Drug Topics

FEBRUARY 17, 2023

Senators lobbed harsh criticisms at pharmacy benefit managers during a legislative hearing.

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STAT

FEBRUARY 17, 2023

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

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Drug Topics

FEBRUARY 17, 2023

Two studies found digital therapeutics can help patients manage their type 2 diabetes effectively regardless of race or ethnicity.

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Fierce Healthcare

FEBRUARY 17, 2023

American Telemedicine Association announced 12 telehealth innovators challenge finalists aburky Fri, 02/17/2023 - 11:45

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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.

STAT

FEBRUARY 17, 2023

A recent study of medical error published in The New England Journal of Medicine reached a shocking conclusion about patient safety: Nearly a quarter century after a highly publicized Institute of Medicine report on the prevalence of patient harm sparked vows to cut the rate by half in five years , “in-hospital adverse events” remain so common that they affect roughly one in four patients.

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Drug Topics

FEBRUARY 17, 2023

The launch of Amgen's adalimumab biosimilar Amjevita was just the start of a wave of biosimilars to treat autoimmune diseases.

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The Checkup by Singlecare

FEBRUARY 17, 2023

One in three adults in the U.S. has prediabetes , according to the U.S. Centers for Disease Control and Prevention (CDC). That means 96 million people across America have blood sugar that is higher than normal. Prediabetes, as the name suggests, is the precursor to diabetes—a serious health condition that occurs when your body cannot properly use insulin, the hormone that helps glucose get to your cells and help your body function.

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STAT

FEBRUARY 17, 2023

The shortage of health care workers in Maine, where I live and work, is a harbinger for the struggles the rest of the country will increasingly confront to hire and retain the individuals who make up the backbone of health care. Maine’s population is the oldest in the nation and is tied with Vermont as being the most rural state. Maine’s health care workers are also among the oldest in the country, with many practitioners approaching or even exceeding retirement age.

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Drug Store News

FEBRUARY 17, 2023

An aging population combined with increasing numbers of people diagnosed with chronic diseases are among the top factors set to influence innovation in the generics drug market in 2023.

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ISPE

FEBRUARY 17, 2023

2023 ISPE Facilities of the Future Conference: Cell & Gene Therapies, Facilities Planning, & More Trudy Patterson Fri, 02/17/2023 - 11:36 iSpeak Blog iSpeak 2023 ISPE Facilities of the Future Conference: Cell & Gene Therapies, Facilities Planning, & More Susan Sandler 17 February 2023 The second day of the 2023 ISPE Facilities of the Future Conference in North Bethesda, Maryland, included keynotes addressing various facets of the industry and their impact on future facilities planning and develo

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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

STAT

FEBRUARY 17, 2023

Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator. The companies disclosed Friday that violations of Good Clinical Practice, the international ethical and quality standards used by all clinical researchers, had been found at sites run by an undisclosed trial operator, leading Pfizer and Valneva to drop trial participants at those loca

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The Thyroid Pharmacist

FEBRUARY 17, 2023

A few years ago, I was asked: “If the supplement police came to your house and said you had to give up all but one of your supplements, which supplement would you keep, and why?” My answer: N-Acetyl Cysteine (also known as NAC for short), because it has numerous benefits on multiple body systems! Research has shown that NAC helps to reduce thyroid antibodies.

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Fierce Healthcare

FEBRUARY 17, 2023

Becerra charges insurer claims of Medicare Advantage pay cuts 'categorically false' rking Fri, 02/17/2023 - 10:13

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Insurance 123

STAT

FEBRUARY 17, 2023

SAN DIEGO — Travere Therapeutics, a biotech focused both on treating rare diseases and distancing itself from controversial founder Martin Shkreli, on Friday won accelerated approval for a drug that treats IgA nephropathy, a rare and deadly autoimmune disease that attacks the kidneys and can lead to organ failure. The drug, which will be sold under the name Filspari, is a once-a-day oral tablet that comes in 200-milligram and 400-milligram doses.

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FDA 99

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Pharmacy Management Software

Drug Store News

FEBRUARY 17, 2023

Orserdu (elacestrant) is the first and only treatment specifically indicated for patients with ESR1 Mutations in ER+, HER2- advanced or metastatic breast cancer.

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FDA 98

STAT

FEBRUARY 17, 2023

Nearly 31.2 million seniors and people with disabilities are now enrolled in a private Medicare plan, known as Medicare Advantage, according to new federal government data analyzed by STAT. That total is 7.1% higher than the 29.1 million people who had a Medicare Advantage plan in 2022. Although that annual growth rate is the lowest since 2016, the private plans now catch roughly half of the entire Medicare population.

