Wed.Apr 10, 2024

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Buyer Beware: Red Yeast Rice Supplements Linked to Deaths, Hospitalizations

Drug Topics

Japan’s health ministry has issued a warning to consumers regarding red yeast rice dietary supplements containing a red species of mold after 5 people died and more were hospitalized after consumption.

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STAT+: Cancer vaccines gain momentum, after years of disappointing results

STAT

SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner. “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Can

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Virginia Governor Vetoes Bill for Lower Prescription Drug Costs

Drug Topics

Governor Glenn Youngkin vetoed bills HB570 and SB274 that would have allowed the state to establish its first Prescription Drug Affordability Board.

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STAT+: Did you say 486%? Why one company thinks such a price hike for its drug is justified

STAT

In an era when huge price hikes for prescription drugs are almost guaranteed to draw criticism, is there any circumstance when a 486% increase for a medicine might appear to be justified? A small company called Harrow argues that it can make the case for an injectable eye treatment that has been used to combat several serious conditions. Company executives maintain the medication, which has been largely out of stock for the past few years, requires substantial investment in order to restore a st

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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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How Pharmacies Can Successfully Leverage 340B

Drug Topics

Eric Fromhart, co-founder and chief growth officer at Aventi Health, discusses how pharmacies can use 340B to increase profits and how they can avoid any potential risks when participating in the program.

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STAT+: Vertex to buy Alpine Immune Sciences for $4.9 billion

STAT

Vertex Pharmaceuticals will buy Alpine Immune Sciences, a maker of protein-based medicines that harness the immune system, for $4.9 billion, the companies announced Wednesday. It is the largest acquisition in Vertex’s history. The acquisition gives Vertex a drug called povetacicept, which has shown promise in treating IgA nephropathy (IgAN), an autoimmune disorder of the kidney that can lead to end-stage renal disease and affects 130,000 people in the U.S.

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NCI director expresses optimism about next era of cancer research, despite shrinking budget and brain drain

STAT

SAN DIEGO — Kimryn Rathmell, director of the National Cancer Institute, gestured toward the screen and asked an audience of clinicians, researchers, and patient advocates what they thought they were looking at. Projected behind her was a patchwork of purple, red, pink, and blue squares. Moments later, a larger-than-life image of Taylor Swift flashed in the middle of the pattern, and laughter rippled through the room here at the American Association for Cancer Research annual meeting as at

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FDA Approves Cilta-Cel for Treatment of Relapsed, Refractory Multiple Myeloma

Pharmacy Times

The indication is for adult patients with multiple myeloma who are refractory to lenalidomide and have previously received at least 1 line of therapy.

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STAT+: Drug shortages reached a record high as 2023 drew to a close

STAT

The number of ongoing and active drug shortages in the U.S. stood at 323 during the fourth quarter of last year — the highest figure reached since such data began being tracked in 2001 — underscoring growing concerns about patient harm across the country. Unresolved shortages have, in fact, been hovering above 300 for more than a year as numerous basic and life-saving medicines are in short supply.

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Psychedelic Medicine Could Fill Care Gap in Psychiatric Care

Pharmacy Times

However, psychedelic medicine has a variety of barriers, including historical perception, access challenges, legal obstacles, and ethical questions.

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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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STAT+: BIO’s top lobbyist exits, signaling reorganization

STAT

WASHINGTON — The biotech industry’s largest trade group has parted ways with its top lobbyist, the group confirmed to STAT, adding to a recent bout of organizational tumult. The departure of Nick Shipley may be part of a greater shake-up spearheaded by the Biotechnology Innovation Organization’s new CEO, John Crowley, who took over in December.

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AMA: 80% of docs have lost revenue amid disruptions from Change Healthcare cyberattack

Fierce Healthcare

Most physicians felt the disruption caused by the cyberattack on Change Healthcare, and many were still seeing the effects in early April, more than a month after the hacking was revealed, accordin | Most physicians felt the disruption caused by the cyberattack on Change Healthcare, and many were still seeing the effects in early April, more than a month after the hacking was revealed, according to a new survey from the American Medical Association.

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Opinion: Cancer is a killer. So is the fear of it

STAT

The widespread attention to the recent revelations of cancer diagnoses by Princess Catherine , actress Olivia Munn , and King Charles , among others, demonstrate yet again that cancer is a feared disease. For good reason: It is a cruel killer, the second leading cause of death in the U.S. and a top killer around the world. So public faith in cancer screening (checking seeming healthy people for signs of hidden disease) is deep, driven by the widespread understanding that finding cancer early &#x

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State public option plans don't reduce premiums, result in low enrollment: industry-backed study

Fierce Healthcare

Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America's Health Care Future argues. | Public option plans may not be reducing premiums and expanding coverage as previously thought they would, a new study shows.

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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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STAT+: Regeneron accused by Justice Department of manipulating Medicare pricing

STAT

The U.S. Department of Justice filed a lawsuit accusing Regeneron Pharmaceuticals of manipulating Medicare pricing by inflating the average sales price for its expensive and widely prescribed Eylea treatment for serious eye disease. In its lawsuit, the Justice Department claimed the company failed for more than a decade to report how it paid “hundreds of millions of dollars” to subsidize Eylea purchases by reimbursing drug distributors for credit-card processing fees.

