Wed.Mar 20, 2024

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FDA Approves Aprocitentan For Treatment of Uncontrolled High Blood Pressure

Drug Topics

Aprocitentan (TRYVIO) from pharmaceutical company Idorsia demonstrated statistically significant and clinically meaningful reductions in blood pressure in combination with other antihypertensive therapies.

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STAT+: New gene therapy, to be priced at $4.25 million, has already transformed children’s lives

STAT

Every morning, Victoria Rasberry gets up before 6 a.m., walks to the bedroom down the hall, and helps her 8-year-old daughter Addi slide into a set of contraptions that squeeze and suck out the thick mucus constantly threatening to choke her airways closed. She feeds Addi breakfast through a stomach tube and makes sure she has the right mix of the 28 different medications required to keep her free of pain, infections, and seizures.

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Star Power: Celebrity Endorsements in Public Health

Pharmacy Times

Celebrities, local advocates, patients, and pharmacists can effectively promote public health initiatives and raise disease awareness by authentically leveraging trusted relationships.

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Overdose deaths hit another record but show signs of leveling off

STAT

The U.S. recorded 107,941 drug overdose deaths in 2022, according to a new federal report — a total that marks an all-time record but also shows signs that the country’s overdose rate may finally be leveling off after years of steady increase. The 2022 total marks only a slight increase from the drug death toll of 106,699 the year before, according to the Centers for Disease Control and Prevention.

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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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Study: Lebrikizumab Demonstrates Improvements in Atopic Dermatitis for Patients of Color

Pharmacy Times

The efficacy data are consistent with other phase 3 studies, reinforcing lebrikizumab's potential as a first-line treatment across a range of skin tones.

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The U.S. banned asbestos, but its health impact will still be felt for decades

STAT

A new rule announced by the Environmental Protection Agency this week puts an end to the use of asbestos, a known carcinogen, in the United States. But researchers caution that we’ll likely still be dealing with the mineral’s public health harms for decades. The recently announced ban covers all forms of asbestos, including chrysotile asbestos, the only form still in use in the U.S., where it can be found in brake linings and is used to manufacture caustic soda (drain pipe cleaner)

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Fetal tissue research gains in importance as roadblocks multiply

STAT

Scientists at the University of Wisconsin-Madison have spent years trying to unravel the details of Down syndrome: What happens inside the womb, how the genetic disorder alters the formation of neurons, and what specific processes affect brain development. The work can’t proceed without studying fetal tissue. Anita Bhattacharyya, an associate professor of cell and regenerative biology, said her lab’s findings so far are significant, having identified a layer of late-developing neur

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Tech company Artera adds new feature to revamp how providers complete referrals

Fierce Healthcare

Artera has spent the past nine years developing tech solutions to solve industrywide pain points and streamline patient communications. | Artera's tech helps healthcare providers deliver timely patient communications with automated referral outreach and real-time responses and automates pre-visit communications to make sure patients and staff are prepared for the appointment.

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STAT+: Medicare expected to negotiate obesity drug prices soon, new analysis predicts

STAT

WASHINGTON — Medicare will likely choose the obesity drug semaglutide for price negotiation “within the next few years,” according to a new analysis from nonpartisan congressional budget experts. That could curb the cost of legislation requiring Medicare to cover obesity drugs, which would increase the chances of Congress actually passing such a bill.

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New Compound Found in Edible Mushroom May Pave the Way for Antioxidant-Based Medicines

Pharmacy Times

The study represents a new era of research into mushrooms as a resource for pharmaceutical development.

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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+: J&J sues former employee for allegedly taking thousands of documents to a new job at Pfizer

STAT

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey. The health care giant alleged that Andrew Brackbill, who most recently worked in the Strategic Customer Group as director of trade channel strategy, downloaded files containing 10-year business plans across different therapeutic product areas; product launch strategies;

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Orchard sets new gene therapy price tag at $4.25M—the steepest of any drug in the US

Fierce Pharma

After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have | After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have broken new boundaries in pricing, too.

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Study Data Suggest SARS-CoV-2 Is Less Severe in Pediatric Patients

Pharmacy Times

Regardless, hygiene practices and prevention measures for SARS-CoV-2 should be strongly practiced to prevent all respiratory viruses.

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Employee experience in healthcare: The importance of EX for patient experience

pharmaphorum

Understanding the employee experience in healthcare is essential for improving the patient experience. Learn more about the importance of employee experience in healthcare and how it impacts patient care.

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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+: Immuno-oncology startup launches with $150 million, ex-Surface, Bluebird exec as CEO

STAT

Robert Ross had thought he would take more time off after his previous company, Surface Oncology, was acquired in September.  The immuno-oncology firm had just managed to weather the stormy public markets, which had battered its valuation. By the time it was acquired, Surface’s stock was trading at around $1 per share. But within a few months, Ross, an oncologist who previously worked at the Dana-Farber Cancer Institute before working at cancer startups like Surface and Bluebird Bio,

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Dispensing Hope: How Pharmacists Are Advocating for Abortion Access

Drug Topics

Supreme Court decisions and state-level legislation have made abortion access in some states more complicated than ever before.

