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State treasurers urge Gilead to lower the price of remdesivir and not pursue “unreasonable profits”

Thu, 09/17/2020 - 14:01

Nearly a dozen state treasurers are asking Gilead Sciences (GILD) to lower the price of its experimental remdesivir treatment for Covid-19, arguing the company is attempting to market an “old drug at prices that are disconnected from economic reality.”

In a letter to Gilead chief executive Daniel O’Day, the state officials cautioned that Gilead should not take “financial advantage” of the pandemic to pursue “unreasonable profits” because it “sets a dangerous precedent for future treatments in development.” The letter was sent by treasurers in Ohio, Pennsylvania, Nevada, Maine, Iowa, Oregon, Colorado, Wisconsin, Texas, Rhode Island, and Massachusetts.

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Listen: The CDC’s credibility crisis, pandemic PR, and virtual conference malaise

Thu, 09/17/2020 - 12:45

How should governments talk about Covid-19? Can the Centers for Disease Control and Prevention rebuild public trust? And when is a steak worth $21 billion?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, our colleague Helen Branswell calls in to discuss how how caving to White House pressure has eroded public trust in U.S. health agencies. Then, University of British Columbia, Vancouver, researcher Heidi Tworek joins us to examine how countries around the world have succeeded — and failed — to communicate clearly about the Covid-19 crisis. Finally, we embark on a lightning round, with takes on Gilead Sciences’ latest deal, the perils of virtual meetings, and the value of making political endorsements.

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Trump’s attacks highlight CDC’s stumbles on public health messaging

Thu, 09/17/2020 - 10:03

WASHINGTON —  Robert Redfield’s statement was unambiguous: A Covid-19 vaccine, he said, might not be available to much of the American public until mid- or late 2021.

But in the next 10 hours, the director of the Centers for Disease Control and Prevention came under attack from President Trump, attempted to walk back his prior statement by plainly mischaracterizing his own words, and then, inexplicably, retracted his own reversal.

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STAT Plus: Amwell rides IPO wave with expanded stock sale

Thu, 09/17/2020 - 06:48

Taking advantage of a pickup in demand for new stocks, American Well Corp. expanded its initial public offering Wednesday, locking in a price that valued the Boston telehealth technology company at $4.1 billion.

The company, also known as Amwell, said it raised $742 million by selling 41.2 million class A shares at $18 apiece, after increasing the price and number of shares offered. Amwell had planned to sell 35 million shares at $14 to $16 a share, according to a filing last week with the Securities and Exchange Commission.

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Virtual Event: Getting real-world data about Covid-19

Thu, 09/17/2020 - 06:47

Editor’s note: A live stream of this virtual event will be embedded above today at 1 p.m. ET. 

A pandemic means society needs information fast. Can researchers provide it?

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STAT Plus: Pharmalittle: Biden-aligned group releases drug-pricing plan; U.S. to ship Covid-19 vaccines lickety-split

Thu, 09/17/2020 - 06:24

Rise and shine, everyone, another busy day is on the way. Most days are quite busy now, though, wouldn’t you say? After all, a pandemic is not a regular occurrence, at least we hope. So we will choose to look on the sunny side and brew another cup of stimulation — maple bourbon is our choice this morning — as we prepare to tackle our growing to-do list. Meanwhile, here are a few items of interest to help you sort out your own priorities. Hope your day goes well and, of course, do stay safe. …

A leading think tank aligned with the Democratic Party is laying the groundwork for an aggressive slate of efforts to lower drug prices that could be implemented almost immediately should Joe Biden defeat President Trump in November, STAT says. The Center for American Progress suggested the first-ever use of a monopoly-busting mechanism known as “march-in-rights” to crack down on companies that overcharge for medicines, and resurrecting an Obama-era proposal to change how Medicare pays for many drugs administered by doctors.

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STAT Plus: Biden-aligned group outlines potential Day 1 drug pricing actions

Thu, 09/17/2020 - 02:00

WASHINGTON — A leading think tank aligned with the Democratic Party is laying the groundwork for an aggressive slate of efforts to lower drug prices that could be implemented almost immediately, should Joe Biden defeat President Trump in November.

