Wed.Jun 18, 2025

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Mark Cuban Cost Plus Drugs, 9amHealth Collaborate to Make Obesity Medications Affordable

Drug Topics

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy Journal Submission of Articles Events Virtual Events Total Pharmacy Solutions Summit Business Business Strategies Patient Services Pharmacy Inv

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FDA to speed reviews for drugs supporting ‘national interests’

PharmaVoice

A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

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Gut Microbiome Composition Could Be Linked With Risk of Cognitive Impairment

Drug Topics

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy Journal Submission of Articles Events Virtual Events Total Pharmacy Solutions Summit Business Business Strategies Patient Services Pharmacy Inv

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STAT+: Gilead won U.S. approval for HIV prevention shot, but when will low-income countries gain sufficient access?

STAT

Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug , the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem. As far as Gilead is concerned, the groundwork exists to meet that goal. Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries.

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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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Elevating Pharmacy Technicians in Community Practice

Drug Topics

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy Journal Submission of Articles Events Virtual Events Total Pharmacy Solutions Summit Business Business Strategies Patient Services Pharmacy Inv

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STAT+: More universities open to private equity deals, and emerging companies turn to new targets

STAT

This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here , and sign up for our morning biotech news roundup newsletter here. Hello all, I have a fresh double shot of espresso in hand, which I’m sure would please my colleague  Ed Silverman , aka Pharmalot. BIO has been busy this year.

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STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service

STAT

LONDON — A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer’s drugs do not justify their high prices, meaning the medicines won’t be made available through the National Health Service. The decision by the U.K.’s cost-effectiveness watchdog reflects how health authorities in different parts of the world have taken different approaches with the drugs, which are the first to have shown they can slow the progression of the dis

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Atogepant Shows Superiority Over Topiramate for Migraine Prevention

Drug Topics

Topline results from a phase 3 trial showed 64.1% of patients on atogepant achieved a 50% or greater reduction in mean monthly migraine days during months 4 to 6.

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Gilead's twice-yearly PrEP drug is cleared by FDA

pharmaphorum

Gilead has FDA approval for a twice-yearly PrEP drug, but could proposed cuts to US funding for HIV prevention programmes hinder its take-up?

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Importance of Skin-Gut Axis Communication in Homeostasis

Drug Topics

The review explored the “emerging” term gut-skin axis and aimed to decipher the bidirectional signaling of the skin and gastrointestinal tract during homeostatic and disease states.

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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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FDA unveils fast-track review path for 'national priorities'

pharmaphorum

FDA Commissioner Marty Makary has revealed a new priority review voucher programme for new medicines deemed to be of national priority for the US

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Midyear Roundup: FDA’s Novel Oncology Drug Approvals in 2025

Pharmacy Times

In the first half of 2025, the FDA approved 7 novel drugs for oncologic conditions, including for non-small cell lung cancer; ovarian cancer; and metastatic, hormone receptor-positive, human epidermal growth factor 2-negative breast cancer.

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Orion and Glykos extend ADC collaboration

Pharmaceutical Technology

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Side effects of Trintellix when starting

The Checkup by Singlecare

Trintellix (vortioxetine) is an antidepressant approved for use in treating major depressive disorder (MDD). It’s usually categorized as a serotonin modulator, which is similar to selective serotonin reuptake inhibitors (SSRIs) but not exactly the same. Trintellix also has a slightly different side effect profile than some other common SSRIs, like Zoloft (sertraline) and Prozac (fluoxetine), often causing less weight gain but more gastrointestinal distress.

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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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AI in Medical Affairs: Revolutionizing Life Sciences with AI-Powered Tools

Viseven

Despite the initial hype settling down, AI remains a hot topic. And it’s not just GenAI in the spotlight, as much of the conversation now focuses on how AI’s broader capabilities can transform the pharmaceutical industry, especially within medical affairs. How will AI reshape this field? What are the risks and challenges? How can AI agents like eVa change medical affairs?

