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RSS FeedPosted by Michael Wonder on 28 Nov 2020
Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...
Posted by Michael Wonder on 23 Nov 2020
Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28)
23 November 2020 - Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28) will be fully funded ...
Posted by Michael Wonder on 16 Nov 2020
Aerie Pharmaceuticals receives positive CHMP opinion for Roclanda in the European Union
13 November 2020 - European Commission Decision Anticipated in Approximately Two Months. ...
Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
Posted by Michael Wonder on 12 Nov 2020
Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away
11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...
Posted by Michael Wonder on 10 Nov 2020
Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis
10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...
Posted by Michael Wonder on 10 Nov 2020
Bausch Health Canada receives a positive recommendation from the CADTH Canadian Drug Expert Committee for Duobrii - a novel topical anti-psoriatic prescription drug
10 November 2020 - Positive CADTH recommendation moves Duobrii closer to federal, provincial and territorial drug plan reimbursement. ...
Posted by Michael Wonder on 01 Nov 2020
CADTH recommends new treatment option for patients with plaque psoriasis
30 October 2020 - The CADTH Canadian Drug Expert Committee has recommended that halobetasol (ulobetasol) propionate with tazarotene (Duobrii) be reimbursed ...
Posted by Michael Wonder on 22 Oct 2020
Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment
22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...
Posted by Michael Wonder on 19 Oct 2020
Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD
19 October 2020 - Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...
Posted by Michael Wonder on 23 Sep 2020
ICER issues final report and policy recommendations on treatments for cystic fibrosis
23 September 2020 - Independent appraisal committee unanimously concludes that Trikafta delivers substantial benefits for patients, family members, and society. ...
Posted by Michael Wonder on 22 Sep 2020
Knight and TherapeuticsMD announce Health Canada approval of Bijuva
21 September 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...
Posted by Michael Wonder on 18 Sep 2020
Decision to fund an additional brand of budesonide with eformoterol
18 September 2020 - PHARMAC is pleased to announce a decision to fund an additional brand of budesonide with eformoterol ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...