ADHD drug delivery specialist Cingulate hit with manufacturing-related FDA rejection
Cingulate will need to take a detour to win its first FDA approval, as the agency has rejected its lead candidate over manufacturing concerns.
MedTech In Focus: AI impact in healthcare
We are seeing it everywhere, Artificial Intelligence in our daily activities – smart thermostats and smart lights in our homes, facial recognition on our phones, robot vacuum cleaners doing our cleaning, navigation
Viridian, awaiting FDA decision, taps WuXi Bio in eye drug supply deal
Viridian aims to challenge Amgen in a blockbuster market, and it’s now tapped Chinese CDMO giant WuXi Biologics in a manufacturing pact.
GLP-1 manufacturer CordenPharma strikes deal for peptide CDMO, lining up new production sites in US and China
Amid a nearly $1 billion GLP-1 manufacturing expansion that began in 2024, CMDO CordenPharma is doubling down on its peptide capacity ambitions.
SK bioscience links up with Colombia to enable local production of varicella vaccine
Korea’s SK bioscience has signed a technology transfer and manufacturing deal with the Colombian government which will allow the South American nation to produce the company’s chickenpox vaccine SKYVaricella.
Niowave kicks off construction of $75M radiopharmaceutical isotope plant in Michigan
Niowave has broken ground on a $75 million facility at its campus in Lansing, Michigan, which will produce Actinium-225. The radioisotope supplier expects the facility to become operational in 2028 and to
Gilead inks another deal with Korean API manufacturer Yuhan, this time worth $140M
Gilead has broadened its partnership with Korean manufacturer Yuhan, agreeing to a $140 million supply deal for active pharmaceutical ingredients for an undisclosed product.
Novartis terminates plant contract with Chinese CDMO Porton, threatens $64M in legal claims
A Novartis cross-border partnership is turning into a standoff. The Swiss pharma has unilaterally terminated a plant leasing contract with Chinese CDMO Porton Pharma Solutions after a regulatory hiccup.
Bristol Myers looks at Houston for potential $1B manufacturing plant
As Bristol Myers looks for suitable sites for a large U.S. manufacturing plant, Houston has emerged as one contender.
As biologics dominate biopharma pipelines, manufacturing hurdles trip up new launches: report
As biologics have increasingly superseded small molecules in the biopharma industry’s pipeline, the mounting complexity of their manufacturing products is putting production and launches under pressure.