Tue.May 16, 2023

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ICYMI: PhRMA CMO Dr. Michael Ybarra speaks with Dr. Fabian Sandoval about clinical trial diversity

PhRMA

Enhancing clinical trial diversity is a challenge, but with a multi-faceted, community-centered approach, we can help underrepresented patients be more involved in the research and development of potential life-saving medical treatments.

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PBMs Face Criticism From Many Angles

Drug Topics

The National Community Pharmacists Association now has plenty of allies in its fight with the pharmacy benefit managers.

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2022 ACC Consensus on Role of Nonstatin Therapies for LDL-Cholesterol Lowering

Pharmacy Times

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

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STAT+: Biden drug czar to summon naloxone makers to White House to discuss pricing

STAT

WASHINGTON — The White House is summoning naloxone manufacturers for a roundtable focused on the medication’s price, the Biden administration’s top drug policy official told STAT. The move would represent the White House’s most concrete action to date to address the price of naloxone , a medication used to reverse opioid overdoses.

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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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The Health Care World According to Dr. Adam Fein

Drug Topics

Adam Fein, Ph.D., talked about some surprising trends in specialty pharmacy and healthcare at the 2023 Asembia Specialty Pharmacy Summit. The number of specialty pharmacy locations may be peaking. And that "gross-to-net bubble" in drug prices that Fein has written about so much — well, it may be shrinking.

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Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health

Fierce Healthcare

Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health dmuoio Tue, 05/16/2023 - 12:40

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FDA Approves Hyaluronic Acid Injection to Boost Skin Radiance

Pharmacy Times

Skinvive by Juvéderm is a first of its kind medication to create skin smoothness that lasts 6 months with optimal treatment.

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STAT+: AI leaders issue a plea to Congress: Regulate us, and quickly

STAT

During an extraordinary hearing Tuesday, members of a Senate subcommittee called for aggressive regulation of generative AI tools — and the makers and users of the technologies themselves urged the senators to quickly follow through. “Regulatory intervention by governments will be critical to mitigate the risks of increasingly powerful models,” said Sam Altman, the CEO of OpenAI, the company behind ChatGPT.

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Taking Gabapentin With Opioids for Acute Conditions Increases Risk of Opioid-Use Disorder

Pharmacy Times

Health care professionals should educate patients that it is possible to effectively manage pain without opioids.

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UnitedHealthcare defends controversial prior authorization policy for colonoscopies

Fierce Healthcare

UnitedHealthcare defends controversial prior authorization policy for colonoscopies fdiamond Tue, 05/16/2023 - 16:43

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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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Opinion: A breakthrough drug will require big changes for eye care doctors

STAT

Advancement in the science of eye care over the past 10 years has led to dramatically better outcomes for many people with impaired vision. Take anti-VEGF medications for wet age-related macular degeneration (AMD) for example. Anti-VEGFs, which are injected into the eye, slow the growth of blood vessels that often lead to wet AMD, one of the leading causes of blindness in the world.

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Increase in ADHD Diagnoses Contributes to Adderall Shortage

Pharmacy Times

Teva is unable to meet demand for dextroamphetamine/amphetamine, and other companies struggle to keep up.

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AstraZeneca is third member to leave PhRMA in five months

STAT

WASHINGTON — AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said. The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.

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ISPE GAMP® Blockchain Special Interest Group

ISPE

ISPE GAMP® Blockchain Special Interest Group Trudy Patterson Tue, 05/16/2023 - 10:24 iSpeak Blog iSpeak ISPE GAMP® Blockchain Special Interest Group James Canterbury Tanya Sharma 16 May 2023 The ISPE GAMP ® Blockchain Special Interest Group is excited to be in its 4th year! For those of you following this space I’m sure you can appreciate the roller coaster of events across crypto, blockchain, and pharma over that time.

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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+: Ketamine clinics’ bust serves as warning of business challenge facing psychedelic therapy

STAT

A chain of luxury ketamine clinics called Field Trip started churning through business strategies at an increasingly rapid pace late last year. The money was running out, clinics were half full, and the company’s vice president of clinical services was under intense pressure to launch an at-home ketamine service. It was a challenging assignment, figuring out how to safely provide a sedative to depressed patients away from clinic supervision, but Elizabeth Wolfson said senior leaders gave

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Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India

Pharma Tutor

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India admin Tue, 05/16/2023 - 15:25 About Author Ramraj Choudhary M.Pharma, (Pharmaceutics) Dr. H.S Gour University, Sagar MP Current Position : Sr.

