Thu.Sep 12, 2024

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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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How Lilly’s sustainability goals come face to face with massive growth

PharmaVoice

Eli Lilly’s head of ESG is maintaining a focus on sustainability even as the company’s expansion plans in weight loss drive a larger footprint and more social scrutiny.

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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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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+: 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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RPS announces proposals to become Royal College

The Pharmacist

The Royal Pharmaceutical Society (RPS) has today (12 September) announced proposals to become the 'Royal College of Pharmacy', with charitable status. It said the suggestion was the outcome of a 'comprehensive independent review' of its constitution and governance, which has taken place over the past 18 months. As a Royal College, the RPS said it […] The post RPS announces proposals to become Royal College appeared first on The Pharmacist.

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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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Opinion: STAT+: How to keep the BIOSECURE Act from hobbling U.S. biotech and pharma

STAT

In a rare display of bipartisan agreement, Congress is getting serious about addressing China’s influence in key industries. This spring’s “TikTok ban” is the most obvious example of this effort. Legislation currently under debate would extend these same principles to the life sciences sector, with major implications and opportunities for the country.

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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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A new threat to Merck’s blockbuster cancer treatment, Moderna’s cutbacks, and obesity drugs for kids

STAT

What’s next for Akeso and Summit Therapeutics after their cancer immunotherapy outperformed Merck’s Keytruda in a large Phase 3 clinical trial? Who’s the iconoclastic outsider behind Summit’s success? Why can’t Moderna turn a profit? And should we be giving weight loss drugs to kids? We talk about all that and more on this week’s episode of “The Readout LOUD.

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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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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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STAT+: Can iTeos and GSK solve TIGIT’s troubles?

STAT

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. I ate three dozen oysters last Saturday while taking a tour of the Island Creek Oyster Farm in Duxbury, Mass. AMA.

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Welsh community pharmacies to get 'above-inflation investment'

The Pharmacist

The Welsh Government has announced an 'above-inflation investment' for community pharmacies in Wales – the details of which will be negotiated with Community Pharmacy Wales (CPW). Cabinet secretary for health and social care Mark Drakeford announced this week that he would uplift the pay of NHS staff on Agenda for Change contracts by 5.5%, and […] The post Welsh community pharmacies to get 'above-inflation investment' appeared first on The Pharmacist.

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STAT+: ‘Put him in jail.’ Steward CEO de la Torre skips hearing, now Congress is poised to hold him in contempt

STAT

Lawmakers in Washington turned their focus to the Steward Health Care bankruptcy scandal on Thursday, even as patients, doctors, and regulators across eight states continue to struggle with the hospital chain’s financially starved facilities. Senators hoped to grill Steward chief executive Ralph de la Torre at the hearing in the Capitol but had to make do verbally attacking an empty chair.

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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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Medicare drug pricing negotiations: What comes next?

pharmaphorum

Explore the ins and outs of Medicare drug pricing negotiations with Alice Valder Curran on this insightful podcast. Learn more about what comes next in this crucial healthcare sector.

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FDA is taking on tampons and ‘misleading’ ads starring Serena Williams

STAT

Good morning! I’ve decided today is the day that I must tell you about my favorite Instagram account: poeticpuppets. It’s an account (run by a Teresa with no H, not me!) where puppets present you with some delicious poetry bites. Enjoy! A lifeline or a pharma handout? Either way, this program is set to expire There’s an obscure U.S. government voucher program due to sunset at the end of this month.

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Wanbury announces new API product portfolio and launch plans

Express Pharma

Wanbury has announced the launch of its new active pharmaceutical ingredients (API) product portfolio for FY24-25. The company outlined a range of products to be commercialised, which cover therapeutic areas including anti-diabetics, antidepressants, anti-histamines, analgesics, anti-inflammatory drugs, antitussives, and anaesthetics. The new products, which are set to be launched in the upcoming fiscal year, include APIs like, Sertraline HCl, Diphenhydramine HCl, Diphenhydramine Citrate, Metfor

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STAT+: Pharmalittle: We’re reading about Moderna R&D cuts, Lilly plant investments and more

STAT

Rise and shine, everyone, another busy day is on the way. However, this is also shaping up as a beautiful day as well, despite forecasts predicting rising heat. The skies are tranquil, birds are chirping, and the official mascots are chasing creatures on the Pharmalot campus. This calls for celebration with a cup of stimulation, and we are opening a new package of pecan pie for the occasion.

