The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc rehearing of Eagle Pharmaceuticals Inc. v. Alex Azar.
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S.
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S.
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
ANAHEIM, Calif. – Is artificial intelligence (AI) ready for prime time in health care? What’s hype and what’s real? That’s the question that was posed to an expert panel at MD&M West.
ANAHEIM, Calif. – The digital health wave is impacting seemingly every aspect of health care, from digital therapeutics where software is the therapy to powerful analytics that bring actionable insights to aid in a clinical situation.
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
