Merck, building on the success of its diabetes blockbuster Januvia, won a first global approval for a long-acting form of the drug, convincing Japanese regulators to approve its new weekly product.
Merck says that it's ready to apply for EU and U.S. marketing approval for the anti-infective bezlotoxumab, flagging a pivotal clinical success which arrived four years after the pharma giant launched its late-stage program. But the pharma giant also sounded taps for a related Phase III effort on actoxumab.
Merck Animal Health announced on Sept. 16 that it has launched Porcilis Ileitis, the first-ever injectable vaccine to treat the form of ileitis caused by the pathogen Lawsonia intracellularis.
Merck's once-a-week omarigliptin proved itself equal to Januvia, stacking up to a daily treatment that brought in about $3.9 billion for the company last year.
A new analysis shows that muscle-related side effects--which are commonly linked to statins--show up more often in Merck's Zocor, Mevacor and Vytorin than in drugs in the rest of the class.
Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.
Partners Merck and Samsung Bioepis recorded their first approval in a sweeping biosimilars alliance, winning a South Korean OK for their copy of Amgen's blockbuster Enbrel.
Merck enlisted Daktari Diagnostics to help it break into the hepatitis C market and execute its strategy of appealing to unserved niche patients, such as hep C patients with dialysis and rare genotype 4 of the virus.
LONDON-- Late last month, partners Eli Lilly and Boehringer Ingelheim announced that their SGLT2 diabetes med, Jardiance, had gone where no others had gone before. While its rivals had always either increased the risk of cardiovascular events or, at best, had no effect, the newcomer showed it could actually lower the risk of heart attack, stroke and death from cardiovascular causes.
As if last week's Jardiance news wasn't enough to worry makers of DPP-4 diabetes drugs, the FDA has now issued a warning that the class of meds might cause "severe and disabling" joint pain.