September, 2024

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Chronic Hand Eczema Studies Show Condition is Common, Burdensome

Drug Topics

LEO Pharma presented data from 2 of the largest multinational real-world studies on the prevalence, severity and treatment of chronic hand eczema at the European Society of Contact Dermatitis congress.

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Marburg virus outbreak in Rwanda draws concern over possibility of international spread

STAT

A large outbreak of Marburg virus in Rwanda is drawing international concern about the possibility of spread beyond the country’s borders. The number of cases detected so far, 27 , already makes the outbreak one of the biggest involving Marburg on record. Nine of those individuals have died. There are currently no licensed vaccines to combat the disease.

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Startup Particle Health files antitrust lawsuit against Epic alleging it uses monopoly power to block competition

Fierce Healthcare

What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations. | Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records giant is trying to muscle out competition in the payer platform market.

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

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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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Experts Develop Multimodal Approach for Treating Long COVID, Other Post-Acute Infectious Syndromes

Pharmacy Times

In the absence of a common treatment for long COVID, researchers from around the world documented the best currently available therapies.

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Ipsen crosses EU finish line with Alagille syndrome drug

pharmaphorum

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.

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STAT+: Health care CEOs dialed back their pay in 2023. They still made $3.5 billion

STAT

Health care stocks stumbled compared with the rest of the market in 2023. Companies missed their profit targets. Some CEOs even lost their bonuses. But the biggest names in health care still made $3.5 billion combined last year, compared with $4 billion in 2022. The average chief executive brought home $11 million, while the median was $4.1 million.

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FTC formally sues PBMs over insulin prices and warns manufacturers

Fierce Healthcare

The Federal Trade Commission is suing the titans of the pharmacy benefit manager industry for anticompetitive practices and artificially raising the price of insulin drug prices, the agency announc | As expected for weeks, the Federal Trade Commission is taking legal action against the biggest three PBMs and its related group purchasing organizations.

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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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FDA Grants Rare Pediatric Disease Designation to MDL-101 for Congenital Muscle Dystrophy

Pharmacy Times

MDL-101 is a proposed novel precision medicine that targets the LAMA1 gene, causing LAMA2 congenital muscular dystrophy type 1a.

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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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The Life Sciences Generative AI Council and a sustainable technological future

pharmaphorum

Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.

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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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Four more health care workers reported illnesses after caring for bird flu case in Missouri

STAT

An investigation into the still unexplained human H5N1 bird flu infection in Missouri has turned up four additional health care workers who developed mild respiratory illness symptoms after caring for the patient in hospital in August, the Centers for Disease Control and Prevention reported on Friday. It is not clear if any of these people were actually infected with H5N1; they were not tested at the time when they were ill.

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Morehouse School of Medicine launches pain equity course focused on racial healthcare disparities

Fierce Healthcare

One of the first pain equity courses for medical students is launching at the Morehouse School of Medicine this fall. | The course offers insights into fostering safe, trustworthy, transparent and empathetic patient-provider interactions. It also emphasizes how to address the unique preferences and needs of Black patients in pain.

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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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AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg

Fierce Pharma

AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.

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Immunotherapy Evolution Continues with Innovative Approaches to Multiple Myeloma Treatment

Pharmacy Times

Experts discuss emerging targets in the immunotherapy landscape and how to improve patient outcomes through innovative approaches.

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China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

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Into the unknown: How quickly can vaccines be developed for Disease X

Pharmaceutical Technology

R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.

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Opinion: Sequencing wastewater material may be the key to getting a grip on the H5N1 bird flu outbreak

STAT

Despite no known infections of H5N1 bird flu among its dairy cows, Missouri recently detected a case in a person with no apparent exposure to possibly infected animals or related products (i.e., raw milk). A close contact and two health workers who cared for the person all developed respiratory symptoms , but were never tested. There has not yet been a wider uptick of other potential cases in the same community to indicate efficient human-to-human transmission — the evolution of which is

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Healthcare conferences to put on your calendar for 2024-2025

Fierce Healthcare

Looking for healthcare events in the fall of 2024 and 2025? We rounded up some of the top conferences, both virtual and live, that are on the calendar. | Here's our roundup of some of the top events in healthcare scheduled in the fall of 2024 and 2025.

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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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New Frontiers in Technology: AI Use in Clinical Trial Patient Recruitment in Health Systems

Pharmacy Times

AI is significantly enhancing the efficiency of identifying and enrolling patients.