In a report published Thursday, the Center for American Progress focuses on two major policy changes: the first-ever use of a controversial monopoly-busting mechanism known as “march-in-rights” to crack down on companies that overcharge for medicines, and the resurrection of an Obama-era proposal to change how Medicare pays for many drugs administered by doctors. It also lays out a handful of other regulatory tweaks that would not require congressional action.

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Opinion: A vaccine alone won’t stop Covid-19. We also need a trusted plan for it

Thu, 09/17/2020 - 01:35

Safe and effective vaccines represent the most effective way to restore the health and economic security disrupted by the Covid-19 pandemic. To help achieve that goal, the U.S. government launched Operation Warp Speed in May to accelerate development and manufacturing of several Covid-19 vaccines, with a goal of having 300 million doses available to the U.S. population by January 2021.

Operation Warp Speed is expediting vaccine development primarily by moving clinical trials forward without pauses between phases, and by scaling up manufacturing capacity before knowing if a candidate works. Three candidates are currently in Phase 3 pivotal trials, with initial results expected as early as this fall. At least three other candidates are expected to enter advanced clinical development soon.

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‘They are really afraid’: Fears about Covid-19 are complicating care for patients with sickle cell

Thu, 09/17/2020 - 01:30

Last November, just as the novel coronavirus was beginning its deadly trajectory through China, the sickle cell community in the U.S. was celebrating. Two potentially transformative drugs for sickle cell had just been approved by the FDA and clinical trials involving cutting-edge gene therapies were well underway.

“One of my colleagues called it ‘The November to Remember,’” recalled Biree Andemariam, chief medical officer of the Sickle Cell Disease Association of America and founding director of the New England Sickle Cell Institute at the University of Connecticut. “Literally, just before the pandemic hit, we had infused our first patient with one of the new drugs. And then everything stopped.”

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STAT Plus: The cost of Gilead’s HIV prevention pill thwarted widespread use, study finds

Wed, 09/16/2020 - 11:25

The escalating cost of the only HIV prevention pill may have been a key factor hindering widespread use in recent years, according to a new analysis by U.S. government researchers, underscoring long-standing concerns over the ability to eradicate the virus.

From 2014 to 2018, total payments made by government programs, commercial insurers, and patients for Truvada, which was approved to prevent HIV in 2012, jumped from $114 million to nearly $2.1 billion. Yet the number of people who were given prescriptions in 2018 was just 204,700, which amounted to less than 20% of those estimated to have benefited from the medication.

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STAT Plus: In research on pigs, scientists test a new way to boost recovery after a heart attack

Wed, 09/16/2020 - 11:00

Scientists have developed a new strategy that uses exosomes — tiny, RNA-loaded packets that cells spit out — to regenerate cardiac cells after damage from a heart attack.

The heart muscles are made of specialized cells that work continuously to pump blood to our entire body. When one of the heart’s blood vessels gets blocked, it can cause a heart attack, which often leads to tissue damage and scars. Scientists have previously explored whether cell transplants could speed recovery after heart attacks, but the cells often failed to graft, and experts worried about the health risks of such a procedure.

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STAT Plus: With Grail in its sights, Illumina pursues grand vision that could reshape the business of cancer diagnoses

Wed, 09/16/2020 - 10:38

Illumina, the dominant maker of machines to sequence DNA, is in talks to purchase Grail, a developer of a blood test to detect cancer that uses Illumina’s technology.

The discussions were first reported by Bloomberg News, and confirmed to STAT by a person with knowledge of the talks. The discussions could still fall apart at any time.

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Opinion: Trump’s ‘most favored nation’ executive order on drug prices is a scam for seniors

Wed, 09/16/2020 - 10:31

The White House announced a most favored nations executive order on Sunday, its latest attempt to lower prescription drug costs in the U.S. The new policy, which relies on international price competition, promises to provide Americans with “the same low prices” for prescription medications available in other countries.

But the policy is founded on incorrect assumptions about how other countries would respond, where seniors’ high out-of-pocket costs really come from, and what it would mean for the U.S. to adopt cost-effectiveness standards used by foreign governments.

