Fri.Jan 27, 2023

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COVID-19 Deaths Increasing Among Those Who Aren't Up to Date on Boosters

Drug Topics

Though, unvaccinated people are at much greater risk for severe outcomes than folks the same age who are caught up on boosters.

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STAT+: Pfizer is scolded by a U.K. trade group for remarks its CEO made about vaccination

STAT

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

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Study Finds Gas Stove Smoke Accounts for 12% of Childhood Asthma in the US

Drug Topics

A study aims to quantify the burden of current childhood asthma in the United States in association with smoke from indoor gas stoves.

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

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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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Breaking: FDA Committee Votes in Favor of New, Unified COVID-19 Vaccine Strategy

Drug Topics

Recommendations from the unanimous vote must be adopted by the FDA and CDC.

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Opinion: How a checklist can help decolonize global health research

STAT

When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.

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Tackling ongoing staffing burnout rates through AI-enabled precision oncology

pharmaphorum

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.

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FDA: CBD Requires Separate Regulatory Pathway from Dietary Supplements, Food

Drug Topics

The agency intends to work with Congress to create a pathway that balances the desire for access with regulatory oversight and risk management.

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Patient centricity and the changing pharmaceutical vista

pharmaphorum

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the indus

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SDOH startup Spatially Health partners with Florida ACO amid new CMS rules on equity

Fierce Healthcare

SDOH startup Spatially Health partners with Florida ACO amid new CMS rules on equity agliadkovskaya Fri, 01/27/2023 - 13:40

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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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J&J copay lawsuit against drug benefit firm gets green light

pharmaphorum

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug

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It’s easy to buy flavored vapes in California, even in cities with longtime bans

STAT

LOS ANGELES – California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers. STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years.

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CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities

Fierce Healthcare

CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities agliadkovskaya Fri, 01/27/2023 - 12:25

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Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

pharmaphorum

As the legendary investor Warren Buffett once said, forecasts about the future usually tell you more about the forecaster than they do about the future. It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. Still, pretty much every business decision is based on some kind of forecast, or scenario; the alternative would be to do nothing, ever.

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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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Federal panel approves plans to safeguard lab-made virus research

STAT

A panel of federal advisers voted unanimously Friday to advance a set of proposals to bolster government oversight of pathogen research that could make viruses more transmissible. The advisers, a collection of biosecurity, ethics and infectious disease experts, united to vote the set of proposals through with minor changes. But some of the scientists who attended the public meeting balked at language that they said could accidentally hinder relatively low-risk gain-of-function research, which ma

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Your guide to strep throat during pregnancy

The Checkup by Singlecare

Dealing with a case of strep throat while pregnant is no fun at all. If you develop strep throat symptoms, such as a sore throat and pain while swallowing—or if you’ve recently tested positive for strep—you are probably wondering what happens next. Is strep throat dangerous for pregnant women? Will it harm the pregnancy? And what treatment options are effective and pregnancy-safe?

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STAT+: After bullying allegations, Eric Lander will return to run a lab at the Broad Institute

STAT

After nearly a year of public silence and private speculation over Eric Lander’s next act, his return to the Broad Institute of MIT and Harvard is now official. Starting in February, the former White House science adviser will resume his position as a core institute member as well as his tenured faculty positions at MIT and Harvard. But the founding director will not be back at the helm of the Cambridge, Mass., biomedical research powerhouse, a role he held from 2003 to 2021, when he was

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Majority of patients repeatedly provide duplicate health information, Carta Healthcare survey finds

Fierce Healthcare

Majority of patients repeatedly provide duplicate health information, Carta Healthcare survey finds aburky Fri, 01/27/2023 - 16:21

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STAT+: Legend says its CAR-T outperformed conventional therapy for multiple myeloma

STAT

Legend Biotech said Friday that its CAR-T therapy Carvykti kept multiple myeloma patients’ cancer in check for longer than conventional therapy in a Phase 3 trial. Carvykti was approved last year, on the basis of an early trial that showed the cell therapy substantially diminished the number of cancer cells in 97% of patients, all of whom had already tried most of the other options available.

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Ipsen’s rare disease drug palovarotene knocked back in EU

pharmaphorum

Ipsen has suffered rather a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against approval. The EMA’s human medicines committee delivered a negative opinion on palovarotene , making it very unlikely that the drug will be approved by the European Commission, although Ipsen says it will be requesting a re-examination of the marketing application.

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STAT+: A bellwether for biosimilars: Why the new competition for Humira matters to pharma, payers, and patients

STAT

After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs. For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders.

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8 Benefits of the Infrared Sauna That Can Reduce Symptoms of Hashimoto’s and Hypothyroidism

The Thyroid Pharmacist

There are common underlying root causes in Hashimoto’s, including nutrient deficiencies , food sensitivities , an impaired ability to handle stress, intestinal permeability, chronic infections , and an impaired ability to handle toxins. [1] Many people have more than just one root cause, and addressing all of these elements can help us feel better.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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White House celebrates end of X-Waiver requirement

Drug Store News

The law change removes the federal requirement for practitioners to have a DATA-Waiver registration to prescribe buprenorphine for the treatment of opioid use disorder.

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EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.

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'I cry and no one cares': Medscape survey shows doctor burnout, depression is getting worse

Fierce Healthcare

'I cry and no one cares': Medscape survey shows doctor burnout, depression is getting worse agliadkovskaya Fri, 01/27/2023 - 15:35

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FDA refuses to regulate CBD, calling on Congress to take charge

Pharmafile

The FDA is calling on the US Congress to work with them on a new regulatory pathway for cannabidiol (CBD). CBD is the non-psychoactive ingredient from the cannabis plant generally considered to have wellness properties. According to the FDA, there have been some safety concerns around CBD, especially with its long-term use. The concerns around the substance relate to its potential to harm the liver, possibilities that it may be detrimental to the male reproductive system as well as the way it in

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FDA panel approves path toward one-shot yearly COVID vaccine

Fierce Healthcare

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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Food Lion, Novant Health partner on food pharmacy pilot program

Drug Store News

The Food as Medicine program gives qualified participants access to nutritious food and encourages them to make healthy lifestyle choices.

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Senators introduced bills to reform PBMs after stalling out in last Congress

Fierce Healthcare

Senators introduced bills to reform PBMs after stalling out in last Congress rking Fri, 01/27/2023 - 15:23

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With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug

Fierce Pharma

With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug aliu Fri, 01/27/2023 - 15:29

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Cigna sues CVS, former exec Amy Bricker over noncompete agreement

Fierce Healthcare

Cigna sues CVS, former exec Amy Bricker over noncompete agreement pminemyer Fri, 01/27/2023 - 12:20

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New UK point of care manufacturing regulatory framework

European Pharmaceutical Review

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Once implemented the manufacturing regulatory framework will apply to all point of care (POC) products manufactured in the UK, such as: Advanced therapy medicinal products (ATMPs), such as cell therapy , gene therapy and tissue engineered products 3D prin

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HCA Healthcare closes out 2022 with revenue gains, lingering capacity constraints

Fierce Healthcare

HCA Healthcare closes out 2022 with revenue gains, lingering capacity constraints dmuoio Fri, 01/27/2023 - 12:42

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