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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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Pharma Pulse 9/12/24: AI Will Force a Transformation of Tech Infrastructure, Obesity Drug Market to be Worth $200 Billion by 2031 & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Moderna cuts spending, and Sarepta’s ‘curse’ on Califf

STAT

Good morning. If you’re following the European Society for Medical Oncology meeting that starts tomorrow, sign up for our ESMO in 30 Seconds newsletter. My colleague Drew Joseph is on the ground in Barcelona (and I’m very jealous of him). Onto the biotech news of the day.

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Darzi review must ‘spur ministers into action’ on community pharmacy

The Pharmacist

Community pharmacy leaders have called for urgent action to 'stop the rot' of pharmacy closures and to invest in the sector, following Lord Ara Darzi's report into the state of the NHS. The Darzi review - a major investigation into the NHS, commissioned by the government - praised the value of community pharmacies and preventative […] The post Darzi review must ‘spur ministers into action’ on community pharmacy appeared first on The Pharmacist.

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World Sepsis Day 2024: Improved clinical trial design and targeted therapies remain key unmet needs: GlobalData

Express Pharma

World Sepsis Day, which takes place annually on September 13, aims to raise awareness of the devastating condition that claims millions of lives globally each year. Sepsis is a life-threatening and complex disease caused by a dysregulated host immune response to an infection. Currently, there is no drug that specifically targets the underlying pathophysiological processes that cause sepsis.

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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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EASD 2024: Innovent shows off mazdutide’s efficacy in diabetes and obesity

Pharmaceutical Technology

The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.

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DP World welcomes MGX-2 Milaha Gulf Express Service at Mundra Port

Express Pharma

DP World, a global provider of smart end-to-end supply chain solutions, marked the arrival of the MGX-2 (Milaha Gulf Express Service-2) on its maiden voyage at DP World Mundra. The fortnightly service connects key ports across the Far East, Indian Subcontinent, and Gulf region, enhancing DP World’s integrated trade networks. The service is expected to facilitate the movement of diverse cargo, providing efficient and seamless logistics solutions to improve India’s trade access to global markets.

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HRT linked to reduced psychosis relapse risk in menopausal women

Pharma Times

New study highlights potential benefits of menopausal hormone therapy

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Pharma industry faces call to expand patient access in low- and middle-income countries

Express Pharma

The pharmaceutical industry is under pressure to ensure that vital health products are accessible to all, regardless of geographic location or socioeconomic status. A new report from the Access to Medicine Foundation provides an analysis of how some of the largest pharmaceutical companies are working to reach patients worldwide, particularly in low- and middle-income countries (LMICs), in pursuit of health equity.

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Centessa reports positive phase 1 clinical data for ORX750

Pharma Times

Promising results for novel orexin agonist in sleep-deprived volunteers

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British drugmaker GSK moves mRNA flu vaccine to late-stage trials

Express Pharma

British drugmaker GSK, announced on Thursday positive results from a mid-stage trial of its seasonal influenza vaccine programme using the messenger RNA (mRNA) technology, and said it would now progress to late-stage clinical development. The data showed that a vaccine candidate produced positive immune responses against both A and B flu strains in younger and older adults, compared with the current standard treatments, GSK said.

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Pharmacists in practice a 'positive development', finds Darzi report

The Pharmacist

Growth in the wider general practice team, including pharmacists, has been a 'positive development' against a backdrop of fewer and unevenly distributed GPs, the Darzi report, published today, suggested. But it emphasised that additional non-GP staff should 'be supplements, rather than substitutes to GPs'. The Darzi review was commissioned by the health and social care secretary Wes […] The post Pharmacists in practice a 'positive development', finds Darzi report appeared first o

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Bad Hires: What Are They Really Costing You?

The Script

We're all likely to make a bad hire at least once. Rx relief explains the possible repercussions and what it can actually cost you.

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Days Go By (1) – Particularly When Responding to an FDA Inspection

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. Walsh — While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified as voluntary or official action indicated (VAI or OAI).

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ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Pharmaceutical Business Review

EN001, a clinical-stage mesenchymal stem cell therapy in ENCell’s pipeline, is developed using mesenchymal stem cells sourced from the early culture stage. Preclinical studies are said to have demonstrated its potential to regenerate damaged nerves and muscles. Last June, ENCell completed a Phase Ia clinical trial of the asset in patients with Charcot-Marie-Tooth disease type 1A.

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