FDA removes hurdle in Endocyte’s path to drug approval
Endocyte Inc. can start enrolling patients again in a clinical trial of its experimental cancer drug, the company announced Monday, clearing away a hurdle to getting the drug approved in Europe.
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Lilly’s ex-partner wins FDA approval for diabetes drug
Amylin Pharmaceuticals Inc. and Alkermes Plc have gained U.S. clearance for Bydureon, a once-weekly diabetes shot. Eli Lilly and Co. co-developed the drug, but ended its partnership with Amylin last year.
At long last, Roche wins approval of Nano
The OK for a new blood glucose monitor comes more than two years after FDA officials declined to approve a previous version of the Nano, which in rare cases generated inflated blood sugar readings because it did not distinguish properly between the sugars glucose and maltose.
Potential Lilly drug doubles good cholesterol
Eli Lilly and Co.’s experimental drug doubled levels of good cholesterol in a study, setting up a race with Merck & Co. and Roche Holding AG to develop a new class of medicines to lower heart risk.
Potential Effient rival shows promise in study
A study showing Johnson & Johnson and Bayer AG’s blood-thinner Xarelto succeeded where rival drugs failed could give the companies entry to a $1 billion-plus market where Eli Lilly already competes.
Lilly, Bristol-Myers approved to market wider Erbitux use
Eli Lilly and Co. and Bristol-Myers Squibb Co. won U.S. approval to expand marketing of the cancer drug Erbitux for late-stage head and neck tumors.
FDA approves first generic versions of Zyprexa
Federal health officials on Monday approved the first generic versions of the blockbuster drug Zyprexa, which posted sales of $5.7 billion last year for Indianapolis-based drugmaker Eli Lilly and Co Inc.
Lilly diabetes drug wins approval for expanded use
Eli Lilly and Co. and Amylin Pharmaceuticals Inc.’s Byetta has received expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.
FDA: Cook Medical’s stent met efficacy, safety goals
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014.
FDA approves Cialis for enlarged prostate
Cialis, Lilly’s blockbuster erectile dysfunction drug, now can be taken to treat enlarged prostate. FDA approval means men who suffer from both disorders can take one medication.
Debate rages over whether Lilly’s Byetta lifts cancer risk
A German researcher disputed the validity of a study that found Byetta and another diabetes drug increase cancer risk.
Health regulatory leaders ready to flock to city
The top event for regulatory professionals in the health care industry is headed to Indianapolis next month. The annual conference of the Regulatory Affairs Professionals Society, or RAPS, is expected to draw thousands of members representing 120 companies and organizations.
FDA gets new report on Lilly diabetes drug
Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Monday that patients taking their potential once-weekly diabetes treatment, Bydureon, saw a significant improvement in cardiovascular risk factors.
FDA deal with drugmakers raises user fees 6 percent
Drugmakers including Eli Lilly an Co. have agreed with regulators on a 6-percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017.
FDA says potential diabetes drug may cause cancer
Dapagliflozin would be the first in a new class of diabetes treatments called SGLT2-inhibitors that work by letting patients excrete excess blood sugar in their urine. Indianapolis-based Eli Lilly and Co. is among several companies pursuing similar drugs.
Lilly, partner find no Bydureon effect on heart rhythm
Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence that their experimental Bydureon diabetes drug causes prolonged heart rhythms.
Lilly drug to detect Alzheimer’s criticized by consumer group
Eli Lilly and Co.’s Amyvid, an experimental imaging agent to detect signs of Alzheimer’s disease in the brain, shouldn’t be approved because of unreliable study results, a consumer-advocacy group said.
Two wins to bring Lilly modest sales
Finally, some new revenue. Eli Lilly and Co. will enjoy modest new sales later this year after U.S. regulators approved a new diabetes drug developed by a partner company, and another company nears approval on a drug that will produce royalties for the Indianapolis-based drugmaker.
FDA OKs new diabetes pill from Lilly, Boehringer
The Food and Drug Administration says it has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients who can't control their blood sugar with older medicines.