After receiving a complete response letter from the U.S. FDA more than three years ago and conducting another phase III trial, Iterum Therapeutics plc is preparing to make its case before an advisory committee Sept. 9 for sulopenem etzadroxil/probenecid as an oral treatment option for women with uncomplicated urinary tract infections caused by specific microorganisms.
Following a bioresearch monitoring inspection, the U.S. FDA slapped Julio Flamini, a clinical investigator at the Research Center of Atlanta, with a warning letter citing a “significant” protocol violation in which a 15-year-old girl was given 10 times the maximum daily dose of an unnamed study drug for a week.
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced Aug. 15 for the 10 drugs selected for the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector.
