STAT

JUNE 5, 2023

SAN FRANCISCO — Primary care tech startup Carbon Health is using artificial intelligence to listen in on patient appointments and automatically write up near-complete notes within minutes, directly in its own electronic health record software. Carbon — which has raised about $750 million in venture funding, including $100 million earlier this year — has been developing the AI-based health record software over the past few months and began using it on patients last month.

Hospitals 267

Hospitals 267

ALiEM - Pharm Pearls

JUNE 5, 2023

Which of the following is the most likely explanation for this skin lesion in a worker handling sheep hides? Bacillus anthracis Group A streptococcus Pseudomonas aeruginosa Staphylococcus aureus (Photo credit: CDC/ James H. Steele, Public domain via Wikimedia Commons) Reveal the Answer Answer: 1. Bacillus anthracis This patient has cutaneous anthrax.

Vaccines 255

Vaccines 255

STAT

JUNE 5, 2023

The Food and Drug Administration has removed a neurologist with financial ties to Biogen and Eisai — which jointly develop and market a pair of controversial Alzheimer’s drugs — from an upcoming advisory panel meeting to review one of those treatments. David Weisman was cleared two months ago by the agency as a temporary voting member of an advisory committee that will meet Friday to consider whether a drug called lecanemab, which is promoted by the companies, should be full

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PharmaVoice

JUNE 5, 2023

Rachel King took the reins at BIO during a rocky time. Now, after steadying the ship, she’s brought the trade association’s focus back to the industry’s most pressing priorities.

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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.

STAT

JUNE 5, 2023

A $203 million tax refund for Blue Cross Blue Shield of North Carolina. Nearly $1.5 billion in profit for Health Care Service Corp., the parent of five Blues plans. A quadrupling of profit at BCBS of Alabama. Publicly traded health insurers were not the only ones in the industry that continued to amass large windfalls in 2022. Many nonprofit and private Blue Cross Blue Shield companies ended last year with sizable gains that added to their mountainous cash reserves, according to a STAT analysis

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PharmaVoice

JUNE 5, 2023

A partnership going on six years between the pharma giant and the Chinese biotech is showing that their CAR-T cell therapy for multiple myeloma is highly effective.

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PharmaVoice

JUNE 5, 2023

Supply chain challenges have eased — but now inflation and manufacturing complexity are triggering a new sense of urgency to bring costs down.

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STAT

JUNE 5, 2023

This article is adapted from STAT’s latest report , Decoding Medicare: 10 key coverage decisions and how they’re made. F or years, patients and medical groups have advocated for Medicare to cover wheelchairs with power-seat elevation, allowing users to, among other things, reach cabinets and countertops more easily and conduct conversations eye to eye.

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BioPharma Dive

JUNE 5, 2023

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

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STAT

JUNE 5, 2023

GLP-1s, a class of drugs including Ozempic and Wegovy that have become widely popular for treating obesity and diabetes, are also being studied for NASH , a form of fatty liver disease. But a new small study suggests GLP-1s may not dominate the disease area as they have others. Akero Therapeutics tested its experimental medicine efruxifermin in conjunction with a GLP-1, and found that patients taking the combination had reduced liver fat and improved markers of liver scarring compared with those

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Diabetes 234

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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HIPAA Pharmaceutical Companies Pharmaceutical Companies 110

STAT

JUNE 5, 2023

In an important reminder that plugging digital tools into a clinical trial will not magically solve problems, Bellerophon Therapeutics announced Monday it would abandon a study of its treatment for pulmonary fibrosis after patients in a Phase 3 trial using a digital endpoint showed no improvement. Bellerophon’s study, which the New Jersey-based company boasted was the first pivotal trial to use a Food and Drug Administration-endorsed endpoint using wearable data, was closely watched by la

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Pharma Times

JUNE 5, 2023

New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes

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STAT

JUNE 5, 2023

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin — in all sorts of directions. So to cope, we are, indeed, brewing cups of stimulation.

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BioPharma Dive

JUNE 5, 2023

The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.

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STAT

JUNE 5, 2023

CHICAGO — Yescarta, the CAR-T therapy made by the Kite unit of Gilead Sciences, prolonged the lives of patients with large B-cell lymphoma by 27% compared to standard treatment in a long-running clinical trial, researchers reported Monday. Proving a meaningful survival benefit for patients with a type of blood cancer represents another milestone for CAR-T therapy, which involves extracting white blood cells from a patient and genetically modifying them to attack cancer.

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Chemotherapy 202

BioPharma Dive

JUNE 5, 2023

Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.

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STAT

JUNE 5, 2023

Since a Texas judge’s decision dropped earlier this spring, Braidwood v. Becerra has sent shudders down public health’s spine. Similar to earlier contraceptive mandate cases, Braidwood involves plaintiff-employers who object to paying for health insurance that includes coverage of disease screenings and PrEP for HIV on moral grounds. Their legal claims challenge the U.S.

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ID Stewardship

JUNE 5, 2023

In this article the artificial intelligence program ChatGPT is interviewed about antimicrobial stewardship. Interview with: ChatGPT by OpenAI Interview by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article posted 6 June 2023 Antimicrobial resistance (AMR) has emerged as a global healthcare crisis, threatening our ability to effectively treat infections and safeguard public health.

