Thu.Feb 13, 2025

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FDA Grants Fast Track Designation to Cannabis Withdrawal Syndrome Therapy

Drug Topics

A dose response is observed with the highest dose of the drug and mitigating withdrawal symptoms for patients with cannabis use disorder.

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STAT+: Biotech is in a dark place

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. I apologize for this depressing, cynical newsletter. I still hope you read it.  Why it’s so bleak out there My recent conversations with folks in the biotech investing world can only be described as bleak.

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Focus on What Matters: Sustaining Your Pharmacy in 2025

Drug Topics

What are some key strategies for keeping your pharmacy thriving in 2025?

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Opinion: How to close America’s life expectancy gap

STAT

It’s no secret that life expectancy in the United States is among the lowest in the developed world and has been since long before the Covid-19 pandemic.  The United States  ranked  29 th  in life expectancy at birth among peer nations in the Organization for Economic Cooperation and Development despite spending almost twice as much on clinical care per person as the average OECD nation.

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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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Pharmacists as the Authority on Ultra-High-Cost Drugs

Drug Topics

Erin Fox, PharmD, MHA, BCPS, FASHP, joined Drug Topics to discuss ultra-high-cost drugs and the American Society of Health-System Pharmacists 2025 Pharmacy Forecast.

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Salesforce or Veeva: How drugmakers can navigate the upcoming CRM split

PharmaVoice

The two companies will let their long-running contract expire this year, and drugmakers will need to decide which is the best platform for them in a changing marketplace.

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More Trending

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From Menarche to Post Menopause: The Vital Role of Pharmacists in Women’s Health

Pharmacy Times

Panelists discuss how menopause marks a significant life transition, characterized by hormonal decline, reproduction cessation, and unique physiological changes requiring medical and emotional support. Health care professionals guide women through lifes reproductive stages, providing comprehensive health care from menarche to post menopause, focusing on individualized prevention of symptom management, and holistic well-being across hormonal transitions.

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Keeping Focus on Bottom Line Amid Industrywide Changes in Pharmacy

Drug Topics

Pharmacy industry experts gathered for a webinar detailing the upcoming trends expected to take shape in 2025.

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FDA Accepts BLA for Lerodalcibep, a Novel Agent to Lower LDL-Cholesterol in Atherosclerotic Cardiovascular Disease

Pharmacy Times

The agency will now review the novel PCSK9 inhibitor for possible approval in patients with or at high risk of atherosclerotic cardiovascular disease.

FDA 145
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Q&A: How Will Suzetrigine Impact the Pain Management Landscape?

Drug Topics

A discussion on the new nonopioid selective NaV1.8 pain signal inhibitor with Madison Irwin, PharmD, BCPS.

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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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EU Urban Wastewater Treatment Directive may compromise EU medicine availability

European Pharmaceutical Review

New analysis by VTT Technical Research Centre of Finland has highlighted the EUs completely underestimated costs of the newly enforced Urban Wastewater Treatment Directive. Based on the new cost estimates, pharmaceutical manufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Immediately following Senate confirmation, Robert F. Kennedy Jr. has been named chair of the Make America Healthy Again Commission, which will be focused on chronic disease and transparency in medical research.

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Bridging Evidence Gaps: The Expanding Role of Real-World Evidence in Regulatory and HTA Decision-Making

Pharmacy Times

The expanding role of real-world evidence in regulatory and health technology assessment (HTA) decision-making highlights its growing acceptance for supplementing clinical trial data, addressing evidence gaps, and informing treatment value, despite challenges in data quality, accessibility, and regulatory compliance.

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CMS, don’t fall behind the rest of the medical community on obesity

PhRMA

PhRMA recently submitted comments in response to the Centers for Medicare & Medicaid Services (CMS) proposed rule which would extend coverage of anti-obesity medicines (AOMs) in Medicare Part D and state Medicaid plans. Currently, AOMs are excluded from Medicare Part D coverage and optional in state Medicaid programs, when used specifically for the treatment of obesity, because they’re labeled as “agents used for weight loss.

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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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Strategies for Addressing Unmet Needs in Women’s Health and Supporting Women During Menopause

Pharmacy Times

Panelists discuss how menopause marks a significant life transition, characterized by hormonal decline, reproduction cessation, and unique physiological changes requiring medical and emotional support. Health care professionals guide women through lifes reproductive stages, providing comprehensive health care from menarche to post menopause, focusing on individualized prevention of symptom management, and holistic well-being across hormonal transitions.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Nationwide median operating margin for rural hospitals sits at 1%, though that metric is negative in 16 states and worsened in Medicaid non-expansion states.

