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RSS FeedPosted by Michael Wonder on 24 Oct 2019
GSK announces U.S. FDA approval of additional indication for Zejula (niraparib) for late-line treatment for women with recurrent ovarian cancer
23 October 2019 - Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency. ...
Posted by Michael Wonder on 24 Oct 2019
Biogen CEO ‘reasonably confident’ once-doomed Alzheimer’s drug will be granted FDA approval
23 October 2019 - “This was a thorough engagement, and as CEO I’m reasonably confident this will lead to market approval ...
Posted by Michael Wonder on 23 Oct 2019
Adalimumab and the challenges for biosimilars
23 October 2019 - Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. ...
Posted by Michael Wonder on 23 Oct 2019
Vertex prices cystic fibrosis combo treatment at $311,000-per-year
22 October 2019 - Vertex Pharmaceuticals has priced its three-drug combination for cystic fibrosis (CF) at $311,503 per year, after winning ...
Posted by Michael Wonder on 23 Oct 2019
FDA approves Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes
22 October 2019 - Novo Nordisk today announced that the U.S. FDA has expanded the label for Fiasp (insulin aspart injection) ...
Posted by Michael Wonder on 22 Oct 2019
Moderna receives FDA fast track designation for propionic acidemia program (mRNA-3927)
22 October 2019 - mRNA-3927 is Moderna’s second rare disease program to receive fast track designation. ...
Posted by Michael Wonder on 22 Oct 2019
BerGenBio receives FDA approval of fast track designation for bemcentinib
22 October 2019 - BerGenBio today announces that the U.S FDA has approved fast track designation for bemcentinib for the treatment ...
Posted by Michael Wonder on 22 Oct 2019
Heron announces FDA approval of supplemental new drug application to expand Cinvanti label for single-dose regimen for patients receiving moderately emetogenic chemotherapy
22 October 2019 - Heron Therapeutics today announced that the U.S. FDA has approved Heron's supplemental new drug application for Cinvanti ...
Posted by Michael Wonder on 22 Oct 2019
Eton Pharmaceuticals announces U.S. FDA approval of Biorphen (phenylephrine HCI) injection
22 October 2019 - Biorphen is the first and only ready-to-use FDA approved injectable formulation of phenylephrine. ...
Posted by Michael Wonder on 22 Oct 2019
Biogen plans regulatory filing for aducanumab in Alzheimer’s disease based on new analysis of larger dataset from Phase 3 studies
22 October 2019 - New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease ...
Posted by Michael Wonder on 21 Oct 2019
Bayer submits supplemental new drug application to FDA for intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg
21 October 2019 - Application seeks to extend duration of use up to six years for Mirena. ...
Posted by Michael Wonder on 21 Oct 2019
Assertio Therapeutics provides regulatory update on long-acting Cosyntropin
21 October 2019 - Assertio Therapeutics today announced that its development partner West Therapeutic Development has received a complete response ...
Posted by Michael Wonder on 21 Oct 2019
FDA approves new breakthrough therapy for cystic fibrosis
21 October 2019 - Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic ...
Posted by Michael Wonder on 21 Oct 2019
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis
21 October 2019 - Stelara is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon ...
Posted by Michael Wonder on 21 Oct 2019
United Therapeutics announces FDA approval of updated label for Orenitram reflecting results of FREEDOM-EV study
21 October 2019 - United Therapeutics today announced that the U.S. FDA has approved a supplement to the new drug application ...