Fri.Sep 29, 2023

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WHO recommends dropping component of many flu vaccines

STAT

The World Health Organization has recommended dropping a component of many flu vaccines because the viruses it protects against appear to have been driven into extinction in the Covid-19 pandemic. A family of viruses known as influenza B/Yamagata has not been seen since March 2020, when flu circulation worldwide declined to very low levels in the face of the onslaught of Covid and the protections people took to avoid contracting it.

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SAEM Clinical Images Series: Only a Flesh Wound

ALiEM - Pharm Pearls

A 49-year-old male was triaged to the Fast Track area with complaints of an abrasion to the neck following an assault. The patient was attending a party with his family when “someone started shooting.” The patient believes some stucco or stone fragment from a brick wall struck him in the neck during the initial incident, but his primary concern was for his more seriously wounded family members.

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Women spend 20% more per year on out-of-pocket health costs, says report

STAT

Women of all ages pay a total of $15.4 billion more than men on annual out-of-pocket medical expenses, according to a new report from Deloitte. In 2021, that meant that women paid about 20% more than men — only 2% of which could be accounted for by maternity care. The fact that the way benefits are currently designed “puts a disproportionate cost on women, above and beyond maternity, was the thing that really surprised us,” said Kulleni Gebreyes, a physician who runs Deloitt

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3 recent FDA adcomm rejections — and why they matter

PharmaVoice

Decisions that could spell doom for drugs in development and already on the shelves.

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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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Dianne Feinstein’s struggle with shingles reflects the long increase in cases

STAT

The trailblazing life of Senator Dianne Feinstein of California, who died on Friday, covers nearly a century of American history, including changes in health care and medicine. Her struggle with shingles, which sent her to the hospital in February and contributed to the deterioration of her health — leading to encephalitis and facial paralysis — also reflects the great shifts regarding that disease.

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The PharmaVoice 100: Trailblazers

PharmaVoice

Leaders who are going where no biopharma executive has gone before and changing the industry along the way.

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More Trending

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Austrian State Secretary to speak at FlyPharma Europe 2023

Pharma Times

FlyPharma Europe is an event for the pharma logistics industry, connecting professionals from across the globe - News - PharmaTimes

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Opinion: AI-driven data analysis could exacerbate misaligned incentives in biomedical research

STAT

This summer OpenAI released Code Interpreter , a plug-in for the popular ChatGPT tool that allows it to take in datasets, write and run Python code, and “ create charts, edit files, perform math, etc. “ It aims to be nothing short of the ideal statistical collaborator or research software engineer, providing the necessary skill and speed to overcome the limitations of one’s research program at a fraction of the price.

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Millions wrongly labelled allergic to penicillin, warns RPS

The Pharmacist

Millions could be missing out on the most effective antibiotic choice because they mistakenly believe they are allergic to penicillin, prolonging their recovery and even leading to hospital admission. The warning comes from the Royal Pharmaceutical Society (RPS) as it launches a new checklist for pharmacists to help inform conversations with patients about penicillin allergy. […] The post Millions wrongly labelled allergic to penicillin, warns RPS appeared first on The Pharmacist.

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STAT+: Sales from controversial drug discount program rose to $54 billion last year

STAT

Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $53.7 billion in 2022, an 18% increase from the previous year, according to the U.S. Health Resources & Service Administration, which oversees the program. The latest data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — of all outpatient drug

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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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NHS medicines access in jeopardy says ABPI

Pharma Times

Review raises concerns about approach taken by the DHSC regarding changes to Statutory Scheme - News - PharmaTimes

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STAT+: Unitaid slams J&J over pricing and patents for a tuberculosis drug

STAT

In a highly unusual move, Unitaid has publicly criticized Johnson & Johnson over its pricing and patenting policies for a key drug used to combat tuberculosis. The global health organization released a letter urging the company to drop so-called secondary patents for its medicine, known as bedaquiline, and to make negotiated prices for the drug available to all countries, regardless of existing arrangements for making purchases.

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PTC to lay off more staff following drug setback in Europe

BioPharma Dive

The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.

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STAT+: Generic makers fall short when providing access to low- and middle-income countries, analysis finds

STAT

A handful of the largest purveyors of generic medicines have made only halting progress to ensure their drugs are accessible for patients in low- and middle-income countries, a new analysis found. For instance, just one of 50 different treatments marketed by these companies — Teva Pharmaceuticals, Sun Pharmaceutical, Cipla, Hikma Pharmaceuticals, and Viatris — had a pricing strategy in place that considered a patient’s ability to pay.

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Sector condemns exclusion of pharmacists during Covid-19 pandemic

The Pharmacist

Excluding pharmacists from benefits available to healthcare workers during the pandemic was ‘shocking’ and ‘disappointing’, sector representatives have told the national Covid-19 public inquiry. Submissions from the National Pharmacy Association (NPA) and the Royal Pharmaceutical Society (RPS) also highlighted the ways that community pharmacists helped protect vulnerable patients during the pandemic.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Structure boosted by early data for experimental obesity drug

BioPharma Dive

Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.

