Glenmark's marketing of a couple of diabetes generics in the United States continues to fluctuate like a yo-yo on a string. Now the India drugmaker can return the drugs to market until April 28.
Adding $10 billion to its stock buyback program might mean Merck & Co. wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Advantage Merck in the melanoma immunotherapy race. The U.S.-based company says its PD-1 drug Keytruda met its goals in a head-to-head study with Bristol-Myers Squibb's Yervoy (ipilimumab), dealing a blow to that company's growing immunotherapy franchise.
India's highest court has granted an injunction against Glenmark Pharmaceuticals, blocking it from producing and marketing a generic of Merck's Januvia (sitagliptin) for treating diabetes. A patent-infringement suit was not affected by the decision.
Merck & Co. says it's expecting yet another rejection from the FDA for its anesthesia drug sugammadex, as the agency scrapped an advisory panel's review of the drug slated for next week. The FDA told the company it plans additional site inspections before it hands the info over to an advisory committee.
Merck's anesthesia drug sugammadex has been cited repeatedly over the years as one of the top experimental meds in the pharma giant's pipeline, a trophy obtained in its megamerger with Schering. But the treatment has racked up a painful series of setbacks over the years, starting with its first rejection at the hands of the FDA 7 years ago and continuing now with a third looming rejection over unresolved questions surrounding a hypersensitivity study performed for its pitch to the agency.
The United Kingdom government has established the scope of the hotly anticipated review into the development and reimbursement of drugs. And the independent panel is being tasked with looking beyond the U.K.'s borders for inspiration, with an analysis of what can be learnt from the U.S. FDA's "breakthrough" designation on its to-do list.
Last month, Merck & Co. finally rolled out its long-awaited sleep drug, Belsomra (suvorexant). After years of delays and disappointments at the FDA, it's safe to say that no one expects the drug to churn out big sales this year. But that's not to say Merck doesn't have its ambitions.
Merck's Keytruda may still be waiting for regulatory approval in Europe, but some patients will soon have access to the therapy thanks to a new program in the U.K.
Last month, Merck finally rolled out its long-awaited sleep drug, Belsomra (suvorexant). After years of delays and disappointments at the FDA, it's safe to say that no one expects the drug to churn out big sales this year.