Thu.Sep 12, 2024

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FDA Approves Guselkumab for Treatment of Ulcerative Colitis

Pharmacy Times

Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.

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Cause of Missouri H5 bird flu case remains a mystery, CDC says

STAT

Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday. But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.

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Non-Medical Switch to Infliximab Biosimilar Demonstrates Similar Outcomes for IBD

Pharmacy Times

Investigators obtained real-world evidence to evaluate the clinical outcomes of non-medical switching from the infliximab (Remicade; Janssen Immunology) to a biosimilar.

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STAT+: A rare disease program, portrayed as both lifeline and pharma handout, is set to expire

STAT

After his son Michael was diagnosed with a devastating, ultra-rare disease in 2019, Terry Pirovolakis dedicated himself to eradicating it.  Pirovolakis, a Canadian IT director, recruited academics and raised $3 million to design a gene therapy. He got Michael treated, an intervention that seems to have helped the 6-year-old stand on his heels for the first time and slow the course of a disease that can be severely cognitively and physically disabling.

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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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New England Ranks as Most Vaccinated Region in the US

Drug Topics

Industry experts and physicians conducted a state-by-state breakdown of vaccination statistics for children and teenagers as well as adults and elderly individuals.

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STAT+: Apple will offer millions of AirPod users a hearing aid. Can it convince them to use it?

STAT

After years of dabbling in hearing health, Apple earlier this week went all-in, announcing that AirPods Pro, the tech giant’s top wireless earbuds, will soon double as hearing aids for people with milder forms of hearing loss. Apple’s redoubled effort on hearing also includes software to test a person’s hearing and to customize the output of the hearing aid.

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More Trending

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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

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STAT+: Moderna touts research progress as it cuts R&D spending by $1.1 billion

STAT

Moderna said Thursday it would cut its annual spending on research and development by 23%, or $1.1 billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate. Stephen Hoge, Moderna’s president, in an interview pointed to Moderna’s “massively productive R&D engine,” citing nine medicines in the late stages of development that he says could be filed with regulators over t

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Novel Silk-Derived Protein Proves Safe, Effective in Treating Severe Dry Eye Disease

Drug Topics

Findings could inform future clinical practices on the treatment of DED for the more than 400 million people worldwide with the condition.

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Opinion: STAT+: How to keep the BIOSECURE Act from hobbling U.S. biotech and pharma

STAT

In a rare display of bipartisan agreement, Congress is getting serious about addressing China’s influence in key industries. This spring’s “TikTok ban” is the most obvious example of this effort. Legislation currently under debate would extend these same principles to the life sciences sector, with major implications and opportunities for the country.

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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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Increased Psychological, Cardiovascular Risks in Relatives of Patients With Cancer

Pharmacy Times

Parents of children with cancer had the highest risk of developing mental illness and cardiovascular diseases.

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A new threat to Merck’s blockbuster cancer treatment, Moderna’s cutbacks, and obesity drugs for kids

STAT

What’s next for Akeso and Summit Therapeutics after their cancer immunotherapy outperformed Merck’s Keytruda in a large Phase 3 clinical trial? Who’s the iconoclastic outsider behind Summit’s success? Why can’t Moderna turn a profit? And should we be giving weight loss drugs to kids? We talk about all that and more on this week’s episode of “The Readout LOUD.

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Treatment Considerations for Patients With Small Cell Lung Cancer, Pre-Existing Interstitial Lung Disease

Pharmacy Times

An overview of the potential treatment strategies for patients were presented at the 2024 World Conference on Lung Cancer.

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STAT+: Can iTeos and GSK solve TIGIT’s troubles?

STAT

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. I ate three dozen oysters last Saturday while taking a tour of the Island Creek Oyster Farm in Duxbury, Mass. AMA.

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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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ESMO: Even after unique trial win, Incyte CEO views PD-1 drug Zynyz as pipeline aide

Fierce Pharma

Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.

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Lehigh Valley Health Network agrees to $65M settlement over ransomware attack that leaked nude photos

Fierce Healthcare

Lehigh Valley Health Network has come to a $65 million class-action lawsuit settlement stemming from a 2023 ransomware attack that led to hundreds of patients’ nude medical record photos being post | After the nonprofit system refused to meet a ransomware gang's demands, over 600 patients' nude medical record photos were posted online. The plaintiffs' legal representation described the settlement as the largest of its kind.

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STAT+: ‘Put him in jail.’ Steward CEO de la Torre skips hearing, now Congress is poised to hold him in contempt

STAT

Lawmakers in Washington turned their focus to the Steward Health Care bankruptcy scandal on Thursday, even as patients, doctors, and regulators across eight states continue to struggle with the hospital chain’s financially starved facilities. Senators hoped to grill Steward chief executive Ralph de la Torre at the hearing in the Capitol but had to make do verbally attacking an empty chair.

