In divvying up U.S. spending on orphan vs. nonorphan indications for drugs approved for both, a new study could fuel future debates and inform policy on orphan drug incentives. The study, led by a team of University of Michigan and Boston University researchers, found that 21% of the total dollars spent in 2018 in the U.S. on the 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases.
The cost of newly FDA approved Pepaxto (melphalan flufenamide) from Oncopeptides AB is designed to put the therapy in the middle of the range compared to other multiple myeloma therapies, CEO Marty Duvall told BioWorld. “There are products well entrenched in that space,” he added.
With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus.
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies.
Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.