Tue.May 23, 2023

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Opinion: Cancer patients shouldn’t be responsible for out-of-pocket costs

STAT

In 2023, just under 2 million Americans will be diagnosed with cancer. Many will endure multiple CT and MRI studies and intensive medical care, including surgery, radiation, chemotherapy, or immunotherapy. Fortunately, advances in treatment and novel therapies have steadily improved survival following a cancer diagnosis. Cancer death rates have declined by 27% over the past 20 years.

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The power of genetics — how research into gene sequencing could revolutionize biopharma

PharmaVoice

Ancient DNA from a deer tooth. A new way to connect genes with disease. Biological super-computing. These genetic advances could play a part in our biopharma future.

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What does generative AI mean for health care? We asked the experts

STAT

Health care companies are racing to incorporate generative AI tools into their product pipelines and IT systems after the technology displayed an ability to perform many tasks faster, cheaper — and sometimes better — than humans. But the rush to harness the power of so-called large language models, which are trained on vast troves of data, is outpacing efforts to assess their value.

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Biotechs blast experiments into space

PharmaVoice

Conducting life sciences research in space’s microgravity could have far-ranging implications for drug development on Earth.

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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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Social media risks for youth mental health highlighted in new surgeon general report

STAT

Amid what he called the worst youth mental health crisis in recent memory, U.S. Surgeon General Vivek Murthy issued an advisory Tuesday warning about social media’s impact on developing young brains. “Through the last two and a half years I’ve been in office, I’ve been hearing concerns from kids and parents,” Murthy told STAT.

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European biotechs choosing Switzerland as base, research shows

European Pharmaceutical Review

New research by IQVIA and recently published in the 2023 Swiss Biotech Report shows that 20 percent of European biotech companies are now headquartered in Switzerland. Sixty three out of a total of 265 companies settling in Switzerland were biotechs. This makes it the second most important sector after ICT, the research found. 2022 statistics by the Swiss federal government confirm that the trend to base here is continuing.

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‘The devil’s in the detail’: What will England’s national Pharmacy First service mean locally?

The Pharmacist

NHS England has recently announced a £645m investment in community pharmacy, some of which will be allocated to a new national Pharmacy First service for England – allowing pharmacists across England to treat seven common conditions – sinusitis, sore throat, earache, infected insect bite, impetigo, shingles, and uncomplicated urinary tract infections in women – under […] The post ‘The devil’s in the detail’: What will England’s national Pharmacy First service mean locally?

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HIV rates decline in U.S., data show, but disparities persist

STAT

The latest accounting of HIV incidence in the United States is a mixed bag. Overall estimated new infections dropped 12% in 2021 compared to 2017, according to data released Tuesday by the Centers for Disease Control and Prevention. But the American South — which has had a longtime HIV problem compared with other areas across the U.S. — was the only region to show a “statistically significant decline.

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Avrobio to sell cystinosis gene therapy to Novartis for $87.5m

Pharmaceutical Technology

Avrobio has announced a deal to sell its investigational haematopoietic stem cell (HSC) gene therapy programme , designed to treat cystinosis, to Novartis in an all-cash deal valued at $87.5m. Novartis will receive an exclusive licence for intellectual property related to the gene therapy platform of Avrobio for use in cystinosis and for other assets.

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Opinion: Three ways to test medical AI for safety

STAT

This article is adapted from “ The AI Revolution in Medicine: GPT-4 and Beyond ,” by Peter Lee, Carey Goldberg, and Isaac Kohane, published by Pearson. “Thrashing.” That’s what old-school computer scientists called it when an operating system is running so many tasks at once that just switching among them basically crashes it.

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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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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The precision therapy has been designed for potently and selectively inhibiting KIT D816V, which is the main underlying driver of the disease. It received FDA approval to treat ISM, advanced SM, including SM with an associated haematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and aggr

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STAT+: Biotech launches with $300 million, joint venture to expedite RNA drug development

STAT

Biotech venture capital may be pacing at a six-year low, but one startup just managed to raise a $300 million Series A mega-round. The round was raised by ReNAgade Therapeutics, a new biotech developing what it hopes will be a one-stop shop for medicines targeting RNA, the genetic blueprints that cells use to make proteins instrumental in numerous diseases.

