EOM 1352: Fri 7 June 2024, 11:36

Current Edition

Discovery Park: Wed 13 November 2024, 10:35
ramusmedical
Regional News

After forking over $900M for Libtayo rights, Regeneron expects slight delay for lung cancer combo

With Libtayo now squarely in Regeneron’s hands, the drugmaker is eager to start cranking out combination therapies. But one near-term prospect is expected to suffer a...
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Regional News

Merck’s Keytruda, on a losing streak, fails in once FDA-rejected liver cancer use and prostate cancer—again

Add two more failures to Merck & Co.’s recent string of Keytruda trial readouts. The once seemingly untouchable immuno-oncology agent appears to have hit a snag i...
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Regional News

Eli Lilly finds stigma is one of the worst parts of migraine as it aims to help break the taboo

It turns out that even more than the blinding pain, the nausea, the photosensitivity or crushing fatigue, the worst part of migraine is often the stigma attached to i...
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Regional News

Covis’ controversial Makena gets FDA hearing date in bid to stay on the market

More than a decade after Makena's FDA approval to prevent recurrent preterm birth and two years after the FDA recommended the drug be pulled from the market, Covis Ph...
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Regional News

Eli Lilly’s Olumiant snags biopharma’s first FDA green light for alopecia areata

Eli Lilly’s commitment to the immunology field has paid off with another important approval for JAK inhibitor Olumiant. And it's an industry first in alopecia areata....
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Regional News

Kyowa Kirin goes for the glow to bring awareness to rare bone disease XLH

Kyowa Kirin International (KKI) takes highlighting awareness of rare disease X-linked hypophosphatemia (XLH) literally with its immersive virtual exhibition, the “Shi...
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Regional News

Aurobindo Pharma slapped with Form 483 as FDA inspectors cite 6 findings

Bad news for Aurobindo Pharma. Just two months after the generics maker closed up shop at its Aurolife Pharma unit in New Jersey, the company’s oral manufacturing fac...
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Regional News

J&J plays up precision therapy approach for Zejula’s prostate cancer bid after mixed results

In 2017 and 2020, Zejula snagged broad FDA labels for ovarian cancer patients who responded well to chemotherapy. But in prostate cancer, the PARP inhibitor appears t...
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Regional News

FDA chides Eli Lilly for second misleading ad in 2 months, this time for diabetes blockbuster Trulicity

After neatly wrapping up concerns over a series of Emgality ads last month, Eli Lilly is back in hot water with the FDA's Office of Prescription Drug Promotion. The ...
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Volume 13 Issue 5

What is Cognitive Debriefing?

Cognitive debriefing is a language test of a linguistically validated questionnaire of healthy volunteers or patients with a specific disease to prove that the transl...
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Catalyst: 12th January 2026
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