Blog
RSS FeedPosted by Michael Wonder on 21 Oct 2016
FDA official warns other drug makers not to copy Sarepta
20 October 2016 - Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval ...
Posted by Michael Wonder on 21 Oct 2016
New treatment recommended for kidney cancer
20 October 2016 - People with kidney cancer set to benefit from a new innovative immunotherapy, after NICE says it should ...
Posted by Michael Wonder on 20 Oct 2016
Oral Otezla (apremilast) receives positive NICE recommendation for adults with chronic plaque psoriasis
20 October 2016 - Approved by NICE for patients with severe plaque psoriasis as defined by PASI and DLQI greater than ...
Posted by Michael Wonder on 19 Oct 2016
FDA approves Lilly's Lartruvo (olaratumab) in combination with doxorubicin for soft tissue sarcoma
19 October 2016 - Lartruvo received the FDA's breakthrough therapy designation and was approved under the Agency's accelerated approval program. ...
Posted by Michael Wonder on 19 Oct 2016
Shire granted EU marketing authorisation of Onivyde, in combination with 5-fluorouracil and leucovorin, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine-based therapy
18 October 2016 - Onivyde in combination with 5-fluorouracil and leucovorin, is the first and only treatment approved for this ...
Posted by Michael Wonder on 19 Oct 2016
FDA approves Genentech’s cancer immunotherapy Tecentriq (atezolizumab) for people with a specific type of metastatic lung cancer
18 October 2016 - First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 17 Oct 2016
Decision to list cholic acid (Cholebiol) for rare disorder
17 October 2016 - PHARMAC is pleased to announce the approval of an agreement with Max Health Limited for the ...
Posted by Michael Wonder on 17 Oct 2016
Sofosbuvir with velpatasvir in chronic hepatitis C: hint of added benefit in two of ten subindications
17 October 2016 - Historical comparisons and considerations of individual study arms unsuitable for conclusions on the other research questions. ...
Posted by Michael Wonder on 17 Oct 2016
Emtricitabine/rilpivirine/tenofovir alafenamide in HIV: added benefit not proven
17 October 2016 - Research questions on adolescents not investigated/evidence on components not simply transferable to the combination. ...
Posted by Michael Wonder on 17 Oct 2016
FDA approves Genentech’s Lucentis (ranibizumab injection) pre-filled syringe
14 October 2016 - First anti-VEGF pre-filled syringe FDA approved to treat people with wet age-related macular degeneration and people ...
Posted by Michael Wonder on 16 Oct 2016
Bad medicine
15 October 2016 - Approving an unproven drug sets a worrying precedent. ...
Posted by Michael Wonder on 15 Oct 2016
Highlights from CHMP October 2016 meeting
14 October 2016 - Eight medicines recommended for approval, including four orphan medicines. ...
Posted by Michael Wonder on 14 Oct 2016
Bristol-Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin
14 October 2016 - CHMP decision based on overall response rate demonstrated by data from two trials, CheckMate -205 and ...
Posted by Michael Wonder on 14 Oct 2016
AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) tablets for appropriate patients with difficult-to-treat chronic lymphocytic leukaemia
14 October 2016 - If granted conditional marketing authorisation by the European Commission, Venclyxto would become the first approved BCL-2 ...
Posted by Michael Wonder on 14 Oct 2016
NICE publishes draft guidance on the use of Imbruvica
14 October 2016 - NICE has published draft guidance on the use of Imbruvica (ibrutinib) by patients with Waldenstrom’s macroglobulinaemia. ...