Teva’s Qnaze meets endpoints in phase-3 trial
JERUSALEM — An investigational drug made by Teva Pharmaceutical Industries for treating allergies is safe and effective, according to results of a late-stage clinical trial announced Wednesday.
Teva said the phase-3 trial of the nasally inhaled drug Qnaze (beclomethasone dipropionate) showed that it significantly relieved symptoms of seasonal and perennial allergic rhinitis compared with placebo while demonstrating a similar safety profile.
Teva reported results from a phase-3 trial of the drug in patients with seasonal allergies at the American Coolege of Allergy, Asthma and Immunology’s annual meeting last year.
Report: Sandoz has as many as 10 follow-on biologics in works
NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.
Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.
Follow-on biologics, also known as biosimilars and sometimes as biogenerics, are copycat versions of biotech drugs. Unlike generic pharmaceutical drugs, which are identical to their branded counterparts, the specially grown cell lines and complex molecular structure of biologics makes it much more difficult to develop follow-on versions, and follow-on biologics may not be identical to the originals, even if they have the work the same way.
Sandoz is one of the leading developers of follow-on biologics for the European market, along with Israeli drug maker Teva Pharmaceutical Industries, the world’s largest generic drug company, and U.S.-based Hospira.
The healthcare-reform law, signed into law by President Barack Obama last year, created a regulatory approval pathway for follow-on biologics in the United States, though Republicans in Congress and several state attorneys general have sought to overturn the law in the legislature and the court system.
PCMA: Sebelius should continue push for cost cuts among state Medicaid programs
WASHINGTON — A group representing the nation’s pharmacy benefit managers said Health and Human Services secretary Kathleen Sebelius should continue encouraging state Medicaid programs to explore affordable pharmacy solutions despite opposition from the independent drug store lobby.
The Pharmaceutical Care Management Association said the current "old-school, fee-for-service" approach used by state Medicaid programs "exposes state governments to political pressure from the independent drug store lobby to set artificially high payment levels," arguing that the focus is on profits instead of patients.
“Medicaid can no longer afford to spend more on pharmacy benefits than Medicare and commercial payers. States should have the flexibility to use the tools other programs use to reduce costs,” said PCMA president and CEO Mark Merritt. “State Medicaid programs can no longer afford to pay pharmacies double or triple what other programs pay.”
The statement from the PCMA followed a document released last week by Sebelius, who urged all 50 state governors to find ways to cut costs through various approaches.