2023

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

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The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease

STAT

The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder. The new medicine , called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics.

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STAT+: UnitedHealth used secret rules to restrict rehab care for seriously ill Medicare Advantage patients

STAT

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT. The documents, which outline parameters for the clinicians who initially review referrals for rehab care, reveal that many patients enrolled in Medicare Advantage plans were routed for a quick denial based on c

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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How to avoid prednisone withdrawal

The Checkup by Singlecare

Millions of people are prescribed prednisone each year for conditions that range from psoriasis and eczema to multiple sclerosis and rheumatoid arthritis. Prednisone belongs to a class of drugs called corticosteroids (also sometimes called glucocorticoids)—steroids that reduce inflammation in the body by replacing cortisol, a hormone produced in the adrenal glands, and slowing down an overactive immune system.

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CVS Health beats the Street with $2.3B in Q3 profit

Fierce Healthcare

CVS Health beat the Street on both earnings and revenue in the third quarter, reporting $2.3 billion in profit. | By comparison, the company reported a $3.4 billion loss in the third quarter of 2022 as it paid out its part in a global settlement over the opioid crisis.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Quitting alcohol — or even drinking less — reduces risk of oral cavity and esophageal cancer, per new analysis

STAT

Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer. Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American C

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STAT+: Complications spiked 25% in hospitals bought by private equity

STAT

There’s ample evidence that private equity buyouts in health care drive up costs. A new study shows quality declines, too. Hospitals acquired by private equity saw a 25% uptick in adverse events compared with controls, according to a new study released today in the Journal of the American Medical Association. The findings add to an accumulating body of literature underscoring the harm that occurs when financial investors take over health care providers — not only hospitals, but nur

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We wish we’d written that: STAT staffers share their favorite stories of 2023

STAT

It’s time to take stock of the year that was in health and science: the meteoric rise of weight loss drugs , the approval of the first CRISPR-based therapy , the continuing effects of abortion access restrictions after the Dobbs decision, and much more. Below is our annual list of stories that STAT staffers loved, and wish that they had written.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Health data breaches hit an all-time high in 2023

STAT

Odds are, you’ve gotten at least one of the unnerving letters in your mailbox this year: “We’re writing to inform you of a cybersecurity incident,” it might start. It’s the standard notice many health care organizations are required to provide when your protected health information gets exposed — and in 2023, data leaks, hacks, and mishandling led more of them to be delivered than ever before.

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U.S. government spent more on health care in 2022 than six countries with universal health care combined

STAT

American taxpayers footed the bill for at least $1.8 trillion in federal and state health care expenditures in 2022 — about 41% of the nearly $4.5 trillion in both public and private health care spending the U.S. recorded last year, according to the annual report released last week by the Centers for Medicare and Medicaid Services. On top of that $1.8 trillion, third-party programs, which are often government-funded, and public health programs accounted for another $600 billion in spendin

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Pregnant cancer patients often have to terminate. Abortion pill restrictions could make that choice even harder

STAT

WASHINGTON — The patient had already made the agonizing decision to start chemotherapy to address her colon cancer, even though she was 30 weeks pregnant. Within a day, the decisions got harder: her colon perforated, and the pain was excruciating. She would need urgent surgery — and she would have to undergo an emergency C-section immediately.

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After ‘SNL’ skit on sickle cell CRISPR therapy, advocates cite errors and stereotypes

STAT

Mary Brown was sipping coffee at home in Ontario, Calif., Sunday morning when a friend sent a video clip that ruined her breakfast. It contained a skit from “Saturday Night Live” the night before about the new gene therapies for sickle cell disease. In it, workers gather for an office white-elephant-style gift exchange. A white employee, played by Kate McKinnon, gives a Black employee with sickle cell, played by Kenan Thompson, enrollment in “Vertex Pharmaceutical and CRISPR

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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STAT+: In the U.S., scientists see barriers to the development of CAR-T therapies. In Spain, a hospital brews its own

STAT

BARCELONA, Spain — Some of the patients waiting in the oncology ward of a hospital here, with its green-tiled floor and white walls, had arrived for a newfangled remedy for blood cancers, what’s known as a CAR-T therapy. The patients were not here for one of the brand-name medicines — a Kymriah or Yescarta — that have shown the power of these cell-based approaches and helped reap their makers hundreds of millions of dollars.

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Kate Cox is one of hundreds in Texas denied abortions despite serious health risks, data show

STAT

A Texas woman’s unsuccessful legal fight for an abortion on medical emergency grounds drew nationwide headlines in recent days, but her plight is hardly a rare occurrence amid vague and highly restrictive state laws in the post-Roe era. Kate Cox is likely one of hundreds, if not thousands, of Texans who’ve faced a similar struggle this year to get an abortion for medical reasons, according to a STAT review of studies and abortion data from other states.

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NIH panel calls for fewer, better-paid postdocs in bid to halt loss of scientists to industry

STAT

A National Institutes of Health working group on Friday recommended a sizable increase in salaries of postdoctoral researchers and a cap on the length of the position in an effort to secure the future of academia’s research workforce amid an unprecedented exodus of young life scientists to industry. The group called for raising minimum postdoc salaries to $70,000 beginning next year — an increase of more than 20% — and adjusting wages for annual inflation, as well as limitin

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STAT+: Humana used algorithm in ‘fraudulent scheme’ to deny care to Medicare Advantage patients, lawsuit alleges

STAT

Medicare Advantage beneficiaries on Tuesday filed a class-action lawsuit alleging that the health insurance giant Humana illegally used an algorithm to prematurely cut off payment for rehabilitation care after patients suffered serious illnesses and injuries. The suit, filed in U.S. District Court in Western Kentucky, argues Humana’s reliance on the algorithm, known as nH Predict, was part of a fraudulent scheme to reap a windfall by systematically denying claims to desperately ill people

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Gene therapy offered this 7-year-old freedom. The price: a grueling year

STAT

PHILADELPHIA — The meds Shelby Campbell needed for her rare blood disorder stopped working just after her sixth birthday. She lost her appetite and was often doubled over in pain. She continued getting blood transfusions but her doctors struggled to manage side effects that threatened her organs. By the time she turned 7, the doctors told her parents they had to do something — soon.

