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Reporting from the frontiers of health and medicine
Updated: 30 min 13 sec ago

STAT+: FTC says the number of pay-to-delay cases remains low, but vows to keep watch

7 hours 41 min ago

Although more drug makers are settling patent infringement lawsuits, the U.S. Federal Trade Commission found that the number of so-called pay-to-delay settlements — which the agency argues unfairly robs Americans of lower-cost alternatives to their prescription medicines — remain very low.

In discussing the findings, which were from fiscal year 2017, agency officials maintained the decline underscores the effects of a 2012 U.S. Supreme Court ruling that such deals can be subject to review for anti-competitive agreements. Since then, the FTC has become more aggressive in challenging some patent settlements between brand-name and generic drug makers.

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How key decisions slowed FDA’s review of Covid-19 vaccine — but also gave it important data

12 hours 17 min ago

In September, as Pfizer and partner BioNTech were quickly advancing a study of their Covid-19 vaccine, dozens of well-known academics sent an open letter to Pfizer’s CEO with a simple plea: Please slow down and collect more data.

It was not until Nov. 20 that the data were submitted to the Food and Drug Administration.

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STAT+: BIO to file lawsuit today to block Trump international drug pricing policy

13 hours 4 min ago

WASHINGTON — The Biotechnology Innovation Organization will file a lawsuit today to block implementation of President Trump’s new policy to lower drug prices, the organization tells STAT.

The “most favored nations” policy, which was unveiled late last month, would peg what Medicare pays for 50 pricey injectable drugs to the lowest price paid in countries like Japan and Belgium. The change could cut reimbursement for some of the best-selling drugs in America, in half, or more.

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STAT+: Up and down the ladder: The latest comings and goings

13 hours 10 min ago

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Zai Lab (ZLAB) hired Alan Sandler as president, head of global development, oncology. Most recently, he worked at the Genentech unit at Roche (RHHBY), where he was senior vice president and global head of product development, oncology.

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STAT+: A longtime health care investor on the wild ride of 2020 and what to expect in 2021

14 hours 9 min ago

It’s time to talk about biotech and 2021. What will the year ahead look like for biotech and pharma companies and for the investors who finance the drugs they develop?

Adam Koppel, a longtime health care investor and industry executive, joined STAT’s biotech podcast, “The Readout Loud” to try to answer that question. Four years ago, he co-founded Bain Capital Life Sciences, a Boston-based life sciences investment fund with more than $2 billion in assets under management.

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STAT+: Pharmalittle: Cyberattacks and criminal gangs target Covid-19 vaccines; whistleblower raps FDA oversight

14 hours 40 min ago

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, not surprisingly, is rather modest. We plan to tackle some chores around the castle, catch up on our reading, and promenade with the official mascot. And what about you? You could enjoy the great outdoors by taking a brisk constitutional or stimulate the economy by purchasing a winter sweater or two. You might also want to touch base with someone who is feeling isolated. Well, whatever you do, have a grand time. But be safe — wear a mask. Enjoy, and see you soon. …

A series of cyberattacks is underway aimed at the companies and government organizations that will be distributing Covid-19 vaccines around the world, The New York Times writes, citing IBM’s cybersecurity division. However, it is unclear whether the goal is to steal the technology for keeping the vaccines refrigerated in transit or to sabotage the movements. The findings were alarming enough that the Department of Homeland Security issued its own warning about the threat.

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CommonHealth, the Android answer to Apple Health Records, expands to 230 health systems

15 hours 8 min ago

A cohort of researchers and developers announced Friday that the Android app CommonHealth — which lets users see and share health data such as lab test results, immunizations, and medications from their records — is now connected to 230 U.S. health systems.

Similar to Apple Health Records for iPhone users, the free app — produced by the nonprofit organization the Commons Project — lets non-iPhone users manage their health data in a single location, a feat previously but unsuccessfully attempted by tech giants Google and Microsoft. Traditionally, such health care data is stored in siloed environments, creating obstacles for patients and clinicians who want to ensure comprehensive health care.

