Tue.Nov 12, 2024

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The recovery community says it offers refuge from opioid addiction. But it’s still hostile to lifesaving addiction medications 

STAT

The last time Mark Palinski went to a Narcotics Anonymous meeting, he was asked to leave and never come back. He stills remembers the argument: All he had done was advocate for the use of the “gold standard” treatment opioid addiction, a common medication called buprenorphine.  To Palinski, buprenorphine is a godsend.

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How DSCSA Serves as the Drug Supply Chain’s Lead Investigator | ASPL 2024

Drug Topics

Pharmacy law experts detailed the Drug Supply Chain Security Act, highlighting the role each entity within the supply chain plays in ensuring the safety and authenticity of US prescription drugs.

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STAT+: DOJ sues to block UnitedHealth takeover of home health giant Amedisys

STAT

The Department of Justice on Tuesday sued to prevent UnitedHealth Group from buying Amedisys, one of the largest home health and hospice chains in the country. The DOJ’s lawsuit, which is joined by the attorneys general from Maryland, Illinois, New Jersey, and New York, is one of the agency’s most aggressive actions to halt UnitedHealth from moving further into the delivery of health care.

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Greater Depression Severity Linked with Increased Diabetes Risk

Drug Topics

A recent study found that with greater depression severity, metabolic and clinical characteristics such as HbA1c, fasting blood glucose, and triglyceride levels increased.

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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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STAT+: A scrap of data on Amgen’s obesity drug candidate wipes out $12 billion in market value

STAT

On Tuesday, a tiny shred of data on Amgen’s lead obesity candidate — not yet verified — erased $12 billion in market value. The data, spotted by an analyst at Cantor Fitzgerald, focused on concerns about potential side effects with the drug, called MariTide. Once they were shared widely in an investor note, the company’s shares fell 7%, a reminder that its stock is in a highly precarious position ahead of a critical readout of the therapy.

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Q&A: Insights on HIV Care, Pharmacists’ Expanding Role

Drug Topics

Cassandra Esperant, PharmD, AAHIVP, leverages her expertise as a clinical pharmacist to advocate for the well-being of individuals with HIV.

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Bayer's rising prostate cancer star Nubeqa crosses blockbuster barrier as Xarelto continues downward descent

Fierce Pharma

Despite generic headwinds to Xarelto and challenges across different sectors of the conglomerate suggesting “twists and turns” in the road ahead, Bayer is confident that the course it’s laid out th | As Xarelto generics continue to eat away at sales, Bayer's Nubeqa and Kerendia are picking up the slack while Regeneron-partnered Eylea makes for a solid base.

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Opinion: How ADHD wired me for scientific discovery

STAT

Imagine a mind that’s constantly buzzing, leaping from one thought to the next, struggling to filter out the noise of a world that feels perpetually turned up to 11. That’s the experience of living with attention deficit hyperactivity disorder, a reality I know intimately. It has profoundly shaped my journey as a scientist, from the setbacks of my early years to the discoveries I’ve made in my laboratory.

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The Nuances of Marijuana’s Potential Rescheduling | ASPL 2024

Drug Topics

FDA experts gathered to discuss the DEA’s rescheduling of marijuana and how it will impact the pharmaceutical supply chain.

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STAT+: How Pfizer used wearables to tap into the promise of an experimental drug

STAT

Pfizer’s promising research on a treatment for a dangerous cancer-related condition is also helping prove out the value of wearables in clinical trials. In September, the pharma giant reported results showing that an experimental antibody could positively impact people with cachexia, a complication sometimes called “wasting syndrome” that can cause people with cancer to lose weight and make it harder for them to tolerate treatments.

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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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FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

Fierce Pharma

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short. | Intercept received a complete response letter from the FDA, dashing the company’s hopes of turning Ocaliva’s accelerated green light into a traditional approval for the rare autoimmune disease primary biliary cholangitis.

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STAT+: Despite setback, AbbVie’s big bet on neuroscience has yet to play out

STAT

For AbbVie, the good news this week is that the failure of a high-profile schizophrenia drug in two key trials hardly marks its last opportunity to make strides in neuroscience. The bad news is that the effort might not get any easier. The company has had high hopes for the schizophrenia treatment, called emraclidine, which was the centerpiece of its $9 billion acquisition of Cerevel Therapeutics.

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Overcoming Failure as a Recent Pharmacy Graduate

Pharmacy Times

Failing is not final, and it does not define what kind of pharmacist or resident a student can be.

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STAT+: AstraZeneca, Daiichi Sankyo change strategy on closely watched cancer drug

STAT

LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of lung cancer, a step that will delay the drug’s arrival on the market and that will add to questions about how widely it could be used.  The medicine, datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies have been pouring investments into.

