Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2018
Alecensaro (alectinib) approved by Health Canada for first-line treatment of ALK-positive lung cancer
13 June 2018 - Targeted oral treatment shown to reduce risk of death or disease progression by more than half compared ...
Posted by Michael Wonder on 13 Jun 2018
Sunovion announces FDA acceptance of new drug application for apomorphine sublingual film
12 June 2018 - Sunovion seeks approval for apomorphine sublingual film for the on-demand treatment of OFF episodes associated with Parkinson’s ...
Posted by Michael Wonder on 13 Jun 2018
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery
13 June 2018 - Avastin is now approved for ten distinct uses across six different types of cancer in the United ...
Posted by Michael Wonder on 13 Jun 2018
AMCP applauds FDA for final guidance on payer and manufacturer communications to improve patient access to emerging therapies
13 June 2018 - The Academy of Managed Care Pharmacy commends the U.S. FDA for issuing final guidance that clarifies ...
Posted by Michael Wonder on 13 Jun 2018
Mylan CEO promises Neulasta biosimilar will offer "significant savings" for patients
12 June 2018 - Nearly two years after taking tremendous heat for the rising cost of EpiPens, pharmaceutical giant Mylan ...
Posted by Michael Wonder on 13 Jun 2018
FDA grants rare paediatric disease designation to A4250; Albireo eligible to apply for priority review voucher
12 June 2018 - Albireo Pharma a clinical-stage orphan paediatric liver disease company developing novel bile acid modulators, today announced the ...
Posted by Michael Wonder on 13 Jun 2018
Nordic Nanovector announces Betalutin has been granted fast track designation in the US for follicular lymphoma
12 June 2018 - Nordic Nanovector announces that the US FDA has granted fast track designation to Betalutin (177Lu-lilotomab satetraxetan) ...
Posted by Michael Wonder on 13 Jun 2018
RegenxBio receives FDA fast track designation for RGX-111 gene therapy for the treatment of mucopolysaccharidosis type I
12 June 2018 - Phase I clinical trial expected to enroll children and adults with MPS I. ...
Posted by Michael Wonder on 13 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
12 June 2018 - Keytruda now first anti-PD-1 therapy approved for patients with advanced cervical cancer and disease progression on or ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
12 June 2018 - The increase in serious antimicrobial drug resistant infections is a critical public health concern and a ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...
Posted by Michael Wonder on 12 Jun 2018
FDA approves addition of positive overall survival data from Phase 3 ASPIRE trial to Kyprolis (carfilzomib) label
11 June 2018 - Kyprolis, lenalidomide and dexamethasone extended median overall survival in relapsed or refractory multiple myeloma patients to 48 ...
Posted by Michael Wonder on 12 Jun 2018
Themis receives EMA PRIME designation for Chikungunya vaccine
11 June 2018 -Themis announced today that the EMA has granted PRIority MEdicines (PRIME) designation to its most advanced program ...
Posted by Michael Wonder on 11 Jun 2018
European Commission approves Prolia (denosumab) for patients with glucocorticoid-induced osteoporosis
8 June 2018 - Third Indication in Europe for Prolia for the treatment of patients at increased risk of fractures. ...