Tue.Oct 17, 2023

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Measuring the long-term cost of restricting abortion access

STAT

When Diana Greene Foster and her team at the University of California, San Francisco, started their study on the lives of women who were denied abortions in 2008, they sought to investigate a rather commonly held view: That having an abortion hurt women’s mental and physical health, including by leading to PTSD and drug and alcohol use disorder.

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AMCP Session Provides Updates on PBM Reform Efforts Currently Stalled in Congress

Pharmacy Times

Reform efforts to consider how health care plans may capitalize on disclosures, balancing out-of-pocket spending access, and how pharmacists can help plan members with the increased transparency of pharmacy benefit managers.

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STAT+: How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse

STAT

Lotte Bjerre Knudsen was still getting used to all the empty benches in her lab when she ran into a tall man with black wide-framed glasses in the hallway: Mads Krogsgaard Thomsen, the new head of research at the Danish drugmaker Novo Nordisk, and her new boss. He was just one of many changes she had found upon returning from maternity leave earlier that week — along with the departures of nearly every colleague with whom she had spent the last three years struggling to create a potential

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PhRMA, industry players urge Supreme Court to overturn abortion pill restrictions

Fierce Pharma

If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.

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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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STAT+: It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials

STAT

The Food and Drug Administration should halt Cassava Sciences’ ongoing clinical trials in Alzheimer’s disease. That, and other thoughts on the fallout from the City University of New York investigation that raised serious doubts about the science underpinning the company’s experimental drug simufilam. Patient safety is paramount to the FDA, so stopping Cassava’s two Phase 3 studies is the ethically correct thing to do.

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Amazon Pharmacy's drone delivery service lifts off with initial service in College Station, Texas

Fierce Healthcare

SEATTLE—Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday. | SEATTLE—Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.

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ESMO: J&J's Rybrevant combo beats Tagrisso on lung cancer progression. Should AZ worry?

Fierce Pharma

Editor's note: This is an evolving story. Please check back on Oct. 23 when the full data of MARIPOSA are presented at ESMO 2023. | A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.

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FDA Approves Pembrolizumab Resectable Non–Small Cell Lung Cancer

Pharmacy Times

Pembrolizumab (Keytruda) gains its sixth approval in non–small cell lung cancer (NSCLC), with the latest indication in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a monotherapy for the post-surgical adjuvant treatment of patients with resectable NSCLC.

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Breast cancer is deadlier for Black women. A study of mammograms could help close the gap

STAT

Are 3D  mammograms  better than standard 2D imaging for catching advanced cancers? A clinical trial is recruiting thousands of volunteers — including a large number of Black women who face disparities in breast cancer death rates — to try to find out.

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FDA to Create Digital Health Advisory Committee By 2024

Pharmacy Times

The committee will help the FDA address issues related to digital health technologies, including artificial intelligence, virtual reality, cyber security, and patient-generated health data.

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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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After long fight, Ardelyx finally bags FDA approval for chronic kidney disease med Xphozah

Fierce Pharma

The third time’s the charm for Ardelyx and its chronic kidney disease med Xphozah (tenapanor). | After the FDA requested more data in 2021, Ardelyx instead defended its drug's profile through two appeals and an advisory committee meeting. Now, the company can celebrate a long-awaited win.

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The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

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Many payers expect IRA to have negative impact on Part D plans

Fierce Healthcare

Changes to the Medicare Part D program—including capping insulin copays and out-of-pocket spending and eliminating the 5% coinsurance requirement for the catastrophic phase—from the Inflation Reduc | A survey of health plans gave further insight into how Medicare Part D will change following the implementation of the Inflation Reduction Act.

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Watch: A conversation with the 2023 STAT Wunderkinds

STAT

E ach year, STAT sets out to celebrate the unheralded heroes of science and medicine, poring over hundreds of nominations from across North America in search for the next generation of scientific superstars. This year’s class of 28 Wunderkinds were selected from more than 170 brilliant researchers. In this video, we chat with Ahmed Ahmed, who studies the impact of unionization on health care workers; Josh Tycko, who’s focused on epigenetic editing; Kristine Chua, who studies how bi

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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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More internal medicine, family practice doctors left the workforce in past 2 years than other specialties, report finds

Fierce Healthcare

More internal medicine, family practice doctors left the workforce in past 2 years than other specialties, report finds dmuoio Tue, 10/17/2023 - 16:27

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Point-of-Care Testing Offers New Opportunities for Pharmacy Technicians

Pharmacy Times

Becoming experts in medical billing for point-of-care testing offers a new avenue for technicians to excel and show their value.

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STAT+: When Medicare paid doctors differently, fewer patients had heart problems

STAT

WASHINGTON — Doctors lowered the incidence of heart disease and strokes among their patients when Medicare rewarded them for focusing on sicker patients, according to research of a pilot program released Tuesday in the Journal of the American Medical Association. The pilot program didn’t increase overall costs at all. The five-year pilot program is one of many that Medicare has run since the Affordable Care Act created an office to test whether Medicare payment policies can influen

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Clinical Overview: Lecanemab Offers Hope for Patients With Alzheimer Disease

Pharmacy Times

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody that targets amyloid plaques, which are thought to play a role in the development and progression of Alzheimer disease.

