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RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 Oct 2018
J&J applauds U.S. proposal on drug prices in TV ads
16 October 2018 - Johnson & Johnson applauded a U.S. government proposal requiring drugmakers to include price of medicines in television ...
Posted by Michael Wonder on 17 Oct 2018
FDA approves Medicines360’s sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to five years
16 October 2018 - Allergan and Medicines360 announced that the U.S. FDA approved Medicines360’s supplemental new drug application to extend the ...
Posted by Michael Wonder on 17 Oct 2018
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA ...
Posted by Michael Wonder on 17 Oct 2018
Extending the user fee approach to pharmaceuticals
16 October 2018 - A central theme in economics is that people who benefit the most from a good or service ...
Posted by Michael Wonder on 16 Oct 2018
Drug price transparency won’t end the patent games
17 October 2018 - Just look at Humira, which is keeping its U.S. monopoly as generics hit the European market. ...
Posted by Michael Wonder on 16 Oct 2018
FDA approves Pfizer's drug for advanced breast cancer
16 October 2018 - The U.S. FDA said on Tuesday it approved Pfizer's drug for an advanced form of breast cancer ...
Posted by Michael Wonder on 16 Oct 2018
FDA guides on minimal residual disease endpoint in haematologic cancer trials
16 October 2018 - FDA Commissioner Scott Gottlieb highlighted minimal residual disease's potential as a surrogate endpoint in clinical trials ...
Posted by Michael Wonder on 16 Oct 2018
Loxo Oncology announces receipt of breakthrough therapy designation from U.S. FDA for LOXO-292 for the treatment of RET fusion-positive thyroid cancer
15 October 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a selective ...