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RSS FeedPosted 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
Pharma keeps ignoring its price problem
14 September 2017 - Want to get pharma companies up in arms? Tell them it doesn't cost that much to get ...
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 ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves new treatment for adults with relapsed follicular lymphoma
14 September 2017 - The U.S. FDA today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves first biosimilar for the treatment of cancer
14 September 2017 - Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and ...
Posted by Michael Wonder on 14 Sep 2017
Closing in on cancer
16 September 2017 - Science will win the technical battle against cancer. But that is only half the fight. ...
Posted by Michael Wonder on 14 Sep 2017
Medicare for all or state control: health care plans go to extremes
13 September 2017 - In one Senate office building, some of the leading lights of the Democratic Party gathered Wednesday ...
Posted by Michael Wonder on 13 Sep 2017
Drug companies tie costs to outcomes
12 September 2017 - But early signs show little evidence that the plans lower prices. ...
Posted by Michael Wonder on 13 Sep 2017
FDA’s Gottlieb plans to close an orphan drug loophole
12 September 2017 - Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, ...