STAT

JUNE 24, 2024

Since Texas’ ban on abortion went into effect, infant deaths in the state increased by nearly 13%, according to a new analysis published on Monday in JAMA Pediatrics. In the rest of the country, infant mortality increased less than 2% over the same period. “We had read the literature that was showing an association [of infant death increases] with prior abortion restrictions or states that are hostile to abortion,” said lead author Alison Gemmill, a demographer and perinatal

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PharmaVoice

JUNE 24, 2024

With a career focused on striking deals, Kaan Cartel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.

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STAT

JUNE 24, 2024

Bird flu snapshot: This is the second installment in a series of regular updates on H5N1 avian flu that STAT is publishing on Monday mornings. To read future updates you can also subscribe to STAT’s Morning Rounds newsletter. As the H5N1 outbreak in dairy herds approaches the three-month mark, America’s top animal health official is calling on farmers to step up the use of personal protective equipment, limit traffic onto their farms, and increase cleaning and disinfection practice

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pharmaphorum

JUNE 24, 2024

Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.

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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.

STAT

JUNE 24, 2024

Alnylam Pharmaceuticals said Monday that its treatment for an increasingly common heart condition cut the risk of death and recurrent cardiovascular complications in a key Phase 3 study, paving the way for the likely approval of the drug. Specifically, on that composite primary endpoint, the drug, called vutrisiran, reduced the risk by 28% compared with placebo in the overall trial population, which included some people who were already taking a treatment for the disease considered the standard

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Labelling 360

Drug Patent Watch

JUNE 24, 2024

The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route.

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Drug Development 105

Pharmaceutical Technology

JUNE 24, 2024

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

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Compounding 105

STAT

JUNE 24, 2024

WASHINGTON — He hardly seems the part of the telehealth industry’s public enemy No. 1. He’s unassuming, self-effacing, soft-spoken, with the bearing of a professor. But as telehealth lobbyists seize on this moment years after pandemic lockdowns to win new protections and incentives from Capitol Hill, Ateev Mehrotra is the industry’s chief critic — determined to warn congressional committees that the booming virtual care business comes with tradeoffs.

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pharmaphorum

JUNE 24, 2024

Fenofibrate, a decades-old drug used to lower cholesterol levels, has been shown to reduce the progression of diabetic retinopathy in a large-scale trial.

Diabetes 110

Diabetes 110

STAT

JUNE 24, 2024

When a new medical device hits the market, there’s typically still some uncertainty about whether it works. Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world.

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Hospitals 314

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pharmaphorum

JUNE 24, 2024

Daiichi Sankyo has a second approval in Japan for Ezharmia, its first-in-class dual EZH1 and EZH2 inhibitor, as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL).Ezharmia (valemetostat tosylate) remains the first and only drug in the class to be approved for marketing around the world, having been cleared in Japan in 2022 for relapsed or refractory adult T-cell leukaemia/lymphoma (ATL).

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STAT

JUNE 24, 2024

It’s been two years since America’s highest court removed a constitutional right — for the first time in history — that Americans have relied on for almost 50 years. Its Dobbs decision opened a Pandora’s box of attacks on reproductive care. On June 24, 2022, six Supreme Court justices decided to legislate from the bench, overturning Roe v.

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Express Pharma

JUNE 24, 2024

Lupin announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility in Somerset, New Jersey, with a Voluntary Action Indicated (VAI) status. The facility was inspected from May 7 to May 17, 2024. “We are very pleased to have received the EIR with a satisfactory VAI status for our Somerset facility.

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STAT

JUNE 24, 2024

The results of a randomized controlled trial published Monday showed oral ketamine tablets were safe and effective for patients with treatment-resistant depression — the latest attempt by researchers to rigorously evaluate psychedelic drugs’ role in treating conditions like depression, anxiety and post-traumatic stress disorder. In the Phase 2 trial, the results of which were detailed in Nature Medicine , patients who took extended release ketamine tablets at an 180mg dosage twice

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Dosage 272

Pharmaceutical Commerce

JUNE 24, 2024

A study examines the economical validity of using this therapy as a treatment for unresectable stage III non–small cell lung cancer.

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STAT

JUNE 24, 2024

Good morning, everyone, to another working week. We hope the weekend respite was relaxing and inspiring, because that oh-so familiar routine of online meetings, deadlines, and what-not has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or more of stimulation.

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Diabetes Packaging 274

The Pharmacist

JUNE 24, 2024

A ‘quantity of controlled drugs’ have been reported stolen from a pharmacy in South Devon, after a break-in during the early hours of the morning. Police were called at around 1.25 am to the Well Pharmacy branch in Churchill Court, Brixham, on Wednesday 19 June. The burglars caused damage and gained entry to the pharmacy, before […] The post Controlled drugs reported stolen from Devon pharmacy appeared first on The Pharmacist.