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Genomics to roll out predictive clinical test across UK

Pharmaceutical Technology

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Captain T Cell joins Bayer Co.Lab Berlin to accelerate TCR therapies

Pharmafile

Captain T Cell, a biotech company developing next-generation T-cell receptor (TCR)-based therapies for solid tumours, has announced its selection for Bayer Co.Lab Berlin, a global life sciences incubator. The partnership will support the company’s efforts to advance both autologous and allogeneic TCR-T cell therapy programmes. The news follows Captain T Cell’s win of the ‘Biggest […] The post Captain T Cell joins Bayer Co.Lab Berlin to accelerate TCR therapies appeared first on Pharm

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Nicole Zitterkopf PhD D(ABMM), MPH, MLS(ASCP)

Blog: Ask a Student Pharmacist

Nicole Zitterkopf PhD D(ABMM), MPH, MLS(ASCP) eomizowh Wed, 06/18/2025 - 12:20 Expand all + Expertise Teaching Expertise Coursework design and delivery of undergraduate, graduate, medical, and community education (hybrid, online, f2f, hands-on clinical laboratory, simulation clinical laboratory). Clinical Expertise Executive-level leadership for clinical and anatomic pathology laboratories serving large healthcare organizations (outpatient and urgent/acute care) focused on the creation and execu

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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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The Art of Agility

Pharmaceutical Commerce

The June issue of Pharmaceutical Commerce highlights the importance of embracing agility—and adaptable strategies—to better navigate industry challenges.

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Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

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Eli Lilly genetic medicine acquisition to address cardiovascular risk

European Pharmaceutical Review

Eli Lilly and Company has agreed to acquire Verve Therapeutics, Inc. in a deal set to advance genetic medicines for individuals at risk of cardiovascular disease. This acquisition has a potential total value of up to approximately $1.3 billion. Verve’s lead programme (VERVE-102) involves a potential first-in-class in vivo gene editing therapy.

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Novo Nordisk seeks digital health partners to boost GLP-1RA weight loss outcomes

Pharmaceutical Technology

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UK regulator overhauls medical device regulation

pharmaphorum

Major changes to medical device regulations in the UK have come into force with an overhaul of post-market surveillance requirements.

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Lisata collaborates with GATC Health on drug development

Pharmaceutical Technology

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Guidance creates access gap in UK for GPP drug Spevigo

pharmaphorum

People in England and Wales with rare and severe skin disease GPP are celebrating the news that they will soon be able to access a new therapy

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Proinflammatory SARS-CoV-2 Cytokines Higher in Men Than Women, Causing Heightened Rates of Severe Disease

Pharmacy Times

When infected with SARS-CoV-2, the virus that causes COVID-19, higher levels of proinflammatory cytokines are released in men compared with women, leading to more severe disease.

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EVerZom receives €3m funding from French government to industrialise exosome technology

Pharmafile

EVerZom, a French biopharma company focused on exosome-based therapies, has announced it has received €3m in funding as part of the France 2030 plan, through the ‘Biotherapies and Bioproduction of Innovative Therapies’ call for projects, operated by Bpifrance on behalf of the French government. This will support the industrialisation of its exosome bioproduction platform to […] The post EVerZom receives €3m funding from French government to industrialise exosome technology appe

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Pharma Pulse 6/18/25: The Complexities of Drug Discounting; How Clinical Operations Teams Are Adapting to Oncology Trial Challenges

Pharmaceutical Commerce

Pharmaceutical Commerce connects biopharma executives to insights on business processes, technologies, and strategies for taking approved drugs to market.

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Bristol Myers Squibb to present positive new data on lymphoma treatment

Pharmafile

Bristol Myers Squibb (BMS) has announced positive results from the TRANSCEND FL phase 2 study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory marginal zone lymphoma (MZL). The new data will be presented at the International Conference on Malignant Lymphoma, Lugano, Switzerland, on 19 June, building on data announced in February.

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FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

The FDA Law Blog

By Mark A. Tobolowsky & Michelle L. Butler & Deborah L. Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. As described in the press release and accompanying FAQ , the CNPV program is designed to reduce review time to 1-2 months following final drug applicati

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Welsh biotech Draig emerges with $140m in financing

pharmaphorum

Draig Therapeutics emerged from the shadows this morning with $140m in funding and a quest to develop new therapies for neuropsychiatric diseases

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FDA Voucher Program Provides Shorter Drug Application Review Time

PharmTech

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

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NHS England chair suggests England can learn from European health schemes

Pharmaceutical Technology

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