The issue: Boehringer's manufacturing site. The FDA is not asking for new clinical studies.
Spurred by a 2013 report of a possible link between drugs like Merck's Januvia and pancreatitis or pancreatic cancer, the FDA and EMA said they have not found a definitive link but will continue to collect data.
Phase-III results, top-lined today, show Lilly's investigational GLP-1 drug is well-positioned to eat into the multi-billion-dollar diabetes market now dominated by Novo Nordisk.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
Governments have been courting industry investment, reports the Wall Street Journal.
The regulator says a 2013 study that indicated a higher rate of heart failure compared to placebo—but not death—has prompted a second look at the diabetes medication.
A six-month pilot program at the University of Chicago improved glycemic control and engaged patients and HCPs through one key device: a mobile phone.
Constant exchange rates provide a positive framework for quarterly and year-end totals, whereas straight percentages indicate lower sales.
Ten pharma companies will share money and biomarker research under an NIH collaboration.
The suit stalls Eli Lilly's biosimilar version of insulin glargine.
Higher prices helped insulate Q4 and annual sales, which fell and rose 2%, respectively. Lilly said its insulin glargine biosimilar will go nowhere if it is not substantially different from the competition.
The companies are changing the key compound.
Three drug purchasing companies have taken the Denmark drugmaker to court in the US. The charge: wrongfully keeping generics off the market.
AZ's delayed diabetes pill was given the FDA nod today, the second treatment of its kind available in the US behind J&J's Invokana.
The company releases 2014 guidance Tuesday, but signals from the previous 12 months indicate the Indiana drugmaker is determined to hit its $20-billion earnings target, patent losses be damned.
The move to digitize a series of books it co-created with Disney for kids with type 1 diabetes was spurred by a meeting with the online diabetes community.
BMS is giving up its stake of the AstraZeneca diabetes joint venture for $2.7 billion up front, and future milestone payments.
The FDA wants more data for the proposed canagliflozin-metformin medication mix.
The drugmaker and partner AstraZeneca say they can't find a comfortable pricing arrangement with German insurers.
Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.
FDA panel briefing documents indicate concern remains over bladder cancer, as the drug dapagliflozin undergoes a second review Thursday.
Phase-IIIb study results indicate Lyxumia—which is approved abroad but not in the US—was "non-inferior" in terms of controlling blood sugar levels regardless of whether the shot was given before breakfast or later.
Novo's global diabetes study finds that only 29% of polled patients were asked what they thought about prescribed regimens.
Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.
The drug maker's vision for 2014: fighting to keep Victoza top-of-mind with a US field force of around 3,000.
Researchers think a two-hormone approach could help control diabetes and obesity.
Researchers say the drug class could be linked to a lower autoimmune risk among diabetics.
The company says it is moving its Januvia sales pitch from defending market share to expanding it.
Amid talk of cost containment, Lilly said it's also enjoying nice returns from some of its older diabetes drugs.
The drug maker is giving its inhaled insulin another go.