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Sanders, Cassidy promise to hold Steward Health Care CEO in contempt after no-show

Fierce Healthcare

Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and crimina | Despite receiving a Congressional subpoena, Ralph de la Torre, M.D., did not attend a Thursday morning hearing where he was scheduled to testify on the for-profit's financial struggles.

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Starmer says no extra NHS funding without big reforms

pharmaphorum

Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms

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Local Therapy Developments Hold Promise for Survival Improvements for NSCLC

Pharmacy Times

In a session at the 2024 World Conference on Lung Cancer, presenters highlight the most significant developments in local therapy for metastatic non–small cell lung cancer and advanced disease.

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Medicare drug pricing negotiations: What comes next?

pharmaphorum

Explore the ins and outs of Medicare drug pricing negotiations with Alice Valder Curran on this insightful podcast. Learn more about what comes next in this crucial healthcare sector.

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Exploratory Analysis Shows Favorable Outcomes for Amivantamab-Lazertinib Treatment in NSCLC

Pharmacy Times

As of May 2024, follow-up and exploratory analyses of MARIPOSA show improvements in outcomes for patients with EGRF-mutated non–small cell lung cancer (NSCLC).

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Iris Telehealth launches Virtual Clinic with AI insights for behavioral health

Fierce Healthcare

Iris Telehealth, a virtual-first behavioral health company, has launched two new technology-driven solutions, its new Virtual Clinic and back-end AI assistant, Iris Insights. | Iris Telehealth, a virtual-first behavioral healthcare managed services organization, unveiled two new technology offerings for health systems and community clinics to increase the efficiency of their behavior health practices.

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Could an Investigational Therapy Help Fill the Gaps in Pain Management?

Drug Topics

Albert Dahan, MD, PhD, professor of anesthesiology at Leiden University Medical Center, talks about the first-in-class dual-NMR agonist cebranopadol.

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Pharma Pulse 9/12/24: AI Will Force a Transformation of Tech Infrastructure, Obesity Drug Market to be Worth $200 Billion by 2031 & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Public Health Matters Video: The Difference Between Misinformation and Disinformation, and How Information Can Inform Evidence-Based Decisions

Pharmacy Times

Tune into this episode of “Public Health Matters” to learn about the Unbiased Science podcast and how guest Jessica Steier, DrPH, PMP, aims to combat misinformation and disinformation, encouraging listeners to make evidence-based decisions.

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EASD 2024: Innovent shows off mazdutide’s efficacy in diabetes and obesity

Pharmaceutical Technology

The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.

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Can you take hydroxyzine during pregnancy?

The Checkup by Singlecare

Hydroxyzine , also known by its brand names Vistaril and Atarax , is a first-generation antihistamine used to treat anxiety, insomnia, and allergy symptoms such as skin rash, hives, and itchiness. It has been FDA approved for use in the U.S. since 1957. Yet, there are no human studies establishing its safety during pregnancy. B ecause of the lack of data, some providers don’t prescribe hydroxyzine during pregnancy —especially during the first trimester and during labor.

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Bridging research and clinical care in a new era of psychiatry

Fierce Pharma

By Dr. L. Alison McInnes and Jimmy Qian | We’re finally moving towards a causality-based nosology for psychiatry: specific symptoms with defined biological underpinnings can now be targeted by new therapies. But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines?

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Why the largest PBMs may be focusing on specific markets: study

Fierce Healthcare

A new study suggests that major pharmacy benefit managers may be focusing on specific payer segments in a bid to maintain strong market share. | A new study suggests that major pharmacy benefit managers may be focusing on specific payer segments in a bid to maintain strong market share.

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FDA is taking on tampons and ‘misleading’ ads starring Serena Williams

STAT

Good morning! I’ve decided today is the day that I must tell you about my favorite Instagram account: poeticpuppets. It’s an account (run by a Teresa with no H, not me!) where puppets present you with some delicious poetry bites. Enjoy! A lifeline or a pharma handout? Either way, this program is set to expire There’s an obscure U.S. government voucher program due to sunset at the end of this month.

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Alignment Healthcare predicts membership surge, targeting 1M enrollees

Fierce Healthcare

Alignment Healthcare CEO John Kao gave strategic insights into how the insurer is thinking about market expansion and star ratings during the Baird Global Healthcare Conference on Wednesday. | Alignment Healthcare downplayed recent concerns surrounding star ratings cut points and stressed sizable long-term membership growth.

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How Lilly’s sustainability goals come face to face with massive growth

PharmaVoice

Eli Lilly’s head of ESG is maintaining a focus on sustainability even as the company’s expansion plans in weight loss drive a larger footprint and more social scrutiny.

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Elevance Health to acquire IU Health Plans

Fierce Healthcare

Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company's Anthem Blue Cross unit announced this week. | Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company's Anthem Blue Cross unit announced this week.

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