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Chemo-free regimen demonstrates efficacy in NSCLC

European Pharmaceutical Review

Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ). This is based on positive topline results for Rybrevant ® (amivantamab-vmjw) in combination with lazertinib, as first-line anti-cancer treatment in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).

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Adlai Nortye IPO gives old Novartis cancer drug new life

BioPharma Dive

The biotech is using the proceeds to bankroll Phase 3 testing of a drug the Swiss pharma studied widely before selling it off for cheap a few years ago.

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Karuna Therapeutics files for FDA approval for schizophrenia treatment

Pharmaceutical Technology

Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.

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Half a million people register organ donation status via NHS App

The Pharmacist

More than half a million people have registered their organ donation decision for the first time via the NHS App, new data has shown. According to NHS England, 546,825 organ donation decisions have been registered for the first time through the NHS App, up 22% from 448,562 last August. The data – which has been […] The post Half a million people register organ donation status via NHS App appeared first on The Pharmacist.

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AI-supported spectroscopy delivers superior pharmaceutical packaging QC

European Pharmaceutical Review

A paper published in the IEEE Sensors Journal has demonstrated 100 percent inline pharmaceutical packaging content verification by combining standard diffuse reflectance MOEMS-EC-QCL spectroscopy with artificial intelligence (AI). It described how a quantum cascade laser (QCL)-based blister-verification sensor with verification via backscattering mid-infrared (IR) spectroscopy substance chemical identification can support blistering machines to achieve a better inline content verification.

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More Than a Feeling: Five Key Challenges When Walking Away From Commercial/340B Duplicate Payments

Drug Channels

Today’s guest post comes from Micah Litow, Chief Operating Officer at Kalderos. According to Kalderos, at least 5% of commercial rebates are paid for prescriptions that also have discounts under the 340B Drug Pricing Program. Micah outlines why it's more than a feeling that manufacturers struggle to walk away from these duplicate payments. But as he explains, reliable data is crucial to avoid hearing that old song that PBMs play.

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FDA approves first-in-class antidepressant

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). Oral selective serotonin (5HT) 1a receptor agonist Exxua is the first approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion.

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The future of cancer care: Fast-tracking sustainability, access, and innovation in the Middle East

pharmaphorum

The future of cancer care: Fast-tracking sustainability, access, and innovation in the Middle East Mike.

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Hutchmed cancer drug set to enter Japanese market through Takeda

Outsourcing Pharma

Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.

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All About the Journey

Pharmaceutical Commerce

A reflection on my time with Pharma Commerce thus far, and a plan of action for moving the brand forward.

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Prescription for success: How creativity is the secret ingredient in pharma marketing

pharmaphorum

Prescription for success: How creativity is the secret ingredient in pharma marketing Mike.

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Kura Oncology shares preclinical data for NSCLC treatment

Pharmafile

Kura Oncology has shared positive preclinical data which supports the development of its next-generation farnesyl transferase inhibitor (FTI) KO-2806 in combination with KRASG12C inhibitors for the treatment of non-small cell lung cancer (NSCLC). The findings of this data have been presented at the 5th RAS-Targeted Drug Development Summit in Boston, US.

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Biogen shuts digital health unit and exits Apple alliance

pharmaphorum

Biogen shuts digital health unit and exits Apple alliance Phil.

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New patent for Cmp Dev drug LIQREV

Drug Patent Watch

Annual Drug Patent Expirations for LIQREV Liqrev is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are two… The post New patent for Cmp Dev drug LIQREV appeared first on DrugPatentWatch - Make Better Decisions.

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We Have an LDT Proposed Rule!

FDA Law Blog: Biosimilars

By McKenzie E. Cato & Allyson B. Mullen & Gail H. Javitt — It’s the moment we’ve all been waiting for , dreading , anticipating. Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a 60-day comment period for stakeholders.

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New patent for Avadel Cns drug LUMRYZ

Drug Patent Watch

Annual Drug Patent Expirations for LUMRYZ Lumryz is a drug marketed by Avadel Cns and is included in one NDA. It is available from one supplier. There are thirteen patents… The post New patent for Avadel Cns drug LUMRYZ appeared first on DrugPatentWatch - Make Better Decisions.

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Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

Pharmafile

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia. The NDA submission is supported by safety and efficacy data from the EMERGENT programme which assessed KarXT as a treatment for schizophrenia. This programme includes three […] The post Karuna Therapeutics submits NDA to FDA for schizophrenia treatment appeared first on Pharmafile.

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MSD eyes March FDA decision on PAH drug sotatercept

pharmaphorum

MSD eyes March FDA decision on PAH drug sotatercept Phil.

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