Blog
RSS FeedPosted by Michael Wonder on 26 Oct 2019
European Commission approves Astellas’ Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
25 October 2019 - Approval follows accelerated assessment, orphan designation by European Medicines Agency. ...
Posted by Michael Wonder on 26 Oct 2019
Dialogue with Chinese authorities on medicine regulation
25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...
Posted by Michael Wonder on 25 Oct 2019
Amgen to make Repatha (evolocumab) available exclusively at its lower list price option in 2020
24 October 2019 - Repatha original list price option will be discontinued effective 31 December 2019. ...
Posted by Michael Wonder on 24 Oct 2019
Older patients (still) left out of cancer clinical trials
24 October 2019 - A decade before he became the US Surgeon General, Vivek Murthy, MD, published a 2004 study in ...
Posted by Michael Wonder on 24 Oct 2019
FDA approves Botox (onabotulinumtoxinA) for paediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy
24 October 2019 - Approval marks 11th Botox therapeutic indication and comes 30 years after the first indications were approved. ...
Posted by Michael Wonder on 24 Oct 2019
Trump set to nominate Texas cancer doctor to head FDA
25 October 2019 - If confirmed, Stephen Hahn would succeed acting commissioner Norman “Ned” Sharpless. ...
Posted by Michael Wonder on 24 Oct 2019
Novartis receives approval for Cosentyx label update in Europe to include dosing flexibility in ankylosing spondylitis
24 October 2019 - New Cosentyx (secukinumab) label to include 300 mg up-titration option is informed by results from the Phase ...
Posted by Michael Wonder on 24 Oct 2019
European Commission approves Opdivo (nivolumab) four week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
24 October 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) flat dosing schedule of ...
Posted by Michael Wonder on 24 Oct 2019
Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
24 October 2019 - The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new ...
Posted by Michael Wonder on 24 Oct 2019
GSK announces U.S. FDA approval of additional indication for Zejula (niraparib) for late-line treatment for women with recurrent ovarian cancer
23 October 2019 - Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency. ...
Posted by Michael Wonder on 24 Oct 2019
Biogen CEO ‘reasonably confident’ once-doomed Alzheimer’s drug will be granted FDA approval
23 October 2019 - “This was a thorough engagement, and as CEO I’m reasonably confident this will lead to market approval ...
Posted by Michael Wonder on 24 Oct 2019
Knight Therapeutics and SIFI announce approval of Netildex in Canada
23 October 2019 - Knight Therapeutics and SIFI today announced that Health Canada has approved Netildex for the treatment of inflammatory ...
Posted by Michael Wonder on 23 Oct 2019
Adalimumab and the challenges for biosimilars
23 October 2019 - Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. ...
Posted by Michael Wonder on 23 Oct 2019
Vertex prices cystic fibrosis combo treatment at $311,000-per-year
22 October 2019 - Vertex Pharmaceuticals has priced its three-drug combination for cystic fibrosis (CF) at $311,503 per year, after winning ...
Posted by Michael Wonder on 23 Oct 2019
Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis
23 October 2019 - If approved, guselkumab will be the first selective IL-23 p19 subunit inhibitor for people in the European ...