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Inhaled vaccines could stop Covid infections, monkey studies show

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. Today, we get into why Amy Abernethy is leaving Verily, and why the ongoing reckoning with AI doesn’t necessarily need the voice of Google to chime in. Plus, Jason Mast pops in to give an update on Uniqure’s puzzling approach to presenting trial results.

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Here are the worst biopharma CEOs of 2023

STAT

Pfizer is this year’s anti-Eli Lilly. If David Ricks is the best biopharma CEO of 2023 , then Pfizer CEO Albert Bourla is, unfortunately, the worst. My annual Worst Biopharma CEO list is typically populated with blockheads and scoundrels. That’s not why Bourla is here. The reason is accountability. Strategic missteps , financial miscalculations, and scientific setbacks have plunged Pfizer into a deep crisis.

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STAT+: Pfizer plans to depart BIO

STAT

WASHINGTON — Pfizer has decided to leave the Biotechnology Innovation Organization, according to two sources familiar with the decision. The departure is a blow to BIO, which represents members ranging from small biotech startups to massive pharmaceutical companies. The group on Tuesday announced its new CEO, rare disease advocate and biotech executive John Crowley.

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New gene therapies confront many sickle cell patients with an impossible choice: a cure or fertility

STAT

As a teenager, Marie Tornyenu was always having to explain herself. If it wasn’t the chronic absences that had her doing homework from a hospital bed, it was the quilted blanket she carried with her on the days she could attend class. “It was a running joke that I was like 80 years old,” she said. “I would usually just laugh it off because the alternative was too depressing.

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House passes site-neutral policy, transparency, PBM reform package

STAT

WASHINGTON — The House passed a relatively major health care package late Monday, an end-of-year victory after the same policies had to be yanked from consideration in September because they lacked bipartisan support. Though the package is unlikely to pass the Senate and become law as-is, its advancing through the House does make each included policy more attractive for a potential government funding deal, as lawmakers draw closer to the Jan. 19 deadline to fund the government and extend

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‘Last roll of the dice’ for a near-term HIV vaccine fails

STAT

A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe. The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa. After multiple other high-profile trials failed , a PrEPVacc investigator described the study this summer as “ the last roll of the dice ” for an HIV vaccine until the 2030s.

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STAT+: J&J to emphasize cancer drugs and stop much of its vaccine research

STAT

Eight months into his tenure, Johnson & Johnson’s R&D chief is putting a big emphasis on medicines for cancer, treatment-resistant depression, and autoimmune disease. To sharpen that focus, R&D chief John Reed told STAT that the company is de-emphasizing two areas that have been mainstays for the drug and medical device giant: infectious disease and vaccines, as well as medicines targeting kidney disease and rare eye conditions.

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STAT+: CVS’s new drug payment plan won’t lower patients’ prices, experts warn

STAT

CVS Health is promising to simplify how its pharmacies get paid for drugs. But that doesn’t mean the drugs will get cheaper. The country’s biggest pharmacy chain said it’s switching to a system where pharmacy benefit managers, employers, and other insurers pay for drugs based on the cost of the drug plus a set markup and dispensing fee.

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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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Is the flu shot market a slam dunk for mRNA vaccines? Experts aren’t so sure

STAT

Here are two things that are true. The world needs more effective flu vaccines. And pharmaceutical companies that learned of the vaccine-making power of the messenger RNA platform during the Covid-19 pandemic need new markets for their technology.

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New England Journal of Medicine reckons with its racist past and complicity in slavery

STAT

The New England Journal of Medicine, the world’s oldest continually published medical journal, publicly reckoned with its history and complicity surrounding slavery and racism Wednesday, publishing the first of a series of essays by independent historians on the role the prestigious publication has played in perpetuating racist thinking in medicine that continues to this day.

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Mexico’s activist ‘companion networks’ quietly provide abortion pills and support to U.S. women

STAT

TIJUANA, Mexico — Just over a decade ago, when Crystal Pérez Lira needed an abortion, she had to leave Mexico. The procedure was illegal in her home state of Baja California and so deeply stigmatized that even Pérez Lira supported the procedure only for those who were raped. Until she unexpectedly got pregnant. She traveled to the U.S. for help, walking alone across the border from Tijuana to San Diego, first for a health check and a compulsory ultrasound, and then back for a se

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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

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STAT+: Critics say HCA’s cost-cutting is endangering Appalachian patients — a warning for the whole U.S. health care system

STAT

ASHEVILLE, N.C. — There was the beeping of monitors, the stiff sheets, the sterile smell of the hospital room. Mostly, there was pain. Sharp, relentless pain. Mike Messino was recovering from a successful surgery, but the nerve blocks had worn off. He spent two full hours waiting for a nurse to inject pain medication. When he’d worked in this hospital, he’d made sure patients didn’t wait longer than 15 minutes for that kind of care.

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STAT+: Mayo Clinic to spend $5 billion on tech-heavy redesign of its Minnesota campus

STAT

Mayo Clinic will spend $5 billion to reinvent its flagship medical campus in Rochester, Minn., infusing digital technologies into several new buildings designed to present a 21st-century vision of clinical care, the organization said Tuesday. The project, to include five new buildings with 2.4 million square feet of space, will merge Mayo’s traditional medical services with its increasing investments in artificial intelligence and digital tools.