Sat.Sep 07, 2024 - Fri.Sep 13, 2024

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Inquiry into unexplained bird flu case in Missouri broadens to a close contact

STAT

A close contact of the person in Missouri who had an unexplained H5N1 bird flu infection last month was also sick around the same time, but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.  The CDC revealed the previously undisclosed information in FluView , its weekly report on influenza activity.

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A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

PharmaVoice

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

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SAEM Clinical Images Series: What’s Coming Out of Your Eye?

ALiEM - Pharm Pearls

A 32-year-old male with no significant past medical history presented to the emergency department (ED) from an outside hospital for further management of right eye pain and vision loss sustained after he was struck by a metal wire while at work. The patient presented to an outside “eye doctor” and was told to go to the nearest hospital for evaluation.

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Three biotechs raise $700M in rare burst of IPO activity

BioPharma Dive

The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.

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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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STAT+: A new drug offers a rare option for brain cancer treatment — and inspires hopes for more

STAT

For more cancer coverage, sign up for STAT’s pop-up newsletter focused on this weekend’s European Society for Medical Oncology conference, one of the biggest oncology meetings of the year. Details here. When Rachel Guberman found out she had brain cancer, she did so much reading and Googling about the disease that she joked she had reached the end of the internet.

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Who’s winning in biotech’s tight market?

PharmaVoice

Three of the largest fundraising rounds in 2024 show where investors are willing to place their bets in biotech.

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Summit lung cancer drug shows ‘striking’ benefit over Keytruda

BioPharma Dive

Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.

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Cause of Missouri H5 bird flu case remains a mystery, CDC says

STAT

Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday. But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.

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Lilly lays down $1B to be ‘first in biology’ with obesity gene therapies

PharmaVoice

The deal, which targets metabolic diseases, is one of a few by Big Pharma to develop lncRNA therapies.

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Apple AirPods get FDA okay for use as OTC hearing aids

pharmaphorum

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.

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From Payroll Pains to Growth Gains: Streamlining Payroll & HR for Success

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

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Gene therapy startup emerges with green light for first-of-its-kind trial

BioPharma Dive

Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.

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STAT+: A rare disease program, portrayed as both lifeline and pharma handout, is set to expire

STAT

After his son Michael was diagnosed with a devastating, ultra-rare disease in 2019, Terry Pirovolakis dedicated himself to eradicating it.  Pirovolakis, a Canadian IT director, recruited academics and raised $3 million to design a gene therapy. He got Michael treated, an intervention that seems to have helped the 6-year-old stand on his heels for the first time and slow the course of a disease that can be severely cognitively and physically disabling.

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3 FDA approval dates to watch in the year’s final push

PharmaVoice

A handful of potential blockbusters are marching toward FDA review.

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Lilly ramps up Irish manufacturing investment by $1bn

pharmaphorum

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.

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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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Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

Express Pharma

The world massively relies on the developments that continue to take place in the pharmaceutical industry to experience an improved quality of life. From producing drugs for rare forms of cancer to generating highly effective vaccinations for various epidemics and pandemics, this industry has always played a pivotal role in safeguarding public health.

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How a government scientist is pushing to supersize research into ultra-processed foods

STAT

CHICAGO — The last place you might have expected Kevin Hall to make a plea for help was at a conference of scientists who work for global food conglomerates. After all, the government researcher is the leading scientific voice in the United States warning that a steady diet of these engineered products might be a crucial driver of the nation’s epidemic of overeating.

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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

FDA Law Blog: Biosimilars

By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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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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Community pharmacy could consider 'working to rule', say CPE and NPA

The Pharmacist

Community pharmacy could consider 'working to rule' under GP-style collective action, sector leaders have suggested. Speaking at the Avicenna Heathrow conference yesterday (8 September 2024), both Community Pharmacy England (CPE) and National Pharmacy Association (NPA) leaders said that 'working to rule' and legal action against the government remained a possibility for the sector.

