Pharma bigwig Pfizer announced that the FDA has agreed to review the New Drug Application of its abuse-deterring extended-release opioid capsules, dubbed ALO-02.
Hospira said on Tuesday that it was recalling more than 60 lots of the pain reliever ketorolac tromethamine injection in the U.S. and Singapore just 5 days after Pfizer said it would pay $15 billion for the specialist in sterile injectable drugs. In fact, on the day the deal was announced, the FDA announced a Hospira recall of the sedative propofol.
Hospira is merging with Pfizer for about $16 billion as the company attempts to revive its long-beleaguered device business and cash in on a growing sterile injectables and biosimilars market.
A Pfizer plant in Ireland that was slated to close last year is still running strong, as sales of blockbuster cholesterol drug Lipitor remain vibrant in some parts of the world three years after losing its U.S. patent.
Last week, international charity Médecins Sans Frontières called on Pfizer to drop its price on pneumococcal vaccine Prevenar 13. The pharma giant responded earlier this week, lopping 20 cents off the per-dose cost through vaccine alliance GAVI. But the way MSF sees it, that's not good enough.
Last year, Pfizer got a federal judge to toss an investor lawsuit tied to its now-withdrawn pain drug Bextra. But that wasn't the only investor suit raising similar issues--namely that Pfizer's board had not been forthright about marketing allegations involving Bextra and other drugs.
The European Medicines Agency accepted Pfizer's application to expand its label for blockbuster vaccine Prevenar 13 back in August, and so far, an advisory committee likes what it sees.
The cost of vaccinating a child in the world's poorest countries is much higher than it was in 2001--68 times higher, according to Medecins Sans Frontieres. The international charity has a problem with that, and it's asking pneumococcal disease vaccine makers Pfizer and GlaxoSmithKline to fix it.
Days after unveiling a $60 million deal with Genentech, personal genomics pioneer 23andMe struck a new database-driven collaboration with Pfizer. There is even talk of a possible resolution with the FDA in 2015.
PCSK9 drugs are the next big market waiting to happen, and with rivals Sanofi/Regeneron and Amgen ahead in the development race, Pfizer wants to make sure it can lock down a solid share of the market. So beyond in-development anti-cholesterol antibody bococizumab, it's working on a wider PCSK9 "franchise," R&D chief Mikael Dolsten said Tuesday at the JP Morgan Healthcare Conference--and that includes a vaccine.