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Optimizing Tacrolimus Levels in Post-Transplant Cyclophosphamide: A Pharmacist-Led Study on Outcomes and Toxicity Management

Pharmacy Times

Andrew Lin, PharmD, BCOP, discusses his pharmacist-led study examining the association between early tacrolimus levels and outcomes post-allogeneic hematopoietic cell transplantation.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Hims & Hers hit the bullseye with its Super Bowl adit sparked a lot of attention from consumers for its brand and weight loss products. But the controversial ad also caught the attention of the pharma industry and lawmakers, who lashed the company for "deceptive" advertising.

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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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CUSP06 Granted FDA Fast Track Designation for Patients With Platinum-Resistant Ovarian Cancer

Pharmacy Times

Currently, the Cadherin-6 targeting antibody-drug conjugate is undergoing evaluation in a phase 1a/1b clinical trial.

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Kennedy confirmed as HHS Secretary

pharmaphorum

The US Senate today confirmed Robert F Kennedy Jr as Health and Human Services Secretary, after a vote that largely followed party lines.

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Enfortumab Vedotin Plus Pembrolizumab Outperforms Chemotherapy in Advanced Urothelial Carcinoma

Pharmacy Times

The combination greatly improved progression-free survival and overall survival.

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Small study finds GLP-1 drug can curb excess alcohol use

pharmaphorum

Novo Nordisk's GLP-1 receptor agonist semaglutide has been shown to help people struggling with alcohol use disorder.

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High Blood Sugar in Diabetes Promotes Rapid Development of Antibiotic-Resistant Staphylococcus Aureus

Pharmacy Times

Diabetes management through insulin could play a significant role in preventing antibiotic resistance.

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Ex-DeepMind scientist launches drug discovery company

pharmaphorum

Another AI drug discovery venture has emerged from the Google DeepMind team, Latent Labs, with $50m in funding for its protein design platform.

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Talazoparib Plus Enzalutamide Meets Primary End Point in Phase 3 Trial of Patients With Metastatic Castration-Resistant Prostate Cancer

Pharmacy Times

Talazoparib in combination with enzalutamide yielded significant improvements in radiographic progression-free survival and overall survival.

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Sanofi, J&J abandon trial of E coli vaccine after poor data

pharmaphorum

Johnson & Johnson and Sanofi's vaccine for preventing invasive disease caused by E coli looks all but defunct after they abandon a phase 3 trial

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FDA Grants Fast Track Designation to Amezalpat for Treatment of Hepatocellular Carcinoma

Pharmacy Times

Building on a previously granted orphan drug designation, the latest FDA action for amezalpat puts the drug in a position for regulatory approval.

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AbbVie and Xilio to collaborate on antibody-based immunotherapies

Pharmaceutical Technology

AbbVie has entered a partnership and option-to-license agreement with Xilio for tumour-activated, antibody-based immunotherapies.

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Bariatric Surgery Improves Adverse Outcomes in Patients with MASH-Related Cirrhosis

Pharmacy Times

This surgery can be significant in reducing the long-term risk of adverse outcomes and decompensation in cirrhosis related to metabolic dysfunction-associated steatohepatitis (MASH).

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Fierce Healthcare - Untitled Article

Fierce Healthcare

As the use of GLP-1 weight loss medications continues to grow, primary care physicians are concerned about the risks of patients using third-party telehealth prescribers to get their hands on these drugs, a new survey found.

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Partnering for Women’s Health: The Pharmacist’s Collaborative Role

Pharmacy Times

Panelists discuss how health care professionals collaborate through interdisciplinary teams, integrated care coordination, and lifecycle-specific approaches to provide comprehensive womens health care, addressing gaps by implementing patient-centered, culturally sensitive models that prioritize holistic well-being across different life stages.

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People with alcohol-use disorder drank less on Ozempic, small study shows

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! A friend and former journalism school classmate wrote a beautiful essay in the New York Times yesterday about grieving with Paddington (the bear and film franchise). I can’t recommend it enough.

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How long does it take to detox from ibuprofen?

The Checkup by Singlecare

Ibuprofen ( Advil and Motrin ) is a nonsteroidal anti-inflammatory drug ( NSAID ) approved by the U.S. Food and Drug Administration (FDA) for mild to moderate pain relief and reduced fever for health conditions like rheumatoid arthritis , muscle aches , toothaches, and backaches. According to James Lyons, MD, a board-certified physician in psychiatry, family medicine, hospitalist care, and emergency medicine, and the medical consultant for Synergy Houses, while the medication is not addictive, s

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