Despite a “volatile” February due to uncertainty in the U.S. and abroad, CEO Marc Casper contends the company is “well positioned” to navigate the geopolitical environment.
The Government Accountability Office found that the FDA continues to face significant vacancies among investigators who conduct inspections in foreign countries.
The vaccine company and contract manufacturer are building a dedicated suite at Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support Vaxcyte’s PCV franchise.
The agency’s inspection identified multiple deficiencies in the company’s quality control procedures, equipment maintenance, and record-keeping practices.
The company reported full-year results including a 7.9% decrease in operating revenue due to a lagging contract development and manufacturing organization business.
The company’s cash deal, which is expected to be completed by the end of 2025, secures purification and filtration technologies used in the production of biologics.
The collaboration aims to enhance clinical timelines and streamline production by leveraging Cellex’s expertise in cell and gene therapy manufacturing.
If the FDA’s decision stands, compounders will have a grace period before the agency enforces rules that would put an end to their making off-brand copies of the drugs.
The South Korean manufacturer and exporter of biosimilars said it has transferred about nine months’ worth of inventory for its products scheduled for U.S. sale in 2025.
Jagsonpal Pharma and Tyche Industries were cited for serious cGMP violations, including data falsification, inadequate quality controls, and obstruction of FDA inspections.
The pharma giant has stockpiled nearly $550 million worth of “pre-launch inventory” for its weight-loss pill orforglipron, in anticipation of regulatory approval.
Production will take place at Celonic’s GMP-certified facility in Heidelberg, Germany, which is equipped to handle complex biologics and bioprocessing technologies.
The company’s manufacturing segment underperformed in the fourth quarter of 2024, driven by weakness in its CDMO business which is expected to continue in 2025.
Albert Bourla told CNBC that Pfizer’s manufacturing operations in Europe could be potentially impacted if President Trump orders pharmaceutical import tariffs on EU.
The error stems from a manufacturing issue which could lead to incorrect dosing calculations, potentially resulting in severe hyperkalemia and life-threatening complications.
The pharma and lab equipment company reported that the business situation “stabilized” last year, despite a “difficult” environment that lasted longer than expected.
The Spanish contract manufacturer, which will report its full-year results on Feb. 25, warned that analysts’ consensus 2024 EBITDA estimates are 10% to 15% too high.
The vaccine maker’s fourth quarter results included a loss of $238 million on a non-cash charge related to the termination of a contract manufacturing agreement.
The actions could postpone NIH-funded clinical trials and create cash flow issues for biotech companies, according to data and analytics firm GlobalData.
The CDMO said construction and infrastructure development in Mourenx, France will begin immediately, with the first supplies of GLP-1 therapies expected in 2026.
The deal with the Chinese manufacturer is meant to accelerate the development and commercialization of Oramed’s oral insulin and other oral drug delivery technologies.
