Thu.Aug 22, 2024

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FDA approves updated Covid-19 vaccines, shots should be available in days

STAT

WASHINGTON — U.S. regulators approved  updated Covid-19 vaccines  on Thursday, shots designed to more closely target recent virus strains — and hopefully whatever variants cause trouble this winter, too. With the Food and Drug Administration’s clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its updated vaccine version to be available a little later.

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New drug trial to investigate treatment for patients with bronchiectasis

Pharma Times

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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Trending Sources

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Columbia medical school gets $400 million gift to fund long-shot basic research

STAT

Columbia University announced Thursday that its medical school has received $400 million to fund a new institute for basic biomedical research to fuel future discoveries that could improve human health and lead to new drug discoveries.  The gift, from Columbia alumni Roy and Diana Vagelos, is the largest single donation given to the school and brings to $900 million the total given to Columbia by the couple since 2010.

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How Gen AI is transforming M&A

Fuld & Company Blog

Generative AI (Gen AI) is revolutionizing the mergers and acquisitions (M&A) process with adoption by M&A practitioners set to increase by 90% by 2025. This growth in adoption is driven by the significant benefits Gen AI offers, including streamlining target sourcing, helping refine strategies, and improving post-merger integrations. Gen AI is driving greater efficiency and addressing complex data challenges throughout the deal-making process.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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STAT+: U.K.’s cost-effectiveness agency gives negative review of Alzheimer’s drug Leqembi

STAT

LONDON — Leqembi, the Alzheimer’s treatment from Eisai and Biogen, has hit another roadblock reaching patients in Europe.  In draft guidance, the U.K.’s cost-effectiveness watchdog on Thursday said that the limited benefits of the drug, also called lecanemab , do not justify its costs, citing not just the price of the treatment but the related expenses of administering it and monitoring for side effects.

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SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Pharma Times

The grant will support clinical trials of rare disease therapy for leukodystrophy

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BioMarin taps Amgen, Roche vets in executive reshuffle

PharmaVoice

Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.

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STAT+: Tome Biosciences, once a high-flying gene-editing startup, is floundering

STAT

Buzzy gene-editing startup Tome Biosciences is floundering, just nine months after launching with $213 million in funding, according to several sources with direct knowledge of the matter. One person with knowledge of the situation told STAT that Tome is winding down operations altogether and seeking a buyer by Nov. 1. Another source reported that there are still options on the table to keep the biotech running.

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Will the IRA squash new drugs? Those worries are likely exaggerated, studies say.

PharmaVoice

There’s no link between revenue and R&D from smaller biotechs, and that’s where most innovation comes from, according to new studies.

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Opinion: In drug development, diversity must be extended to preclinical research

STAT

The pharmaceutical industry has long operated on a one-size-fits-all model, developing drugs primarily tested on, and thus best suited for, people of European descent. This approach ignores — and potentially harms — the billions of people of color on the planet. Lack of diversity occurs at all levels of the pharmaceutical ecosystem, from the makeup of C-suite and research staffs to participation in clinical trials.

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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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NICE rules Alzheimer’s-slowing drug lecanemab too expensive for NHS

The Pharmacist

The UK medicines regulator has approved lecanemab – the first drug shown to slow cognitive decline in patients in the early stages of Alzheimer’s – but NICE said it was too costly for the NHS. NICE’s draft guidance, published today, has been put out for a four-week consultation after the committee concluded the benefits of […] The post NICE rules Alzheimer’s-slowing drug lecanemab too expensive for NHS appeared first on The Pharmacist.

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STAT+: Digital therapeutics pioneer Pear’s treatments get a second life, a year after bankruptcy

STAT

Over a year after Pear Therapeutics filed for bankruptcy and shut down, its smartphone apps for people with substance use disorder and opioid use disorder are again available to patients.  After acquiring Pear’s Food and Drug Administration-cleared apps, called reSET and reSET-O,in December 2023 , virtual addiction treatment company PursueCare this month began offering them to its patients.

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The fall and rise of digital therapeutics

pharmaphorum

Discover how digital therapeutics (DTx) have evolved in the wake of COVID-19, and how they are changing the landscape of healthcare. Explore the fall and rise of DTx and their potential impact on patient care.

