With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out.
A higher rate than expected of serious bleeding, including five deaths, in ovarian cancer patients receiving upifitamab rilsodotin (UpRi) led the U.S. FDA to place a partial clinical hold on two trials, possibly delaying Mersana Therapeutics Inc.’s BLA filing targeted for later this year.
The death of a patient caused Seattle Children's to pause its phase I study of relapsed/refractory pediatric acute myeloid leukemia (AML). It’s another hitch in the world of ground-breaking CAR T treatments that can have a serious downside.
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
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