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The FDA is encouraging drugmakers to work together to get agency qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs. Read More
Takeda is ending all trials of its type 2 diabetes drug fasiglifam after determining that the drug’s benefits were outweighed by liver risks. Read More
Sponsors of drugs with salt-based active ingredients are urged to follow the United States Pharmacopeia’s (USP) strict naming rules for such drugs, but the FDA may make an exception when the name of the salt contains “vital information” for clinical use, new draft guidance states. Read More
The European Commission is launching a pilot program to help drugmakers avoid last-minute conflicts with health technology assessors as they are bringing products to market. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More
Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More
While FDA’s CDER breakthrough therapy designations for new drug products have taken off dramatically, CBER has been a lot more conservative in approving applications for the new designation. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More