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European Pharmaceutical Review

FEBRUARY 17, 2023

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase. Giacomo Chiesi, Head of Chiesi Global Rare Diseases stated that symptoms of the disorder include “impaired hearing, speech and mobility that progress from childhood into adulthood.

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FDA 90

STAT

FEBRUARY 17, 2023

The Inflation Reduction Act of 2022 , which includes provisions requiring Medicare to negotiate lower drug prices for some of the United States’ most costly drugs, marks the first time in decades that the pharmaceutical industry has lost a major policy battle. So, as expected, drug corporations are attacking the new law. The industry’s latest red herring ?

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Drug Topics

FEBRUARY 17, 2023

Although contraceptives are widely available, many patients of color still face barriers to access.

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STAT

FEBRUARY 17, 2023

Ginkgo Bioworks CEO Jason Kelly has spent much of the last decade talking to almost anyone who will listen — investors, journalists, TV presenters, congressional committees  — about the importance of biotechnology to the future of, well, just about everything. This year, Kelly will have a chance to advocate more formally. In December, he was named chairman of a new 12-person congressional commission tasked with issuing a set of policy recommendations for how the U.S. governmen

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Fierce Healthcare

FEBRUARY 17, 2023

Optum study: Accountable Medicare Advantage models produce better outcomes, greater efficiency pminemyer Fri, 02/17/2023 - 13:40

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STAT

FEBRUARY 17, 2023

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 is still shaping up. We plan to tackle mounds of paperwork, promenade with the official mascot, catch up on our reading, and hold a listening party with Mrs. Pharmalot (the rotation will include this , this and this ).

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Vaccines 88

Fierce Pharma

FEBRUARY 17, 2023

Blueprint gears up for Ayvakit expansion, with blockbuster sales on the line aliu Fri, 02/17/2023 - 10:17

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Drug Store News

FEBRUARY 17, 2023

Metabolic Daily is a proprietary probiotic supplement that looks to improve the metabolization of sugar and carbohydrates, the company said.

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Fierce Pharma

FEBRUARY 17, 2023

After 3-plus years and multiple FDA approvals, Gilead's cell therapy head Christi Shaw leaving next month esagonowsky Fri, 02/17/2023 - 13:24

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PharmaVoice

FEBRUARY 17, 2023

Jacopo Leonardi’s latest venture is in the burgeoning field of macrophage inhibitors that could target a wide range of cancers.

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Fierce Pharma

FEBRUARY 17, 2023

As HQ move nears completion, Merck finds a buyer for its sprawling Kenilworth campus fkansteiner Fri, 02/17/2023 - 14:41

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STAT

FEBRUARY 17, 2023

A French appeals court has overturned a record fine levied three years ago against Novartis and Roche for allegedly engaging in anti-competitive practices, the second time this month the companies defeated a country’s antitrust authorities. The Autorité de la Concurrence, France’s competition watchdog, had accused Roche and Novartis of abusing their dominant position to sell a drug used to treat age-related macular degeneration to the detriment of an older and cheaper treatmen

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Drug Store News

FEBRUARY 17, 2023

In 2022, private label sales hit a new record, according to the Private Label Manufacturers Association.

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STAT

FEBRUARY 17, 2023

In the aftermath of the Food and Drug Administration’s Aduhelm debacle , the agency’s neuroscience chief Billy Dunn has another controversial approval decision to make. It will once again test his willingness to apply the FDA’s doctrine of “regulatory flexibility” to a medicine with less-than-convincing clinical data.

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Fierce Pharma

FEBRUARY 17, 2023

Apellis wins FDA approval for first geographic atrophy drug fkansteiner Fri, 02/17/2023 - 18:06

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FDA 113

Pharmig

FEBRUARY 17, 2023

Whilst we have seen attendance to online meetings/conferences/webinars increase significantly over the last 3 years or so, there is still nothing better than attending an in-person training course and the benefits this style of training brings to an individual, their team, or their company. The post Benefits of attending in-person practical training courses appeared first on Pharmig.

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STAT

FEBRUARY 17, 2023

Christi Shaw, the CEO of Gilead’s Kite Pharmaceuticals cell therapy unit, is leaving the company, Gilead said Friday in a statement. Shaw, who took the Kite role in July 2019, had previously said that she was inspired to take the role in part by the experience of watching her sister fight cancer. Under her leadership, the once-embattled division, which makes personalized CAR-T treatments for blood cancers, has begun to be a significant contributor to Gilead’s overall business.

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Fierce Healthcare

FEBRUARY 17, 2023

Why Traditional Cybersecurity is Failing Healthcare jpiatt Fri, 02/17/2023 - 16:24

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