Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2017
Takeda announces FDA approval of Alunbrig (brigatinib) 180 mg tablets
3 October 2017 - New dosing option will reduce pill burden for patients living with ALK positive non-small-cell lung cancer. ...
Posted by Michael Wonder on 03 Oct 2017
Seattle Genetics receives FDA breakthrough therapy designation for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin lymphoma
2 October 2017 - Designation based on positive Phase 3 ECHELON-1 trial evaluating Adcetris in front-line advanced Hodgkin lymphoma; data will ...
Posted by Michael Wonder on 03 Oct 2017
Breakthrough cancer treatments raise difficult questions
1 October 2017 - The approval of a first-of-its kind cancer therapy creates new challenges related to safety, access, and costs. ...
Posted by Michael Wonder on 29 Sep 2017
FDA grants priority review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
29 September 2017 - Roche today announced the US FDA has accepted the company’s supplemental biologics license application and granted priority ...
Posted by Michael Wonder on 28 Sep 2017
FDA approves new treatment for certain advanced or metastatic breast cancers
28 September 2017 - The U.S. FDA today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human ...
Posted by Michael Wonder on 27 Sep 2017
Application for additional indication of Lenvima for hepatocellular carcinoma accepted for review by U.S. FDA
27 September 2017 - Eisai has announced that the application submitted for an additional indication of its in-house discovered and ...
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
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 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 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
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 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
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 ...