STAT

DECEMBER 2, 2024

Since the start of the bird flu outbreak in U.S. cattle more than eight months ago, health authorities have reported 55 human cases of H5N1 viral infections, a startling number in a country that had previously reported only one. All, though, have been mild. The fact that none has been severe has been a shock, though a welcome one, certainly. For more than two decades, H5N1 — which has been confirmed in nearly 1,000 people, largely in Asia and Egypt — has had a well-earned repu

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PharmaVoice

DECEMBER 2, 2024

Intrinsic Medicines is entering phase 2 trials in Parkinson’s disease and IBS for its human milk oligosaccharide drug candidates next year.

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STAT

DECEMBER 2, 2024

LONDON — Novartis is paying $1 billion upfront in a licensing deal for an experimental Huntington’s disease treatment from PTC Therapeutics, the companies said Monday. The agreement also includes another $1.9 billion in possible payments if certain development, regulatory, and commercial milestones are hit.  “This agreement with PTC is intended to bolster our neuroscience pipeline and reflects our strategic focus and commitment to explore new and potentially transformat

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Drug Pricing 351

BioPharma Dive

DECEMBER 2, 2024

At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.

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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

Communication

STAT

DECEMBER 2, 2024

This is the online version of STAT’s email newsletter Health Care Inc, delivered to your inbox every Monday.  Sign up here.  The explosion of ‘value-based care’ on Wall Street “Value-based care” — that familiar, vague phrase that has no real definition but that everyone supports — is firmly entrenched in Wall Street vernacular.

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The Pharmacist

DECEMBER 2, 2024

The government will introduce a men’s health strategy to tackle cardiovascular disease, prostate and testicular cancer and mental health, health secretary Wes Streeting has announced. It will include a call for evidence on what is working and what more needs to be done to close the life expectancy gap between men and women, Mr Streeting […] The post Government launches first-ever men’s health strategy appeared first on The Pharmacist.

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The Pharmacist

DECEMBER 2, 2024

The lowest monthly total of minor illness referrals yet have been recorded for August, according to latest Pharmacy First data for England. Some 87,405 claims for minor illness consultations in August were submitted to, processed and published by the NHS Business Services Authority (NHSBSA) by 25 November. This was nearly 50,000 fewer than those recorded […] The post GPs made fewer Pharmacy First minor illness referrals in August, data suggests appeared first on The Pharmacist.

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STAT

DECEMBER 2, 2024

With the recent conclusion of the 2024 election, the spotlight now shifts back to Congress as it enters the final weeks of the 118th session. While time is limited and there is much to accomplish, Congress has a critical opportunity to reshape health care affordability, enhance transparency, reduce costs, and lay a strong foundation for future reforms through the Lower Costs, More Transparency Act (LCMT) and Health Care PRICE Transparency Act 2.0.

Hospitals 346

Hospitals 346

BioPharma Dive

DECEMBER 2, 2024

Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.

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STAT

DECEMBER 2, 2024

A handful of the 20 largest restaurant chains across the U.S. received failing grades when it came to adopting policies for restricting the overuse of antibiotics in the meat they serve, according to an analysis by a nonprofit that tracks the issue in food-producing livestock. The five chains — Olive Garden, Dairy Queen, Arby’s, Little Caesars, and Sonic — were cited because they lack public policies to ensure their meat suppliers comply with U.S.

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Express Pharma

DECEMBER 2, 2024

What has been the investment into the company’s Research & Development (R&D) facility in Pune and other locations? We, at OmniActive, invest over 10 per cent of the total outlay into Research & Development. Through pioneering seed programmes and conducting stringent trials, we are continuously raising the standards of our specialty branded ingredients to garner consumer trust globally.

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Dosage Packaging Communication 96

STAT

DECEMBER 2, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Hope you had a restful, tasty holiday. In today’s Readout, we discuss former FDA Commissioner Scott Gottlieb publicly speaking out against the nomination of Robert F. Kennedy Jr. for HHS secretary, we see there’s a massive talent gap in radiopharmaceuticals, and more.

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Drug Pricing Drug Development 309

Express Pharma

DECEMBER 2, 2024

In recent years, GLP-1 receptor (GLP-1R) products have gained immense popularity. Currently, four innovative GLP-1Rs are approved worldwide for obesity, all of which are injectables. This leaves a gap in the obesity market for an oral GLP-1R product. 63 drugs are in active development, with four Phase III products racing to earn the inaugural approval in this untapped market, says GlobalData.

