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RSS FeedPosted by Michael Wonder on 20 Aug 2020
New agreement means NICE recommends combination treatment for some lymphoma patients
20 August 2020 - Hundreds of people with a form of blood cancer will benefit from a new treatment following the ...
Posted by Michael Wonder on 20 Aug 2020
Polaryx Therapeutics receives FDA fast track designation to PLX-200 for the treatment of patients with juvenile neuronal ceroid lipofuscinosis
20 August 2020 - Polaryx Therapeutics announced today that the U.S. FDA has granted fast track designation to PLX-200 for ...
Posted by Michael Wonder on 20 Aug 2020
US FDA awards fast track designation to paxalisib for glioblastoma
20 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 20 Aug 2020
Health Canada grants market authorization for Tecentriq in combination with bevacizumab, the first immunotherapy combination treatment, for the most common form of liver cancer
19 August 2020 - Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of ...
Posted by Michael Wonder on 19 Aug 2020
Inquiry into approval processes for new drugs and novel medical technologies in Australia
19 August 2020 - Following a referral on 13 August 2020 from the Minister for Health, The Hon Greg Hunt ...
Posted by Michael Wonder on 19 Aug 2020
US may need to look to Germany to reform drug pricing
19 August 2020 - US administrative and legislative efforts are moving the United States and Germany more into alignment on drug ...
Posted by Michael Wonder on 19 Aug 2020
Financing drug innovation in the US: current framework and emerging challenges
19 August 2020 - The current US drug innovation financing framework rests on the notion that a defined period of marketing ...
Posted by Michael Wonder on 19 Aug 2020
The antibiotic paradox: why companies can’t afford to create life-saving drugs
19 August 2020 - Paratek Pharmaceuticals successfully brought a new antibiotic to the market. So why is the company’s long-term survival ...
Posted by Michael Wonder on 19 Aug 2020
Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis
19 August 2020 - Galapagos announces today that Gilead Sciences received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 19 Aug 2020
Dupixent (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis
18 August 2020 - First biologic approved in Canada for adults with severe chronic rhinosinusitis with nasal polyposis. ...
Posted by Michael Wonder on 18 Aug 2020
NICE appoints two directors to key new positions
18 August 2020 - NICE has announced the appointment of two new directors to key positions in newly formed directorates. ...
Posted by Michael Wonder on 18 Aug 2020
EMA publishes agenda for 17-20 August CHMP meeting
18 August 2020 - The EMA has published a draft agenda for this week's CHMP meeting (written procedure). ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
Posted by Michael Wonder on 18 Aug 2020
The FDA response to COVID-19 at six months: regulatory innovation in the face of a pandemic
18 August 2020 - The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases ...
Posted by Michael Wonder on 18 Aug 2020
FDA initiatives to accelerate the development of COVID-19 therapeutics
18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...