If Merck has answers regarding the efficacy of its mumps vaccine, it's not being forthright, says a letter filed by an attorney representing two former Merck virologists who are now whistleblowers.
Another indication may be on the horizon for the generic BCG vaccine as Massachusetts General Hospital got an OK from the FDA for a Phase II trial of the vaccine's ability to help patients with Type I diabetes.
South Korea's Celltrion and Samsung Bioepis are poised to gain new or expanded approval for biosimilars of some of the world's best-selling biological drugs, setting up a regulatory knowledge base on approvals and bringing commercial competition to major drugmakers not unlike that seen by small-molecule generics from India decades ago.
In game theory, the so-called Judo strategy involves using the size and strength of opponents against them. And that's exactly what Yale Professor Barry Nalebuff thinks Merck should employ when it rolls out its next-gen hepatitis C regimen, setting up a battle with Gilead and AbbVie.
A study released today that pitted Hospira's biosimilar Inflectra against its reference drug Remicade in patients with rheumatoid arthritis is good news for Hospira, and by default Pfizer. It found that patients who were switched to the copy did just as well, with no unexpected side effects, as they had on Merck and Johnson & Johnson's Remicade.
Merck's copies of the blockbuster anti-inflammatory treatments Enbrel and Remicade met their goals in Phase III, burnishing the pharma giant's plans to elbow its way into the long queue of companies readying cheaper versions of some of the world's best-selling medicines.
The market for next-gen hepatitis C drugs is already dominated by Gilead and AbbVie, who boast exclusive contracts with the country's largest pharmacy benefits managers and health insurers. But Merck & Co. is prepping its own contender, which could launch next year. What should it do to win a piece of the pie?
Last month, Merck & Co. said Januvia passed its heart safety test. Now, the much-anticipated TECOS trial has had its airing at the American Diabetes Association meeting, and the study authors say the drug is in the clear.
U.S. payers are striking out at drug spending again, highlighting the cost to taxpayers. According to a commissioned report, 10 hot new "breakthrough" meds are expected to cost publicly funded healthcare plans more than $50 billion over the next decade.
Merck is launching Sivextro, the newly approved antibiotic it picked up in its $9.5 billion buyout of Cubist, in the U.K. Pharmafile reports it is the first oral treatment to be released in the oxazolidinone class of antibiotics in more than a decade.