read More
