Immutep Limited announced it will pair its lead immunotherapy product with Merck’s blockbuster PD-1 inhibitor Keytruda to treat three solid tumor types in a single trial. Source: BioSpace
Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA. Source: BioSpace
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Source: Drug…
The FDA should revise its draft guidance on ANDA submissions to clarify sponsors’ responsibility for reviewing existing guidances on generics, stakeholders said in comments to the agency. Source: Drug Industry…
The EMA’s Pharmacovigilance Risk Assessment Committee recommended contraindicating the use of Zytiga (abiraterone acetate) with Xofigo (radium-223 dichloride) and prednisone/prednisolone, after preliminary clinical trial results showed the combination posed an…
Most oncology treatments that received the FDA’s accelerated approval pathway in the past 25 years have demonstrated a clinical benefit, according to a review by agency officials published in the…
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…
Four firms in Switzerland, the United Kingdom and the U.S. were hit with Form 483s for having inadequate cleaning and sanitization procedures, in addition to batch record issues. Source: Drug…
The FDA warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling. Source: Drug GMP Report
Abiomed, Inc. will pay the U.S. government $3.1 million to settle allegations that the company sought to influence doctors to use the company’s line of heart pumps in a kickback…