Blog
RSS FeedPosted by Michael Wonder on 15 May 2019
Cystic fibrosis drug campaign makes no progress in year
10 May 2019 - It is a year on from the delivery of more than 1,000 letters to Downing Street, ...
Posted by Michael Wonder on 14 May 2019
A million Americans need this drug. Trump’s deal won’t help enough of them.
13 May 2019 - A donation of HIV prevention drugs from the pharmaceutical giant Gilead could benefit shareholders more than patients. ...
Posted by Michael Wonder on 08 May 2019
RedHill Biopharma submits new drug application for Talicia for H. pylori Infection
7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, ...
Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...
Posted by Michael Wonder on 04 May 2019
Qternmet XR approved in the US for the treatment of type 2 diabetes
3 May 2019 - The US FDA has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as ...
Posted by Michael Wonder on 01 May 2019
Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain
1 May 2019 - Complete response letter requests additional chemistry manufacturing and controls and non-clinical information. ...
Posted by Michael Wonder on 01 May 2019
FDA approves first treatment for all genotypes of hepatitis C in paediatric patients
30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...
Posted by Michael Wonder on 30 Apr 2019
Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV
29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living ...
Posted by Michael Wonder on 28 Apr 2019
ViiV Healthcare announces CHMP positive opinion for Dovato (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection
26 Apri 2019 - Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine ...
Posted by Michael Wonder on 25 Apr 2019
FDA approves Bausch Health's Duobrii (halobetasol propionate and tazarotene) lotion 0.01%/0.045% for plaque psoriasis in adults
25 April 2019 - First and only topical lotion combining halobetasol propionate and tazarotene in one formulation. ...
Posted by Michael Wonder on 23 Apr 2019
US FDA approves Duaklir Pressair (aclidinium/formoterol) for patients with chronic obstructive pulmonary disease
17 April 2019 - Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information. ...
Posted by Michael Wonder on 14 Apr 2019
Cystic Fibrosis scandal: MP demands answers on delay of vital NHS drugs deal
11 April 2019 - Theresa May yesterday vowed to take action over the lack of an NHS deal for cystic fibrosis ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 25 Mar 2019
HIRA puts brakes on Gilead’s AIDS treatment receiving reimbursement
22 March 2019 - The reimbursement plan for Gilead Science Korea’s Biktarvy, an acquired immune deficiency syndrome (AIDS) treatment, has been ...
Posted by Michael Wonder on 13 Mar 2019
Aerie Pharmaceuticals announces U.S. FDA approval of Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
12 March 2019 - Aerie Pharmaceuticals today announced that the U.S. FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% ...