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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. The drug's label already includes an overall survival win from a key trial.

FDA 139
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EU gives narrower label to Apellis, Sobi’s PNH drug

pharmaphorum

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

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AC Immune claims half a win for tau drug in Alzheimer’s trial

pharmaphorum

Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. AC Immune has a lot riding on the tau hypothesis.

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UCB Entered into a Research Collaboration with Ariceum Therapeutics to Discover New Modalities for Immune-related Diseases and Cancer

PharmaShots

Ariceum's expertise in radiochemistry & labeling technology will be useful to UCB in enhancing its capacity & discovery of highly distinctive products for immune-related diseases Ariceum will use a special library to screen against oncology targets of interest.

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FDA declines Eli Lilly’s bowel disease drug over manufacturing issues

Pharmafile

However, concerns weren’t expressed over the clinical data package, safety or label for the medicine. Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon. read more

FDA 119
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Oral penicillin challenge deemed safe and effective in low-risk allergy patients

Hospital Pharmacy Europe

Removing the label of being allergic to penicillin involves intra-dermal skin testing followed by an oral penicillin challenge. The primary outcome of interest was a physician-verified positive immune-mediated oral penicillin challenge within one hour after the intervention. None of these were deemed to be serious.

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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

The FDA Law Blog

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Importantly, because FDA has sovereign immunity from damages claims, sponsors trapped in S. That bill is S.