Fri.Nov 17, 2023

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Flu season is approaching, CDC says

STAT

Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday. With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.

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SAEM Clinical Images Series: Pediatric Genitourinary Bleeding

ALiEM - Pharm Pearls

A 4-year-old female with no significant past medical history is brought to the Emergency Department by her grandmother for concern for two days of progressive vaginal bleeding. The grandmother first noted blood in the patient’s underwear the previous morning when she was helping the patient wipe and she noticed it again prior to arrival, this time saturating the patient’s underwear.

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STAT+: Even as Wegovy rides high, interest surges in weight loss drugs that preserve muscle

STAT

Have you ever seen a mouse with a set of muscles more appropriate for a bodybuilder or comic book superhero? Well, 25 years ago, researchers at Johns Hopkins University made it happen. By silencing a gene responsible for producing a protein called myostatin, they directed tiny mouse bodies to grow double the amount of lean muscle they would normally, leading to mice with bulky arms, defined pectorals, and an overall more substantial body mass.

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??A startling drop in U.S. life expectancy — and how pharma could help turn the tide

PharmaVoice

The recently observed dip was particularly acute for men, who now live an average of 5.8 fewer years than women.

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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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Preterm birth and infant mortality measures in U.S. remain stubbornly high

STAT

P reterm births and infant mortality are at alarming levels in the U.S., according to a new report published on Thursday by March of Dimes. In 2022, 10.4% of all babies were born premature — before 37 weeks of gestation — a slight improvement after the decade-high 10.5% peak of 2021, but still higher than the global average of 9.9%. This makes the U.S. the country with the highest risk of preterm birth among its wealthy peers: In the U.K., for instance, the rate is 7.6% ; in Italy,

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NHS trials artificial intelligence system to prevent avoidable admissions

Pharma Times

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

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More Trending

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Navigating Legal Waters: Study Delves into Inequitable Conduct in Drug Patent Cases

Drug Patent Watch

Researchers from West Virginia University College of Law have conducted a study examining the frequency of drug patent invalidations based on inequitable conduct. The findings, published in JAMA, shed light… The post Navigating Legal Waters: Study Delves into Inequitable Conduct in Drug Patent Cases appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Doctors divide over reforming a secretive panel that determines their Medicare pay

STAT

WASHINGTON — Doctors are splitting, specialty by specialty, over whether and how to overhaul a secretive panel that helps determine how much Medicare pays them for their work. Doctors who get paid more by Medicare generally like the way the panel operates now. But doctors who are paid relatively less are looking for ways they say would make the process more fair.

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Guest Post: Five Things You Need to Know About Prediabetes

Putting Patients First Blog

Guest Post: Five Things You Need to Know About Prediabetes November 17, 2023 By: Robert A. Gabbay, MD, PhD, the ADA’s Chief Science and Medical Officer, American Diabetes Association November is American Diabetes Month® (ADM) at the American Diabetes Association® (ADA). This month often focuses on type 1 and type 2 diabetes. However, prediabetes is also a pressing health concern in the U.S.

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STAT+: A digital pill shows early promise in detecting opioid overdose, sleep apnea

STAT

Gathering health data remotely is a pain. Forgetting to slip on a wearable is easy, and hooking yourself up to a large monitor is intrusive. Celero Systems has another idea: What if your remote patient monitor was small enough to swallow? A team of researchers has tested Celero’s device in humans for the first time, successfully capturing heart and respiratory data in 10 patients with sleep apnea.

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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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Micron Biomedical receives funds to produce needle-free vaccines

Pharmaceutical Technology

Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

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Opinion: We tried to quantify how harmful hospital ransomware attacks are for patients. Here’s what we found

STAT

This article is part of a partnership between First Opinion and Tradeoffs, a nonprofit news organization exploring our confusing, costly, and often counterintuitive health care system. To learn more about how ransomware hurts hospitals and patients, listen to a  deeper dive  from Tradeoffs, and  subscribe  to never miss an episode.

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New NIHR Research Delivery Network in England announced by DHSC

Pharma Times

The University of Leeds and NHS organisations will host the network in 2024 - News - PharmaTimes

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STAT+: Biden appoints Vanderbilt oncologist to head National Cancer Institute

STAT

WASHINGTON — President Biden on Friday said he plans to appoint cancer researcher and doctor Kimryn Rathmell to lead the National Cancer Institute. Rathmell will assume leadership of the $7.3 billion agency amid the administration’s efforts to relaunch Biden’s Cancer Moonshot initiative with an emphasis on screening, prevention, and better treatment.

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Training needs for new pharmacy services ‘will vary’

The Pharmacist

Learning needs for community pharmacy teams ahead of the launch of new clinical services this winter are likely to ‘vary quite a lot’ and not all pharmacies will be ready for the proposed start dates, Community Pharmacy England (CPE) has suggested. The negotiator’s director of NHS services, Alastair Buxton, has set out some steps pharmacy […] The post Training needs for new pharmacy services ‘will vary’ appeared first on The Pharmacist.

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STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

STAT

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 rather modest. Besides the usual promenading with the official mascots, we hope to catch up on our reading and manicure the Pharmalot grounds. We may also have time for a listening party with a rotation that would likely include this , this , this , and this.

