Blog
RSS FeedPosted by Michael Wonder on 25 Jan 2017
Novartis says court battle will delay its Enbrel copy until 2018 at least
25 January 2017 - The Novartis copy of Amgen's blockbuster psoriasis drug Enbrel will not go on sale before 2018 ...
Posted by Michael Wonder on 25 Jan 2017
Are new drugs for hepatitis C safe? A report raises concerns
24 January 2017 - Drugs approved in recent years that can cure hepatitis C may have severe side effects, including ...
Posted by Michael Wonder on 25 Jan 2017
Atlantic Healthcare receives FDA agreement to initiate rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
24 January 2017 - FDA to accept sections of the regulatory application ahead of final Phase 3 data expected in ...
Posted by Michael Wonder on 25 Jan 2017
Trump considers an entrepreneur with sweeping reform plans to run the FDA
23 January 2017 - Two weeks ago, Dr. Joseph Gulfo ran a panel at the Biotech Showcase in San Francisco ...
Posted by Michael Wonder on 24 Jan 2017
Roche says FDA grants priority review for Actemra
24 January 2017 - The U.S. FDA has granted priority review designation of Roche's rheumatoid arthritis medication Actemra for giant cell ...
Posted by Michael Wonder on 24 Jan 2017
America’s biopharmaceutical companies launch groundbreaking, multi-year initiative heralding new era of medicine
23 January 2017 - Advertising and public affairs campaign will convene national health care dialogue, educational events and stakeholder engagements across ...
Posted by Michael Wonder on 23 Jan 2017
Ocular Therapeutix resubmits NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery
23 January 2017 - Ocular Therapeutix today announced that it has resubmitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 23 Jan 2017
Bristol-Myers Squibb provides regulatory update in first-line lung cancer
19 January 2017 - All first-line lung registrational studies continue. ...
Posted by Michael Wonder on 22 Jan 2017
UCB files Briviact (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patients with partial-onset seizures
19 January 2017 - Application follows recent FDA general advice letter supporting use of extrapolated data to assess monotherapy use ...
Posted by Michael Wonder on 21 Jan 2017
U.S. FDA acknowledges receipt of Shire’s new drug application for SHP465 for ADHD
19 January 2017 - Shire announced that the U.S. FDA has acknowledged receipt of the Class 2 resubmission of a new ...
Posted by Michael Wonder on 21 Jan 2017
Benefit-risk assessments at the US Food and Drug Administration: finding the balance
20 January 2017 - The US FDA’s independent evaluation of medical products for safety and effectiveness prior to granting approval ...
Posted by Michael Wonder on 20 Jan 2017
Allergan announces FDA approval of Rhofade (oxymetazoline hydrochloride) 1% cream for the topical treatment of persistent facial erythema associated with rosacea in adults
19 January 2017 - Once daily treatment reduces persistent facial erythema associated with rosacea through 12 hours. ...
Posted by Michael Wonder on 20 Jan 2017
FDA approves Trulance for chronic idiopathic constipation
19 January 2017 - The U.S. FDA today approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adult ...
Posted by Michael Wonder on 19 Jan 2017
Statement from FDA Commissioner announcing FDA Oncology Center of Excellence launch
19 January 2017 - Today the U.S. FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard ...
Posted by Michael Wonder on 19 Jan 2017
What Trump's libertarian pals don't understand about the FDA -- or reality
18 January 2017 - Days before Donald Trump’s inauguration as President of the United States, there's already a reality-TV-sized dose ...