So much for a speedy review of Eliquis, the new anticoagulant from Bristol-Myers Squibb and Pfizer. Best expectation for an approval? Next spring.
There is the concept associated with evolution that you must adapt or die. Now some experts are suggesting the same thing for drugmakers when it comes to the growing threat of compulsory licensing.
The expected news on Xarelto has been delivered to Johnson & Johnson ($JNJ) and Bayer. In its complete response letter, the FDA turned down their request that it be approved to prevent heart attacks and strokes in patients with acute coronary syndrome, a common heart ailment, a use that would have significantly enhanced the drug's financial value.
Onyx's risky attempt to win an approval for the multiple myeloma drug carfilzomib on the basis of mid-stage data from a single-arm study cleared a major hurdle yesterday evening when an FDA advisory group gave its drug a unanimous thumbs up.
Eleven years after shaking up the HIV drugs market by slashing prices, Cipla Chairman Yusuf Hamied is looking to do the same with cancer drugs.
Bayer is giving the U.S. Patent and Trademark Office something to chew over. It has filed a patent on a process to manufacture a chewable drug delivery dosage that doesn't require heat or pharmaceutical grade water to manufacture and is done without extrusion, explains in-Pharma Technologist.
Sanofi is on track to find out whether its $20 billion deal for Genzyme will pay off with a near-term drug approval. The pharma giant says that Genzyme has submitted applications for the MS drug Lemtrada in both the U.S. and Europe. Bayer is partnered on the program.
Bristol-Myers presents promising PD-1 data; Genentech boasts solid T-DM1 results; GSK aces pivotal studies; Ariad's ponatinib shines; Bayer's regorafenib delays stomach cancer; Zytiga impresses in prostate cancer; Aveo makes a PhIII case for tivozanib; Seattle Genetics expands its CD-30 horizons; ADCs arrive.
Bayer looks to secure blockbuster status for regorafenib; J&J demonstrated impressive results among pre-chemo prostate cancer patients; Aveo raises the flag for tivozanib; Seattle Genetics plans to look at new indications for Adcetris.
The balloting turned against J&J after 6 of 10 outside experts concluded that the risk of bleeding and doubts about its pivotal data prevented them from endorsing an approval for preventing heart attacks and strokes among patients with heart problems.