Wed.Feb 07, 2024

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CGM Can Help Pregnant Patients With T1D Improve TIR, Outcomes

Drug Topics

Despite previously suggested benchmarks, investigators found that spending less time-in-range (TIR) can still improve maternal and perinatal outcomes among pregnant patients with type 1 diabetes (T1D).

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Safety Analysis Shows PPSV23 Is Not Associated With Higher Risk of Serious Outcomes

Pharmacy Times

The 23-valent pneumococcal polysaccharide vaccine was most likely associated with a higher risk of immunological events for those who were immunocompromised, but the events were low.

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STAT+: AI can speed up drug discovery but don’t expect it to cure cancer, yet

STAT

David Reese calls it a “hinge moment” — the turning point when biotech and big tech merge to attack human disease with artificial intelligence. At Amgen, where he’s led drug research and development since 2018, Reese said this moment has finally arrived. The proof lies not only in organizational changes, such as his recent appointment as the company’s first chief technology officer, but also in Amgen’s broader push to embed AI into every aspect of the dr

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Cardiovascular Mortality Rates Increased From 2020 to 2022, Correlating With Pandemic

Pharmacy Times

Investigators also found that the mortality rates for cardiovascular disease from 2020 to 2022 reversed the improvements of reduced mortalities in the preceding decades.

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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+: Government warns Medicare Advantage insurers not to deny care based on AI

STAT

In recent months, the federal government has repeatedly told Medicare Advantage insurers that they cannot use artificial intelligence or algorithms to deny medical services the government routinely covers. But in finalizing a rule to that effect, it also stepped into a thicket of questions from insurers about a technology that is especially difficult to pin down: What is AI?

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Heart Failure Biomarkers Improve Prediction of Cardiovascular Disease Associated With Type 2 Diabetes

Pharmacy Times

The investigators identified 4 prognostic factors with high predictive ability and supported by moderate to high strength evidence beyond what is already available for cardiovascular disease.

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Amazon cuts hundreds of jobs in One Medical, Pharmacy units

Fierce Healthcare

Amazon is eliminating a "few hundred roles" across One Medical and Amazon Pharmacy, the company confirmed Tuesday. | Amazon is eliminating a "few hundred roles" across One Medical and Amazon Pharmacy, the company confirmed Tuesday.

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Can exercise help treat long Covid? New study finds patients improve with self-paced approach

STAT

Fatigue leads the list of persistent problems experienced by people with long Covid — which is why patients have pushed back against treatment approaches that endorse escalating levels of exercise for a condition that researchers are still trying to understand. They fear post-exertional malaise, the debilitating price to be paid for pushing their bodies too hard.

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Many Excess Deaths Attributed to Natural Causes During Pandemic Likely Caused by COVID-19

Drug Topics

In terms of geographic representation, nonmetropolitan counties, the West, and the South had higher excess deaths than reported COVID-19 deaths.

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STAT+: Mystery of allergic memory gets closer to answer: a rare group of B cells

STAT

Maria Curotto de Lafaille’s lab was trying to make human plasma cells in a dish. These weren’t just run-of-the-mill cells, though. The team was vying for something specific: plasma cells that churn out immunoglobulin E (IgE), the antibody that drives allergic reactions.  It was the mid-2010s, and from a research bench at the Immunology Network of A*STAR in Singapore, one of Lafaille’s postdocs, Sriram Narayanan, was plopping donated human B cells into a culture dish wit

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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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Policy Changes Can Help Implement Continuous Glucose Monitoring

Pharmacy Times

By involving pharmacists, patients can see improved medication adherence, improved outcomes, and, as a result, reduced health care costs

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Virgin Pulse, HealthComp unveil rebrand as employer health company eyes accelerated growth

Fierce Healthcare

Three months following the merger of Virgin Pulse and benefits administrator HealthComp, the combined company has rebranded as Personify Health with its sights set on revamping the patient experien | Personify Health introduced what it calls a personalized health platform that combines HealthComp's health plan administration capabilities with Virgin Pulse's holistic wellbeing solutions and comprehensive health navigation.

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Jazz buys KRAS inhibitors from Redx in $880m deal

pharmaphorum

Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.

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STAT+: Years into an addiction crisis, a med school lecture still minimized opioid risks

STAT

Amid ongoing concern over opioid addiction, a university in Florida has been criticized for allowing a lecture that conveyed “false and misleading” information about the use of the prescription painkillers by a local physician who, in years past, had ties to opioid makers. At issue was a lecture that was given last October at Nova Southeastern University in Fort Lauderdale, Fla., by Martin Hale, an  orthopedic surgeon, to first-year medical students about managing pain.

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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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Brighter times ahead for biotech in 2024?

pharmaphorum

As the pandemic recedes and the global economy stabilises, are there promising signs for the biotech industry's financial outlook in 2024? Learn more about the potential for recovery, reducing bankruptcies, and attracting investors.

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STAT+: RayzeBio co-founder, industry veterans launch new biotech VC with $310 million

STAT

Three biotech VC veterans, including one of the co-founders of radiopharma success story RayzeBio, are launching a new investment fund called Scion Life Sciences. Scion was started by former Apple Tree Partners colleagues Sam Hall and Aaron Kantoff, along with Tadd Wessel, managing partner of the health care private equity firm Petrichor. They raised $310 million for its first fund, blowing past their original $250 million target.

