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.

Vaccines 360
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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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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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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+: Gene therapy pioneer Jim Wilson believes he can commercialize rare-disease drugs in a tough climate

STAT

If you’d told Jim Wilson three years ago that he’d be stepping down as director of the University of Pennsylvania’s storied Gene Therapy Program, he wouldn’t have believed you. And yet he’s now doing exactly that. Wilson, a gene therapy pioneer who has spent decades devising ways to deliver functional copies of missing or defective genes to patients, recently announced that he’s leaving Penn to found a pair of companies focused on developing gene therapi

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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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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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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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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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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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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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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+: Pharmalittle: We’re reading about a negative U.K. review of Leqembi, Bavarian Nordic’s strong earnings, and more

STAT

Good morning, Pharmalittle fans! Adam Feuerstein here, filling in for Ed. I drink my morning coffee from a heavy, thick diner mug. I suggest you do the same. Here’s some news for your Thursday morning. … Eisai and Biogen secured approval in the U.K. for their Alzheimer’s treatment, Leqembi, but at the same time, the U.K.’s cost-effectiveness watchdog agency issued draft guidance that said the drug’s limited benefits do not justify its costs, STAT reports.

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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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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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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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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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Updated COVID shots from Pfizer, Moderna cleared by FDA

BioPharma Dive

The approval of both reformulated messenger RNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.

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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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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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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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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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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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FDA approves and authorises updated mRNA COVID-19 vaccines

Express Pharma

The US Food and Drug Administration approved and granted emergency use authorisation (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalisation and death.

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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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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.