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RSS FeedPosted by Michael Wonder on 13 Sep 2018
FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 13 Sep 2018
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 (TPS ≥1%)
12 September 2018 - Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial. ...
Posted by Michael Wonder on 12 Sep 2018
FDA to review supplemental biologics license application for Praluent (alirocumab) injection as potential treatment to reduce major adverse cardiovascular events
12 September 2018 - FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy. ...
Posted by Michael Wonder on 12 Sep 2018
Trump's early efforts to trim drug costs face patient backlash
11 September 2018 - President Trump’s bid to revamp Medicare to lower drug prices for seniors is getting pushback from ...
Posted by Michael Wonder on 12 Sep 2018
Gottlieb on price gouging
12 September 2018 - Here’s something you don’t see every day: the Commissioner of the FDA took a very public ...
Posted by Michael Wonder on 12 Sep 2018
Are we being misled about precision medicine?
12 September 2018 - Doctors and hospitals love to talk about the cancer patients they’ve saved, and reporters love to write ...
Posted by Michael Wonder on 12 Sep 2018
Statement from FDA Commissioner and Center for Devices and Radiological Health Director on agency efforts to work with tech industry to spur innovation in digital health
12 September 2018 - Owing to digital advances, we’re experiencing a reimagination of health care delivery. ...
Posted by Michael Wonder on 12 Sep 2018
FDA awards five grants to advance the development of paediatric medical devices
12 September 2018 - The U.S. FDA announced today that it has awarded five grants totalling up to $6 million per ...
Posted by Michael Wonder on 12 Sep 2018
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of idiopathic pulmonary fibrosis
12 September 2018 - FibroGen today announced that the U.S.FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, ...
Posted by Michael Wonder on 11 Sep 2018
FDA grants breakthrough therapy designation for Concentric Analgesics’ CA-008 in post-surgical pain
11 September 2018 - Concentric Analgesics announced today that it has received breakthrough therapy designation from the U.S. FDA) for CA-008 ...
Posted by Michael Wonder on 11 Sep 2018
Bertilimumab granted fast track designation for the treatment of bullous pemphigoid
11 September 2018 - Company to provide corporate update during conference call with live audio webcast on Thursday 13 September at ...
Posted by Michael Wonder on 11 Sep 2018
Pharma executive says he had 'moral requirement' to raise drug price 400%
11 September 2018 - A pharmaceutical company executive defended his company's recent 400% drug price increase, telling the Financial Times that ...
Posted by Michael Wonder on 11 Sep 2018
Minimal residual disease negativity data, a measure of undetectable disease, added to Venclexta (venetoclax tablets) label
11 September 2018 - Minimal residual disease-negativity is defined as having disease at a threshold of less than one chronic lymphocytic ...
Posted by Michael Wonder on 11 Sep 2018
Amicus Therapeutics announces regulatory and clinical updates for AT-GAA in Pompe disease
10 September 2018 - Amicus Therapeutics announced today regulatory and clinical advancements in its development program AT-GAA for Pompe disease. ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...