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Opinion: The U.S. needs to pressure India to improve drug safety

STAT

On Feb. 2, the Food & Drug Administration issued an alert warning about “Made in India” artificial eye drops that were potentially contaminated with rare drug-resistant bacteria suspected to be the cause of 55 adverse events, including three deaths and several other cases of vision loss from eye infections. These unfortunate events should not come as a surprise.

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Legislators reintroduce bill aimed at easing barriers to virtual mental health care in Medicare

Fierce Healthcare

Legislators reintroduce bill aimed at easing barriers to virtual mental health care in Medicare pminemyer Tue, 05/16/2023 - 16:38

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Pfizer RSV vaccine seen as effective against severe disease, FDA documents say

STAT

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine. The agency’s analysis said the vaccine was also shown to be effective at preventing non-severe lower respiratory tract RSV disease that required medical attention at 180 days af

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FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report

Fierce Pharma

FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report aliu Tue, 05/16/2023 - 09:41

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STAT+: Boundless Bio tests a cancer drug targeting once-mysterious DNA loops

STAT

SAN DIEGO — Peering through a microscope more than a half century ago, researchers made a head-scratching finding: they spotted tiny rings of DNA in tumor cells that were largely absent in healthy cells. Now, a San Diego biotech company is targeting these loops of genetic material to try to control the growth and spread of deadly tumors. Boundless Bio is testing a small-molecule drug against what scientists call extrachromosomal DNA, in an initial clinical trial of patients with solid tum

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Shortages Persist in an Evolving Profession

Pharmacy Times

Low compensation, stressful environment spark technician exodus; replacing them has been difficult.

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STAT+: General Catalyst, Andreessen Horowitz bet on large language models for health care 

STAT

OAKLAND, Calif. — In a rare partnership, heavyweight tech venture firms General Catalyst and Andreessen Horowitz are co-leading a $50 million seed round aimed at exploring large language models in health care — a high-profile bet that there’s money to be made commercializing the artificial intelligence technology for health systems.

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Threats and opportunities facing retail pharmacy

Drug Store News

Traditional drug store retailers seek to become one-stop healthcare destinations amid competition from online players and others.

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STAT+: FTC files lawsuit to block Amgen’s purchase of Horizon Therapeutics

STAT

The Federal Trade Commission on Tuesday sued to block Amgen’s $27.8 billion acquisition of Horizon Therapeutics , signaling possible tougher scrutiny of biopharma takeovers even as the pace of deals starts to pick up.   The acquisition, announced in December, was seen as another move by a large pharma company to build out its rare disease pipeline.

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New startup aims to build generative AI for healthcare armed with $50M from General Catalyst, A16z

Fierce Healthcare

New startup aims to build generative AI for healthcare armed with $50M from General Catalyst, A16z hlandi Tue, 05/16/2023 - 08:37

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AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA

Fierce Pharma

AstraZeneca follows AbbVie, Teva in surprising departure from lobbying group PhRMA zbecker Tue, 05/16/2023 - 11:06

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Research consortium picks eight rare diseases to advance gene therapies

Pharmaceutical Technology

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. This news was announced during the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles.

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Oscar de la Renta unveils summer fragrances

Drug Store News

Oscar de la Renta is adding a tropical touch to the warmer temperatures ahead with the launch of two new fragrances—Alibi Eau Sensuelle and Bella Tropicale.

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Telehealth company Included Health ventures into home care

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Nature’s Bounty addresses hair loss, weight management concerns with latest supplements

Drug Store News

New launches include Hair Growth and Metabolism Booster, which aim to help support women’s hair growth and weight loss goals, the company said.

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HCA Healthcare CFO: Envision Healthcare's bankruptcy won't disrupt Valesco, its recently optioned staffing JV

Fierce Healthcare

HCA Healthcare CFO: Envision Healthcare's bankruptcy won't disrupt Valesco, its recently optioned staffing JV dmuoio Tue, 05/16/2023 - 17:38

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STAT+: Pharmalittle: FTC may sue to block Amgen deal for Horizon; Supreme Court declines Teva appeal on skinny labeling

STAT

Oh, what a beautiful morning! Pardon the cliché, but crystal clear blue skies and deliciously cool breezes are encompassing the Pharmalot campus today. So we will celebrate our good fortune with a delightful cup of stimulation. Our choice today is toasted hazelnut. As always, you are invited to join us, or grab a water bottle if you prefer. In any event, the to-do list is growing so we are passing along the latest laundry list of interesting items for you to peruse.

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Evaluating Response to TRD Treatment

Drug Topics

Ms Maroney drives a conversation regarding response to treatment-resistant depression.

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