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RSS FeedPosted by Michael Wonder on 19 Sep 2017
FDA acceptance of NDA for CAM2038 for opioid use disorder
18 September 2017 - The FDA has assigned a Prescription Drug User Fee Act target date of 19 January 2018. ...
Posted by Michael Wonder on 19 Sep 2017
FDA grants “fast track” status to Cancer Prevention Pharmaceuticals’ lead drug CPP-1X/sul for treatment of familial adenomatous polyposis
18 September 2017 - CPP-1X/sul aims to prevent disease progression in patients with familial adenomatous polyposis. ...
Posted by Michael Wonder on 19 Sep 2017
U.S. FDA grants fast track designation to Pluristem's PLX-PAD for the treatment of critical limb ischemia
18 September 2017 - Pluristem’s on-going phase III CLI trial has been selected for accelerated approval pathways in both the U.S. ...
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 ...
Posted by Michael Wonder on 18 Sep 2017
New indication for Briviact (brivaracetam): UCB’s newest anti-epileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
15 September 2017 - Approval applies a newly established regulatory pathway which allows monotherapy treatment options to reach epilepsy patients sooner. ...
Posted by Michael Wonder on 18 Sep 2017
Janssen submits supplemental new drug application to U.S. FDA for Zytiga (abiraterone acetate) to treat men with earlier stages of metastatic prostate cancer
14 September 2017 - Filing supported by data from pivotal LATITUDE trial evaluating Zytiga in combination with prednisone and androgen deprivation ...
Posted by Michael Wonder on 17 Sep 2017
Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older
14 September 2017 - Aptiom provides an important new treatment option for children and adolescents four to 17 years of age ...
Posted by Michael Wonder on 17 Sep 2017
Cheaper drug trials would lower prices: FDA chief
15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA ...
Posted by Michael Wonder on 17 Sep 2017
CSL Behring announces FDA approval of Privigen [immune globulin intravenous (human), 10% liquid] for the treatment of chronic inflammatory demyelinating polyneuropathy in adults
14 September 2017 - Privigen shown to improve functional abilities in patients with a rare neurological condition. ...
Posted by Michael Wonder on 14 Sep 2017
Tragedy, perseverance, and chance — the story of CAR-T therapy
13 September 2017 - In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia. Though her parents were told that ...
Posted by Michael Wonder on 14 Sep 2017
FDA permits marketing of mobile medical application for substance use disorder
14 September 2017 - Today, the U.S. FDA permitted marketing of the first mobile medical application to help treat substance use ...
Posted by Michael Wonder on 14 Sep 2017
Teva receives FDA priority review for first line use of Trisenox (arsenic trioxide) in patients with low to intermediate risk acute promyelocytic leukaemia
12 September 2017 - Teva Pharmaceutical Industries announced today the U.S. FDA has accepted for review the company’s supplemental new ...