Rise and shine, everyone. Another busy day is on the way. And you know what this means - a long list of meetings and deadlines awaits. In our case, we will also be conducting our own version of R&D: reading documents and studies and all sorts of provocative things. So no need to dilly dally. Grab a cup of stimulation and dig in. Hope your day goes well and, if you run across anything interesting, keep us in mind...
FDA Panel Nixes Expanded Use Of Amgen Cancer Med (Bloomberg News)
FDA Says Ulcer Drugs May Raise Diarrhea Risk (Reuters)
Apotex Pays $444M To Settle Plavix Litigation (Financial Times)
Roche Digs In For Long Fight As Illumina Rejects $5.7B Bid (Reuters)
Merck Bloodthinner Shows Bleeding Risk In Study (Associated Press)
Sanofi Sees 12 Percent Profit Drug From Generic Rivals In 2012 (Pharma Times)
Roche Breast Cancer Drug Gets FDA Priority Review (Reuters)
Pfizer Grapples With Superfund Site (Bridgewater Patch)
Glaxo Pulls Cash Out Of The Eurozone Over Crisis (The Guardian)
Merck Rotavirus Vaccine Not Linked To Bowel Problems In Study (Reuters)
Sanofi Loses Challenge To Generic Lovenox Approval (Bloomberg News)
Australia May Limit Chemical Supplies To Stop Terrorism (InPharma Technologist)
FDA Approves Sanofi Prescription Shampoo For Lice (Associated Press)
Judge Certifies Lawsuit Against Bayer Over Vitamin Claims (Nutra Ingredients)
Pfizer India To Sell Animal Health Unit (Dow Jones)
Uganda Drugmakers Starts Making AIDS Medicine (New Vision)
India And EU Free Trade Deal Hits A Roadblock (Live Mint)
EDITOR'S NOTE: Please check this post for updates throughout the morning
2 Comments
Always a good read to start the day, Ed!
In case you missed it: http://mobile.bloomberg.com/news/2012-02-07/actavis-4-drugmakers-to-pay-25-2-mln-in-louisiana-settlement.html?cmpid=hooks
In regards to Roche's breast cancer drug getting FDA Priority Review. At the recent semi-annual meeting of the Gynecologic Oncology Group (GOG), one of the attendees posted on ASCO Connection about his take on the meeting. He found himself considering the endpoints of clinical trials. Should it be the response rate? Should it be the proportion of patients who have no tumor growth at six months? Should it be overall survival?
A physician replied to the posting about this conversation being long overdue in an era of biological agents, like Omnitarg (pertuzumab). He felt adopting the same endpoints in molecular medicine, as in the era of cytotoxic chemotherapy, may lead to erroneous conclusions. He pointed out the use of Avastin (bevacizumab) in frontline ovarian carcinoma have shown modest improvement in disease free interval while overall survival may not be increased.
Further teasing out the data showed that shortly after Avastin (bevacizumab) was discontinued, patients tended to recur (rebound). Are they using these drugs wrong? Are the expectations of improvement in efficacy despite discontinuation of a biological agent too high?
If anything, they should be higher with biologics. This priority review is nothing but another end-around by Roche, like with Avastin (bevacizumab).
Yes. Biologic therapy is on the ascendancy. The possibility of eradicating cancer by selective destruction of tumor blood vessels may represent an attractive therapeutic avenue. However, it's going to take "combination" anti-vascular therapy to make a difference. And there is promising diagnostic technology on the therapeutic horizon to accomplish that.