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RSS FeedPosted by Michael Wonder on 14 Apr 2020
LifeMax receives fast track designation for LM-030 for the treatment of Netherton syndrome
14 April 2020 - LifeMax Laboratories today announced that the FDA granted fast track designation to LM-030, an investigational therapy licensed ...
Posted by Michael Wonder on 14 Apr 2020
Drug evaluation during the COVID-19 pandemic
14 April 2020 - The search for a treatment for COVID-19 is testing our country’s ability to quickly develop, test, ...
Posted by Michael Wonder on 14 Apr 2020
Alnylam receives fast track designation for vutrisiran for the treatment of the polyneuropathy of hATTR amyloidosis
14 April 2020 - Alnylam Pharmaceuticals announced today that the U.S. FDA has granted fast track designation to vutrisiran, an ...
Posted by Michael Wonder on 14 Apr 2020
Vaccine development is a case of 'market failure'
13 April 2020 - Reliance on the private market to develop vaccines has failed, leaving us vulnerable to pandemics such as ...
Posted by Michael Wonder on 14 Apr 2020
Pharmacologic treatments for coronavirus disease 2019 (COVID-19): a review
13 April 2020 - The pandemic of coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 ...
Posted by Michael Wonder on 14 Apr 2020
Regulators split on anti-malarials for COVID-19
11 April 2020 - US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and ...
Posted by Michael Wonder on 14 Apr 2020
Potential coronavirus drugs may cost as little as $1, study says
10 April 2020 - Treatments being studied sell for hundreds of times their cost. ...
Posted by Michael Wonder on 14 Apr 2020
Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs
13 April 2020 - In July 2018, the FDA first published a table listing all surrogate measures that it has used, ...
Posted by Michael Wonder on 14 Apr 2020
COVID-19: world needs a global approach to fight: Bill Gates
12 April 2020 - Over the past few weeks, I’ve spoken to dozens of experts about COVID-19, and there’s clear ...
Posted by Michael Wonder on 13 Apr 2020
Fennec Pharmaceuticals announces FDA filing acceptance and priority review of new drug application for Pedmark
13 April 2020 - FDA grants priority review and sets a Prescription Drug User Fee Act target action date of 10 ...
Posted by Michael Wonder on 13 Apr 2020
How a premier U.S. drug company became a virus ‘super spreader'
12 April 2020 - Biogen employees unwittingly spread the coronavirus from Massachusetts to Indiana, Tennessee and North Carolina. ...
Posted by Michael Wonder on 10 Apr 2020
FDA approves first therapy for children with debilitating and disfiguring rare disease
10 April 2020 - Today, the U.S. FDA approved Koselugo (selumetinib) for the treatment of paediatric patients, 2 years of age ...
Posted by Michael Wonder on 10 Apr 2020
This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready?
6 April 2020 - It seems like an agency tailor-made for a crisis like the coronavirus pandemic. ...
Posted by Michael Wonder on 10 Apr 2020
EicOsis EC5026 granted fast track designation by FDA for neuropathic pain
9 April 2020 - EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics based on inhibition of ...
Posted by Michael Wonder on 10 Apr 2020
Ensuring access to medications in the US during the COVID-19 pandemic
9 April 2020 - The coronavirus disease 2019 (COVID-19) pandemic continues to rapidly evolve. ...