By Bill Berkrot
(Reuters) – Forty percent of patients, most with a particularly aggressive form of leukemia, responded to an experimental Agios Pharmaceuticals Inc drug, including several who experienced complete remission, according to data presented at a medical meeting on Friday.
New data from the ongoing Phase I clinical trial appears to confirm the early promise seen with the Agios drug, AG-221.
By Bill Berkrot
(Reuters) – The U.S. Food and Drug Administration,
responding to a lawsuit filed by Amarin Corp over
information the company wants to disseminate for its fish oil
drug, said it had no objection to Amarin sharing the data with
The FDA’s letter to Amarin, dated June 8 and filed with a
U.S. District Court judge in New York, appears to undercut the
lawsuit, saying the small drugmaker should have come to the
agency with its concerns “as other pharmaceutical companies
sometimes do” before filing a complaint against it in court.
June 8 (Reuters) – Details of a large heart safety study
presented on Monday appear to give Merck and Co’s
diabetes drug Januvia a clean bill of health, possibly setting
the stage for a return to sales growth for the drugmaker’s
Merck in April said the study, called Tecos, of 14,724
patients with type 2 diabetes and a history of heart disease
demonstrated that adding Januvia to usual care did not increase
major heart problems any more than adding a placebo, removing a
cloud that has been holding back sales of the medicine and the
company’s share price.
June 8 (Reuters) – A large study demonstrated the heart
safety of Sanofi’s injectable type 2 diabetes
drug lixisenatide and appears to rule out other potential health
hazards as well, according to data presented at a medical
meeting on Monday,
The results pave the way for the French drugmaker to file
for U.S. approval of the medicine, which it said it plans to do
in the third quarter of this year.
June 7 (Reuters) – Novo Nordisk’s IDegLira
combination drug for type 2 diabetes led to significant
reductions in blood sugar, weight and rate of hypoglycemia
compared with Sanofi’s top-selling Lantus insulin
product, according to data from a late-stage trial presented at
a medical meeting on Sunday.
The Novo drug, given by once-daily injection, combines its
experimental long-acting insulin degludec with liraglutide, a
type 2 diabetes treatment sold under the brand name Victoza that
was recently approved under another name for weight loss.
June 6 (Reuters) – A long-acting insulin being developed by
Eli Lilly and Co demonstrated greater blood sugar
reduction than Sanofi SA’s top-selling Lantus in
patients with type 2 diabetes, according to data from three
Phase III trials presented on Saturday.
More patients in the studies who received Lilly’s basal
insulin peglispro (BIL) also got their blood sugar down to the
American Diabetes Association (ADA) recommended target of less
than 7 percent using a common measure known as A1c, researchers
By Bill Berkrot
(Reuters) – The National Institutes of Health said on Thursday it had suspended operations of a facility that makes products used for clinical research after the discovery of fungal contamination in two vials of albumin.
Vials made from the same batch of albumin had been administered to six patients, though it is not known if those were also contaminated, the agency said. The six patients are being monitored and no signs of infection or illness have emerged.
June 2 (Reuters) – The U.S. government will hold a forum on
Tuesday to help find ways to ensure the responsible use of
antibiotics, whose overuse is creating drug-resistant
“superbugs” that pose a serious risk to public health.
The White House Forum on Antibiotic Stewardship will bring
together some 150 representatives from food companies,
retailers, drugmakers, farmers, medical societies and others
involved in human and animal health to discuss limiting the
overuse of antibiotics in livestock, animal feed and humans.
By Bill Berkrot
(Reuters) – The U.S. government will hold a forum on Tuesday to help find ways that ensure the responsible use of antibiotics at a time concern is growing that their overuse is creating drug-resistant super bugs that pose a serious risk to public health.
The White House Forum on Antibiotic Stewardship will bring together some 150 representatives from food companies, retailers, drugmakers, farmers, medical societies and others involved in human and animal health to discuss limiting the overuse of antibiotics in livestock, animal feed and humans.
May 30 (Reuters) – An experimental biotech drug being
developed by Johnson & Johnson may offer hope to
multiple myeloma patients who have run out of options, according
to data from a midstage study released at a cancer meeting on
J&J plans to use the Phase II study to seek U.S. and
European approval of its antibody daratumumab to treat the blood
cancer. The drug received breakthrough designation from the U.S.
Food and Drug Administration, which can help speed the approval