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Opinion: Drug companies’ payments and gifts affect physicians’ prescribing. It’s time to turn off the spigot

19 hours 28 min ago

Each year, about half of all U.S. doctors accept money or gifts from drug and device companies, totaling more than $2 billion. These payments range from free meals during which doctors listen to drug reps pitch their latest products, to travel to luxury locales to serve as paid “consultants.”

The conflicts of interest created by these payments are clear. Yet the medical community has resisted stopping this flow of cash, arguing that industry payments do not harm patients and may even have benefits. Few serious efforts have been made to rein in this practice. We believe stronger action — a total ban on drug industry payments to physicians — is needed. Now.

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Opinion: Replace the ‘cold steel’ of hospital-bed shackles with the warmth of compassion

19 hours 33 min ago

“Why do they have that cold steel on my son’s ankle?”

The father of Jacob Blake, a 29-year-old Black man who was newly paralyzed from the waist down, wanted to know why his son was shackled to his hospital bed. Jacob Blake had been shot in the back seven times by police in Kenosha, Wis., and the bullets had severed his spinal cord. He was absolutely no flight risk, yet a police officer had cuffed him to the bed.

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‘Already in short supply’: How climate change could chip away at sleep health

19 hours 37 min ago

In October 2015, Nick Obradovich was living in San Diego when an intense heatwave smothered Southern California, with temperatures spiking to 99 degrees during the day and hovering in the mid-70s at night — nearly eight degrees warmer than an average October.

“I was hot and grumpy,” he said. “I just wasn’t getting much sleep with the nights not getting as cool as they normally would be.”

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AstraZeneca’s confusing vaccine data, biotech in 2021, and a guide to the ASH conference

Thu, 12/03/2020 - 13:38

Can too much Covid-19 vaccine be a bad thing? Is biotech in a bubble? And how do you make blind mice see again?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. Georgetown virologist Angela Rasmussen joins us to break down AstraZeneca’s confusing Covid-19 vaccine data and what they might mean for the future of the pandemic. Then, longtime healthcare investor Adam Koppel calls in to offer some predictions for how 2021 will play out in biotech. Finally, we bring you a non-Covid lightning round, with the latest in hematology, a coup for AI in biology, and a breakthrough in aging research.

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CDC advisory panel’s lone dissenter on why long-term care residents shouldn’t receive Covid-19 vaccine first

Thu, 12/03/2020 - 12:58

When a Centers for Disease Control and Prevention advisory committee voted Tuesday to recommend residents of long-term care facilities should be at the front of the line — with health care providers — for Covid-19 vaccines, the lone dissenting voice came from a researcher who studies vaccines in older adults.

Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population.

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STAT+: With growing usage and few generics, Medicare spending on inhalers is climbing

Thu, 12/03/2020 - 12:15

Over a recent seven-year period, Medicare Part D spending on inhalers used to control respiratory problems increased $2 billion, or a whopping 44%, as more people used the devices, according to a new study. However, a lack of lower-cost generic options has also allowed prices to remain high.

From 2012 to 2018, the federal health care program spent $39.7 billion — adjusted for inflation and discounts — on inhalers to help plan beneficiaries combat asthma and chronic obstructive pulmonary disease, or COPD. By 2018, the nine different classes of inhalers accounted for nearly 5% of roughly $120 billion in overall spending by the Part D plan after rebates and other discounts.

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Public health experts are pressuring Biden to include health expertise in his Cabinet

Thu, 12/03/2020 - 11:41

Prominent public health experts are pressuring President-elect Biden and his team to include a doctor or experienced health professional in the Cabinet — and growing increasingly alarmed this week that their warnings will go unheeded.

Several former state and local health officials, leaders of public health advocacy groups, and representatives from physician groups have placed calls to contacts advising Biden, drafted formal correspondence to the transition, or, in the case of numerous physician groups, worked to draft open letters stressing the necessity for Biden to appoint high-ranking officials with medical expertise.