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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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FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy

Drug Topics

The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.

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COVID-19 Hospital Burden Associated With Increased Inpatient Adverse Events Among Patients With and Without COVID-19

Pharmacy Times

High COVID-19 hospital caseload strain led to increases in inpatient adverse events among patients both with and without SARS-CoV-2 infection.

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STAT+: RNA startup Orna Therapeutics cuts more jobs

STAT

Biotech startup Orna Therapeutics has cut more jobs in its second round of layoffs in the last year, STAT has learned.  Orna was part of a buzzy cohort of companies established in the wake of the Covid pandemic, planning to create a new, more durable type of RNA-based medicines. It launched in 2021 and quickly garnered attention from Gilead subsidiary Kite Pharma, Bristol Myers Squibb, Novartis, and Merck.

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Daiichi and AZ pull Dato-DXd filing with FDA and try again

pharmaphorum

Daiichi Sankyo and AstraZeneca give up on their NSCLC application for Dato-DXd, and refile seeking a narrower label

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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 CEO defends corporate oversight, $80B revenue target amid China probes

Fierce Pharma

Despite China’s investigations into insurance fraud, allegedly illegal importation of unapproved drugs and improper collection of patient data that have implicated senior executives, AstraZeneca CE | Despite China’s investigations that have implicated senior executives, AstraZeneca CEO Pascal Soriot argued that the company did not lose oversight and remains on track to achieve his ambitious $80 billion-by-2030 revenue goal.

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Merck drug for rare tumour hits phase 3 target

pharmaphorum

Merck KGaA is shaping up to take on Daiichi Sankyo and Ono Pharma in the market for tenosynovial giant cell tumour (TGCT) therapies after its drug candidate pimicotinib cleared a phase 3 trial.The German group said the CSF-1R inhibitor given as a once-daily, oral dose hit its primary endpoint in the MANEUVER study, achieving an objective response rate (ORR) at week 25 of 54% compared to 3.2% for a matched placebo in patients with TGCT, a rare disease affecting the joints and tendons.

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OpenAI isn’t built for health care. So why is its tech already in hospitals, pharma, and cancer care?

STAT

The company behind ChatGPT didn’t set out to tackle health care.

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Varying Messaging Strategies Increases Likelihood of Vaccination Against HPV

Pharmacy Times

There were differences in the variables that influenced vaccination decision making for adults aged 18 to 26 years and for parents making the decision to vaccinate their child

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Copayment Burden Affects Medication Adherence in Chronic Conditions

Drug Topics

High copayments can be a structural barrier to medication therapy adherence.

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New Model Can Assess Blast Phase Progression Risk in Myeloproliferative Neoplasms

Pharmacy Times

According to the study, 20% of patients with myeloproliferative neoplasms progress to blast phase.

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Digital unicorn Lyra Health lays off 2% of workforce amid restructuring, impacting non-clinicians

Fierce Healthcare

Lyra Health, a provider of mental health benefits for employees, laid off 2% of its total workforce last Monday, Fierce Healthcare has learned. | The layoffs affected 77 people, according to a former employee who was part of the cuts and spoke on the condition of anonymity. At least some of the employees received severance for 12 weeks with health benefits.

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NHS England relaunches anti-smoking pill programme

pharmaphorum

'Game-changer' daily pill to quit smoking returns to NHS after three-year absence after a deal between Teva and NHS England

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Bispecific Antibody Receives FDA Orphan Drug Designation for the Treatment of Multiple Myeloma

Pharmacy Times

LBL-034 could be best in class in treating individuals with multiple myeloma.

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Neurogene shares fall on Rett syndrome gene therapy data

pharmaphorum

Neurogene says Rett syndrome gene therapy improves clinical symptoms, but a serious adverse event causes shares to fall

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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine 

Pharmaceutical Technology

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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Proposed Biosimilar to Ocrelizumab Shows Comparability With Reference Product

Pharmacy Times

Ocrelizumab (Ocrevus; Genentech) is used for the management and treatment of multiple sclerosis.

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Collaboration between Merck and Ginkgo Bioworks for Improving Biologics Manufacturing Achieves First Milestone

BioPharm

Ginkgo Bioworks has achieved the first milestone in an ongoing partnership with Merck, known as MSD outside of the United States and Canada, aimed at improving biologics production.

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Pfizer explores sale of hospital drugs unit amid activist investor’s call for accountability: Reuters

Fierce Pharma

After a series of acquisitions and an activist investor’s accusation of overspending, Pfizer is exploring an opportunity to slim down by divesting its hospital drugs unit,

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Pharmacists Combat Flu Misinformation and Expand Vaccine Access

Pharmacy Times

Kristi Veis discusses the importance of flu vaccinations and the role of pharmacists in administering them.