Month: June 2021

Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug

WASHINGTON — Former health secretary Donna Shalala called for a federal investigation into the Food and Drug Administration’s polarizing approval of a Biogen treatment for Alzheimer’s disease, citing STAT’s revelation Tuesday that regulators were far more closely aligned with the company than previously disclosed. “When you see a report like this, you have to investigate […]

STAT+: Mallinckrodt cleared to sell a rare disease drug to a startup, but parents worried over ongoing access

A federal bankruptcy court judge has approved the sale of a rare disease drug to a startup company backed by venture capitalist Peter Thiel, a notable step in one of the latest dramas over access to experimental medicines. At issue is adrabetadex, which Mallinckrodt (MNKKQ) was studying to combat Niemann-Pick type C, or NPC, a […]

STAT+: Gene therapy to regenerate cardiac muscle after a heart attack passes a key test in pigs

By delivering a viral payload of gene silencers directly to the heart, scientists have developed a new strategy for regenerating cardiac muscle after damage from a heart attack. Described in a paper published Wednesday in Science Translational Medicine, the approach led to new cell growth and improved heart function in pigs. The findings, though preliminary, […]

STAT+: Pharmalittle: Most doctors disagree with FDA approval of the new Alzheimer’s drug; women underrepresented in life sciences C-suites

Good morning, everyone, and how are you today? The heat continues to rise here on the Pharmalot campus, where we are hoping for storm clouds to wash away the humidity that has characterized the past few days. One can dream, yes? To cope, we are quaffing some cups of stimulation and distracting ourselves by foraging […]

STAT+: Revised analysis nudges up cost-effective price for Biogen’s Alzheimer’s drug to $3,000 to $8,400 a year

The controversial new Alzheimer’s drug from Biogen (BIIB) would be cost-effective only if priced between $3,000 and $8,400, which represents an 85% to 95% discount off the $56,000 list price, due to “insufficient” evidence the drug benefits patients, according to a revised analysis. The assessment is very similar to an evaluation that was issued last […]

Opinion: Listen: A sister on watching the mental health care system fail her brother

In this week’s episode of the “First Opinion Podcast,” Lizzy Feliciano talks about her brother, Louis, who died after years of suffering from depression, anxiety, and alcohol misuse. She struggled to help him find a program that could treat all of his issues holistically, not just one at a time. In a cruel twist of […]

STAT+: The health tech tracker for the third quarter: 11 pivotal industry events to watch

The third quarter will answer crucial questions about the near-term future of digital health. Will the upstart companies that enabled care and clinical trials to continue remotely during the pandemic have the same resonance and revenue growth as it recedes? Will they keep finding exit avenues via acquisitions, IPOs, or SPAC mergers? The next three […]

STAT+: Poll: Most neurologists and primary care doctors disagree with FDA’s approval of Alzheimer’s drug

A majority of U.S. physicians disagree with the decision by the Food and Drug Administration to approve the Alzheimer’s drug from Biogen (BIIB) and believe the medicine should not be routinely used for patients, according to a new survey from STAT and Medscape. In addition, nearly two-thirds of the 200 primary care physicians and neurologists […]

Opinion: Copay assistance should count as part of patients’ cost sharing for medications

The Biden administration has made health equity a priority and it has been a constant theme of conversation on Capitol Hill. But where do we go from here? One place is stopping health insurance companies and pharmacy benefit managers from pulling the rug out from underneath people who need help affording their medications through copay […]

Demand is growing for continuous glucose monitoring for type 2 diabetes. Primary care doctors need to prepare

In the last year, Jai Smith has cycled through 13 primary care doctors. Ever since being diagnosed with type 2 diabetes in 1995, she’s tried her best to manage a disease that has devastated her family: Her grandmother and four uncles died from its complications. But she’s struggled to find a doctor in her hometown […]

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