Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2020
Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease
1 June 2020 - New Brilinta indication expands treatment to high-risk coronary patients without a history of stroke or heart ...
Posted by Michael Wonder on 01 Jun 2020
Lilly's Taltz (ixekizumab) is the first IL-17A antagonist to receive U.S. FDA approval for the treatment of non-radiographic axial spondyloarthritis
1 June 2020 - Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis, also known ...
Posted by Michael Wonder on 01 Jun 2020
Health economic assessment of Vimizim in mucopolysaccharidosis type IVA (Morquio A syndrome)
29 May 2020 - TLV has developed a health economic knowledge base for the regions of the drug Vimizim (elosulfase alfa) ...
Posted by Michael Wonder on 01 Jun 2020
Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)
27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...
Posted by Michael Wonder on 01 Jun 2020
U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis
27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...
Posted by Michael Wonder on 01 Jun 2020
CHMP issues positive opinion to extend Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes
29 May 2020 - Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation ...
Posted by Michael Wonder on 01 Jun 2020
Menlo Therapeutics receives FDA approval of Zilxi (minocycline) 1.5 % topical foam, the first topical minocycline treatment for rosacea
29 May 2020 - Zilxi now approved for inflammatory lesions of rosacea in adults. ...
Posted by Michael Wonder on 01 Jun 2020
Boehringer Ingelheim receives positive CHMP opinion for a third nintedanib indication in pulmonary fibrosis
29 May 2020 - The opinion is for the treatment of adults with other chronic fibrosing interstitial lung diseases with a ...
Posted by Michael Wonder on 01 Jun 2020
Takeda receives positive CHMP opinion for pre-filled syringe presentation of Takhzyro (lanadelumab) for use as a preventive treatment for hereditary angioedema attacks
29 May 2020 - Validation of type II variation will allow Takeda to commence launches in Europe later this year. ...
Posted by Michael Wonder on 31 May 2020
Nabriva Therapeutics receives positive EU CHMP opinion for Xenleta (lefamulin) for the treatment of community-acquired pneumonia
29 May 2020 - If approved, Xenleta has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous and ...
Posted by Michael Wonder on 31 May 2020
Johnson & Johnson receives positive CHMP opinion for Janssen’s investigational preventive Ebola vaccine regimen
29 May 2020 - The investigational Ebola vaccine regimen leverages Janssen’s established AdVac and PER.C6 technologies and Bavarian Nordic’s MVA-BN technology. ...
Posted by Michael Wonder on 31 May 2020
CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...
Posted by Michael Wonder on 31 May 2020
Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...
Posted by Michael Wonder on 31 May 2020
FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 31 May 2020
Highlights from the May 25-28 CHMP meeting
29 May 2020 - Eight new medicines recommended for approval. ...