The FDA approved Fate Therapeutics' investigational new drug application for its chimeric antigen receptor natural killer cell therapy FT536. The allogeneic, engineered induced pluripotent stem cell-derived natural killer cell therapy was developed as a treatment for specific relapsed or refractory solid tumors.
The US Biomedical Advanced Research and Development Authority, a US HHS office, is hosting a biopharmaceutical manufacturing industry conference Thursday to explore physical infrastructure needs for improving future pandemic responses, including domestic sources of vaccines, therapeutics, raw materials and manufacturing supplies. The focus of the free event will be the role of public-private partnerships in the US biomanufacturing infrastructure.
US President Joe Biden said he directed federal agencies to procure 500 million COVID-19 tests in addition to the more than 420 million tests already under contract. The White House has set up a website US households can use to order four tests per month at no cost, senior administration officials said.
Merck learned two important lessons recently when one of the company's facilities was unable to get a needed filter assembly: It pays to be proactive, and it's crucial to maintain change control, writes Mark Petrich, formerly the director of single-use engineering at Merck. The company had planned for unexpected supply disruptions and requests for technical alternatives, but it lacked functional equivalencies in other areas.
SK, the holding company that owns SK bioscience, is making a $350 million equity investment in the Center for Breakthrough Medicines, which plans to add 2,000 employees, automated manufacturing and 700,000 additional square feet of capacity at its facility in suburban Philadelphia.
A disruption in the US supply of Novo Nordisk's obesity drug Wegovy may be due to potential violations of good manufacturing practices uncovered in a US FDA inspection at a Catalent syringe filling facility in Belgium. Neither Catalent nor Novo Nordisk confirmed the link, but Jefferies analyst David Windley, who reported it, said the Catalent facility will likely be allowed to reopen without being reinspected.
The demand for saliva as a reliable testing medium is increasing amid a surge in COVID-19 cases, and laboratories considering adding new assays to their offerings should consult with those who order tests and should develop a policy for handling testing fluids outside manufacturer parameters, as most assays are developed specifically for blood. If handled correctly, saliva diagnostics have potential for "increasing access in low resource settings, reducing healthcare costs, driving precision healthcare, and providing more equitable healthcare solutions for remote and rural communities," said Chamindie Punyadeera, professor at Griffith University in Brisbane, Australia.
Diagnosing mucopolysaccharidosis disorders can be difficult and requires urine-based tests to identify abnormally high levels of glycosaminoglycan and enzymatic activity assays to confirm decreased levels of lysosomal enzymes associated with high GAG levels. This piece discusses the measurement of GAG levels and the use of urinary GAG concentrations as predictive biomarkers of the efficacy of enzyme replacement therapy as a treatment for MPS I.
Beam Therapeutics has partnered with Pfizer to use precision gene editing to correct mutations in the central nervous system, liver and muscle cells. Pfizer paid Beam $300 million upfront and pledged over $1 billion in potential milestone payments for three rare disease programs.
Electron diffraction, or nanocrystallography, yields a high-definition view of nanosized solids and allows rapid screening and characterization of crystalline compounds "directly from nano-sized batches of nanocrystalline products without the need for time-consuming purification, scale-up or recrystallisation," writes Eric Hovestreydt, CEO of ELDICO Scientific.