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Vaccines Hospitals 93

STAT

JUNE 5, 2023

CHICAGO — As commissioner of the Food and Drug Administration, Robert Califf has made clear he’d like to do away with the votes that punctuate meetings of expert panels evaluating new drugs for approval. On Sunday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, took issue with his boss. It’s true that the FDA has no obligation to follow what the advisory committee recommends, but the votes help, Pazdur said at STAT@ASCO, STAT’s event at th

Drug Development 200

Drug Development 200

European Pharmaceutical Review

JUNE 5, 2023

Based on an in silico analysis of over 12,000 small molecule drugs and drug impurities , a recent paper has reported that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. In total, 40.4 percent of the analysed active pharmaceutical ingredients (APIs) and 29.6 percent of the API impurities were revealed as potential nitrosamine precursors.

Drug Development 93

Drug Development Packaging 93

STAT

JUNE 5, 2023

CHICAGO — The annual meeting of the American Society of Clinical Oncology is back in full force here, with plenaries and poster sessions as packed as before the pandemic.        The big news from the first few days is that the AstraZeneca drug Tagrisso cuts deaths in half when given to non-small cell lung cancer patients with an EGFR mutation after surgery.

Drug Pricing 188

Drug Pricing Drug Development 188

European Pharmaceutical Review

JUNE 5, 2023

A two-year study monitoring microbial contamination of adipose tissue-derived stem cells (ADSC)-based advanced therapy medicinal products (ATMP) during manufacture , showed over 40 percent of lipoaspirate samples were contaminated with thirteen different microorganisms. over 40 percent of lipoaspirate samples [from ADSC-based ATMPs] were contaminated with thirteen different microorganisms” This is the first study to show this observation, according to the authors of the paper.

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Documentation 93

STAT

JUNE 5, 2023

In response to concerns about pollution caused by antibiotic production, an industry group is launching a new system to certify that manufacturers meet environmental goals. The idea is to create a far-reaching standard for measuring discharge from antibiotic production facilities, since standards currently vary across the globe. Pharmaceutical companies that obtain a certificate can then use the document to satisfy customers — such as government agencies — that are increasingly inc

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Documentation Pharmaceutical Companies Pharmaceutical Companies 187

PharmExec

JUNE 5, 2023

Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.

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STAT

JUNE 5, 2023

There’s now a two-party showdown for one of the largest home health companies in the country. UnitedHealth Group and its Optum division on Monday formally proposed to buy Amedisys for $100 per share, or about $3.3 billion. The offer comes a few weeks after Option Care Health proposed a $3.6 billion takeover. However, Option Care’s deal is an all-stock transaction, whereas UnitedHealth would pay all cash — a potentially more attractive offer for Amedisys shareholders who want

Hospitals 186

Hospitals 186

Pharma Times

JUNE 5, 2023

Company’s phase 3 study showed treatment with Tagrisso reduced risk of death by over half - News - PharmaTimes

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STAT

JUNE 5, 2023

In the third episode of “Color Code,” we take a look at efforts on Long Island to address racial disparities in maternal and infant mortality. In the U.S., Black women are three times more likely than white women to die as a result of childbirth. Black babies also have an infant mortality rate that is twice as high as it is for white babies.

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Outsourcing Pharma

JUNE 5, 2023

Encouraging clinical data has been released by Biovie, a company developing drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

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Express Pharma

JUNE 5, 2023

Parexel announced it has been rated the “Top CRO to Work With” by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey. Among the 34 CROs included in the survey, Parexel received the highest average rating across all 26 performance attributes evaluated. In this survey — which measures the quality of working relationships between CROs and investigative sites globally — respondents were asked to rate the importance of 26 performance attributes.

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European Pharmaceutical Review

JUNE 5, 2023

Ninety-four percent of advanced stage (3 or 4) classic Hodgkin lymphoma patients treated with nivolumab, a PD-1 checkpoint inhibitor plus AVD chemotherapy (N-AVD) had one-year progression-free survival (PFS), according to Phase III trial results. This was compared with 86 percent of patients given brentuximab vedotin, a monoclonal antibody (mAb), and AVD (BV-AVD).

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Chemotherapy Immunity Immunization 83

Express Pharma

JUNE 5, 2023

The Indian pharma sector is a trendsetter in multiple ways on the global stage. It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. Therefore, it is no surprise that India supplies over 50 per cent of the global demand for various vaccinations, 40 per cent of the generic demand in the US, and 25 per cent of the total pharmaceuticals in the UK.

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Packaging Vaccines Biosimilars 87

BioPharma Dive

JUNE 5, 2023

The pioneering executive has rejoined small startup Alkeus Pharmaceuticals to help launch a Stargardt disease treatment he’s long viewed as a “perfect” drug.

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Express Pharma

JUNE 5, 2023

Indoco Remedies has acquired 85 per cent of equity stake of the US-based FPP Holding Company for $4 million from Contract Pharmacal Corp. FPP Holding is the holding company of Florida Pharmaceutical Products, based in Florida and engaged in marketing and distribution of generic pharma products in the US. The strategic investment by Indoco marks a significant milestone, solidifying its position as a key player in the US market, said a company statement. “ This development will facilitate exchange

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BioPharma Dive

JUNE 5, 2023

Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.

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