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Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Fierce Pharma

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. | The company is accusing former employee Andrew Brackbill of downloading thousands of confidential strategy-related files before leaving for rival Pfizer.

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Ophelia's virtual OUD care now in-network for Medicaid, dual-eligible Highmark Wholecare members

Fierce Healthcare

Ophelia, a virtual provider of opioid use disorder (OUD) treatment, is now in-network for Highmark Wholecare members. | Ophelia has been part of Highmark Health’s network in Pennsylvania since 2021, serving 2.9 million commercial members. It is now in-network for Wholecare Medicaid and dual-eligible members. Ophelia works with 13 Medicaid plans overall.

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Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension

Fierce Pharma

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

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Focus On Obesity Management Before Addressing Comorbidities

Drug Topics

The latest guidelines advise managing obesity first, then treating a patient’s other conditions to produce optimal outcomes.

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PocketHealth lands $33M to build out its medical image exchange platform

Fierce Healthcare

PocketHealth, a medical image exchange platform, has raised $33 million in a series B round. | PocketHealth, founded in 2016 by Rishi and his brother Harsh, gives patients instant access to their medical images from partner providers and enables image exchange between providers.

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STAT+: A scientific mystery highlights the blind spots in genomics databases

STAT

The two patients had both died young from heart problems. When researchers looked at their DNA, they spotted another commonality: The two shared a particular version of a gene that helps the heart beat. Perhaps, the researchers thought, the variant could explain their heart conditions. Genomic datasets indicated the variant was rare, meaning it could be the cause of a rare disease.

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Amedisys says Oregon regulators are reviewing its $3.7B acquisition by UnitedHealth

Fierce Healthcare

Amedisys disclosed Tuesday that Oregon regulators are probing the company's potential acquisition by UnitedHealth Group. | Amedisys disclosed Tuesday that Oregon regulators are probing the company's potential acquisition by UnitedHealth Group.

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After Opdivo flop in liver cancer, Bristol Myers finds Yervoy combo could save lives

Fierce Pharma

Bristol Myers Squibb is gunning for newly diagnosed unresectable liver cancer—again—after an immunotherapy setback five years ago. | Bristol Myers Squibb is gunning for newly diagnosed unresectable liver cancer—again—after its Opdivo monotherapy setback five years ago and a subsequent market withdrawal.

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Flashback: 2005 Tennessee Medicaid disenrollment led to increased crime, study finds

Fierce Healthcare

Large-scale Medicaid disenrollment in Tennessee nearly 20 years ago led to increased total crime rates, a new study by the National Bureau of Economic Research found. | A new study, that draws parallels to current day redeterminations, delves into the relationship between mass Medicaid disenrollment in 2005 and how it may have led to violent crime.

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With exec appointments and new pharma unit, Bayer's overhaul takes shape

Fierce Pharma

Early this month at an investor event, Bayer CEO Bill Anderson—the agent for reform of the troubled company—declared that employees “are ready for change. They’re saying bring it on.” | Early this month at an investor event, Bayer CEO Bill Anderson declared that employees “are ready for change." On Wednesday, Anderson answered the call with changes to the company’s leadership.

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Vicore’s lung disease digital therapy gets breakthrough tag

pharmaphorum

Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis

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7 foods to avoid while taking metformin

The Checkup by Singlecare

Metformin is an FDA-approved drug for the treatment of Type 2 diabetes. It has a long history of success in lowering blood sugar levels, especially when combined with diet changes and exercise. Although metformin is only approved for use in treating Type 2 diabetes, it has several off-label uses, including as a treatment for polycystic ovary syndrome (PCOS), gestational diabetes, and drug-induced weight gain.

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AI and the battle against AMR

pharmaphorum

Discover how AI is being utilised in the fight against antimicrobial resistance (AMR), particularly in addressing MRSA infections.

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Novo is building a really big computer

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, everyone. Damian here with the latest megaround in biotech venture capital, a rough month for biotech’s neuroscience renaissance, and Novo Nordisk’s big computer.

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Lonza to acquire major biologics manufacturing facility

European Pharmaceutical Review

Lonza has agreed to acquire one of the world’s largest biologics manufacturing sites (by volume), for a total of $1.2 billion from Roche. The acquisition of the manufacturing facility will significantly increase Lonza’s capacity of the manufacture of large-scale biologics, to meet demand for commercial mammalian contract manufacturing. At present, the Genentech Vacaville facility in the US has a total bioreactor capacity of around 330,000 litres.

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EU pharma legislation reforms inch closer to fruition

pharmaphorum

EU pharma legislation gets closer to fruition as European Parliament's ENVI committee votes in favour of amendments, but industry remains concerned

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Germany largest revenue contributor in Europe’s LIMS market

European Pharmaceutical Review

According to a report by Arizton, the Europe laboratory information management system (LIMS) market is expected to reach $912.47 million by 2028. The market is growing at a CAGR of 10.16 percent between 2022-2028, the research found. Factors shaping the market partnerships and collaborations “promise huge demand and growth opportunities for small and medium-sized firms to enter the [European LIMS] market” With pharmaceutical and biotechnological industries making large R&D investments, the

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OTC Product Roundup: Women's Health

Drug Topics

These OTC products are recommended to address a variety of symptoms associated with women's health issues.

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