New Migraine Drug Will ‘Change The Paradigm’ Of Treatment, Says CEO
Nurtec ODT, recently approved by the Food and Drug Administration, is reported on by CNBC. In other news, a Louisiana law bans insurer "white bagging" (bypassing hospital pharmacies), and the FDA also approves a new smallpox treatment, Tembexa.
Biohaven CEO Says Drug Approval Is 'Monumental' For Migraine Patients
Biohaven CEO Vlad Coric told CNBC Tuesday a recent approval of the company’s migraine drug will “change the paradigm” of migraine prevention and treatment. The U.S. Food and Drug Administration last week approved the medicine, Nurtec ODT, for preventative treatment of migraines. That comes about a year after Nurtec was first launched to treat the symptoms of debilitating headaches, making it the first pill approved for both acute treatment and prevention, according to Coric. (Clifford, 6/8)
New Louisiana Law Bans Insurer Practice Known As White Bagging
Louisiana hospitals are cheering a new state law that bans health insurers' controversial practice of white bagging, or bypassing hospital pharmacies for certain drugs. Across the country, health insurers are increasingly setting policies that funnel services away from hospitals in favor of less expensive settings. In this case, they're shipping doses of expensive physician-administered drugs, commonly cancer infusions, directly to hospitals instead of allowing hospitals to buy them using discounts and retrieve them from their in-house pharmacies. Insurers have defended the practice by arguing that getting drugs from their own network of specialty pharmacies helps keep healthcare more affordable. (Bannow, 6/8)
Regeneron Shareholders Urged To Boot Board Member Over Exec Pay Practices
Two prominent shareholder advisory firms are urging Regeneron Pharmaceuticals (REGN) shareholders to remove a director who is on the compensation committee, citing concerns over “problematic” pay practices and “excessive” awards given to the top two executives. In separate investor alerts, the advisory firms argue the Regeneron board has showered chief executive officer Leonard Schleifer and president and chief scientific officer George Yancopoulos with upfront performance stock units worth $130 million over five years, rather than annual grants. This approach may lock in executives, but the firms say it also robs the board of flexibility if job performance changes during that time. (Silverman, 6/8)
FDA Approves 2nd Smallpox Treatment, Tembexa
The US Food and Drug Administration (FDA) has approved Tembexa (brincidofovir) to treat smallpox. This is the second approved smallpox drug; the first, TPOXX (tecovirimat), was approved in 2018.The World Health Organization declared smallpox eradicated in 1980, but since then many nations have expressed concerns that the variola virus, which causes smallpox, could be used as a bioweapon. (6/8)
In updates on the opioid crisis —
Retired DEA Official Says Distributors' Pill Monitoring Systems Were A Systemic Failure
While a retired high-ranking official with the Drug Enforcement Administration said drug distributors’ neglect in reporting suspicious opioid pill orders was part of a systemic failure, the defendants said the real issue was with the regulator’s practices. The official — Joe Rannazzisi, head of the Office of Diversion Control for the DEA from 2006 to 2015 — testified Tuesday in Charleston at the ongoing opioid trial. Cabell County and Huntington are accusing the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of fueling the opioid crisis by sending excessive shipments of opioids into the area for eight years before a reduction in the number of pills shipped made users turn to illicit drugs. (Hessler, 6/8)
San Francisco Chronicle:
SFPD's Fentanyl Bust: 'Enough Lethal Overdoses To Wipe Out San Francisco's Population Four Times Over"
San Francisco police arrested five men and seized 16 pounds of fentanyl — enough to kill the city’s population four times over — in a narcotics operation in Oakland meant to block deadly drugs from entering the city’s Tenderloin neighborhood, authorities said Tuesday. The arrests and seizures last Thursday involved two semi-automatic guns that were not registered, more than $45,000 in cash and nearly 30 pounds of drugs, including the fentanyl. (Hernández, 6/8)