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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Medicine struggles to define chronic Lyme. Long Covid has only made it harder

STAT

Going to the doctor is already tricky enough for people with chronic symptoms of Lyme disease. Their concerns often dismissed by mainstream medicine, those patients now face an additional hurdle: ruling out long Covid.  The two illnesses — one seeping in over the course of decades and another suddenly springing to life on a massive scale — share many qualities, including being widely misunderstood.

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Patients With Difficult-To-Treat Asthma Require Different Intervention Methods Based on Comorbidities

Pharmacy Times

To help with treatment response and compliance as well as optimize treatment, communication between patients and health care providers is necessary.

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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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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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Gridlock over schedule II telehealth prescribing could impede extension of pandemic-era flexibilities

Fierce Healthcare

Over 300 organizations sent letters to the White House and Congress on Tuesday asking them to extend telehealth controlled substance prescribing rules for an additional two years. | Stakeholders that support the prescription of all controlled substances via telehealth are fighting an uphill battle to get the pandemic-era prescribing flexibilities extended.

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Digital Solution Implementation

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

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Biden administration finalizes rules to ensure insurers pay for mental health care 

STAT

The Biden administration on Monday announced it would finalize a highly anticipated proposal meant to force health insurers to cover mental health care on the same basis as physical health conditions.  It is the latest salvo in a long-running federal government effort to crack down on insurance plans skimping on treatment for conditions including anxiety, depression, and addiction.

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The Future of Bispecific Antibodies in Aggressive B-Cell Lymphomas

Pharmacy Times

Presenter Krish Patel, MD, discusses the use of epcoritamab (Epkinly; AbbVie) and glofitamab (Columvi; Genentech) in aggressive B-cell lymphomas as monotherapies and in combination regimens.

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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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SCAN embraces 'rebels with a cause' founding in new brand identity

Fierce Healthcare

SCAN Group is refreshing its visual identity, building its new look around honoring the "rebels with a cause" that founded the company and who continue to inspire its work. | SCAN Group is refreshing its visual identity, building its new look around honoring the "rebels with a cause" that founded the company and who continue to inspire its work.

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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 Clears New Disposable Insulin Patch Pump For Patients With T1D and T2D

Drug Topics

Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).

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5 burning questions about Missouri’s mysterious H5 bird flu case

STAT

News that a person in Missouri contracted H5 bird flu despite having no known contact with infected animals or birds — in other words, no evident route of infection — raises pressing questions public health officials are surely scurrying to answer. The rationale for that urgency is this: An unexplained H5 infection raises the possibility of person-to-person spread of a flu virus that has never before circulated in humans, and to which people would not have immunity.

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FDA Grants Orphan Drug Designation to AISA-021 for Systemic Sclerosis

Pharmacy Times

The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.

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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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After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned

Fierce Pharma

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

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Rite Aid emerges from bankruptcy with $2.5B in exit financing and a new CEO at the helm

Fierce Healthcare

Retail pharmacy chain Rite Aid has emerged out of bankruptcy after slashing about $2 billion from its debt, the company announced last week. | Retail pharmacy chain Rite Aid has emerged out of bankruptcy after slashing about $2 billion from its debt, the company announced last week.

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GSK’s Depemokimab Significantly Reduces Asthma Exacerbations

Pharmaceutical Commerce

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.

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FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

Drug Topics

DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.

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STAT+: Detailed data show Summit therapy beat Merck blockbuster Keytruda in late-stage lung cancer trial

STAT

SAN DIEGO — For years, Merck’s drug Keytruda has dominated cancer immunotherapy, racking up dozens of approvals, extending the lives of patients, and bringing in billions of dollars to the pharma giant. But detailed data presented by Summit Therapeutics on Sunday demonstrated that the company’s experimental therapy has done what no other has done before: beat Keytruda in a head-to-head late-stage trial in lung cancer.

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From Opioids to Cannabis: The Impact of Cannabis Rescheduling on Pharmacy Revenue Streams

Pharmacy Times

The DEA will have a hearing in December 2024 regarding the potential reclassification of cannabis to Schedule III, which could significantly impact the regulatory environment for pharmacies and their involvement in the cannabis market.

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In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Fierce Pharma

Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

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AMA study: The 4 largest PBMs control 70% of the market nationally

Fierce Healthcare

The four largest pharmacy benefit managers in the U.S. | The four largest pharmacy benefit managers in the United States control 70% of the national market, according to new data from the American Medical Association.

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Creyon Bio secures second patent for AI-powered oligonucleotide engineering

Outsourcing Pharma

Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.

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NCPA Calls on CMS to Establish PBM Protection for Independent Pharmacies

Drug Topics

As Medicare open enrollment begins, the NCPA is urging CMS to facilitate appropriate PBM contracting for pharmacies in the upcoming plan year.

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STAT+: Novo Nordisk’s amylin pill leads to substantial weight loss in early study

STAT

Novo Nordisk on Tuesday reported that its new obesity pill that targets the amylin hormone led to substantial weight loss in an early study, boosting the company’s pipeline of next-generation candidates that may be more effective than Wegovy. In a Phase 1 trial, a 50-mg dose of the daily pill called amycretin, which activates receptors of both the amylin and GLP-1 hormones, led to 10.4% weight loss at about three months after the start of treatment.

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New Perspectives in CML Management: Personalized Approaches and Adaptive Strategies

Pharmacy Times

Optimizing outcomes for patients with chronic myeloid leukemia (CML) requires personalized treatment, adaptive dosing, and precise genetic insights.

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J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis

Fierce Pharma

Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better chall | Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challenge AstraZeneca’s Tagrisso.

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Biden admin mandates mental health parity in final rule

Fierce Healthcare

The Biden administration is strengthening private health coverage for individuals seeking mental health and substance use disorder (SUD) care in a final rule unveiled Monday. | The feds are attempting to better regulate mental health coverage by bolstering protections around prior authorization, step therapy and provider networks.

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Does the flu shot make you tired?

The Checkup by Singlecare

An estimated 8% of Americans get the flu each year, according to the Centers for Disease Control and Prevention (CDC). If you’ve ever been suddenly sidelined by influenza, you’ve experienced the misery of being completely drained—too weak to even get out of bed. As you wait for the debilitating flu infection to run its course, you’d do anything to speed up the process.

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Education Is Crucial to Close Gaps in Colorectal Cancer Risk Awareness

Drug Topics

The #MyCRChistory campaign encourages the public to share their family history of colorectal cancer.

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STAT+: House passes bill that targets China biotechs

STAT

WASHINGTON — The House Monday passed a bill by 306 to 81 votes to make drug companies stop doing business with some Chinese biotechs within eight years if they want to remain in good standing with the federal government. The BIOSECURE Act would prohibit the U.S. government from contracting with, or providing grants to, companies that do business with a “biotechnology company of concern.

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CDC Recommends Preventative Action Amid Rising Cases of West Nile Virus

Pharmacy Times

Cases have been detected in 33 US states so far this year, and the virus has recently hospitalized the former Chief Medical Advisor to the President of the US Anthony Fauci.

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GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

Fierce Pharma

GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.

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Providers, vendors building health AI have 'shared responsibility' to ensure safe adoption industrywide

Fierce Healthcare

BOSTON—There’s no shortage of providers and vendors working to develop and deploy artificial intelligence in healthcare—but not all who are delivering care are in a position to make use of these no | Healthcare AI has a tough battle on adoption, trust and responsible use, particularly among organizations lacking in-house tech expertise. Whether it's a vendor or another health system, stakeholders must be prepared to help their peers along the way, experts say.

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