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Labelling Diabetes Drug Development 89

STAT

DECEMBER 2, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! I hope you had a lovely holiday weekend and feel rested and ready for the last sprint of 2024.

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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.

Drug Patent Watch

DECEMBER 2, 2024

The traditional marketing models that once dominated the pharmaceutical industry are rapidly becoming obsolete, paving the way for innovative approaches that leverage technology, data, and patient-centricity. This comprehensive guide explores the new business models reshaping pharmaceutical marketing, offering insights into how companies can transform their strategies to achieve market domination.

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STAT

DECEMBER 2, 2024

The Supreme Court heard a case on Monday regarding the Food and Drug Administration’s decision to block several flavored vaping products from the market. The court’s decision next year could change the way the agency regulates tobacco and other products under its purview.  The FDA was sued by two e-cigarette manufacturers after the agency denied their marketing applications in 2021.

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Documentation 284

pharmaphorum

DECEMBER 2, 2024

Four years after buying US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.

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BioPharma Dive

DECEMBER 2, 2024

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

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Compounding Compounding Pharmacies Diabetes 59

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Pharma Times

DECEMBER 2, 2024

Race to create first oral drug for obesity intensifies

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BioPharma Dive

DECEMBER 2, 2024

Using tumor-treating fields alongside chemotherapy improved patient survival, Novocure said. Elsewhere, Cytokinetics got a key PDUFA date and Fate Therapeutics swapped CEOs.

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Chemotherapy 59

pharmaphorum

DECEMBER 2, 2024

Novartis has made a return to the Huntington's disease stage by licensing an oral mRNA splicer from PTC Therapeutics for $1 billion upfront

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Express Pharma

DECEMBER 2, 2024

Indoco Remedies, a research-oriented pharmaceutical company with a global presence, has announced a strategic partnership with Clarity Pharma, a UK-based distributor. The collaboration will see Indoco launch approximately 20 products in the UK over the next 18 months. The company stated that it will continue to supply products under its existing B2B partnerships alongside this new initiative.

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Pharmaceutical Companies Pharmaceutical Companies 52

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.

pharmaphorum

DECEMBER 2, 2024

Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.

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PharmaTech

DECEMBER 2, 2024

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

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Express Pharma

DECEMBER 2, 2024

Indoco Remedies, a research-oriented pharmaceutical company with a global presence, has announced a strategic partnership with Clarity Pharma, a UK-based distributor. The collaboration will see Indoco launch approximately 20 products in the UK over the next 18 months. The company stated that it will continue to supply products under its existing B2B partnerships alongside this new initiative.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

DECEMBER 2, 2024

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant* — We recently blogged on FDA’s draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices , which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing.

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Documentation 52

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Pharmacy Management

Putting Patients First Blog

DECEMBER 2, 2024

PREVIEW: Join us for the 104th Annual Membership Meeting and Luncheon December 2, 2024 By: Leah Poffenberger, Senior Manager, Communications The National Health Council (NHC) is capping off another year of patient advocacy with its 104 th Annual Membership Meeting and Luncheon on Dec. 12 in Washington, DC. The NHC looks forward to this opportunity to connect with all our member organizations who have helped to make this year a success for the patient community.

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Communication 52

PharmExec

DECEMBER 2, 2024

Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7 and DREAMM-8 Phase III trials in patients with relapsed or refractory multiple myeloma.

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Putting Patients First Blog

DECEMBER 2, 2024

NHC Comments on Patient Priorities for the Lame Duck NHC Comments on Patient Priorities for the Lame Duck (PDF) November 22, 2024 The Honorable Chuck Schumer The Honorable Mike Johnson Majority Leader Speaker United States Senate U.S House of Representatives 322 Hart Senate Office Building 568 Cannon House Office Building Washington, DC 20510

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Packaging Hospitals 52

European Pharmaceutical Review

DECEMBER 2, 2024

New guidelines from the The US Pharmacopeia (USP) on mass spectrometry-based quantification of host cell protein (HCP) impurities in biologic drugs are available, as of 1 December. This follows an announcement by USP about its intent to revise General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry.

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Documentation 52

PharmExec

DECEMBER 2, 2024

Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic CAR T-cell therapy for multiple myeloma, and P-CD19CD20-ALLO1, a dual CAR T-cell therapy in early trials for B-cell malignancies and autoimmune diseases.

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