Tue.Aug 20, 2024

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Video: Legislation, FTC Interim Report Positive Progress in Fight for PBM Reform

Drug Topics

Bipartisan support—in a polarized Congress—underscores the importance of pharmacy benefit manager reform.

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23andMe inches closes to cancer immunotherapy, guided by its genetic database

PharmaVoice

Dr. Jennifer Low, head of 23andMe’s therapeutics division, is taking the company into new territory with a potential cancer treatment that targets a unique pathway.

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Pharmacists Play Key Role in Warning Patients About Harms of Sourcing GLP-1s Online

Drug Topics

Timothy Mackey, MAS, PhD, discusses the dangers associated with sourcing GLP-1s from illegal online pharmacies and the key role pharmacists play in warning patients.

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Integration of Palliative Pharmacists to Elevate Oncologic Care

Pharmacy Times

Palliative pharmacists are invaluable assets of oncologic care.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA Grants Tentative Approval to Treprostinil for PAH Associated With PH-ILD

Drug Topics

Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.

FDA
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STAT+: Lilly’s Zepbound slashed risk of developing diabetes

STAT

Eli Lilly’s obesity drug Zepbound significantly cut the risk of developing type 2 diabetes, showing the benefits of long-term use of the blockbuster therapy. In a Phase 3 trial that lasted over three years, people with pre-diabetes taking Zepbound had a 93% lower risk of progressing to diabetes compared with people on placebo, Lilly said Tuesday.

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Does Ozempic increase the risk of suicidal thoughts? A new study muddles the picture

STAT

A new observational study found that people taking Ozempic and Wegovy appeared to experience suicidal thoughts at a higher rate than people on other drugs, though experts raised concerns about the methodology and the findings contradict what some other studies have found about the class of GLP-1 diabetes and obesity drugs. Academic researchers analyzed a World Health Organization database that tracks suspected adverse drug reactions, and found that there was a 45% greater rate of reports of suic

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Amidst Push for PBM Reform, NACDS Grassroots Efforts Bloom

Drug Topics

Inviting members of Congress into the pharmacy helps legislators experience first hand the value that pharmacists bring to their communities.

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Epic touts new AI applications to streamline charting and bring research insights to the point of care

Fierce Healthcare

Health IT giant Epic is pushing ahead rapidly to build out artificial intelligence technologies and generative AI features in its electronic health record software. | The goal, according to Epic executives, is to ease the documentation burden for clinicians, streamline charting and coding and bring evidence-based medical insights and research right to doctors' fingertips at the point of care.

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STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance

STAT

The Food and Drug Administration’s responsibilities don’t end when a drug hits the market after it’s approved: the agency is also continuously assessing products after they’re widely available for any safety issues. And a group of researchers — including two from the FDA’s Center for Drug Evaluation and Research — think artificial intelligence could uncover more signs of these issues, including from electronic health records, social media posts, a

FDA
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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 study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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STAT+: Congressional probe questions clinical trials run in China, citing Army involvement

STAT

A House committee is investigating whether brand drug companies are collaborating with the Chinese military when they run clinical trials in that country.  “For over a decade, it appears that U.S. biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s,” according to an Aug. 19 letter that the House China committee sent to t

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Expert: Emphasis on Diabetes Research Can Close Gaps in Marginalized Communities

Pharmacy Times

Jasmine Perry discusses the More Than a Script program in an interview with Pharmacy Times.

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Teamwork is good for science — but maybe not for young researchers’ careers

STAT

Science is a team sport, and those teams are getting larger. While that expansion might help researchers answer complex biomedical questions by working together, a recent study suggests that this trend has hampered the career prospects of Ph.D. graduates. The authors analyzed 40 years of data from a National Science Foundation survey that tracks Ph.D. graduates.

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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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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

FDA
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GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive-Stage Small–Cell Lung Cancer

Pharmacy Times

The breakthrough therapy designation was granted based on ongoing data from the ARTEMIS-001 phase 1 open-label, multi-center trial.

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GSK bags breakthrough status for B7-H3 ADC for lung cancer

pharmaphorum

GSK gets FDA breakthrough status for its B7-H3 directed ADC, licensed from Hansah Pharma in a $1.

FDA
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FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors

Pharmacy Times

Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.