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Gilead plots long-term cell therapy growth, maintains confidence in Trodelvy despite trial miss

Fierce Pharma

Despite markedly slower cell therapy growth from the third to the fourth quarter of 2023—and a recent setback for Trodelvy—historically HIV-focused Gilead Sciences is not discouraged amid its | Despite a tame level of fourth-quarter growth, recent advances should drive long-term cell therapy sustainability, Gilead execs said. Overall, the company is pushing to generate 30% of its revenues from oncology by 2030.

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The GLP-1 panic is alive and well

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, all. Damian here with news of a new biotech venture fund, a bold bet against a billion-dollar deal, and the weight of expectations on Eli Lilly.

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Montefiore Medical Center pays $4.8M after OIG investigation of insider data breach

Fierce Healthcare

Montefiore Medical Center has agreed to a $4.75 million settlement over data security failures federal officials uncovered when investigating an employee who had sold patient information to crimina | Federal officials investigated the New York City-based health system after an incident in which an employee's inappropriate access and sale of patient data wasn't detected for more than a year.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

The FDA Law Blog

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

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This week in clinical trials: 15th-19th January 2024

pharmaphorum

Stay updated on the latest clinical trials happening from January 15th to January 19th, 2024. Explore trials by ExeVir, NurixTx, Synendos Therapeutics, and Oxford BioTx.

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Opinion: AI assurance labs intended to test health care technology have an equity problem

STAT

As leaders across federal agencies swiftly advance regulations for AI in health care, one proposal now seems too big to fail. That proposal is for the implementation of AI assurance laboratories — places where AI model developers can develop and test AI models according to standard criteria that would be defined with regulators.

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JP Morgan 2024 – Simon Arkell

pharmaphorum

In this interview, Simon Arkell, co-founder and CEO of Ryght, discusses his vision whilst at JP Morgan 2024 and how generative AI is transforming the industry.

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Eisai, Biogen likely to miss early launch goal for Alzheimer's drug Leqembi

Fierce Pharma

Even with Leqembi now sporting a full FDA approval and benefiting from the simpler Medicare coverage that distinction brings, Eisai and Biogen’s latest Alzheimer’s disease med appears to be moving | While Japan’s Eisai had set the goal to reach 10,000 patients with Leqembi by the end of its 2024 fiscal year, which wraps up in March, only 2,000 patients in the U.S. were receiving the amyloid-busting antibody as of Jan. 26, Eisai explained in a third-quarter earnings presentation.

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Understanding the Implications of the FDA’s New Boxed Warning for CAR T-Cell Therapy

Pharmacy Times

In November 2023, the FDA announced an investigation of CAR T-cell therapy based on several reported secondary T-cell malignancies.

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STAT+: Pharmalittle: We’re reading about worries over a Novo deal, a PBM bill, and more

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? Consider the alternatives, if you must. And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is maple bourbon — and get started.

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Beauty benefits: Focus on ingredients

Drug Store News

Every year, HRG conducts a review of the new health, beauty, and wellness products released to identify trends and shifts in the market.

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GSK backs up its Blenrep rehab bid with survival data

pharmaphorum

GSK has revealed the data it hopes will allow a return to the US market for Blenrep, which was the first BCMA-targeting drug to launch there but was withdrawn from sale after it failed a confirmatory trial.

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Catalent receives another regulatory wrist slap at Indiana plant included in Novo buyout

Fierce Pharma

As part of the acquisition of manufacturing giant Catalent, Novo Nordisk will fork over $11 billion for three of the CDMO’s plants. | While Catalent’s Bloomington, Indiana, site is no stranger to FDA reprimands, its latest write-up is notable given that the site forms part of the $16.5 billion deal Novo Holdings struck to acquire Catalent earlier this week.

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General Mills loads up cereals with puffed up flavors

Drug Store News

Featuring puffed-up and larger-than-life squares that are filled with a vanilla crème, the Loaded cereal lineup will include Cinnamon Toast Crunch, Trix and Cocoa Puffs.

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Amgen makes progress with its Horizon prize Tepezza, but there's much work left to do

Fierce Pharma

After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepez | After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepezza—an instant blockbuster that saw a perplexing slide in just its third full year on the market.

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Does diabetes cause dizziness?

The Checkup by Singlecare

Feeling unsteady or off-balance can be scary, especially if the sensation comes on suddenly. If you’ve been diagnosed with diabetes mellitus , dizziness may be an uncomfortably familiar experience. That’s because diabetes can cause blood sugar swings and dehydration—common causes of dizziness or lightheadedness. Untreated or poorly managed diabetes can also lead to complications such as vestibular dysfunction, which makes you feel unsteady on your feet.

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Could Novo-Catalent deal face antitrust hurdles?

pharmaphorum

Eli Lilly has called on financial regulators to look into the antitrust implications of Novo Holdings purchase of Catalent and the sale of three manufacturing facilities to Novo Nordisk.

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Despite insurance coverage, people living in poor neighborhoods have worse surgical outcomes: study

Fierce Healthcare

Patients living in poor neighborhoods are more likely to have worse postsurgical outcomes even if they’ve got insurance coverage, according to a