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From PDURS to D2C, Frontiers Health speaks to cutting edge healthcare news

pharmaphorum

Stay up to date on cutting edge healthcare news, from PDURS to D2C, with Frontiers Health. Explore the latest in digital health trends and innovations.

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STAT+: FDA approves schizophrenia drug that could alter how disorder is treated

STAT

For decades, doctors caring for people with schizophrenia have relied on mood-regulating drugs that target the brain chemical dopamine. On Thursday, the Food and Drug Administration approved for the first time a new type of medicine that may change the way the psychiatric disorder is treated.  The drug, called Cobenfy, will be sold by Bristol Myers Squibb.

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STAT+: What Pfizer’s decision to pull its sickle cell drug means for patients, the company, and the FDA

STAT

Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and scrambling for ways to notify their patients about a drug that has long divided the community.  The move underscored the severity of the risks recently seen in studies of the drug, Oxbryta , in which researchers have reported a number of deaths among patients who were receiving it.

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Sickle cell community scrambles to find safe plan after a drug is pulled from the market

STAT

She knew what it was to have pain she couldn’t put into words, but this was worse. As a child, Nana-Bilkisu Habib had felt it in her arms or legs or back, but this was everywhere, as if her whole body were shutting down. She couldn’t move. Her dad had to carry her into the car and lay her in the backseat. She spent the drive to the hospital reciting verses of the Quran, praying that she would make it through.

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Opinion: Millions of people are missing from U.S. disability data

STAT

Many disabled people are not included in official U.S. data. This is because there is “ No Box to Check ” to indicate their particular disability on surveys from the U.S. Census Bureau and other federal agencies. The questions used to identify people with disabilities are missing millions. Two question sets are most often used to assess disability in U.S. federal surveys: the American Community Survey Six (ACS-6) or the Washington Group Short Set (WG-SS).

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Can MRIs ensure prostate cancer screening does more good than harm?

STAT

Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment  would do more harm than good.

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STAT+: Electronic health records giant Epic Systems sued over alleged monopolistic practices

STAT

The health data company Particle Health has filed an antitrust lawsuit against Epic Systems, alleging that the electronic health record vendor has used its control of patient data to thwart competition and undermine its business. The suit filed Monday in federal court in the Southern District of New York is a full-throated assault on Epic’s dominance in the market for electronic health records, charging that the privately held company has become a “behemoth” and a “mo

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STAT+: The little-known Chinese biotech whose cancer drug beat Keytruda has global ambitions

STAT

Recent headlines about a potent new immunotherapy have mostly focused on the U.S. company helping to develop it. Less attention has been paid to Akeso, a Chinese biotech that had kept a low profile until its drug bested Merck’s mega-blockbuster Keytruda in a late-stage lung cancer trial.  Now, Akeso’s leaders want you to know that its recent success isn’t a one-off.

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STAT+: Pfizer pulls sickle cell treatment Oxbryta off global markets

STAT

Pfizer said Wednesday that it was removing Oxbryta, a pill for the treatment of sickle cell disease, from all markets globally due to high risks of severe safety events, including deaths.  The decision is a stunning blow for a drug that was approved in 2019 , heralded as a new way to treat the inherited blood disorder. Pfizer acquired the maker of Oxbryta, a biotech company called Global Blood Therapeutics, in 2022 for $5.4 billion.

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Opinion: The fraught history of the pelvic exam

STAT

When I was a medical student in the 1980s, the school hired “pelvic instructors” who taught us how to do exams in a painless and respectful way. They even allowed us to perform practice examinations on them. But at the same time, senior doctors urged me to perform pelvic exams on anesthetized women about to get surgery — women who never gave consent.

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STAT+: Baltimore claims Biogen ‘bribed’ PBMs to favor its pricey MS drug over generics

STAT

In the latest slap at a pharmaceutical company by a local government, the city of Baltimore has filed a lawsuit accusing Biogen of striking an “unlawful” scheme with the largest pharmacy benefit managers to block generic competition of a best-selling multiple sclerosis treatment. The effort allegedly originated as Biogen planned to fend off generic companies that hoped to sell lower-cost alternatives to Tecfidera which, several years ago, had been a franchise product and generated

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STAT+: Prime Medicine shrinks CRISPR ambitions and gets cash infusion from Bristol Myers Squibb

STAT

Prime Medicine, founded with gene-editing tech from the lab of star Harvard biochemist David Liu and backed by blue chip investors, made little secret of its ambition.  It laid out plans to use its new gene-editing technology across 18 different diseases, listing conditions as disparate as ALS, congenital blindness, and muscular dystrophy.

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