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Dr Reddy’s rolls out Nerivio, drug-free non-invasive migraine management device, in India

Express Pharma

Dr Reddy’s Laboratories announced the roll-out of Nerivio in India, a state-of-the-art United States Food and Drug Administration (USFDA) approved wearable therapy device for drug-free management of migraine. Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migraine with or without aura [ for adults and adolescents aged 12 years and above.

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The return of biotech’s “bump factor” amid an economic downturn

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a deep dive on a historic moment for genome editing, mixology tips from a biotech lifer, and a look at why scientists are interested in muscle-building drugs.

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The Power of Centralized Distribution in the Face of DSCSA Compliance

Pharmaceutical Commerce

With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficieny.

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EC approves lebrikizumab for atopic dermatitis

European Pharmaceutical Review

The European Commission has approved Ebglyss (lebrikizumab) for atopic dermatitis patients 12 years and older with a body weight of at least 40kg, who are candidates for systemic therapy. Almirall has licensed the rights to develop and commercialise lebrikizumab for the treatment of dermatology indications in Europe. The company said it will launch lebrikizumab in Germany, with further European rollout planned throughout 2024.

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First electronic product information (ePI) published for selected human medicines

World Pharma News

The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a medicine includes its summary of product characteristics, labelling and package leaflet.

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Daiichi Sankyo signs agreement with Japan to supply Covid-19 vaccine

Pharmaceutical Technology

Daiichi Sankyo has signed an agreement with Japan's MHLW to deliver 1.4 million doses of its omicron-adapted mRNA vaccine for Covid-19.

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Lilly plans new $2.5B manufacturing plant as obesity drug demand ramps up

BioPharma Dive

Following the approval of Zepbound, Lilly is adding capacity to avert shortages and restricted access.

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Q&A With Jade Shields, Vice President of Corporate Affairs at Ferring Pharmaceuticals

PharmExec

Shields discusses Ferring’s recent $5 million endowment to the American Society of Reproductive Medicine.

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Trial for novel CGRP migraine medicine gleans positive results

European Pharmaceutical Review

Results from AbbVie’s Phase III study, PRODROME , published in The Lancet showed that UBRELVY ® (ubrogepant) 100mg for acute treatment of migraine significantly reduced the likelihood of development of moderate or severe headache compared to placebo within 24 hours post-dose. This was demonstrated when the calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) was administered during the prodrome phase (ie, one to sixurs before the predicted onset of headache pain) of a migraine a

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Analyzing Risks of Online Marketing for Teeth Whitening Products, Post-COVID

PharmExec

Heliyon study evaluates online information, labeling accuracy, and quantitative analysis of high peroxide content gels.

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Interview: CRO PPD of Thermo Fisher - the processes and difficulties within rare diseases

Outsourcing Pharma

OSP was delighted to speak to Galina Nesterova, executive medical director at the Rare Disease & Pediatrics Center of Excellence, and Susan McCune, vice president of pediatrics and clinical pharmacology both within medical science and strategy at PPD, part of Thermo Fisher. They answered some pertinent questions surrounding rare diseases.

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Simplify and Accelerate Benefits Verification with a Fully Integrated, Adaptable Platform

Drug Channels

Today’s guest post comes from Maria Kirsch, President of Patient Services at EVERSANA. Maria discusses the challenges patients and healthcare providers face accessing specialty therapies. She introduces us to ACTICS ® eAccess , EVERSANA’s technology platform for electronic prior authorization and benefits verification that can be used for both the pharmacy benefit and the medical benefit.

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Frontiers Health 2023: Hakim Yadi, Closed Loop Medicine

pharmaphorum

Frontiers Health 2023: Hakim Yadi, Closed Loop Medicine Mike.

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Prange Group and Adragos Pharma to acquire Fresenius Kabi’s Norwegian manufacturing site

Outsourcing Pharma

Definitive agreements with Fresenius Kabi have been signed by Prange Group and its affiliate Adragos Pharma for its sterile pharmaceutical production site in Halden, Norway.

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Digital health company BehaVR hits the merger trail again

pharmaphorum

Digital health company BehaVR hits the merger trail again Phil.

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Q32 Bio to merge with Homology Medicines

Pharmaceutical Business Review

Homology Medicines will issue shares of its common stock to Q32 Bio stockholders as part of the merger deal , in return for cancelling Q32 Bio’s capital stock. Pre-merger Homology Medicines stockholders are anticipated to own around 25% of the combined company, with the remaining 75% stake expected to be held by pre-merger Q32 Bio stockholders.

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FDA’s Janet Woodcock will step down early next year

pharmaphorum

FDA’s Janet Woodcock will step down early next year Phil.

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New patent for Celgene Intl drug ZEPOSIA

Drug Patent Watch

Annual Drug Patent Expirations for ZEPOSIA Zeposia is a drug marketed by Celgene Intl and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Celgene Intl drug ZEPOSIA appeared first on DrugPatentWatch - Make Better Decisions.

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FDA approves Merck’s Keytruda for gastric cancer treatment

Pharmafile

Merck, known as MSD outside of the US, has announced that the US Food and Drug Administration (FDA) has approved Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.