Sat.Dec 23, 2023 - Fri.Dec 29, 2023

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Slideshow: 2023 Vaccine Approvals

Drug Topics

Vaccine approvals included two immunizations for RSV and a new pentavalent meningococcal shot.

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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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Adverse events increased after hospitals acquired by private equity, study finds

Fierce Healthcare

A hospital’s acquisition by a private equity firm is linked to a rise in adverse events despite the pool of lower risk patients they tend to admit, according to a Medicare Part A claims analysis pu | Hospital-acquired adverse events among Medicare beneficiaries were 25% higher within the three years after a private equity acquisition compared to control hospitals, researchers found when reviewing millions of Part A claims.

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Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. | Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Slideshow: 2023 Biologic Product Approvals

Drug Topics

Biologic approvals ranged from gene therapies for hemophilia A to a cellular therapy to treat type 1 diabetes.

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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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Top 5 Pharmacy Times Pediatrics Articles of 2023

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read pediatrics-related articles on Pharmacy Times in 2023.

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BMS strikes again, with $4.1bn RayzeBio takeover bid

pharmaphorum

Bristol-Myers Squibb makes a foray into the radiopharmaceutical category with a $4.

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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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Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

Fierce Pharma

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. | After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. Shortly before the holiday, Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain hospital meds.

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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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Top 5 Pharmacy Times Oncology Articles of 2023

Pharmacy Times

From newsworthy moments to groundbreaking research, these were the most-read oncology-related articles on Pharmacy Times in 2023.

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Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients

pharmaphorum

Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.

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Opinion: Remembering Betty Rollin, who told her breast surgeon that post-operative appearance mattered to her—and other women

STAT

Women who had undergone disfiguring surgery for breast cancer, according to one surgeon in the 1970s, needed to “stick an old sock in their bra and get on with their lives.” It was this climate that Betty Rollin, then a television correspondent for NBC, entered when she was diagnosed with the disease in 1975. Rollin, who died of voluntary assisted suicide in Switzerland in November at age 87, became a highly visible activist not only for women with breast cancer but also end-of-lif

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Regeneron fends off Viatris' Eylea biosimilar with patent win

Fierce Pharma

Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. | A West Virginia judge found that Viatris' proposed biosimilar stepped on one of the three patents that Regeneron sued over. Shortly after, the company expanded its suit against another biosimilar contender, setting the stage for Regeneron's defense in Eylea's last few months of exclusivity.

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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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Slideshow: 2023 Biosimilar Approvals

Drug Topics

In addition to the numerous adalimumab (Humira) biosimilars that launched this year, multiple new biosimilar products were approved by the FDA in 2023.

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Eisai working on wristband sensor for brain amyloid

pharmaphorum

Eisai and Oita University have developed a machine learning-powered wearable that can predict whether someone is at risk of developing Alzheimer’s disease

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STAT+: Cytokinetics heart drug aficamten succeeds in pivotal study

STAT

An experimental medicine from Cytokinetics significantly improved exercise capacity for patients with a rare, progressive heart disease, the company said Wednesday — a result that compared favorably with a competing treatment from Bristol Myers Squibb. The study enrolled about 300 people with obstructive hypertrophic cardiomyopathy, or HCM, a hereditary disorder that restricts blood flow.

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Unilever set to acquire K18

Drug Store News

Unilever announced the signing of an agreement to acquire biotech hair care brand K18.

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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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FDA warns of rare hypersensitivity reaction due to antiseizure drugs

Pharmaceutical Technology

FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.

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What are potassium-rich foods?

The Checkup by Singlecare

About potassium | Daily intake of potassium | Potassium-rich fruits | Vegetables | Meat and seafood | Nuts and legumes | Other potassium-rich foods | Meal plan Have you ever woken up in the middle of the night with an awful leg cramp or felt faint after a light workout? These may be signs that your body is missing an important mineral: potassium. The good news for those with low potassium levels is that you can find it in many of the foods at your local grocery store.

