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RSS FeedPosted by Michael Wonder on 23 Oct 2018
DBV Technologies announces submission of biologics license application for Viaskin Peanut to the U.S. FDA
22 October 2018 - DBV Technologies today announced the submission of a biologics license application to the U.S. FDA for Viaskin ...
Posted by Michael Wonder on 22 Oct 2018
Edge in U.S. cancer drug development spurred by regulatory and reimbursement policies
22 October 2018 - It is presumed that anticipated regulatory and reimbursement policies are important considerations in the research and development ...
Posted by Michael Wonder on 22 Oct 2018
Trump and his team fight for health consumers, starting with drug price transparency
22 October 2018 - Drugs like EpiPen have exorbitant prices due to price gouging. The Trump administration is taking steps to ...
Posted by Michael Wonder on 22 Oct 2018
Eiger BioPharmaceuticals receives FDA rare paediatric disease designation for lonafarnib for the treatment of progeria and progeroid laminopathies and plans NDA filing in 2019
22 October 2018 - Designation enables priority review voucher eligibility upon NDA approval. ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 20 Oct 2018
FDA approves label update for Genentech’s Rituxan (rituximab) in two rare forms of vasculitis
19 October 2018 - Rituxan label updated to include information for follow up treatment in adult patients with granulomatosis with polyangiitis ...
Posted by Michael Wonder on 20 Oct 2018
FDA approves asthma indication for Dupixent (dupilumab)
20 October 2018 - Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype. ...
Posted by Michael Wonder on 20 Oct 2018
FDA snubs Novartis bid to repurpose inflammation drug for heart attacks
19 October 2018 - The U.S. FDA has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases ...
Posted by Michael Wonder on 19 Oct 2018
ViiV Healthcare submits new drug application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
18 October 2018 - Priority review voucher used with submission with anticipated target action date of six months. ...
Posted by Michael Wonder on 19 Oct 2018
AbbVie announces global resolution of Humira (adalimumab) patent disputes with Fresenius Kabi
18 October 2018 - Agreements provide non-exclusive license to Fresenius Kabi for Humira related intellectual property in the U.S. effective 30 ...
Posted by Michael Wonder on 18 Oct 2018
Advancing toward the goal of global approval for generic drugs: FDA proposes critical first steps to harmonise the global scientific and technical standards for generic drugs
18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...
Posted by Michael Wonder on 18 Oct 2018
Immusoft receives rare paediatric disease designation for treatment of MPS I
17 October 2018 - Company seeks to use engineered B cells to deliver missing enzyme for patients. ...
Posted by Michael Wonder on 18 Oct 2018
Albireo receives FDA fast track designation for A4250
17 October 2018 - Albireo Pharma today announced the U.S. FDA has granted Fast Track designation to lead product candidate ...
Posted by Michael Wonder on 18 Oct 2018
FDA grants breakthrough therapy designation to Kadmon's KD025 for chronic graft-versus-host disease
17 October 2018 - Kadmon Holdings today announced that the U.S. FDA has granted breakthrough therapy designation to KD025, the company’s ...
Posted by Michael Wonder on 17 Oct 2018
AbbVie announces supplemental new drug application accepted for priority review by U.S. FDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for previously untreated chronic lymphocytic leukaemia
17 October 2018 - The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer ...