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RSS FeedPosted by Michael Wonder on 15 Jan 2019
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously treated hepatocellular carcinoma
14 January 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...
Posted by Michael Wonder on 14 Jan 2019
Samsung faces resistance from big pharma in the U.S.
11 January 2019 - Incumbent biologic drug makers use rebates and exclusive contracts to fend off competition from new entrants. ...
Posted by Michael Wonder on 14 Jan 2019
US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy
14 January 2019 - FDA grants a priority review based on Phase 3 ATTR-ACT study findings. ...
Posted by Michael Wonder on 14 Jan 2019
Why pharmaceutical companies are on a shopping binge
14 January 2019 - With the cost of R&D so high, it may make sense to spend money on a competitor. ...
Posted by Michael Wonder on 14 Jan 2019
A revolutionary drug that could treat a rare and devastating disease is prohibitively expensive. But one state has a plan to pay for its potential $5 million price tag.
13 January 2019 - A one-time treatment for a devastating rare disease could be paid for with an instalment plan as ...
Posted by Michael Wonder on 12 Jan 2019
Ocular Therapeutix submits supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
10 January 2019 - Application expands the current Dextenza post-operative pain label as the first intra-canalicular insert for drug delivery. ...
Posted by Michael Wonder on 11 Jan 2019
US FDA sets PDUFA date for Scenesse
10 January 2019 - FDA does not plan to hold advisory committee meeting. ...
Posted by Michael Wonder on 11 Jan 2019
Partial government shutdown's impact on FDA drug approvals
10 January 2019 - As the partial federal government shutdown drags on into its third week, its impact is being felt ...
Posted by Michael Wonder on 10 Jan 2019
FDA approves 59 novel drugs in 2018
8 January 2019 - The past year proved to be a big one for the U.S. FDA and the approval ...
Posted by Michael Wonder on 09 Jan 2019
OncoNano receives authorisation to proceed from FDA for IND application and fast track designation for ONM-100, intra-operative imaging agent to detect tumours and metastatic lymph nodes that often go undetected during surgery
4 January 2019 - FDA says proposed Phase 2 clinical trial may proceed. ...
Posted by Michael Wonder on 09 Jan 2019
RadioMedix and Curium announce FDA fast track designation for 64Cu dotatate
9 January 2019 - RadioMedix and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu dotatate, was granted ...
Posted by Michael Wonder on 09 Jan 2019
Can the record breaking number of FDA new drug approvals continue?
9 January 2019 - The late 1990s had been thought of as a golden-age for the drug industry. ...
Posted by Michael Wonder on 09 Jan 2019
The future of FDA's electronic safety surveillance
9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions. ...
Posted by Michael Wonder on 09 Jan 2019
Biotech proposes paying for pricey drugs by instalment
8 January 2019 - Bluebird Bio develops plan to sell gene-replacement therapy with annual payments contingent on continued effectiveness. ...
Posted by Michael Wonder on 08 Jan 2019
CDER’s work to ensure drug safety is an ongoing top priority
8 January 2019 - Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s wide array of new ...