Tue.Apr 02, 2024

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STAT+: FDA clears digital stethoscope company’s AI algorithm for heart failure

STAT

An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from the Food and Drug Administration on Tuesday. The goal is to help primary care doctors more easily identify the often-hidden condition. The stethoscope is the result of a collaboration between Mayo Clinic researchers, who built the algorithm, and the startup Eko Health, which built the hardware.

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A dementia-focused VC digs past anti-amyloid for neuroscience diamonds in the rough

PharmaVoice

Even as new drugs like Eisai and Biogen’s Leqembi make a splash in Alzheimer’s, VCs like the Dementia Discovery Fund have invested in the next wave of therapies.

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Trending Sources

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STAT+: Watch: Medicare billing forms are running out of space for growing health care prices

STAT

WASHINGTON — Health care costs are getting so high that prices are literally running off of the page. Medicare on a couple of occasions recently has had to deal with billing forms that don’t provide adequate space for prices. CMS last month said it was adding two digits to the Medicare claims processing system for hospital and doctor office charges, called the Fiscal Intermediary Shared System, so that it can now accommodate prices just a penny shy of $100 million.

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ICR collaboration forms national NHS patient database registry for Lynch syndrome patients

Pharma Times

The genetic condition affects one in 279 people in England and significantly increases cancer risk

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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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STAT+: Verve Therapeutics ‘pauses’ tests of its gene editor for heart disease and prioritizes a backup treatment

STAT

Verve Therapeutics said Tuesday that it is pausing testing of its closely watched gene-editing treatment for high cholesterol after a patient receiving the drug experienced elevated liver enzymes and low platelet levels. The news represents a setback for an ambitious project to not only bring forward one of the first gene-editing treatments in humans, but to also do so not for a rare condition but for the leading killer in the developed world.

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Ending the silence: Why the menopause matters in the workplace

pharmaphorum

Discover the importance of addressing menopause in the workplace and the benefits of hormone replacement therapy (HRT) through this insightful and informative article on breaking the stigma.

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More Trending

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

By Sara W. Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s. And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides im

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STAT+: The biotech scoreboard for the second quarter: 32 stock-moving events to watch

STAT

Here is STAT’s biotech scoreboard, our regular ledger of stock-moving biotech events, for the second quarter and middle of the year: Obesity catalysts, first. Danish drugmaker Zealand Pharma — yes, there’s another Danish drug maker in obesity — is developing a long-acting amylin analog called petrelintide. The experimental medicine has garnered attention for its potential to show incretin-like weight loss with muscle preservation, and a tolerable side-effect profile.

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‘Cliff’ Countdown: Balancing Internal and External Growth

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.

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Securing the future: Innovating pharmaceutical supply chain for resilience and safety

pharmaphorum

Explore the innovative use of artificial intelligence (AI) and machine learning (ML) in securing the pharmaceutical supply chain for resilience and safety. Learn how cutting-edge technology is shaping the future of pharmaceutical logistics.

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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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Acorda files for bankruptcy, reveals asset sale plan

BioPharma Dive

Stalking horse bidder Merz Therapeutics could get rights to Acorda’s three marketed drugs if its $185 million proposal holds.

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The future of AI: Machine learning working together with scientific expertise

pharmaphorum

In a new episode of the pharmaphorum podcast recorded live on site at WIRED Health in London in March, web editor Nicole Raleigh spoke with Elise de Reus, co-founder of Cradle, the generative AI platform that helps scientists to design and program proteins.

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Researchers reveal people with Parkinson’s more likely to experience delirium in hospital

Pharma Times

Two out of three people with the neurodegenerative condition experienced delirium in hospital

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Ipsen licenses Sutro ADC in $900m deal

pharmaphorum

Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).

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GS Krishnan re-elected ABLE President for 2024 -2026

Express Pharma

GS Krishnan, President of Association of Biotechnology Led Enterprises (ABLE) has been re-elected for another two-year term from April 2024 – 2026. Krishnan, with three decades of experience in the bio industrial sector, currently – Director, external stakeholder relations at Danish biotech company, Novonesis and Independent Consultant/Advisor to various biotech companies, assumed ABLE president’s role in April 2021.

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EP monographs allow rFC for water testing

European Pharmaceutical Review

Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters. The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters.

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Acorda filed for bankruptcy, and Merz is eyeing its assets

pharmaphorum

Acorda Therapeutics has filed for bankruptcy protection, hoping to keep operating while it tries to arrange the sale of its main assets to a US subsidiary of Germany’s Merz. The announcement made last night US time sparked a run on Acorda's shares, down almost 62% at the time of writing. The news emerged shortly after Acorda cancelled its fourth-quarter results conference call, which was scheduled to take place yesterday.

