Tue.Jul 02, 2024

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CDC looks to expand capacity to test for H5N1 bird flu in people

STAT

As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people. In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time.

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How BeiGene is taking on established blockbusters with an expanding blood cancer arsenal

PharmaVoice

BeiGene’s Brukinsa is the first in a hematology franchise that the company hopes will rival top-sellers and introduce a new lineup of medicines for patients.

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STAT+: FDA approves Eli Lilly’s early Alzheimer’s treatment

STAT

Eli Lilly’s early Alzheimer’s treatment was approved by the Food and Drug Administration on Tuesday, making it the second drug on the U.S. market aimed at slowing progression of the debilitating neurological disease. The treatment, whose scientific name is donanemab and will be sold under the brand name Kisunla, will compete with Eisai and Biogen’s Leqembi, which got full approval last year.

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Cartesian data add to progress, questions for CAR-T in autoimmune disease

BioPharma Dive

The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.

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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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Moderna receives $176 million from BARDA for mRNA influenza vaccines

STAT

Moderna has been awarded $176 million by the Biomedical Advanced Research and Development Authority to accelerate development of messenger RNA-based pandemic influenza vaccines, the company announced in a statement Tuesday. BARDA, a strategic preparedness arm of the Department of Health and Human Services, has said for weeks that it has been in talks with mRNA vaccine manufacturers with an aim to diversify the government’s pandemic flu vaccine response capacity.

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Lilly drug for Alzheimer’s approved by FDA

BioPharma Dive

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

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More Trending

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Sobi starts rolling FDA filing for chronic gout drug

pharmaphorum

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

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Opinion: Senate, FTC cracking down on pharma patent shenanigans

STAT

Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition.

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Researchers find whole genome sequencing improves care for paediatric cancer

Pharma Times

Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children

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STAT+: How controversial was the decision by FDA’s Peter Marks to approve Sarepta’s gene therapy? Check its footnotes

STAT

The unilateral decision by Peter Marks, a top official at the Food and Drug Administration, to approve the gene therapy Elevidys , a treatment for Duchenne muscular dystrophy, despite the misgivings of his staff, looks even more surprising on a close examination. Marks’ decision to overrule three different review teams appears unprecedented in recent FDA history.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Moderna gets US funding for bird flu vaccine development

BioPharma Dive

BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.

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STAT+: Report shows U.S. biotechs are wary of Chinese partnerships due to looming BIOSECURE Act

STAT

A looming anti-China biotechnology bill has spooked U.S. life sciences companies, according to a new report. The report by the China-based L.E.K. Consulting quantifies what until now has been mostly a vibe check. At this year’s Biotechnology Innovation Organization’s international conference, multiple biotech companies told STAT they plan to switch from striking deals with Chinese companies to U.S.

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The power and potential of regenerative medicine

pharmaphorum

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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STAT+: The biotech scorecard for the third quarter: 19 stock-moving events to watch

STAT

H​​ere is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third quarter: Late last month, Alnylam Pharmaceuticals reported positive, top-line results from its HELIOS-B clinical trial testing vutrisiran in an increasingly common heart disease called ATTR-CM. Detailed study results are being presented at the annual meeting of the European Society of Cardiology in late August.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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Supreme Court to weigh whether the FDA was heavy-handed with flavored e-cigarette products

STAT

WASHINGTON — The Supreme Court  took up an e-cigarette case Tuesday, weighing Food and Drug Administration decisions blocking the marketing of sweet flavored products amid a surge in vaping by young people. The FDA is appealing a lower court ruling siding with vape companies who argue the FDA unfairly denied more than a million applications to market fruit or candy flavored versions of nicotine-laced liquid that’s heated by the e-cigarette to create an inhalable aerosol.

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Sharp increase in use of high-strength nicotine vapes

The Pharmacist

There has been a sharp increase in the use of high-strength nicotine amongst vape smokers in England, a study has revealed. Researchers at University College London (UCL) found that the proportion of adults using high-strength e-liquids has increased to 32.5%, compared to an average of 3.8% between July 2016 and June 2021. The increase is […] The post Sharp increase in use of high-strength nicotine vapes appeared first on The Pharmacist.

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Q&A: The U.S. is losing control of hypertension. China’s ‘village doctors’ have lessons

STAT

The U.S. has slid backward on control of high blood pressure, despite ready access to medicines and other tools to moderate its risks. Dan Jones, former president of the American Heart Association, thinks the nation can learn from China. Researchers there recently detailed the success of community health workers — well trained people but not M.D.s — helping thousands of people living with high blood pressure in rural regions.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Changing Faces: Pharma and biotech hires from April 2024

pharmaphorum

Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.

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STAT+: Former Mass General president Peter Slavin will run Cedars-Sinai in Los Angeles

STAT

Peter Slavin, who ran Massachusetts General Hospital in Boston for nearly two decades before stepping down in 2021 , has taken a new job heading up Cedars-Sinai Medical Center in Los Angeles. Slavin, 66, starts Oct. 1 as president and chief executive of Cedars-Sinai, an institution dubbed the “hospital for Hollywood stars.” He’ll also lead parent Cedars-Sinai Health System, which includes several other owned and affiliated hospitals and a network of outpatient clinics.

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Techinvention Lifecare has been engaged by Botswana Vaccine Institute for its Veterinary Vaccine Manufacturing Facility

Express Pharma

Techinvention Lifecare has been appointed as a consultant by Botswana Vaccine Institute (BVI) to monitor setting up of the new cGMP compliant, vaccine manufacturing unit in its existing facility at Gaborone, Botswana. According to the statement, the scope encompasses comprehensive project management role for the state-owned Botswana Vaccine Institute (BVI), that has been manufacturing and supplying critical veterinary vaccines since the 1970s, in the region and beyond.

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STAT+: Pharmalittle: We’re reading about FTC probing Teva patents, a Moderna flu vaccine contract, and more

STAT

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of maple bourbon for the occasion. Spring has sprung, after all.

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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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Which pharmaceutical drugs have the most drug patents in Slovakia?

Drug Patent Watch

This chart shows the drugs with the most patents in Slovakia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

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GPs defend decision to turn off Pharmacy First updates

The Pharmacist

The British Medical Association (BMA) has defended its decision to advise GPs in England to turn off the Update Record functionality that allows pharmacies to share clinical updates from Pharmacy First consultations. In a statement shared with The Pharmacist, Dr David Wrigley, deputy chair and digital lead of BMA's GP Committee, said the BMA was […] The post GPs defend decision to turn off Pharmacy First updates appeared first on The Pharmacist.

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Advancing sleep health: Wearable technologies revolutionize clinical trials and patient care

Outsourcing Pharma

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Körber teams up with Nymi for contactless shopfloor identification in pharma

Express Pharma

Körber, a leading company for Manufacturing Execution Systems (MES) in pharma manufacturing, announces a strengthened partnership with Nymi, a biometric wearable company, to deliver secure and contactless user authentication solutions in pharmaceutical production. Building on a foundation of successful collaboration in the past, Nymi now joins the Körber Ecosystem as part of the “PAS-X K.ME-IN” partner certification program on the “Ready” level.

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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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Apellis will appeal CHMP’s rejection of pegcetacoplan

pharmaphorum

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.

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FDA approves Eli Lilly’s alzheimer’s drug

Express Pharma

The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families.

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FTC launches probe of Teva over ‘improper’ patents; report

pharmaphorum

The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book

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Esteve invests €100 million in Spanish API manufacturing muscle

Outsourcing Pharma

The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).

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Eisai and Bristol Myers Squibb terminate ADC development deal

Pharmaceutical Technology

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

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