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RSS FeedPosted by Michael Wonder on 11 Jul 2018
Amsterdam looks to lure more companies from London after EMA move
11 July 2018 - Amsterdam is stepping up efforts to attract collateral firms to work with the EMA when it ...
Posted by Michael Wonder on 11 Jul 2018
Statement from FDA Commissioner on agency’s efforts to advance development of gene therapies
11 July 2018 - Once just a theory, gene therapies are now a therapeutic reality for some patients. ...
Posted by Michael Wonder on 11 Jul 2018
Supply of 100 UK medicines to be disrupted, warns EMA
11 July 2018 - EMA said work to license them after Brexit has not been done. ...
Posted by Michael Wonder on 11 Jul 2018
Ottawa heightens scrutiny on opioid manufacturers’ marketing
11 July 2018 - The federal government is stepping up its regulatory scrutiny of opioid manufacturers and signalling that it ...
Posted by Michael Wonder on 11 Jul 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) & low-dose Yervoy (ipilimumab) is the first immuno-oncology combination approved for MSI-H/dMMR mCRC patients who progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
11 July 2018 - Opdivo & Yervoy is now approved in three tumour types, dosing and administration varies by tumour. ...
Posted by Michael Wonder on 11 Jul 2018
Could FDA use off-label data for drug approvals? It’s possible, agency official says
10 July 2018 - The FDA might one day use data gathered from off-label uses of drugs to determine whether ...
Posted by Michael Wonder on 10 Jul 2018
Brett Kavanaugh, Trump’s pick for court, has left trail of opinions on health care and pharma issues
10 July 2018 - Brett Kavanaugh, President Trump’s nominee for the Supreme Court, has left a trail of rulings and ...
Posted by Michael Wonder on 10 Jul 2018
FDA budget matters: a cross-cutting data enterprise for real world evidence
10 July 2018 - Over time, as our experience with new medical products expands, our knowledge about how best to maximise ...
Posted by Michael Wonder on 10 Jul 2018
EMA identifies gaps in industry preparedness for Brexit
10 July 2018 - Survey indicates that some companies need to step up efforts to ensure medicine supply in the ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 10 Jul 2018
FDA grants fast track designation to Aclaris Therapeutics’ investigational JAK inhibitor for the treatment of alopecia areata
9 July 2018 - Aclaris Therapeutics announced today that the U.S. FDA has granted fast track designation to Aclaris’ investigational topical ...
Posted by Michael Wonder on 10 Jul 2018
Health Canada approves Gazyva for previously untreated advanced follicular lymphoma
9 July 2018 - Gazyva is the first anti-CD20 treatment in 15 years for the most common subtype of indolent lymphoma. ...
Posted by Michael Wonder on 09 Jul 2018
Simponi (golimumab) receives European Commission approval for early dose optimisation treatment in patients with ulcerative colitis
9 July 2018 - Approval follows positive opinion by the CHMP and analyses of the PURSUIT-Maintenance study. ...
Posted by Michael Wonder on 09 Jul 2018
Only immuno-oncology combination therapy approved by Health Canada as first-line treatment for advanced or metastatic renal cell carcinoma
9 July 2018 - Opdivo (nivolumab) and Yervoy (ipilimumab) combination is the first and only treatment to show significantly superior ...
Posted by Michael Wonder on 09 Jul 2018
Enzyvant announces initiation of RVT-802 rolling BLA submission for the treatment of complete DiGeorge anomaly
9 July 2018 - Completion of rolling BLA submission anticipated by end of 2018. ...