2023

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Around 14% of Americans Have Experienced Long COVID Symptoms

Drug Topics

Although long COVID has emerged as a major public health concern, it has not yet been clearly identified as a clinical condition.

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AI in Biomedical Research Is Revolutionizing Drug Development, Clinical Innovation

Pharmacy Times

AI is expected to significantly quicken the pace of drug design and development, while improving the success rate of new medicines.

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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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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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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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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

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Researchers Link Inflammation With Long Covid Symptoms in Women

Pharmacy Times

Women with inflammation during COVID-19 infection are at higher risk for Long Covid symptoms, according to study results.

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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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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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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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Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery

pharmaphorum

Talking techbio with NVIDIA: Accelerated computing, NLP, and GenAI in drug discovery Mike.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The FDA Law Blog

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

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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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FDA Approves MDMA for Clinical Trial Use Investigating Schizophrenia

Pharmacy Times

The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.

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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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COVID-19 Infection Could Be Detected in Lungs, Heart, Causing Inflammatory Damage

Pharmacy Times

Investigators found thinner ventricular walls, disorganized and ruptured myocardial fiber, mild inflammatory infiltration, and mild epicardia or interstitial fibrosis in the hearts of mice infected with COVID-19.

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Study: Pandemic Shows Link to Increased Exposure of Opioids to Postpartum Women

Pharmacy Times

Analysis indicates that there was a larger increase of filled prescriptions for individuals who delivered by cesarean birth.

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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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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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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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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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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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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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STAT+: FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma

STAT

The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer. “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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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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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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STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia

STAT

LONDON — Regulators in the U.K. on Thursday approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new phase of genetic medicine.   The authorization of the therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is itself not a surprise.

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STAT+: UnitedHealth faces class action lawsuit over algorithmic care denials in Medicare Advantage plans

STAT

A class action lawsuit was filed Tuesday against UnitedHealth Group and a subsidiary alleging that they are illegally using an algorithm to deny rehabilitation care to seriously ill patients, even though the companies know the algorithm has a high error rate. The class action suit, filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan and their families by the California-based Clarkson Law Firm, follows the publication of a STAT investigation Tuesday.

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STAT+: UnitedHealth pushed employees to follow an algorithm to cut off Medicare patients’ rehab care

STAT

The nation’s largest health insurance company pressured its medical staff to cut off payments for seriously ill patients in lockstep with a computer algorithm’s calculations, denying rehabilitation care for older and disabled Americans as profits soared, a STAT investigation has found. UnitedHealth Group has repeatedly said its algorithm, which predicts how long patients will need to stay in rehab, is merely a guidepost for their recoveries.

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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.

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Life expectancy for men in U.S. falls to 73 years — six years less than for women, per study

STAT

The life expectancy of men in the U.S. is nearly six years shorter than that of women, according to new research published on Monday in JAMA Internal Medicine. At least partially as a consequence of over 1 million Covid-19 deaths, life expectancy in the U.S. has declined significantly over the past few years, falling from 78.8 years in 2019 to 77 in 2020 and 76.1 in 2022 — undoing over two decades of progress.

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Study suggests Covid rebound is far more common with Paxlovid than without

STAT

A small and preliminary study published Monday seems to indicate that patients receiving the drug Paxlovid are far more likely to experience Covid rebound than those who did not take it. That conclusion runs counter to previous statements by Pfizer, which makes Paxlovid, and by researchers at the Food and Drug Administration who have argued that while it is not uncommon for people with Covid to have symptoms reemerge after they seem to have recovered, it is not clear that Paxlovid increases the

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Wegovy cuts risk of heart attacks in milestone cardiovascular trial

STAT

PHILADELPHIA — Novo Nordisk’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardiovascular trial that affirms the treatment offers health benefits beyond weight loss. The company in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%.

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