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RSS FeedPosted by Michael Wonder on 28 Sep 2017
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
27 September 2017 - The U.S. FDA today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose ...
Posted by Michael Wonder on 26 Sep 2017
FDA approves Grifols Prolastin-C liquid [alpha-1 proteinase inhibitor, liquid] for the treatment of alpha-1 anti-trypsin deficiency
22 September 2017 - Prolastin-C Liquid is the first liquid formulation of an alpha-1 anti-trypsin deficiency replacement therapy manufactured in the ...
Posted by Michael Wonder on 25 Sep 2017
Intellipharmaceutics receives complete response letter from the FDA for Rexista NDA
25 September 2017 - FDA response provides path toward commercialisation of Rexista. ...
Posted by Michael Wonder on 25 Sep 2017
BioCryst's Rapivab (peramivir injection) receives FDA approval for a paediatric indication
21 September 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has approved a supplemental new drug application for ...
Posted by Michael Wonder on 25 Sep 2017
Kiadis Pharma receives FDA Regenerative Medicine Advanced Therapy designation for ATIR101
20 September 2017 - Kiadis Pharma today announces that the US FDA has granted ATIR101, Kiadis Pharma’s lead investigational product for ...
Posted by Michael Wonder on 24 Sep 2017
Allergan receives refusal to file letter from FDA for Vraylar (cariprazine) supplemental new drug application for the treatment of negative symptoms in schizophrenia
22 September 2017 - Allergan today announced that it received a refusal to file letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 23 Sep 2017
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
22 September 2017 - First anti-PD-1 therapy approved in the U.S. for these patients with disease progression on or after two ...
Posted by Michael Wonder on 23 Sep 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with sorafenib
22 September 2017 - The CheckMate -040 pivotal study evaluated Opdivo in patients with and without active Hepatitis B or C ...
Posted by Michael Wonder on 19 Sep 2017
Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US
18 September 2017 - GSK and Innoviva today announced that the FDA has approved once-daily, single inhaler triple therapy fluticasone ...
Posted by Michael Wonder on 19 Sep 2017
U.S. FDA approves new indication for Ipsen’s Somatuline Depot (lanreotide) injection for the treatment of carcinoid syndrome
18 September 2017 - Ipsen today announced that the U.S. FDA has approved a supplemental indication for Somatuline Depot (lanreotide) ...
Posted by Michael Wonder on 19 Sep 2017
FDA approves Symbiomix Therapeutics’ Solosec (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women
18 September 2017 - First and only single dose oral therapy approved for most common U.S. gynecologic infection that can ...
Posted by Michael Wonder on 18 Sep 2017
Biosimilar cancer drug threat closing in for Roche
19 September 2017 - The long-heralded threat of cut-price competition to its top-selling biological cancer medicines is finally becoming a ...
Posted by Michael Wonder on 18 Sep 2017
Strategies that delay market entry of generic drugs
18 September 2017 - Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although ...
Posted by Michael Wonder on 18 Sep 2017
Neos Therapeutics receives U.S. FDA approval of Adzenys ER (amphetamine) extended-release oral suspension for the treatment of ADHD in patients 6 years and older
15 September 2017 - Neos Therapeutics to launch third medication in ADHD franchise in January 2018. ...
Posted by Michael Wonder on 18 Sep 2017
Seqirus receives FDA approval of Afluria Quadrivalent (influenza vaccine) for people five years of age and older in the U.S.
14 September 2017 - Expanded Afluria Quadrivalent age indication offers protection against four influenza virus strains for people five years of ...