Content about Monoclonal antibodies

LONDON — GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

The drug maker announced the start of a phase-3 trial of Benlysta (belimumab) in patients with vasculitis, a condition in which the body's immune system attacks blood vessels, leading to inflammation, disruption of blood flow and possible damage to the organs. The drug is being tested in patients with a common form of the disease known as anti-neutrophil cytoplasmic antibodies-positive vasculitis.

NEW YORK — A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan, but hasn't heard back from it, according to published reports.

The Associated Press reported that Royalty Pharma's $11-per-share offer for Elan represented a 4% premium over its closing price Friday. Royalty buys royalty interests in drug products that are in late-stage development or have already entered the market, but doesn't develop or market drugs of its own, the AP reported.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

HORSHAM, Pa. — Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

J&J subsidiary Janssen Biotech submitted an application to the FDA for Stelara (ustekinumab) for adult patients with the disease, which affects more than 2 million people in the United States, according to the National Psoriasis Foundation. Another subsidiary is seeking approval for Stelara for the same usage in Europe.

ABBOTT PARK, Ill. — Patients with a form of arthritis that affects young adults taking a drug made by Abbott experienced improvements in their condition after a year of treatment, according to late-stage clinical trial results.

Abbott announced Monday the first long-term patient-reported health outcomes data for the phase-3 "ABILITY-1" trial of Humira (adalimumab) in patients with nonradiographic axial spondyloarthritis, or nr-axSpA. Results of the trial were presented at the American College of Rheumatology's annual scientific meeting in Washington.

WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.

SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.

LONDON — British drug maker GlaxoSmithKline will acquire development partner Human Genome Sciences for $3.6 billion, GSK said Monday.

The deal, worth $14.25 per share, would give GSK full ownership of the lupus drug Benlysta (belimumab), as well as albiglutide, an experimental drug for diabetes, and darapladib, an experimental heart disease drug.

SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.

NEW YORK — GlaxoSmithKline said its offer to buy Human Genome Sciences was "full and fair" Wednesday after HGS turned it down last week, according to published reports.

Reuters reported that GSK's $13-per-share, $2.6 billion offer for HGS would give the former full control of Benlysta (belimumab), the first new drug approved by the Food and Drug Administration for lupus in more than half a century. The two companies developed the drug together under a partnership, and the drug received approval in March 2011.