Blog
RSS FeedPosted by Michael Wonder on 14 Nov 2019
10 year update on study results submitted to ClinicalTrials.gov
14 November 2019 - A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results ...
Posted by Michael Wonder on 13 Nov 2019
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...
Posted by Michael Wonder on 13 Nov 2019
FDA’s Project Orbis may expand to Singapore and Switzerland
12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...
Posted by Michael Wonder on 13 Nov 2019
Viracta receives fast track designation for nanatinostat combination for the treatment of EBV-associated lymphomas
12 November 2019 - Viracta Therapeutic, announced today that the U.S. FDA has granted fast track designation for nanatinostat in ...
Posted by Michael Wonder on 13 Nov 2019
Actelion withdraws regulatory filings to extend the indication of Opsumit (macitentan 10mg) in CTEPH
12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings ...
Posted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...
Posted by Michael Wonder on 13 Nov 2019
Exelixis’ partner Ipsen announces Health Canada’s approval of Cabometyx (cabozantinib) tablets for the treatment of patients with previously treated advanced hepatocellular carcinoma
12 November 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...
Posted by Michael Wonder on 12 Nov 2019
X4 Pharmaceuticals receives breakthrough therapy designation from the FDA for mavorixafor for the treatment of WHIM syndrome
12 November 2019 - X4 Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for mavorixafor (X4P-001) ...
Posted by Michael Wonder on 12 Nov 2019
EMA publishes agenda for 11-14 November CHMP meeting
11 November 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Nov 2019
Google’s ‘Project Nightingale’ gathers personal health data on millions of Americans
11 November 2019 - Search giant is amassing health records from Ascension facilities in 21 states; patients not yet informed. ...
Posted by Michael Wonder on 12 Nov 2019
Merck’s Ervebo [Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live] granted conditional approval in the European Union
12 November 2019 - Authorisation represents significant advancement in the global response to Ebola. ...
Posted by Michael Wonder on 11 Nov 2019
FDA admits it goofed when granting orphan status to an opioid addiction treatment
8 November 2019 - In an unusual move, the FDA has acknowledged a mistake and revoked orphan drug status for ...
Posted by Michael Wonder on 11 Nov 2019
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for patients with previously treated advanced hepatocellular carcinoma
11 November 2019 - The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication. ...
Posted by Michael Wonder on 11 Nov 2019
F2G receives US FDA breakthrough therapy designation for Olorofim
11 November 2019 - First anti-fungal agent to receive breakthrough therapy designation. ...
Posted by Michael Wonder on 11 Nov 2019
Lipocine receives complete response letter for Tlando from U.S. FDA
11 November 2019 - Lipocine announced today that it has received a complete response letter from the United States Food ...