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RSS FeedPosted by Michael Wonder on 14 Dec 2019
FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups
13 December 2019 - The U.S. FDA today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to ...
Posted by Michael Wonder on 14 Dec 2019
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir for children living with HIV
13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible ...
Posted by Michael Wonder on 14 Dec 2019
FDA issues new analysis linking greater generic competition and lower generic drug prices
13 December 2019 - Greater competition among generic drug makers is associated with lower generic drug prices, according to a new ...
Posted by Michael Wonder on 14 Dec 2019
FDA approves Xeljanz XR (tofacitinib) extended-release tablets for the treatment of ulcerative colitis
12 December 2019 - Xeljanz XR provides adult patients living with moderately to severely active UC the first and only once-daily ...
Posted by Michael Wonder on 13 Dec 2019
CHMP grants positive opinion for expanded use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are transplant eligible
13 December 2019 - If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for ...
Posted by Michael Wonder on 13 Dec 2019
Pfizer receives positive CHMP opinion for Vyndaqel for use in patients with transthyretin amyloid cardiomyopathy, a rare and fatal disease
13 December 2019 - If approved by the European Commission, Vyndaqel will be the first pharmacologic therapy in the EU ...
Posted by Michael Wonder on 13 Dec 2019
Novartis receives positive CHMP opinion for Beovu (brolucizumab) for the treatment of wet AMD
13 December 2019 - In two head-to-head clinical trials, patients on Beovu achieved vision gains that were non-inferior to aflibercept at ...
Posted by Michael Wonder on 13 Dec 2019
Highlights from the December 9-12 CHMP meeting
13 December 2019 - EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting. ...
Posted by Michael Wonder on 13 Dec 2019
Sarepta Therapeutics announces FDA approval of Vyondys (golodirsen) injection for the treatment of Duchenne muscular dystrophy in patients amenable to skipping exon 53
12 December 2019 - Vyondys 53 is Sarepta’s second RNA exon-skipping treatment for DMD approved in the U.S. ...
Posted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...
Posted by Michael Wonder on 13 Dec 2019
Novartis completes certification of initial sites in Ontario for first approved Canadian CAR-T therapy, Kymriah (tisagenlecleucel)
12 December 2019 - Ontario government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical need. ...
Posted by Michael Wonder on 12 Dec 2019
European Commission approves Evenity (romosozumab) for the treatment of severe osteoporosis in post-menopausal women at high risk of fracture
11 December 2019 - First New Osteoporosis Medicine Approved in the European Union Since 2010. ...
Posted by Michael Wonder on 12 Dec 2019
BioCryst submits new drug application for oral, once daily berotralstat (BCX7353) to prevent HAE attacks
11 December 2019 - BioCryst Pharmaceuticals announced it has submitted a new drug application to the U.S. FDA for approval ...
Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...
Posted by Michael Wonder on 12 Dec 2019
Seqirus announces Health Canada approval of first cell-based seasonal influenza vaccine
11 December 2019 - Seqirus, a global leader in influenza prevention, announced today that its cell-based quadrivalent influenza vaccine has ...