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Stress Awareness Month: 4 Tips to Create a Calm Workplace

PioneerRx

Pharmacy work isn’t always fun, no matter how much we love it. In the fast-moving world of pharmacy, there are some certainties: flu season, DIR fees, and.

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Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

Animal welfare is a crucial consideration in the adoption of alternative methods like recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR) for bacterial endotoxin testing (BET). These methods aim to impede animal suffering by reducing dependence on horseshoe crab blood. At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products.

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AZ, Daiichi Sankyo file Dato-DXd for second indication

pharmaphorum

AstraZeneca and Daiichi Sankyo file for approval of datopotamab deruxtecan (Dato-DXd) for second indication in breast cancer.

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Lonza appoints new Chief Executive

European Pharmaceutical Review

Wolfgang Wienand has been chosen to succeed Albert Baehny as the CEO of Lonza. Wienand will join the contract development and manufacturing organisation (CDMO) in the summer of 2024. He has been CEO of the Swiss CDMO Siegfried Holding AG since 2019. Baehny has held his Chief Executive Officer ad interim role since October 2023 and will support Wienand through the transition period.

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Bharat Biotech, Bilthoven Biologicals B.V. partner to produce and supply oral polio vaccines

Express Pharma

Bharat Biotech and Bilthoven Biologicals B.V., (BBio), a wholly owned subsidiary of Serum Institute of India, based in Netherlands, announced a collaboration to further strengthen the production and supply security of Oral Polio Vaccines (OPV). A requisite agreement has been signed between BBIL and BBio wherein BBIL will procure drug substances for the production of oral polio vaccines to be supplied within India and globally.

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‘Not clear’ when new contract negotiations will conclude

The Pharmacist

It is ‘not yet clear’ when negotiations for the new contractual framework will conclude, Community Pharmacy England (CPE) has said – despite the start of April marking the end of the existing contract agreed in the summer of 2019. With talks on arrangements for the coming 2024/25 financial year still in progress with the Department […] The post ‘Not clear’ when new contract negotiations will conclude appeared first on The Pharmacist.

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The Growing Future of Drug Manufacturing

PharmaTech

With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.

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Verve pauses base editing study after treatment side effect

BioPharma Dive

Lab test abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its gene editing therapy for heart disease.

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The Power of Patient Adherence Tools to Improve the Patient Journey

Pharmaceutical Commerce

Why manufacturers should leverage technology to address low adherence rates.

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Ginkgo, in search of more cell therapy tools, buys another startup

BioPharma Dive

An acquisition of Modulus Therapeutics is the latest move by Ginkgo to accumulate technologies that can help other companies develop cellular medicines.

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Bristol Myers Squibb’s Director of Business Operations for MSAT, Carl Allenspach, Highlights Collaboration and Interactive Exchange at INTERPHEX

PharmaTech

Carl Allenspach, director of business operations, manufacturing, science, and technology organization at Bristol Myers Squibb discusses the interactive and collaborative important of INTERPHEX.

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Bora Pharmaceuticals completes Upsher-Smith acquisition, expanding North American footprint

Outsourcing Pharma

Bora Pharmaceuticals Co., Ltd. yesterday (April 1) finalized the acquisition of Upsher-Smith Laboratories, Inc., a leading generics manufacturer based in Minnesota, U.S., from its previous owners, Sawai Group Holdings and Sumitomo Corporation of Americas.

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Roivant reveals positive immune drug data, share buyback plans

BioPharma Dive

A Pfizer drug licensed to a Roivant subsidiary surpassed expectations in a type of uveitis, while a stock purchase plan will see Roivant buy out shares owned by Sumitomo Pharma.

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Data integration - has an influx of solution providers led to a litany of false starts and wasted effort?

Outsourcing Pharma

OSP was lucky enough to talk to David Menzies (pictured), executive director, technology solutions at ICON to find out how he thinks the pharma industry needs to overcome the real-world data challenges.

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FDA approves Roche’s test for malaria in blood donors

Pharmafile

Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas Malaria test for use on the cobas 6800/8800 systems. The test is intended to help healthcare professionals in reducing the risk of patient infection from blood transfusions, as the cobas Malaria test ‘provides a highly sensitive and specific solution to […] The post FDA approves Roche’s test for malaria in blood donors appeared first on Pharmafile.

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Advancements in endometrial treatment - HUTCHMED & Innovent's cancer combo NDA accepted with Priority Review

Outsourcing Pharma

In an important announcement today (April 2), HUTCHMED and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.

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FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment

Pharmafile

AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-Dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

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What CVS Pharmacy’s New Cost-Plus Reimbursement Approach Means for PBMs, Pharmacies, Plan Sponsors, and Prescription Prices (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. For more on acquisition cost reimbursement for pharmacies, see Sections 8.4. and 12.3.4. of our new 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. Click here to see the original post from December 2023.