Archive for January 2022

Michigan’s Attorney General is pursuing court approval to begin an investigation into Eli Lilly over the high insulin prices the company charges. Source: Drug Industry Daily

Protection against Omicron-related death in people 50 and older reached as high as 95 percent after a booster dose of a messenger RNA (mRNA) vaccine, the UK Health Security Agency (UKHSA) announced Thursday. Source: Drug Industry Daily

Merck’s Keytruda (pembrolizumab) has made a couple of headlines this week, drawing attention as a potential weapon against latent HIV infections, and winning approval in Europe as a kidney cancer monotherapy. Source: Drug Industry Daily

Prominent industry figures have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in trials, but they hope it will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors adjust to the new recommendations. Source: Drug Industry Daily

Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Source: Drug Industry Daily

Researchers from the University of Minnesota and 46brooklyn Research have shown in a new analysis that prices of entecavir, a generic drug that’s one of the first-line treatments used to treat chronic hepatitis B (CHB), from 2014 to 2018 stayed artificially high despite a dramatic increase in generic competition. Source: Drug Industry Daily

A number of academic and medical institutions are still not reporting their trial results as required by federal law, a new analysis shows. Source: Drug Industry Daily

Fiscal 2022 is already setting a dismal pace for generic drug approvals, which sunk to a record low last year under the full brunt of COVID-19 supply-chain and clinical trial interruptions. Source: Drug Industry Daily

Sierra Oncology has announced that its experimental blood cancer treatment has reached all primary and key secondary endpoints in a phase 3 study, including maintaining platelet counts. Source: Drug Industry Daily

The FDA, as part of its Drug Competition Action Plan, has released final guidance for companies preparing to submit abbreviated new drug applications (ANDAs) to the agency for generic products. Source: Drug Industry Daily