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STAT

JUNE 24, 2024

VALLETTA, Malta — The most sweeping corruption trial in the history of this Mediterranean country kicked off with a former prime minister and a host of top government officials parading through a phalanx of police into a courthouse. Hundreds of onlookers crammed narrow cobblestone streets, some screaming of their distrust in the government and disdain for the men who allegedly used their power to line their pockets.

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Hospitals 269

pharmaphorum

JUNE 24, 2024

Alnylam shares spike after vutrisiran aces HELIOS-B trial in ATTR-cardiomyopathy, setting up regulatory filings

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STAT

JUNE 24, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. On top of today’s Alnylam news, we have Congress gearing up to vote on Medicare coverage for multi-cancer screenings and obesity drug coverage. Also, updates on Vertex’s type 1 diabetes cell therapy, and a push for phage therapy.

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Diabetes Drug Pricing Drug Development 252

pharmaphorum

JUNE 24, 2024

Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer

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Pharmaceutical Technology

JUNE 24, 2024

Big pharma and their packaging partners are collaborating to cut emissions and deliver more sustainable solutions for injectables.

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Packaging 95

Express Pharma

JUNE 24, 2024

Sun Pharma announced the successful completion of the merger of Taro Pharmaceutical Industries with its subsidiary. As part of this merger, Sun Pharma acquired all outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates. As a result of the merger, Taro is now a private company and wholly owned by Sun Pharma.

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pharmaphorum

JUNE 24, 2024

Novo Nordisk boosts manufacturing capacity for GLP-1 drugs again, unveiling a $4.

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European Pharmaceutical Review

JUNE 24, 2024

SGS customers now have easier access to biopharmaceutical insights as the Birsfelden, Switzerland lab adds a stability studies service. The lab now offers reliable, cost-efficient stability testing, including sample storage and related analytical services under controlled conditions, adhering to ICH Q5C guidelines. SGS project managers oversee studies.

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Pharma Times

JUNE 24, 2024

The manifesto calls on the next UK government to make dementia a key health priority

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The Pharmacist

JUNE 24, 2024

‘A number’ of community pharmacies will be commissioned by NHS England (NHSE) to provide the respiratory syncytial virus (RSV) vaccine to older adults from this autumn. A letter published today by NHSE and the UK Health Security Agency announced the introduction of a new RSV vaccination programme from 1 September 2024, for older adults and […] The post 'A number' of pharmacies to provide RSV vaccine in new NHS programme appeared first on The Pharmacist.

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Vaccines Community Pharmacies 71

EMCrit Project

JUNE 24, 2024

a unique ventilatory mode unfortunately only available on Hamilton vents EMCrit Project by Scott Weingart, MD FCCM.

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World Pharma News

JUNE 24, 2024

A new AI-powered program will allow researchers to level up their drug discovery efforts. The program, called TopoFormer, was developed by an interdisciplinary team led by Guowei Wei, a Michigan State University Research Foundation Professor in the Department of Mathematics. TopoFormer translates three-dimensional information about molecules into data that typical AI-based drug-interaction models can use, expanding those models' abilities to predict how effective a drug might be.

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BioPharma Dive

JUNE 24, 2024

Phase 3 trial results should support an approval application for the drug, which analysts view as a potential competitor to Roche’s blockbuster medicine Hemlibra.

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Express Pharma

JUNE 24, 2024

With the submission of regulatory marketing applications for its once-daily vanzacaftor triple, also known as the vanza triple program (vanzacaftor/tezacaftor/deutivacaftor) with the European Medicines Agency (EMA) and the US FDA, Vertex Pharmaceuticals is expected to hold its lead in the development of therapies for the treatment of cystic fibrosis (CF).

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The Guardian - Pharmaceutical Industry

JUNE 24, 2024

Vermont senator will grill CEO of Danish pharma giant whose drugs cost Americans 10 times more than abroad The blockbuster weight-loss drugs Wegovy and Ozempic are arguably as omnipresent in the American zeitgeist as Taylor Swift or the iPhone. The drugs and others in its class are associated with the sparkle of Hollywood, on the lips of Oprah and considered transformative by doctors.

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Diabetes 63

Pharmaceutical Commerce

JUNE 24, 2024

The latest news for pharma industry insiders.

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BioPharma Dive

JUNE 24, 2024

The American Diabetes Association’s annual meeting provided a forum for early trial results on several would-be weight loss drug competitors.

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Diabetes 62

Pharmaceutical Technology

JUNE 24, 2024

The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.

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Vaccines 59