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STAT+: Pharmalittle: FDA’s Hahn defends Covid-19 vaccine vetting; U.K. denies cutting corners to approve Pfizer shot

Thu, 12/03/2020 - 06:30

Top of the morning to you, and a fine one it is. Sunny skies and cool breezes are enveloping the Pharmalot campus, where the short person is, once again, hovering over a laptop and the official mascot is happily snoozing in a corner. All of which means we are able to focus on the tasks at hand. First up is brewing another cup of stimulation. Our choice today is cinnamon dolce. Feel free to join us. Meanwhile, here are a few items of interest to get you going. We hope today is productive and enjoyable. Meanwhile, stay in touch and stay safe — wear a mask. …

Food and Drug Administration Commissioner Stephen Hahn defended his agency’s vetting process for the Pfizer (PFE) Covid-19 vaccine, saying a thorough and meticulous review is needed to assure a skeptical public of safety and effectiveness, The Wall Street Journal tells us. Hahn maintained the agency has had 150 people working days, nights and weekends in parallel teams to review the test data submitted. His comments came on the day that U.K. regulators cleared the Pfizer vaccine for general distribution.

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STAT+: Steered by a former Uber Health exec, a new startup aims to bridge in-home care and telemedicine

Thu, 12/03/2020 - 06:00

Telemedicine has become a lifeline during the Covid-19 pandemic, but it is not enough help for many patients whose medical needs demand in-person care.

It is that yawning gap in service that ex-Uber Health leader Dan Trigub and partner Inna Plumb are targeting with a new company called MedArrive, which was launched out of stealth mode Thursday. The startup will use paramedics and EMTs to deliver home-based care — from vaccinations and diagnostic testing to fall prevention —  under the remote supervision of physicians. It plans to begin providing services early next year.

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Opinion: Extending health care to all ethically and practically: lessons from Covid-19

Thu, 12/03/2020 - 05:49

The long-standing debate over whether health care is a right or a privilege seems particularly heartless during a global pandemic. Guided in part by aftereffects of the pandemic, we believe there is a straightforward way to equitably resolve this contentious issue.

The Affordable Care Act essentially claimed that health care is a right and should be accessible to everyone. Those who believe it is a privilege argue that while it may be beneficial, there is no moral wrong done if an individual does not have health care, and there is no obligation to help people obtain health care if they aren’t able to gain access to it by themselves.

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Opinion: A better way to roll out Covid-19 vaccines: Vaccinate everyone in several hot zones

Thu, 12/03/2020 - 01:40

Dear CEOs of Pfizer, Moderna, and AstraZeneca,

Thank you for rapidly mobilizing your scientific resources and your vaccine clinical trial networks. (We also thank Operation Warp Speed and others for organizing and underwriting your efforts to tame Covid-19.)

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Opinion: Make science bipartisan again

Thu, 12/03/2020 - 01:35

The Biden-Harris administration faces daunting challenges. Chief among them is tackling the Covid-19 pandemic and bending the case curve. This challenge cannot be met, let alone overcome, without a national plan plus substantial new investment in public health, science, and technology. And it will require prioritizing science over politics.

The recent election was particularly divisive. Those who have been elected or reelected now have a responsibility to heal the nation — not only from the pandemic but also from the bitter partisan divide.

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‘There absolutely will be a black market’: How the rich and privileged can skip the line for Covid-19 vaccines

Thu, 12/03/2020 - 01:30

Bill Lang didn’t get much of a break over Thanksgiving. Almost every day last week, the medical director at a high-end concierge medical practice, WorldClinic, heard from clients asking when a Covid-19 vaccine would be available.

Two patients even texted on Thanksgiving day. “Since then, I’ve had at least three texts or calls every day just asking, ‘When do you think I can get a vaccine?’” said Lang, who is based in Washington, but also speaks with patients across the U.S. and internationally.

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