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RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 Oct 2018
EyePoint Pharmaceuticals receives FDA approval of Yutiq (fluocinolone acetonide 0.18 mg intravitreal implant)
15 October 2018 - The first long-lasting, FDA approved micro-insert for up to three years of continuous control in chronic, non-infectious ...
Posted by Michael Wonder on 15 Oct 2018
Statement by FDA Commissioner on FDA’s new steps to modernise drug development, improve efficiency and promote innovation of targeted therapies
15 October 2018 - The FDA continues to advance new policies, modernise our programs and advance opportunities for developing more targeted ...
Posted by Michael Wonder on 13 Oct 2018
FDA approves Stiolto Respimat supplemental new drug application to add data on COPD exacerbation reduction
11 October 2018 - Stiolto Respimat is the first in its class to have exacerbation data in the product labelling. ...
Posted by Michael Wonder on 12 Oct 2018
U.S. FDA approves Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease
11 October 2018 - This label expansion adds to six existing Xarelto indications granted since initial launch. ...
Posted by Michael Wonder on 12 Oct 2018
Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR206
11 October 2018 - Spero Therapeutics announced today that SPR206, a product candidate within Spero’s Potentiator Platform, has been granted qualified ...