Bruised and battered by its failings with the controversial Alzheimer’s drug Aduhelm, Biogen is looking to right the ship with a new helmsman. The company is on the hunt for a new chief executive officer.
According to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS), three more deaths have been reported potentially associated with the Alzheimer’s drug Aduhelm since Biogen indicated during November 2021 that the company was investigating the death of a 75-year-old woman who died from a brain abnormality.
The U.S. Senate on February 15 voted to confirm Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration after some senators had argued his ties to the pharmaceutical industry or views on birth control made him unfit for the role.
Investor interest in the development of prescription digital therapeutics (PDTs) grew enormously in 2021, spurred by the telehealth boom of the pandemic. But determining approval pathways with regulators as well as methods to prove the value of prescription digital therapeutics (PDTs) will be essential in making sure that payers accept these very new treatments, according to Med Ad News’ annual special feature, “Value of Medicines.”
Each new president enters the White House with big dreams and unique challenges. For President Joe Biden, 2021 was dominated by the evolving COVID-19 pandemic, an historically difficult transition of power, and a focus on packing an ambitious combination of economic relief, infrastructure investment, and social spending initiatives into a handful of multi-trillion dollar omnibus bills to push through a tightly-divided Congress.
The COVID-19 pandemic that became evident in the United States in early 2020 had a profound and disruptive effect upon cancer research and treatment, but the lessons learned can be used to improve healthcare delivery in multiple indications, according to the AACR Report on the Impact of COVID-19 on Cancer Research and Patient Care that was released February 9th.
Biogen Inc. is urging Medicare to broadly reimburse the company’s recently authorized Alzheimer’s drug, in response to a proposal by the U.S. government to sharply limit coverage of new drugs for the brain-wasting disease.
While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.
At least 1 in 5 Americans have been infected with COVID-19. In other news, the U.S. Food and Drug Administration approved Gilead Sciences’ supplemental New Drug Application for Veklury (remdesivir) for adults and adolescents with COVID-19 who are not hospitalized but are at high risk of progression to severe COVID-19, hospitalization or death.
Biogen shares fell on January 12 after the Centers for Medicare and Medicaid Services (CMS) issued its draft national coverage decision for the company’s controversial Alzheimer’s drug Aduhelm.