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STAT+: Lung cancer drug from iTeos, GSK shows response, boosting TIGIT as a viable target

STAT

BARCELONA, Spain — A targeted immunotherapy being developed by the biotech iTeos Therapeutics and GSK delivered promising response rates in patients with a type of lung cancer, propelling the treatment into a pivotal Phase 3 trial and adding fuel to a broader debate about the validity of the target. The companies reported on Saturday that their combination of a TIGIT-targeting antibody and GSK’s Jemperli increased the percentage of patients who saw their tumors shrink versus those

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Digital Solution Implementation

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

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Starmer says no extra NHS funding without big reforms

pharmaphorum

Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms

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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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CPE ‘pushing for’ £645m investment to cover wider cost pressures

The Pharmacist

Community Pharmacy England (CPE) has revealed it plans to ask for more of the £645m set out as an investment in the sector last November to be used to offset wider cost pressures facing the sector. When the highly anticipated Pharmacy First common conditions service was launched in England, it was backed by a £645m […] The post CPE ‘pushing for’ £645m investment to cover wider cost pressures appeared first on The Pharmacist.

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STAT+: How hospitals could make money off of Kamala Harris’ medical debt relief plan

STAT

WASHINGTON — The largest health system in North Carolina simply wasn’t interested in canceling its patients’ medical debt. That is, until the state government dangled billions of dollars in incentive payments.  Other health systems have gotten just cents on the dollar to cancel unpaid bills they probably couldn’t collect on anyhow — take Cook County, Ill., which aims to pay about a penny per dollar to cancel an estimated $1 billion of medical debt.

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Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety

Drug Patent Watch

The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of nanotechnology. This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients.

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How Chiesi is walking the walk on pharma sustainability

pharmaphorum

Discover how Chiesi is leading the way in pharmaceutical sustainability by partnering with EcoVadis and implementing innovative practices. Learn how they are making a positive impact on the environment and society.

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GPhC to consult on online pharmacy guidance

The Pharmacist

The General Pharmaceutical Council (GPhC) will release a consultation on changes to guidance for online pharmacies 'within the next couple of weeks', chief executive Duncan Rudkin has said. Proposed changes will emphasise the importance of a 'two-way dialogue between patients and prescriber', which may require further interaction beyond an asynchronous questionnaire, Mr Rudkin suggested.

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STAT+: Apple will offer millions of AirPod users a hearing aid. Can it convince them to use it?

STAT

After years of dabbling in hearing health, Apple earlier this week went all-in, announcing that AirPods Pro, the tech giant’s top wireless earbuds, will soon double as hearing aids for people with milder forms of hearing loss. Apple’s redoubled effort on hearing also includes software to test a person’s hearing and to customize the output of the hearing aid.

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The ‘Rule of Three’: How the FDA is Hacking Drug Prices

Drug Patent Watch

In the labyrinthine world of pharmaceuticals, where the cost of life-saving medications can often feel like a roll of the dice, the FDA is implementing a strategy that aims to bring some much-needed transparency and affordability to the market. This strategy, known as the ‘Rule of Three,’ is a game-changer in the battle against soaring drug prices.

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Moderna, trailing rivals, checks its RSV shot expectations

BioPharma Dive

During an investor presentation Thursday, executives admitted to being overly optimistic their vaccine could wrest significant market share away from GSK's and Pfizer's products this year.

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Original pack dispensing allowed from January

The Pharmacist

Pharmacists in England will be allowed to dispense 10% more or less than the prescribed amount in order to dispense medications in the original packs from January 2025. This follows changes to the Human Medicines Regulations (HMRs) that have allowed original pack dispensing (OPD) for private prescriptions since October 2023. Community Pharmacy England (CPE) has […] The post Original pack dispensing allowed from January appeared first on The Pharmacist.

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STAT+: FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’

STAT

WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who should be involved in health care AI governance, the U.S. Food and Drug Administration commissioner said that health systems need to take a leading role. “I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on liability when these algorithms go wrong,” said Robert Cal

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