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Orsini Specialty Pharmacy Selected as part of the Limited Specialty Pharmacy Network For VYJUVEK™

Orsini Pharmacy

Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that Krystal Biotech has selected it as part of the limited specialty network for VYJUVEK™ ( beremagene geperpavec-svdt) , the first gene therapy for the treatment of Dystrophic Epidermolysis Bullosa (DEB). For more information about VYJUVEK, see the Full Prescribing Information or [link].

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ChatGPT in medicine: STAT answers readers’ burning questions about AI

STAT

Artificial intelligence is often described as a black box: an unknowable, mysterious force that operates inside the critical world of health care. If it’s hard for experts to wrap their heads around at times, it’s almost impossible for patients or the general public to grasp. While AI-powered tools like ChatGPT are swiftly gaining steam in medicine, patients rarely have any say — or even any insight — into how these powerful technologies are being used in th

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Croda Pharma and BSI partner for vaccine adjuvant QS-21 production

Pharmaceutical Technology

Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. QS-21 is a potent component of adjuvant systems used in vaccines for diseases such as RSV, malaria and shingles, as well as in new vaccines and immunotherapy treatments such as cancer.

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STAT+: Learning to treat long COVID could help those struggling with chronic fatigue syndrome, too

STAT

CONCORD, N.H. — Veronica Dane had always been active, from playing soccer as a kid to working a demanding job as a critical care nurse. Until, one day, she just couldn’t do it anymore. She started eliminating activities and duties, whittling away the things that had once brought joy and a steady income but were now, instead, bringing unbearable physical pain.

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The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies

Drug Channels

In 2022, the PBM market remained highly consolidated—although there were some intriguing share shifts among the largest players. Below, you’ll find Drug Channels Institute's latest estimates of pharmacy benefit manager (PBM) market share based on equivalent prescription claims. I also provide commentary on recent market developments and offer some helpful tips for interpreting the figures.

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STAT+: Congress highlighted a chemo drug’s price to blast PBMs — but it’s not a PBM issue

STAT

WASHINGTON — Congress blasted drug middlemen at a hearing Tuesday, with multiple lawmakers pointing to a huge discrepancy between how much a chemo drug costs at CVS and its price from Mark Cuban’s Cost Plus Drugs. There’s just one problem: PBMs don’t have anything to do with that discrepancy. The chemo drug in question, Imatinib, costs $17,000 at CVS and just $72 at Cost Plus Drugs.

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Venus Remedies get Kenyan GMP certification for manufacturing facilities in Baddi

Express Pharma

Venus Remedies has secured a Good Manufacturing Practices (GMP) certification from Kenya for all its production facilities in Baddi. Acknowledging the commitment of Venus Remedies to quality assurance and international manufacturing standards, the Pharmacy and Poisons Board (PPB) of the Kenyan Health Ministry granted the certification following a rigorous audit of the company’s production facilities in Baddi.

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FDA budget battles, prisons’ sobering Covid response & BIO’s CEO search is on

STAT

You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter in your inbox on Tuesdays and Thursdays. House committee sets up for budget fight UPDATE: Late on Monday night, House Appropriations Chair Kay Granger indefinitely postponed markup of this FDA budget bill, citing the ongoing debt ceiling talks.

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Positive data for AnaMar’s fibrosis therapy

Pharma Times

Receptor antagonist AM1476 developed as an anti-fibrotic treatment for lung and skin disorders

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STAT+: Achieve Life Sciences drug helps smokers quit in trial but would face stiff competition if approved

STAT

Seattle biotech Achieve Life Sciences on Tuesday announced an experimental drug meant to help people quit smoking did exactly that in a clinical trial, paving the way for the company to seek approval for a product that would face stiff competition. In the study, dubbed ORCA-3, participants took either the smoking cessation drug cytisinicline or a placebo pill three times a day for six or 12 weeks.