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STAT Plus: Pharmalittle: Lilly drug helped Covid-19 patients; FDA confirms AstraZeneca vaccine trial is on hold

Wed, 09/16/2020 - 06:33

Top of the morning to you, and a fine one it is. Once again, a cool breeze and sunny skies are lifting our spirits here on the Pharmalot campus, where the short person is hunched over a laptop for another round of remote learning and the official mascot is bounding about the grounds vainly hunting for squirrels. As for us, we are up to the usual activities: quaffing cups of stimulation and poking around for items of interest. On that note, here are a few to start the day. Hope your journey is successful and, of course, do stay in touch. …

A drug being developed by Eli Lilly (LLY) helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, STAT writes. Only one of three doses met the primary goal of significantly reducing patients’ levels of the virus after 11 days. Lilly indicated the interim results reinforced the potential of the drug to help Covid-19 patients, and the company will discuss with regulators whether there is enough evidence to support authorization for emergency use during the pandemic.

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Lilly’s Covid-19 antibody helps patients rid their systems of virus sooner

Wed, 09/16/2020 - 03:45

A drug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.

The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus. 

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Remote monitoring is rapidly growing — and a new class of patient-consumer is driving the shift

Wed, 09/16/2020 - 01:40

A cardiac patient in Carlsbad sends their doctor in San Francisco a readout of their heart rate, courtesy of an Apple Watch. A New Yorker with hypertension texts with an Alabama health coach about data from their smart blood pressure cuffs. A person with diabetes snaps a photo of their dinner and uses an app to predict how it will impact their blood sugar.

Health care is undergoing a monumental shift toward remote patient monitoring — and a new class of patient-consumer is leading the charge, according to a new STAT report. The transformation — which began years ago as healthy people moved to optimize wellness and people with chronic conditions pushed for more convenient care — has taken on a more permanent tone amid the Covid-19 pandemic.

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Opinion: Medicaid needs to change its archaic rules for women seeking permanent contraception

Wed, 09/16/2020 - 01:35

For many women who don’t want to have more children, childbirth offers a safe and convenient time for adopting the permanent form of birth control known formally as tubal ligation, and informally as having your tubes tied. For women whose health care is covered by Medicaid, senseless bureaucracy can make this difficult.

A patient we will call Sofia (we aren’t using her real name to protect her privacy) is a perfect example of this issue. She had wanted to have a tubal ligation after she delivered her fourth child in March. The timing was bad: It was the peak of Covid-19 in Massachusetts, where Sofia was having her baby, and staffing and resource limitations meant she was unable to get the procedure as planned. She left the hospital with a plan to reschedule her procedure for later.

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As controversies swirl, CDC director is seen as allowing agency to buckle to political influence

Wed, 09/16/2020 - 01:30

In his first address to the staff of the Centers for Disease Control and Prevention, Robert Redfield called the Atlanta-based agency “the best science-based, data-driven agency in the world.”

His voice breaking repeatedly as he tried without success to hold back tears, Redfield — named director of the CDC in March 2018 — told thousands of employees he had long dreamed of leading the prestigious institution, considered the gold-standard for public health agencies around the globe. He made them a solemn vow.

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STAT Plus: Lawmakers demand drug makers stop threatening to end discounts for safety-net hospitals

Tue, 09/15/2020 - 12:45

Dozens of U.S. lawmakers sent sharply worded letters to the Trump administration and the pharmaceutical industry trade group to demand drug makers stop threatening to curtail discounts provided to a federal program for safety-net hospitals.

The bipartisan effort comes in response to recent steps taken by at least five large drug companies to reduce discounts they offer to the 340B drug discount program. Created in 1992, the program requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve indigent populations.

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CDC study: Covid-19 complications killed 121 Americans under age 21 through July

Tue, 09/15/2020 - 10:00

A true saving grace of the pandemic is that Covid-19 poses far less risk to children than to adults, particularly older adults. But in rare cases, it has made children and young adults severely sick or even been fatal.

In a new report that analyzed fatal Covid-19 cases in Americans under age 20, researchers found that some of the same patterns of deaths in older populations carried over to younger populations: There was a disproportionate burden among children and young adults with underlying health conditions and those who were Latinx, Black, or American Indian or Alaska Native.

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