Top news
* AbbVie Inc. and Biogen Inc. are voluntarily withdrawing Zinbryta, or daclizumab, intended to treat relapsing multiple sclerosis. The withdrawal comes after reports of encephalitis, a swelling of the brain, and meningoencephalitis, inflammation of brain tissue and the spinal cord, were associated with the drug.
* At a March 1 White House summit, President Donald Trump said drugmakers that helped fuel the opioid epidemic should face federal litigation. But when it comes to dealers of illicit substances, such as fentanyl, Trump suggested an even harsher punishment — declaring they should pay the "ultimate penalty."
Health and Human Services Secretary Alex Azar, however, was more focused on ensuring access to treatment facilities and medication-assisted therapies for Americans addicted to opioids — which "are essential to this fight" — and on lifting the stigma associated with those products and services.
On the policy front
* Sen. Chuck Grassley, R-Iowa, a longtime critic of the so-called 340B program that requires drug companies to give discounts to nonprofit hospitals, yesterday proposed a bill that would require the facilities to disclose how much they save and what they do with the money.
* A majority of Medicare Payment Advisory Commission members said at a meeting yesterday that they will back a proposal in April recommending urban, stand-alone emergency rooms have their Medicare payments cut, maybe by 30%. The commission is also recommending that stand-alone emergency rooms, which are being opened by large hospital chains, receive the lower rates given to smaller hospitals that are not running full time.
Drug and product pipeline
* Paris-based drugmaker Sanofi and New York-based Regeneron Pharmaceuticals Inc. said the U.S. Food and Drug Administration will review Dupixent, or dupilumab, as an add-on maintenance treatment for asthma. The FDA is expected to respond by Oct. 20. The drug is approved for dermatitis.
* An investigation into the increase in a rare side effect in patients receiving Regeneron's eye drug Eylea has been linked to syringes used to inject the medicine into the eye. However, no association between the increase in the rate of the side effect and Eylea itself was found.
* Carlsbad, Calif.-based Ionis Pharmaceuticals Inc. said a phase 1/2 study of IONIS-HTTRx showed the drug significantly reduced the mutant huntingtin protein, the cause of Huntington's disease, a genetic disorder that results in the death of brain cells. Ionis is developing the therapy with Swiss drugmaker Roche Holding AG.
Operational activity
* Irish pharmaceutical company Perrigo Co. plc's fourth-quarter 2017 earnings rose 1.5% year over year, but sales for the period declined 3.6%. The company is targeting full-year 2018 adjusted EPS of $5.05 to $5.45.
* San Francisco-based Nektar Therapeutics reported a lower net loss and a rise in revenue for the fourth quarter of 2017 versus the prior-year period. The net loss for 2017 was $96.7 million, or 62 cents per share, compared with a loss of $153.5 million, or $1.10 per share, in 2016.
* Endo International plc obtained a preliminary injunction barring QuVa Pharma Inc. from selling a product that would compete with Vasostrict, Endo's vasopressin injection used to increase blood pressure in adults with low blood pressure.
* The U.S. FDA warned healthcare professionals and patients against using drug products from Cantrell Drug Co. Inc., including opioid products and other medicines intended for sterile injection. The regulator said it is raising concerns about deficiencies in Cantrell's compounding operations, including its quality and safety check processes.
Other features
* Bloomberg News highlighted U.S. drug giant Merck & Co. Inc.'s exploration of so-called oncolytic viruses, or those that infect and break down cancer cells, that may boost its blockbuster immunotherapy Keytruda. Merck disclosed last week that it intends to acquire Sydney-based Viralytics Ltd. to gain rights to its lead product Cavatak, an investigational oncolytic immunotherapy.
* Earnings of U.S. hospital operators, including Tenet Healthcare Corp. and LifePoint Health Inc., were boosted by patient admissions amid one of the worst flu seasons in the country, Reuters noted.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng declined 1.48% to 30,583.45, and the Nikkei 225 fell 2.50% to 21,181.64.
In Europe, around midday, the FTSE 100 was down 0.93% to 7,108.93, and the Euronext 100 was down 1.36% to 1,004.59.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
