At GPhA last week, one of the CEO’s on an industry panel said that big pharma spent more on DTC (direct-to-consumer) advertising than on R&D. Clearly, generic companies don’t like this promotional activity, but I was skeptical of the facts. A quick Google of DTC costs brought an article in the New England Journal of Medicine with [...]
Archive for the 'News Commentary' Category
Can and Should ANDA Labeling Differ from the RLD?
Published February 11th, 2010 in ANDA's and News Commentary. 0 CommentsIn the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their labeling to that of the current Reference Listed Drug.
For a [...]
Roche’s Actemra Approved For RA After Year’s Delay
Published February 11th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsJohn Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications (‘The Pink Sheet,’ Dec. 7, 2008). He attributed the low approval rate in part to the submission of applications that require amendments, often because the original submissions were incomplete or incorrect. A recent example [...]
News on the Biosimilar Front
Published February 8th, 2010 in News Commentary and Uncategorized. 0 CommentsTuesday, February 2nd, Teva Pharmaceuticals announced that the FDA will review its new biologic license application (BLA) to sell a biotechnology medicine, Neutroval, to boost white blood cells, which is “similar” to Amgen Inc’s Neupogen®(filgrastim). The new product is already marketed as TevaGrastim in Europe. There is a regulatory pathway for approving generic versions of [...]
505(b)(2) Food Revealed
Published February 4th, 2010 in News Commentary and Uncategorized. 0 CommentsTalking about teaching old dogs new tricks! For over 40 years we’ve been spilling ketchup from those nasty packets. Today, Heinz revealed a vast improvement:
We can only wish all 505(b)(2) drug developments could impact so many lives!
Once Daily Trazodone Approved
Published February 4th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsYesterday, 2/3/10, FDA approved under 505(b)(2) Canadian-based Labopharm’s once-daily version of trazodone HCl for the treatment of depression (as of this writing, this approval is not posted on the FDA web site). The initial PDUFA date was July 18, 2009 but this was missed because FDA found issues when inspecting the API manufacturing facility – [...]
In a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come from new fees on food facilities ($220 million) and generic drug makers ($38 million in user application fees [...]
The trend in Big Pharma continues to shift from small molecules to biologics. PhRMA announced that it added seven (7) new members to its roster at the end of the year. The new PhRMA members are Cubist Pharmaceuticals, Inc., Lexington, MA; OSI Pharmaceuticals, Inc., Melville, NY; Alexion Pharmaceuticals, Inc., Cheshire, CT; Ferring Pharmaceuticals, Inc., [...]
No turkey, no Black Friday specials, just a thank you note.
Little did we know that in 1984 Congress would provide for a regulatory pathway that would provide such a cornucopia of beneficial products that we see under development today. US consumers should give thanks for the role drugs play in improving health and extending lives, a [...]
FDA’s DAARP is now DAAP, DPAP is now DPARP
Published March 10th, 2010 in News Commentary. 0 CommentsEffective March 15th, the FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products is being reorganized. This reorganization is part of some other reassignments announced yesterday (3/09/2010) by the FDA.
The “R” part – Rheumatology, will move to the Division of Pulmonary and Allergy Products, which will be renamed the Division of Pulmonary, Allergy, and Rheumatology Products. [...]