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Focussing on finding value in health sciences marketing

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with life sciences advisor Randall Hein, CEO of Heinsight LLC, and health sciences marketing expert Krystle Buntemeyer, CEO of SCORR Marketing, about the trends and changes for health sciences marketing over the past few years.

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Elevar commits $600M+ to take Hengrui's liver cancer cocktail to market in US and beyond

Fierce Pharma

As Elevar Therapeutics and Hengrui Pharmaceuticals await an FDA decision on their combination therapy for newly diagnosed unresectable liver cancer—approved in China back in February—the partners a | As Elevar Therapeutics and Hengrui Pharmaceuticals await an FDA decision on their combination therapy for newly-diagnosed unresectable liver cancer—approved in China back in February—the partners are lining up a new global commercialization pact.

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Novo Nordisk stops trial of Ozempic in kidneys as interim analysis shows success

Pharmaceutical Technology

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

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DSN Top Women 2023 agenda, speaker lineup set

Drug Store News

Deborah Gilboa, MD, will deliver the keynote as retailers—including Ulta Beauty, Costco, Publix, Meijer, CVS, Rite Aid and Family Dollar—and suppliers round out the sessions and panel discussions.

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Kaiser Permanente agrees to $200M settlement after investigation reveals 'several' behavioral care deficiencies

Fierce Healthcare

Kaiser Permanente’s insurer arm has agreed to a $200 million settlement over “deficiencies in the plan’s deliver and oversight of behavioral healthcare” to its members, the California Department of | An investigation launched last year by a California regulator uncovered a laundry list of shortcomings related to plan enrollees' behavioral care.

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The Value of a Pharmacy Technician

Pharmacy Times

Pharmacy Technician Day celebrates the myriad contributions of the unsung heroes of health care.

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Lilly, AbbVie, BMS and more rally against UK's 'arbitrary' growth cap on branded drug market

Fierce Pharma

Even as pharma giants try to get a handle on the Inflation Reduction Act in the U.S., drug pricing tensions continue to flare overseas. | With the U.K. working to tweak the Statutory Scheme for branded medicines, the Association of the British Pharmaceutical Industry is making its discontent known—and it’s managed to rally more than 20 major drugmakers to its cause.

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10 ways to get rid of a dry cough

The Checkup by Singlecare

If you’ve ever had a dry cough, you know how irritating it can be. Dry coughs can be uncomfortable and distracting and can make it difficult to get a good night’s sleep. If you’ve had this nagging type of cough that won’t go away, it’s likely you’ve wanted a way to treat it fast. Unlike productive, wet coughs, which cause mucus to come up, dry coughs are unproductive coughs ,when you cough without mucus or phlegm.

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NICE recommends Roche biologic for lymphoma

European Pharmaceutical Review

In final guidance , the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma. NICE’s recommendation coincides with the Medicines and Healthcare Products Regulatory Agency (MHRA) granting a licence for glofitamab” The bispecific monoclonal antibody (BsAb) treatment is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.

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Sigma Beauty, Disney collaborate on Beauty and the Beast collection

Drug Store News

The limited-edition collection, inspired by characters, songs and moments from the film, features eyeshadow palettes, a makeup brush, a matching beauty bag, a cheek palette and lip creams.

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STAT+: Revenue cycle management company Waystar files for IPO

STAT

Revenue cycle management company Waystar filed for an initial public offering Monday with the Securities and Exchange Commission. The company did not specify how many shares it plans to offer or what share price it is targeting. Previous reports have pegged the company’s potential valuation at $8 billion, which would make it larger than competitor R1 RCM, which is valued at a $5.5 billion market cap.

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Retail pharmacy lends a helping hand

Drug Store News

In this latest column, editor-in-chief Nigel Maynard looks at how retail pharmacy has a track record of providing meaningful care to customers, as well as a legacy of charitable giving.

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Leverage Technology for Success in Independent Pharmacy

Drug Topics

Ravi Patel, PharmD, MBA, MS, discusses the role of artificial intelligence in community pharmacies.

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FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. For example, the applications are New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or a Biologics License Applications (BLAs).

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STAT+: Pharmalittle: People with obesity harmed by exclusion from studies; Teva sues Colorado over ‘unconstitutional’ program

STAT

Rise and shine, everyone, another busy day is on the way. We can tell, in part, because the official mascots are racing about the grounds at top speed and the number of cars and trucks passing outside our window is picking up. But this is to be expected, yes? So as we collect our thoughts about the day ahead, we are firing up the coffee kettle for another cup of stimulation.

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Navigating DSCSA Compliance: Finding the Right Partner

PioneerRx

As you might have heard, there’s been a slight change of plans in the world of DSCSA compliance. On August 30, the FDA announced a “1-year stabilization period.

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