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Sunshine transparency reporting for emerging pharma: Simplify, streamline, and secure

pharmaphorum

Discover how Sunshine transparency reporting can be simplified, streamlined, and secured for emerging pharmaceutical companies with a focus on Healthcare Professionals (HCP) and Healthcare Organisations (HCO).

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Opinion: Mental health screening tools for kids are 30 years out of date

STAT

Suicide is the second leading cause of death among children aged 10 to 14 in the U.S. That’s evidence of a systemic failure in identifying and addressing mental health concerns in young people. Compounding the problem is the average delay of 11 years between the onset of a mental health condition and its diagnosis. Think about it: a child exhibiting signs of mental health challenges at age 6 may not receive proper diagnosis or treatment until age 17.

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Can pink eye cause a fever?

The Checkup by Singlecare

You’re shivering one minute and sweating the next. A fever can be a sign you caught the latest flu that’s circulating in the community. However, this unpleasant symptom can accompany many different conditions, including conjunctivitis , the medical term for pink eye. “Conjunctivitis could stem from a viral infection, and when this occurs, someone may also have other symptoms such as fever, body aches, nasal discharge, and cough ,” says Edgar Navarro Garza , MD, a board-certified pediatrician at

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STAT+: Pharmalittle: We’re reading about a 486% drug price hike, AstraZeneca CEO pay, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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FDA appears receptive to surrogate endpoint supporting accelerated approval of multiple myeloma drugs

Fierce Pharma

New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. | New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions.

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Biosimilars in Retina Space Expected to Grow in 2024, Coming Years

Pharmacy Times

In a review, investigators focused on ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech) as growth opportunities in the biosimilar space.

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UK calls time-out on post-Brexit rules opposed by industry

pharmaphorum

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S. FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses.

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Vertex wagers $4.9bn on Alpine kidney disease therapy

pharmaphorum

In another departure from its focus on genetic medicines, Vertex Pharma has agreed a $4.9 billion purchase of Alpine Immune Sciences, adding a mid-stage drug candidate for kidney disease IgA nephropathy (IgAN). The $65-per-share deal is due to close within the next three months, said Vertex, which plans to fund the acquisition with cash in hand. It is the largest acquisition in the biopharma sector so far in 2024.

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How Efficient Logistics Can Change the Lives of Rare Disease Patients

Pharmaceutical Commerce

If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.

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Study Suggests Patients With Low-Risk CLL May Stop Specialized Follow-Up Visits

Pharmacy Times

The results demonstrated similar overall survival between patients with chronic lymphocytic leukemia who discontinued specialized follow-ups versus those who continued.

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Novartis halts recruitment of Kisqali trials as it adjusts production methods

Fierce Pharma

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kisqali (ribociclib) as it makes adjustments to its manufacturing processes for the drug.

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AskBio CSO steps down, has new project in stealth mode

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we get some optimism from the new director of the National Cancer Institute, despite a brain drain playing out in the industry and stagnant funding numbers. Also, advocates press the federal government to encourage manufacturing for the prostate cancer drug Xtandi.

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Essential adds neuroblastoma drug with Renaissance buy

pharmaphorum

Essential Pharma has bought Renaissance Pharma, adding its first developmental drug candidate, a therapy for rare cancer neuroblastoma.

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What to do during Mounjaro shortage

The Checkup by Singlecare

Mounjaro (tirzepatide) , an injectable drug prescribed for high blood sugar in people with Type 2 diabetes , has recently been in short supply. The Food and Drug Administration (FDA) first reported the shortage in December 2022, but availability issues have continued long after that. In fact, as recently as April 2, 2024, the FDA announced that shortages of certain Mounjaro dosages were expected to continue at least through the end of April.

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One year after unwinding, community health centers struggle with Medicaid reenrollment

Fierce Healthcare

Almost all community health centers (95%) are reporting Medicaid disenrollment, influencing the level of care provided to individuals that rely on these locations. | States have handled the Medicaid redetermination process with varying degrees of success. A new study looks at how community health centers have been impacted.

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Changing Faces: Digital and supplier hires from March 2024

pharmaphorum

Discover the latest trends in leadership appointments and C-suite hires in the digital and supplier space from March 2024 in our in-depth analysis.

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Banner Health CEO Peter Fine to retire after 24 years, handing the reins to health system president

Fierce Healthcare

Banner Health CEO Peter Fine will retire on June 30 after 24 years in the $14 billion system’s top role, according to a Tuesday announcement from its Board of Directors. | Fine is credited by the $14 billion nonprofit system's board with growing Banner Health "from its roots as a hospital system to its identity today as a fully integrated healthcare enterprise.

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The Importance of Hemoglobin A1c Management in Type 2 Diabetes

Pharmacy Times

Pharmacists can help to interpret HbA1c and glucose results when patients come to pick up medications and contact prescribers and/or make recommendations based off patient results.

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