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Renamed, common liver diseases might get fairer shake at treatment, researchers hope

STAT

A slate of liver diseases got a rebrand this year. Experts hope the change can generate more conversation — and research interest — for conditions that still lack treatments.  A group of over 200 physicians, public health experts, industry representatives, regulatory officials, and patient advocates made the call in a supermajority vote: Non-alcoholic fatty liver disease, or NAFLD, would be renamed metabolic dysfunction-associated steatotic liver disease.

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Insulin Storage and Beyond Use Dates – Free Downloadable PDF

Med Ed 101

We’ve taken the time to create a new free PDF resource. In my practice, I always run into nursing staff and caregivers who are using expired insulin or who are not dating the insulins that are in use. Insulin Storage and Beyond Use Dates Free PDF should be a vital resource designed to help healthcare […] The post Insulin Storage and Beyond Use Dates – Free Downloadable PDF appeared first on Med Ed 101.

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AZ makes another cell therapy play with $1.2bn Gracell buy

pharmaphorum

AstraZeneca agrees a $1.

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7 home remedies for alcohol-induced heartburn

The Checkup by Singlecare

Heartburn can make it feel like your insides are on fire. The painful affliction is a common one, with more than 60 million Americans experiencing the burning pain at least once a month. The condition is most often caused by acid reflux (when stomach acid travels up the esophagus). Over time, persistent heartburn can lead to gastroesophageal reflux disease (GERD)—a chronic form of heartburn—esophageal damage, or cancer.

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STAT+: 3 CRISPR advances to watch in 2024

STAT

Life in the CRISPR lane tends to move at lightning speed. This year saw the first-ever approval of a medicine based on the gene editing technology, barely more than a decade after publication of its first demonstration by Nobel laureates Jennifer Doudna and Emmanuelle Charpentier. The landmark decision paves the way for in vivo therapies, which edit cells inside the body, to reach patients, as well as treatments based on more efficient genome editors with fancier DNA-altering tricks up their sle

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International Delight brings cold foam to the refrigerated aisle

Drug Store News

Available in three flavors—French Vanilla, Caramel Macchiato and Sweet & Creamy—the coffee shop-style foam comes with a topper that both creams and foams coffee.

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BMS wagers $14bn on Karuna’s schizophrenia drug

pharmaphorum

BMS has reached a $14bn agreement to buy Karuna and its KarXT schizophrenia candidate, due for an FDA verdict next September

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What causes lower back pain and black stool? Related conditions and treatments

The Checkup by Singlecare

Lower back pain and black stool causes are not usually connected. Lower back pain is very common and can be caused by poor posture, heavy lifting, osteoarthritis, menstrual cramps, and more. Black stool can be caused by certain medications, foods, or supplements, but it can also be a sign that you’re bleeding from inside your gastrointestinal (GI) tract.

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STAT+: Philips pays $2.4 million for allegedly giving kickbacks to sleep labs

STAT

Philips agreed to pay $2.4 million to settle allegations that the free masks it gave to sleep labs were kickbacks — incentives that encouraged sleep physicians to prescribe Philips’ respiratory care products. The masks, according to a press release from the Department of Justice, were used to diagnose and treat sleep disorders. Philips Respironics, a subsidiary of Philips, allegedly gave out masks from 2016 to 2021.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand. The CAR T cells need to persist in the blood to expand and elicit maximal effect, and there is a correlation between expansion and persistence and response.

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Cytokinetics rockets on positive heart drug trial

pharmaphorum

Cytokinetics rises on report that its aficamten drug improved symptoms in people with rare disease obstructive hypertrophic cardiomyopathy

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How to get Ozempic prescribed for weight loss

The Checkup by Singlecare

Over the past year, it’s been nearly impossible to miss the various news stories and social chatter surrounding Ozempic (semaglutide) and its revolutionary ability to help people lose weight. Ozempic is a brand name for the prescription drug semaglutide, which was originally developed for Type 2 diabetes management. Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent.

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Opinion: Does food as medicine help patients with diabetes? Here’s what a new clinical trial says

STAT

Food-as-medicine programs that address food insecurity and diet-related chronic diseases have drawn widespread attention from policymakers , payers, and health care providers. But what is the evidence that such programs work as intended? Some research suggests that food as medicine can improve health and lower health care costs, but until now there has been little evidence from randomized clinical trials.

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