Drug Topics

DECEMBER 24, 2023

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

Vaccines 196

Vaccines Immunization 196

STAT

DECEMBER 28, 2023

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

Nursing Homes 145

Nursing Homes Documentation Insurance 145

Fierce Healthcare

DECEMBER 27, 2023

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.

Hospitals 136

Hospitals 136

Fierce Pharma

DECEMBER 27, 2023

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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FDA 131

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.

Drug Topics

DECEMBER 26, 2023

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

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STAT

DECEMBER 29, 2023

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.

Insurance 145

Insurance 145

Fierce Pharma

DECEMBER 27, 2023

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.

Hospitals 118

Hospitals 118

Drug Topics

DECEMBER 25, 2023

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

FDA 112

FDA 112

STAT

DECEMBER 27, 2023

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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The Checkup by Singlecare

DECEMBER 26, 2023

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.

Grocery Stores 111

Grocery Stores Packaging Labelling 111

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.

FDA

Fierce Pharma

DECEMBER 29, 2023

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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Med Ed 101

DECEMBER 27, 2023

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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STAT

DECEMBER 26, 2023

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

Hospitals 145

Hospitals Nursing Homes Insurance 145

Pharmacy Times

DECEMBER 29, 2023

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

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pharmaphorum

DECEMBER 29, 2023

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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The Checkup by Singlecare

DECEMBER 29, 2023

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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Mayo Clinic Compounding 105

STAT

DECEMBER 27, 2023

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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Pharmacy Times

DECEMBER 29, 2023

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

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Drug Store News

DECEMBER 28, 2023

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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The Checkup by Singlecare

DECEMBER 26, 2023

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

DECEMBER 29, 2023

My son Thomas has carried around a needle since he entered kindergarten at the age of 5. That was a big responsibility for a small child to carry an injector loaded with lifesaving epinephrine, but since he was 19 months old, he has worked with our entire family to manage his anaphylactic food allergies, asthma, and eosinophilic esophagitis. We are not alone.

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FDA Hospitals 132

pharmaphorum

DECEMBER 29, 2023

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

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Drug Store News

DECEMBER 27, 2023

The lawsuit claims that UnitedHealth Group and its PBM, OptumRx, have been assessing pharmacy DIR fees in violation of federal antitrust laws and state laws governing contracts.

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The Checkup by Singlecare

DECEMBER 28, 2023

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.

Insurance 104

Insurance Insurance Coverage FDA Documentation 104

STAT

DECEMBER 27, 2023

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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Drug Topics

DECEMBER 25, 2023

Women with PCOS were more likely to begin fertility treatment with ovulation induction compared to those without PCOS.

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Pharmaceutical Technology

DECEMBER 29, 2023

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

FDA 111

FDA 111

The Checkup by Singlecare

DECEMBER 29, 2023

Common creatine side effects | Serious side effects | Side effects timeline | Interactions | Safety warnings | How to avoid side effects | How to treat side effects Creatine is a naturally occurring amino acid that is vital to producing short-burst muscle energy. It’s also vital to brain function, muscle repair, muscle hydration, and the body’s production of hormones, such as estrogen, testosterone, and insulin.

Dosage 94

Dosage Labelling FDA 94

STAT

DECEMBER 28, 2023

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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pharmaphorum

DECEMBER 28, 2023

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

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Pharmaceutical Technology

DECEMBER 28, 2023

J&J has acquired a global license for South Korean LegoChem’s ADC for $100m upfront along with milestone-based payments and tiered royalties.

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European Pharmaceutical Review

DECEMBER 28, 2023

In this exclusive interview, Andreas Harstrick, the Chief Medical Officer of Affimed unveils the potential of innate cell engagers for treating lymphoma. As well as presenting recent findings from the pivotal AFM13-104 study, Andreas also reflects on the challenges encountered and conquered in developing Affimed’s innate cell engager, Acimtamig, which targets CD30 on lymphoma cells and CD16A on NK cells.

Immunization 84

Immunization Chemotherapy Medical Schools FDA 84

STAT

DECEMBER 27, 2023

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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pharmaphorum

DECEMBER 23, 2023

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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FDA 105