Merck’s sugammadex review has been stymied once again. The drug maker said Monday that it received a Complete Response Letter from the FDA saying the regulator was concerned about “operational aspects of a hypersensitive study the agency had requested in 2008.” An FDA committee was set to review the drug, which counteracts muscle relaxants used in surgery, in July, saying it needed more time with the data. The CRL could mean additional delay. Merck said in a statement it is working with the FDA on next steps. The drug is already used in 40 other countries. Pharmalot’s Ed Silverman notes that this sort of setback is the type still-newish R&D head Roger Perlmutter is working to eliminate as part of his overhaul, which has so far included erasing several senior management positions. A major restructuring has been on the minds of many. Silverman quotes Bernstein analyst Tim Anderson as saying a recent investors’ dinner with the R&D chief indicated further changes will not involve big R&D cuts.
AbbVie has hit a watershed moment of sorts, signing what FierceBiotech notes is “its first big pact on a clinical-stage program.” The deal of note is an agreement with Belgian firm Ablynx, to develop what could be a new way for the drug maker to expand its hold on the RA market, if the now-Phase II medication makes it to market. The deal includes $175 million up front, which will help Ablynx bring the experimental nanobody through Phase II testing, after which it will hand it off to AbbVie for Phase III development and commercialization. An additional $665 million is in the offing, depending on milestone achievements. The compound, officially known as ALX-0061 is for a technology that is smaller than the typical antibody. Reuters says the nanobodies are around a tenth of the size of normal antibodies, and Phase IIa results showed an improvement among RA patients.
PR and annual-report writers curious about what resources investors look to for guidance should check out this Wall Street Journal article which shows that Wall Street really does go behind the numbers and looks at a variety of data, for free, by exercising the Freedom of Information Act and getting the government to find the details for additional context. The Journal says investors have used FOIA to research subjects like adverse-event reports, in this case for a Vertex cystic fibrosis drug, while investors in other fields have been requesting and receiving data about things like SEC investigations and pollution regulations.
Roche’s alectinib, an experimental treatment for anaplastic lymphoma kinase positive non-small cell lung cancer, got the FDA’s breakthrough-therapy designation. The company said in its Monday announcement that it will share the documentation that led to this designation at the European Cancer Congress, which is being held in Amsterdam later this month.
FDA said Friday that it is requiring medical devices to have unique tracking codes that include the make, date of manufacture and lot number. The New York Times reports that the goal is to help the regulator identify problematic devices—which include items like pacemakers and hip replacements—earlier. The codes will be kept in a public database, and Science World reports that doctors, hospitals and insurers will be able to add device codes to medical records. The new system starts in 2014.