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Machine learning can predict outcomes for inkjet printed pharmaceuticals

European Pharmaceutical Review

Using inkjet printing, optimised machine learning (ML) models predicted the printability of drug formulations with an accuracy of 97.22 percent, a paper published in International Journal of Pharmaceutics: X has shown. Inkjet printing makes formulation and printing parameter optimisation time-consuming. This is especially true for additive manufacturing and the production of unique dosage forms and personalised medicines.

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STAT+: Pharmalittle: Pfizer and Novo disclose upbeat data on oral weight loss drugs; PBM trade group blasts House committee over hearing

STAT

Rise and shine, another busy day is on the way. We can tell because the official mascot and his stay-over playmate are furiously bounding about the Pharmalot grounds and the rumble of vehicles passing outside our window is growing noisier. But this is to be expected. So we will pursue the usual routine and trot down to the Pharmalot cafeteria for a cup of stimulation.

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Scarlet Therapeutics gains funding for blood cell platform

Pharma Times

Vital financing will allow the company to build a pipeline of novel therapies targeting serious conditions

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A deep dive on generative AI in health care, Pear sold for parts, and progress on stretchable skin

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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Blueprint wins key FDA approval for rare disease drug

BioPharma Dive

The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future. But the drug’s sales potential isn’t clear, and a top competitor is close behind.

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5 Steps to Decrease the Readmission Rate of CHF Patients

cureatr

According to the Centers for Disease Control and Prevention (CDC), about 6.2 million people in the U.S. have heart failure (HF) — and that number is only increasing. The American Heart Association predicts that nearly 8 million Americans are estimated to be living with HF by 2030.

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FDA Approves the Cyltezo Pen, an autoinjector option for Adalimumab

Big Molecule Watch

On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially approved in August 2017 as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases including rheumatoid arthrit

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Capturing transporter structure paves the way for drug development

World Pharma News

Scientists at St. Jude Children’s Research Hospital and the University of Texas Southwestern Medical Center studied the structure and function of a transporter involved in cancer and immunity. They captured six structures of the transporter, including when it was bound to an inhibitor, providing unprecedented insight into how it works. The findings, published in Cell, have implications for drug development.

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Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation

Big Molecule Watch

We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Amgen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product. Briefing for the PI motion was to be completed by July 21, 2023, and a hearing was scheduled for August 4, 2023.

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ReNAgade debuts with $300M and an ‘all-in-one’ system for delivering RNA drugs

BioPharma Dive

Staffed by many former Alnylam and Moderna employees, the startup is developing technologies that could be useful in a variety of RNA drugmaking methods.

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ReNAgade Therapeutics enters RNA therapy arena with $300m

Pharmaceutical Technology

ReNAgade Therapeutics has burst onto the RNA technology scene by announcing a $300m financing round. As per the company, the round, led by MPM BioImpact and F2 Ventures, is the largest Series A funding round of 2023. Founded by MPM BioImpact, ReNAgade’s portfolio includes novel lipid nanoparticles (LNPs). With its delivery system, Cambridge, Massachusetts-based biotech says it aims to “address major limitations in RNA therapeutics by enabling the delivery of RNA medicines to previously inaccessi

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Wave shelves ALS drug following trial setback

BioPharma Dive

A small study found patients on the experimental therapy fared no better than those receiving a placebo, dealing yet another blow to Wave’s research efforts.

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Top 20 Cell and Gene Therapy Companies Based on 2022 Total Revenue

PharmaShots

Shots: Standing tall and gradually paving its way through extensive research, Cell and Gene Therapy is a beacon of hope when treating rare and inherited diseases. Cell and gene therapy aims to prevent, treat, and potentially reduce the effects of the underlying cause of genetic diseases. Propelled by constant innovatory winds, the Cell and Gene therapy market is anticipated to grow by 20 percent year-over-year through 2025.