European Commision approves subcutaneous version of Remsima for IBD and ankylosing spondylitis

The European Commission (EC) has authorised the world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis. The authorisation for the subcutaneous (SC) formulation now applies to all previously approved indications for the intravenous (IV) formulation in adults including: ankylosing spondylitis (AS),

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C-Path obtain FDA’s positive response for drug induced skeletal muscle injury biomarkers

Critical Path Institute (C-Path) announced that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the FDA issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of

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MHRA to allow for early access to Alnylam’s ultra-rare disease treatment, lumasiran

The MHRA has granted Alnylam’s lumasiran a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). The decision will allow patients with the ultra-rare disease primary hyperoxaluria type 1 (PH1) access to the drug before its official approval by the European Commission. PH1 is an ultra-rare orphan disease affecting around 90 patients in

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European Commission approves AstraZeneca’s pancreatic cancer treatment

The European Commission has approved AstraZeneca (AZ) and Merck/MSD’s PARP-inhibitor Lynparza for the treatment of patients with BRCA-mutated metastatic pancreatic cancer. The approval was based on results from the phase 3 POLO trial of Lynparza in advanced pancreatic cancer patients whose tumours carry BRCA mutations. About 5-7% of metastatic pancreatic cancers are caused by mutations in one

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Eight medicines set to receive EU approval from CHMP

The European Medicines Committee’s human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications. Gilead’s remdesivir has been previously recommended for conditional approval for treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. The drug is the first medicine against

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FDA announce new pilot program to communicate patient reported outcomes for cancer clinical trials

FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval

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FDA approves Merck/MSD’s antibiotic drug for bacterial pneumonia

Merck/MSD has won an approval from the FDA for its Gram-negative antibiotic Recarbrio, as a treatment for hospital-acquired and ventilator-associated bacterial pneumonia. Recarbrio is a combination treatment comprised of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Imipenem works to kill the bacteria associated with the infection while the other

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UK allows NHS use of Gilead’s remdesivir for Coronavirus patients

The UK medicines regulator has cleared early access to Gilead Sciences’ coronavirus drug remdesivir for people hospitalised with severe coronavirus infection, although supplies will initially be limited. MHRA has approved the drug under the Early Access to Medicines Scheme (EAMS), used to speed up access to unlicensed drugs for life-threatening or seriously debilitating conditions. The

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