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RSS FeedPosted by Michael Wonder on 12 Sep 2018
Health Canada approves Merck's Stromectol (ivermectin) for the treatment of intestinal strongyloidiasis and onchocerciasis
11 September 2018 - The product's availability is expected in November 2018. ...
Posted by Michael Wonder on 12 Sep 2018
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of idiopathic pulmonary fibrosis
12 September 2018 - FibroGen today announced that the U.S.FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, ...
Posted by Michael Wonder on 12 Sep 2018
Shire granted EU marketing authorization for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease
12 September 2018 - Marketing authorisation will enable patient access to Veyvondi throughout Europe. ...
Posted by Michael Wonder on 11 Sep 2018
FDA grants breakthrough therapy designation for Concentric Analgesics’ CA-008 in post-surgical pain
11 September 2018 - Concentric Analgesics announced today that it has received breakthrough therapy designation from the U.S. FDA) for CA-008 ...
Posted by Michael Wonder on 11 Sep 2018
Bertilimumab granted fast track designation for the treatment of bullous pemphigoid
11 September 2018 - Company to provide corporate update during conference call with live audio webcast on Thursday 13 September at ...
Posted by Michael Wonder on 11 Sep 2018
Pharma executive says he had 'moral requirement' to raise drug price 400%
11 September 2018 - A pharmaceutical company executive defended his company's recent 400% drug price increase, telling the Financial Times that ...
Posted by Michael Wonder on 11 Sep 2018
Minimal residual disease negativity data, a measure of undetectable disease, added to Venclexta (venetoclax tablets) label
11 September 2018 - Minimal residual disease-negativity is defined as having disease at a threshold of less than one chronic lymphocytic ...
Posted by Michael Wonder on 11 Sep 2018
Amicus Therapeutics announces regulatory and clinical updates for AT-GAA in Pompe disease
10 September 2018 - Amicus Therapeutics announced today regulatory and clinical advancements in its development program AT-GAA for Pompe disease. ...
Posted by Michael Wonder on 11 Sep 2018
Cipher Pharmaceuticals receives Health Canada approval of Xydalba (dalbavancin hydrochloride)
10 September 2018 - Cipher Pharmaceuticals today announced it received Health Canada approval of Xydalba (dalbavancin hydrochloride), the first and ...
Posted by Michael Wonder on 11 Sep 2018
New law to protect patients against medicine shortages
11 September 2018 - The supply of critical and life-saving medicine to Australian patients will now be protected with the Parliament ...
Posted by Michael Wonder on 10 Sep 2018
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
10 September 2018 - European approval based on results from pivotal Phase 3 trial KEYNOTE-189 demonstrating Keytruda in combination with pemetrexed ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 10 Sep 2018
European Commission expands labelling for Janssen’s Invokana and Vokanamet to include positive data on cardiovascular outcomes
7 September 2018 - Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling now approved to include positive cardiovascular outcomes from ...
Posted by Michael Wonder on 09 Sep 2018
GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients
7 September 2018 - GlaxoSmithKline today received a complete response letter from the US FDA regarding its application for mepolizumab ...
Posted by Michael Wonder on 07 Sep 2018
Tezepelumab granted breakthrough therapy designation by US FDA
7 September 2018 - AstraZeneca’s first breakthrough therapy designation for a respiratory medicine. ...