Wed.Mar 22, 2023

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Breast Cancer Detection Drug Up For FDA Approval

Drug Topics

The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection. An NDA has been submitted to the FDA.

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Food Allergy Highlights Opportunities for Inclusive, Representative Research Studies

PhRMA

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

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How Inappropriate Antibiotic Prescribing Harms Patients

Drug Topics

According to a study, patients are frequently prescribed broad-spectrum antibiotics instead of narrowly tailored antibiotics, which would be more optimized to treat them.

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Viral roots: A look at how modern outbreaks began

PharmaVoice

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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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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FDA Extends High Cholestorol Treatment to Young Children

Drug Topics

Evkeeza, which treats a rare form of high cholesterol, is now approved for patients as young of 5 years.

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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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Welcome to Phoenix: Things to Do at APhA 2023

Drug Topics

As sessions end for the day, head out to explore the city of Phoenix.

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Senate panel advances bill to reform PBMs and bring more FTC scrutiny on industry

Fierce Healthcare

Senate panel advances bill to reform PBMs and bring more FTC scrutiny on industry rking Wed, 03/22/2023 - 14:47

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Balancing Risks and Rewards: Are Alzheimer Disease Treatments Worse Than the Illness?

Drug Topics

How can current Alzheimer disease treatments be used to best treat patients living with the disease?

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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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Patients want their medical test results immediately, even when its bad news, survey finds

Fierce Healthcare

Patients want their medical test results immediately, even when its bad news, survey finds hlandi Wed, 03/22/2023 - 12:13

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Celebrate Your Story at the American Associated Pharmacies 2023 Annual Conference

Drug Topics

The 2023 AAP Annual Conference will take place in New Orleans from April 20 to 22.

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Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD

Fierce Pharma

Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37

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Warren pushes FTC to 'carefully scrutinize' CVS-Oak Street deal

Fierce Healthcare

Warren pushes FTC to 'carefully scrutinize' CVS-Oak Street deal pminemyer Wed, 03/22/2023 - 16:58

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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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Innovations and unique opportunities

Drug Store News

Regional pharmacy chains are thriving as a result of diversifying their pharmacy offerings.

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Is it safe to buy prescriptions from Canada?

The Checkup by Singlecare

It’s no secret that prescription drugs cost more on average in the U.S. than they do anywhere else in the developed world. In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. Naturally, this has people looking beyond the border for more affordable alternatives, and Canada seems like an obvious choice.

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Walmart kicks off hunt for new beauty brands

Drug Store News

The company's accelerator program, Walmart Start, will choose at least five unique brands to receive access to key resources specific to launch successfully at Walmart.

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CPHI Pharma Awards marks 20th anniversary

European Pharmaceutical Review

The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an

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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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RFID: The future of smart labelling?

Pharmaceutical Technology

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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Collaboration to produce 3D screen printed pharmaceuticals

European Pharmaceutical Review

Hovione, a contract development and manufacturing organisation (CDMO) and Laxxon Medical, a pharma-tech company will collaborate to advance 3D screen printing technologies for the pharmaceutical industry. Under the agreement, Hovione will establish Laxxon’s 3D screen printing technology at Hovione’s current good manufacturing practice (cGMP) production sites first in Portugal and later in the US.

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Opinion: Living kidney donors rely on a promise to protect our future health. We’re scared it will go away

STAT

Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems.

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After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court

Fierce Pharma

After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39

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Opinion: The lesson biotech absolutely should not take from Silicon Valley Bank’s failure

STAT

As a five-time biotech CEO, I’ve guided my companies through recessions, supply chain disruptions, Wall Street volatility, even a global pandemic. Yet nothing quite prepared me for the news on Thursday, March 9, that my cell therapy company’s ability to make payroll could be jeopardized by the mother of all bank runs unfolding at Silicon Valley Bank.

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US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi

Fierce Pharma

US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi fkansteiner Wed, 03/22/2023 - 09:50

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STAT+: FDA advisory panel recommends conditional approval of Biogen’s drug for rare form of ALS

STAT

An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.

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Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference

ISPE

Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Trudy Patterson Wed, 03/22/2023 - 12:08 iSpeak Blog iSpeak Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Liz M. Dooley, MSc. 22 March 2023 The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year.

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Carrying the torch of his slain brother, a Chicago ER doctor struggles against the violence around him

STAT

CHICAGO — Abdullah Hassan Pratt is giving a tour of a sheep heart that sits, heavy and sodden, in his hand. Dressed all in black, with his Jordans and easy manner, Pratt doesn’t look all that different from his audience: dozens of teenagers from this city’s roughest and poorest neighborhoods. One student raises a tentative hand, utterly confused by how blood travels through the heart.

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The Most Important Audit in Pharmacy

indispensable health

What is the most important Audit in Pharmacy? Our ManageRx team thinks the single most important audit is the Controlled Substance Invoice Audit. In fact, we think that if you are not conducting an audit like this, we would argue that you are neglecting your responsibilities. Why? Why is the Controlled Substance Invoice Audit so important? It is critical to stop drug diversion in your pharmacy, surgery center, or any location using controlled drugs.

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STAT+: 89bio treatment reduces liver scarring in patients with NASH, meeting study goals

STAT

Biotech company 89bio said Wednesday that its experimental treatment improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH. The results met the main goal of a mid-stage clinical trial, with the potential for less frequent injections than a similar experimental treatment being developed by a competing drugmaker.

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Becerra takes bipartisan hits from senators over Medicare Advantage pay rule as lobbying efforts heat up

Fierce Healthcare

Becerra takes bipartisan hits from senators over Medicare Advantage pay rule as lobbying efforts heat up rking Wed, 03/22/2023 - 16:17

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Opinion: The much-maligned ‘quality-adjusted life year’ is a vital tool for health care policy

STAT

Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year ( QALY ) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warned of the potential for these approaches to discriminate, arguing that “All lives are worth living. It’s unconscionable that a health care bureaucracy would so callously determine that someone’s life is worth less,” suggesting tha

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Giant hosts dietitian classes in April

Drug Store News

Giant's dietitians are offering free virtual classes for families throughout April.

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STAT+: Cerebral and other telehealth startups face new legal and regulatory challenges over ad models

STAT

A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT. For years, Cerebral and other telehealth companies have used free tracking technologies  known as “pixels” — provided by big technology companies like