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RSS FeedPosted by Michael Wonder on 19 Aug 2020
Coronavirus: CSL reveals delivery date for COVID-19 vaccine as it progresses with clinical trials
19 August 2020 - Australia’s biggest health care company, CSL, expects to start delivering “emergency doses” of a COVID-19 vaccine ...
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
Mylan brings critical access to the multiple sclerosis community by launching a more affordable treatment option through a first generic to Tecfidera
19 August 2020 - Mylan today announced the launch of the first FDA approved therapeutically equivalent, substitutable generic of Biogen's ...
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
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
Adding sickle cell disease to FDA’s priority review voucher list of neglected tropical diseases
18 July 2020 - On 16 July, Putting Rare Diseases Patients First! filed a citizen’s petition to add sickle cell ...
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 ...
Posted by Michael Wonder on 18 Aug 2020
Imfinzi granted FDA priority review for less-frequent, fixed-dose use
18 August 2020 - Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits ...
Posted by Michael Wonder on 18 Aug 2020
European Medicines Agency has accepted for review a marketing authorisation application for Voraxaze
17 August 2020 - BTG Specialty Pharmaceuticals, today announced the EMA has accepted for review a marketing authorisation application for ...
Posted by Michael Wonder on 17 Aug 2020
Creating a coronavirus vaccine is only the first step. It’ll take years to manufacture and distribute.
18 August 2020 - The world is hoping a safe and effective COVID-19 vaccine will soon become available. So far, ...
Posted by Michael Wonder on 17 Aug 2020
PTC announces the acceptance of the European marketing authorisation application for Evrysdi (risdiplam) for the treatment of spinal muscular atrophy
17 August 2020 - Marketing authorisation application based on data from multiple pivotal trials in infants, children and adult patients with ...
Posted by Michael Wonder on 17 Aug 2020
Clinical trials of coronavirus drugs are taking longer than expected
14 August 2020 - Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a ...