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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.

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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

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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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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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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

An update on the Janssen jab at the PRAC’s latest meeting concluded that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects, but its labelling will be updated to recommended increased vigilance in people with thrombocytopenia and a recent history of blood clots.

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Is Dulera a steroid?

The Checkup by Singlecare

Dulera is also prescribed off-label to help with breathing problems in adults with chronic obstructive pulmonary disorder (COPD). Because Dulera contains an ICS (mometasone) and bronchodilator (formoterol), your provider may prescribe it off-label for symptom relief, particularly in cases of mild asthma. Is Dulera a steroid?

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Cancer vaccines: providing the edge in oncology

pharmaphorum

Using a vaccine to utilise the patient’s own immune system to fight cancer is particularly attractive because of the targeted approach made possible by this technology. While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response.

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