Mon.Aug 12, 2024

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Q&A: Unveiling the Current State of PBMs’ Role in Independent Pharmacy

Drug Topics

Tom DePietro, PharmD, owner of DePietro’s Pharmacy in Dunmore, Pennsylvania, discussed the current state of independent pharmacy and the role pharmacy benefit managers play within the supply chain.

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What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

STAT

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.

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Trending Sources

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Get Into Politics or Get Out of Pharmacy

Drug Topics

Our congressional representatives have plenty of interaction with PBM lobbyists. It’s time they hear from patients as well.

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Opinion: The FDA should withdraw approval of more than 400 tainted medicines

STAT

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.

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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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23andMe to launch GLP-1 telehealth offering, shuts down internal drug development business

Fierce Healthcare

Consumer genetic testing company 23andMe sees an opportunity to get in on the weight loss boom. | 23andMe plans to launch a GLP-1 weight loss telehealth membership through its Lemonaid Health platform by the end of the month.

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Merck Discontinues Study Evaluating Vibostolimab/Pembrolizumab Combination for SCLC

Pharmacy Times

The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.

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Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Fierce Pharma

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

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KFF: A look at prior authorization trends in Medicare Advantage

Fierce Healthcare

Prior authorization denials in Medicare Advantage jumped between 2021 and 2022, according to a new analysis from KFF.

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Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy

Fierce Pharma

Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. | Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce

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The politics of health: How elections will impact life sciences

pharmaphorum

Explore how the recent and upcoming elections may impact the field of life sciences and medical technology. Stay informed about the intersection of politics and health advancements.

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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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Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults

Fierce Pharma

Locked in a closely watched respiratory syncytial virus (RSV) vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. | Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.

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MSD adds bispecific cancer antibody via $1.3bn Curon deal

pharmaphorum

MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.

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After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo

Fierce Pharma

Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the U.S., Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with | Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.

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STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? After all, we can only move forward. So what better way to cope than with a refreshing cup or two of stimulation?

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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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Article retractions muddy MDMA waters after FDA denial

pharmaphorum

Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD

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A tough week for MDMA-assisted psychotherapy

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.

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Study Finds Increased Risk of Mental Health Disorders Following Cardiovascular Hospitalization

Pharmacy Times

Risk of developing anxiety or depression is highest within the first year after cardiovascular hospitalization.

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NICE updates on controversial multiple myeloma decisions

pharmaphorum

Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.

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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 Approves Palopegteriparatide for Treatment of Hypoparathyroidism

Pharmacy Times

Palopegteriparatide is a prodrug of parathyroid hormone designed to provide continuous exposure of the hormone over a 24-hour dosing period.

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Daxxify maker Revance agrees to $924M buyout by private skin care company Crown Laboratories

Fierce Pharma

After treading the commercial path alone for the past year and change, Revance Therapeutics, maker of the Botox rival Daxxify, has agreed to fly the Crown Laboratories flag. | Revance and Crown Laboratories—a privately held skin care company with multiple marketed products of its own—are merging, the companies said in a release Monday. Under the deal, which has won the unanimous blessing of Revance’s board of directors, Crown will enter a tender offer to acquire all outstanding Revance stock for

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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FDA approves nasal spray for emergency allergic reactions

The Checkup by Singlecare

There’s a new needle-free treatment option for people at risk for life-threatening allergic reactions. On August 9, the U.S. Food and Drug Administration (FDA) approved neffy, a nasal spray for the emergency treatment of anaphylaxis. It’s the first epinephrine product that does not have to be administered by injection. The approval comes more than three decades after epinephrine was first approved by the FDA for the treatment of anaphylaxis in 1987.

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Pharma Pulse 8/12/24: Balancing Profitability and Mission, Minority Groups Remain Underrepresented in Vitiligo Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Morning Rounds: Getting healthier in the checkout aisle and the alcohol aisle

STAT

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. It’s Brittany subbing for Theresa this fine Monday. Thank you for all of the excellent song recommendations over the weekend. If you want to check out my road trip playlist, you can find it here.

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Pharmacy Deserts are Becoming a National Problem

Pharmaceutical Commerce

A lack of access could shut out patients in need of maintenance drugs for complex conditions.

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Potential Role for IVIG in Treating Systemic Sclerosis With Muscular, Digestive Manifestations

Pharmacy Times

The systematic review summarized all available evidence on the subject, finding that intravenous immunoglobulin could have a role in treatment.

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Maintaining a Specialty Medication Regimen

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

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FDA clears first anaphylaxis nasal spray at second attempt

pharmaphorum

ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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Does Farxiga cause weight loss?

The Checkup by Singlecare

Nearly half of U.S. adults want to lose weight , and many are looking for solutions that can aid them in their journey. Some are turning to Farxiga (dapagliflozin) , a Type 2 diabetes drug that can cause weight loss as a side effect. This medication improves blood glucose levels by removing excess sugar from the body. Farxiga also can reduce the risk of hospitalization from heart failure and slow down kidney disease progression in patients with chronic renal disease.

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Another AIM defection as BiVictriX plans to delist

pharmaphorum

BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.

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New Finding for Diabetic Wounds Has Potential for Use in Developing New Therapeutics

Pharmacy Times

Many patients are unaware of wound complication, so it is valuable for pharmacists to communicate prevention methods with all patients with diabetes.

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M&A is ready to explode, and that’s good news for pharma layoffs

PharmaVoice

Deals driven by obesity meds are fueling an M&A comeback.

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FDA Grants RMAT Designation for KYV-101 to Treat Patients With Progressive Myasthenia Gravis

Pharmacy Times

The autologous, fully human CD19 chimeric antigen receptor T-cell product, KYV-101, is being studied for the treatment of patients with progressive myasthenia gravis.

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