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Listen: BioMarin’s executive shakeup, a GLP-1 lowers diabetes risk, and a deep look at Recursion’s AI bona fides

STAT

What does the hiring of a well-known industry dealmaker mean for the future of BioMarin Pharmaceuticals? Can Eli Lilly’s blockbuster obesity medicine lower the risk of diabetes? And will Recursion Pharma, the AI drug developer, live up to all the hype? We discuss all that and more on this week’s episode of “The Readout LOUD.

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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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Oral nutritional supplement errors impact pharmacy workload

The Pharmacist

A consultation into the standardisation of pack sizes of oral nutritional supplements (ONS) has highlighted the potential for prescribing errors, patient safety risks, increased waste and cost, and increased workload for community pharmacists under the current system. The Advisory Committee on Borderline Substances (ACBS) has decided to explore these concerns before recommending any action on […] The post Oral nutritional supplement errors impact pharmacy workload appeared first on The Pha

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BioMarin revamps leadership with ex-Roche, Amgen execs

pharmaphorum

BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change

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UK health regulator rejects lecanemab as treatment for Alzheimer’s

The Guardian - Pharmaceutical Industry

Decision by Nice to rule out drug being available on NHS comes despite medicines licensing body giving green light The UK’s health regulator has rejected a drug that can slow the progression of Alzheimer’s disease, saying its benefits are too small to justify the costs of the therapy and close monitoring of patients for signs of “serious side-effects”.

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H1 Connect links doctors to global humanitarian missions

Outsourcing Pharma

H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.

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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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An Extra Layer of Transparency and Accountability

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

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Breaking barriers in science: Thermo Fisher's Melanie Adams-Cioaba on innovation and inclusion

Outsourcing Pharma

In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.

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Fujifilm Opens Billingham Production Facility

Pharmaceutical Commerce

The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.

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33% of Healthcare SMEs tap big data for diagnostic breakthroughs, suggests TTBS

Express Pharma

India’s healthcare sector is undergoing a surge in digital transformation, driven by a strong digital infrastructure and a growing economy. According to the latest ‘SME Digital Insights’ study by Tata Tele Business Services (TTBS) in collaboration with Cyber Media Research (CMR), 33 per cent of healthcare SMEs recognise the potential of big data analytics to enhance diagnostics, while 31 per cent see artificial intelligence (AI) as a valuable tool for streamlining operations and accelerating dr

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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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BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer

pharmaphorum

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

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Eugia gets USFDA warning letter for Unit-3 in Pashamylaram

Express Pharma

Eugia Pharma, a wholly-owned subsidiary of Hyderabad-based Aurobindo Pharma received a warning letter from the USFDA. Eugia’s facility at Pashamylaram near Hyderabad was inspected between January 22 to February 2, 2024, after which serevral observations were issued. Subsequently, the company received Official Action Indicated (OAI) status in May 2024.

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US insomniacs have a new prescription DTx option

pharmaphorum

US insomniacs have a new prescription DTx option Phil.

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Pharma Pulse 8/22/24: OM1 Appoints New President, Navigating Global Regulatory Hurdles & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

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Alkem MedTech signs agreement with Exactech to manufacture and market knee and hip replacement implants in India

Express Pharma

Alkem MedTech, a wholly-owned subsidiary of Alkem Laboratories has entered into an agreement with Exactech, a global medical device company headquartered in Gainesville, Florida, USA, to manufacture and market Exactech’s large joint replacement implants in India. Exactech develops, manufactures and markets joint replacement implants, surgical instruments and smart technologies that enhance surgeons’ ability to improve patients’ mobility worldwide.

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Changing Faces – Digital and supplier hires from July 2024

pharmaphorum

Changing Faces explores the digital and supplier hires of July, including Biomedica, Signant Health, Arima Genomics, and more. Stay updated on this exciting industry.

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Leo Pharma’s Timber bet falls flat following Phase III failure

Pharmaceutical Technology

Leo Pharma spent $36m to acquire Timber Pharmaceuticals last year, along with its lead dermatology asset TMB-001.

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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.