FDA
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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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Medicare Advantage's growth a bad omen for hospitals, S&P Global warns

Fierce Healthcare

The upward trajectory of Medicare Advantage (MA) enrollment is likely to become an issue for hospitals and other healthcare providers forced to contend with plans’ prior authorization requirements | Prior authorization burdens and "a challenging contract negotiation season" on the horizon are likely headwinds for providers, and hospitals in particular, according to a recent report.

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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Employers are bracing for healthcare costs to spike in 2025. Here's why

Fierce Healthcare

Employers are up against escalating healthcare costs, driven by mounting prescription drug expenses, inflation and worsening chronic conditions, a new survey shows. | Employers are up against escalating healthcare costs, driven by mounting prescription drug expenses, inflation and worsening chronic conditions, a new survey shows.

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Targeting AZ's Tagrisso, Johnson & Johnson's Rybrevant combo wins key FDA nod in first-line lung cancer

Fierce Pharma

A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. | A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. But the real battle against the EGFR king has yet to start.

FDA
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Payer Roundup—Devoted Health raises $112M; L.A. Care eliminates prior auth codes

Fierce Healthcare

Below is a roundup of payer-centric news headlines you may have missed during the month of August 2024. | This month, Devoted Health completed its series E funding round, L.A. Care Health Plan slashed prior auth codes for catheter supplies, and Illinois signed laws cracking down on insurers involving colonoscopies, inhalers and more.

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Teva faces fresh Copaxone kickbacks case from Medicare providers as it defends against DOJ claims

Fierce Pharma

For years, Teva has been defending itself against allegations that it used illegal Medicare co-pay schemes to fuel sales of its multiple sclerosis drug Copaxone. | The new lawsuit, filed in a Kansas court, comes as Teva defends against similar allegations made by the U.S. government.

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Opinion: Improving the FDA-EMA parallel scientific advice program to advance complex generics

STAT

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics and biosimilars — represent a system-critical industry that delivers around 80% of medicines used worldwide at a fraction of the cost of branded medicines.

FDA
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CDK9 inhibitors: Disrupting cancer cell growth and the treatment paradigm

pharmaphorum

Learn about the exciting potential of CDK9 inhibitors in disrupting cancer cell growth and changing the treatment landscape for cancer patients. Stay updated on the latest research and developments in this promising field.

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Carbon Health founder steps back from top role, Kaiser hospitals roll out AI scribe

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Carbon Health founder steps back from top role Carbon Health ‘ s chief executive and co-founder  Eren Bali is taking a step back from the primary care tech company, returning instead to the education company Udemy  he co-founded as its chief technology office

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FDA Approves Amivantamab-Vmjw and Lazertinib for First-Line Treatment of NSCLC

Pharmacy Times

The combination is the first and only multi-targeted chemotherapy-free regimen that demonstrated superiority compared with osimertinib for non–small cell lung cancer (NSCLC).

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J.D. Power: MA plans beat commercial coverage on consumer satisfaction

Fierce Healthcare

Amid significant scrutiny from lawmakers and regulators on Medicare Advantage, a new report suggests that consumer satisfaction with these plans is notably higher than with commercial insurance.

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Buoyed by muscular dystrophy data, Avidity raises $345m

pharmaphorum

Avidity Bio raises $345m from its second big public offering of 2024, after reporting encouraging Duchenne muscular dystrophy data.

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After Europe deal, Organon pays $22.5M to expand Emgality marketing pact with Lilly

Fierce Pharma

After picking up the European rights to Eli Lilly’s Emgality and Rayvow late last year, women’s health outfit Organon is upping its migraine accord with the Big Pharma company. | Organon has expanded a deal with Eli Lilly to become the sole promoter and distributor of Lilly’s migraine antibody Emgality in Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates.

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Expert says supplies of mpox vaccine unlikely to suffice

pharmaphorum

Emergent BioSolutions has agreed to donate 50,000 doses of its mpox vaccine for use in the current outbreak, but an expert has warned supplies are unlikely to meet demand

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Chronic Care Management: How Your Pharmacy Can Support Patients for the Long Haul

PioneerRx

Chronic conditions make up the bulk of your pharmacy work. Patients with chronic conditions need certain medications for the rest of their lives to achieve a.