Report: Banning ‘pay for delay’ settlements likely won’t happen
NEW YORK — Legislation to ban patent litigation settlements between branded and generic drug companies appears unlikely to find success, according to published reports.
The Hill, a newspaper that covers Congress, reported on Sunday that language in the Senate appropriations bill that would ban so-called “pay for delay” settlements between drug makers did not appear likely to pass. The newspaper reported that the Senate appeared likely to support a resolution supported by the House that did not contain the language.
The deals, whereby a generic drug maker that has won the right to market its version of a drug prior to the expiration of the branded drug’s patent agrees to put off launching its version in exchange for the brand company paying it — in the form of cash or, more commonly, a promise not to launch an “authorized generic,” essentially the branded drug marketed under its generic name at a lower price — have attracted controversy in recent years. Opponents, including the Federal Trade Commission, said the deals unfairly keep cheaper generic drugs off the market, while supporters, including generic and brand drug makers, said they still allow generic launch before patent expiration, and that delaying launch after patent expiration would be illegal anyway.
Axium receives ACHC accreditation
LAKE MARY, Fla. — The Accreditation Commission for Health Care has accredited specialty pharmacy provider Axium Healthcare Pharmacy, Axium said Tuesday.
Axium said the accreditation was given for its headquarters in Florida and for sites in Mississippi and Puerto Rico. The ACHC was formed by home care and community-based providers with the goal of helping companies improve business operations and patient care quality. Organizations obtain accreditation by submitting to peer review of their internal policies, processes and patient care delivery, which are compared with national standards.
“Accreditation provides our patients, physicians, payers and manufacturers assurance of Axium delivering a high-quality, patient-focused care and personalized superior service,” Axium president and CEO Mark Montgomery said.
Citing safety concerns, Lilly suspends cancer drug trial
INDIANAPOLIS — Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.
The company had been conducting a phase-3 trial of the pharmaceutical drug tasisulam as a second-line treatment for patients with melanoma whose cancer could not be removed or had spread to other parts of the body. Melanoma, the deadliest form of skin cancer, is diagnosed in 68,000 people in the Untied States every year, according to the American Cancer Society.
Trials of the drug in patients with leukemia, soft tissue sarcoma, breast, ovarian and kidney cancers will continue due to differences in dosing.
“We are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial,” said Richard Gaynor, Lilly VP oncology product development and medical affairs.