Mon.Dec 02, 2024

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Cannabis Could Help Reduce Opioid Use in Patients with Chronic Pain

Drug Topics

Most patients with reduced opioid prescriptions during cannabis use had chronic musculoskeletal pain.

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Scientists confront a mystery: Why have U.S. bird flu cases been so mild?

STAT

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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Trending Sources

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FDA Approves Ustekinumab-kfce as Biosimilar to Ustekinumab

Pharmacy Times

The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

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STAT+: Novartis to pay $1 billion upfront to license Huntington’s drug from PTC

STAT

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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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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Influenza Vaccine Least Effective for Children Facing Secondary Infection

Drug Topics

Researchers addressed vaccine effectiveness for individuals with direct household contacts that reported influenza.

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STAT+: How often ‘value-based care’ is uttered on Wall Street

STAT

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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STAT+: ‘Significant talent shortage’ threatens the rise of radiopharmaceuticals

STAT

Radiation is a core part of cancer treatment, and has been for generations. But over the last couple of years, there’s been a surge of interest in a new type of treatment , one that is testing drug developers and health care practitioners alike.  This isn’t your grandfather’s radiation therapy: Instead of propelling external beams of radiation toward the general part of the body infested with cancer tumors, pharmaceutical companies, biotech investors, and scientists are

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Legislators urge DOJ to investigate PBMs for potential role in opioid epidemic

Fierce Healthcare

A group of legislators is calling on the Department of Justice to dig into whether pharmacy benefit managers played a role in the opioid epidemic. | A group of legislators is calling on the Department of Justice to dig into whether pharmacy benefit managers played a role in the opioid epidemic.

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Opinion: Congress’ critical opportunity to reshape health care

STAT

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.

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Sanofi charts biggest China investment to date with plans for €1B insulin 'manufacturing base' in Beijing

Fierce Pharma

Shortly after a similarly sized venture from Pfizer, French pharma juggernaut Sanofi has unveiled a major manufacturing outlay in China, marking its biggest investment in the country to date. | Sanofi is laying out roughly 1 billion euros ($1.04 billion) to establish a new production base in the Beijing Economic and Technological Development Zone. The new manufacturing site, which will become Sanofi’s fourth in China, is being designed to beef up local end-to-end insulin production.

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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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STAT+: Big restaurant chains get an ‘F’ for antibiotic use in their meat supplies

STAT

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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FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Fierce Pharma

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.

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Despite probe, China reimbursing AstraZeneca drug

STAT

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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M&A or affiliation improved rural hospitals' margins, reduced risk of closure: report

Fierce Healthcare

Nearly half of rural hospitals moved out of the high-risk category after a merger, acquisition or affiliation with a larger system, a new analysis has found. | The analysis, conducted by healthcare consulting firm Dobson DaVanzo, found that among 110 rural hospitals that closed between 2011 and 2021, more than half were standalone hospitals without support from larger systems.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Bird flu theories, the worst-rated restaurants, and not your grandfather’s radiation therapy

STAT

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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After temporary reprieve, Advanz Pharma's liver med Ocaliva loses marketing nod in Europe

Fierce Pharma

After a rough few months for Intercept and Advanz Pharma's Ocaliva on both sides of the Atlantic, the other shoe has dropped for the rare liver disease drug in Europe. | The General Court of the European Union decided not to extend a suspension of the European Commission’s decision to revoke Ocaliva’s marketing authorization. In turn, Intercept's liver disease drug, which is marketed by Advanz Pharma overseas, has lost its EU approval.

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STAT+: Supreme Court tackles case involving FDA’s oversight of flavored vapes

STAT

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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Looming PREP Act Expiration Could Impact Health Care Access for Rural Patients

Pharmacy Times

The Act is set to end at the end of 2024, which will affect pharmacists’ abilities to administer COVID-19 tests, vaccines, and treatment that are distributed by the federal government.

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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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Fierce Healthcare Fundraising Tracker—Sirona Medical picks up $42M; Alloy banks $16M for menopause care

Fierce Healthcare

At Fierce Healthcare, we keep track of all the venture capital being funneled into the health tech and digital health industries. | Beta Bionics landed $60 million for diabetes management solutions, Medicaid startup Diverge Health picked up $52 million backed by GV and TailorMed secured $40 million for its patient financial assistance platform. Check out other recent funding rounds.

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Best Practices for Standardizing Step-Up Dosing

Pharmacy Times

Panelists discuss how specific recommended dosing schedules exist for step-up medication administration, and protocols should incorporate flexibility for individualized dose adjustments based on patient response, tolerability, and clinical factors while maintaining systematic documentation of any deviations from standard escalation timelines.

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.

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Dosing Frequency and Formulary Decisions for Bispecific Antibodies

Pharmacy Times

Panelists discuss how when selecting between weekly and biweekly dosing schedules for talquetamab and teclistamab in multiple myeloma treatment, health care institutions must carefully weigh factors like patient convenience, monitoring requirements, resource utilization, and total cost of care alongside clinical outcomes to determine optimal treatment pathways for both patient and health system benefits.

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ICHRA-focused StretchDollar raises $6M with help from Oscar Health

Fierce Healthcare

Health benefits startup StretchDollar has raised $6 million from its latest seed funding rounds to improve its self-service platform, the company announced today. | Health benefits startup StretchDollar has raised $6 million, with help from Oscar Health, as the two companies put their weight behind ICHRAs.

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Dr. Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma

Pharmacy Times

It is the only immuno-oncology drug approved by various regulatory authorities around the world such as the USFDA, DCGI, EMA, MHRA, NMPA and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

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Orexo exits depression DTx alliance with GAIA

pharmaphorum

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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Monitoring Serum Magnesium Levels Helps Manage Hypomagnesemia for Patients With Type 2 Diabetes

Pharmacy Times

The pharmacist’s role includes determining if there are any medications that are contributing to magnesium deficiency for patients with diabetes who are at an increased risk.

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Novartis pays $1bn upfront for Huntington's drug from PTC

pharmaphorum

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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Study Finds Associations Between Memory Difficulties and History of Asthma in Children

Pharmacy Times

Asthma onset earlier in childhood may be linked to more severe difficulties that could extend to executive function abilities.

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BMS files legal challenge to HHS' 340B rebate decision

pharmaphorum

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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Veradigm launches AI scribe for small and independent practices

Fierce Healthcare

Veradigm has launched an ambient AI scribe powered by AvodahMed to allow practitioners to save time generating patient encounter notes and reduce provider burnout. | AvodahMed and Veradigm worked closely to integrate the scribe into Veradigm's EHR solutions to maximize the time savings of the technology.

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Patients With Anemia and Myelofibrosis Have Worse Survival Outcomes When Treated With Ruxolitinib

Pharmacy Times

Anemia is a common adverse effect of ruxolitinib, calling for new approaches to mitigate risks.

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How Many Hours are Really in a Day?

The FDA Law Blog

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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Photoacoustic Breast Imaging Can Reduce Skin Tone Biases While Detecting Cancer Early

Pharmacy Times

When different skin tones are considered in imaging systems, women will receive more equitable screening and care.

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