Merck & Co.

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NEWS
Every week brings news of clinical trials, ranging from launches, first-patient dosing, full enrollment, interim data or final data. Here’s a look at some of the clinical trial news from last week.
There were a number of major companies reporting their second-quarter financials for the year. Here’s a look at five of the bigger announcements this week.
FDA
The U.S. Food and Drug Administration approved the anti-PD-1 therapy as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.
The DMC recommended the trial continue without changes in order to determine other dual-primary endpoints, such as event-free survival.
A new study identifies the risk factors that could help healthcare providers recognize patients being treated for diabetes who are most likely to have low blood sugar.
Merck will invest $680 million to build a manufacturing facility in Durham and expand an existing site in Wilson.
FDA
Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
FDA
For LENVIMA plus KEYTRUDA Combination Treatment as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment
The Fortune 500 list is compiled of the 500 U.S.-based companies that generate the most revenue. In the latest ranking, one dozen biopharma companies were included, with one, Johnson & Johnson, breaking into the top 50 and only four in the top 100.
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