Sat.Nov 09, 2024 - Fri.Nov 15, 2024

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Providers Prefer Increased Pneumonia, IPD Coverage and Lower Age Recommendation For Pneumococcal Vaccines

Pharmacy Times

Reasons for supporting the lowering of the age-based pneumococcal vaccine recommendation included the likelihood it would increase vaccination rates in multiple age groups and demographics.

Vaccines 144
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Prescription Drugs in the US Must Be Viewed as Critical Infrastructure | ASPL 2024

Drug Topics

Stephen Schondelmeyer, PharmD, PhD, FAPhA, gave a presentation on US drug shortages and their global implications.

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‘What’s your pain right now?’ Sickle cell, loss, and survival in America

STAT

ST. LOUIS — All morning, nurses had been coming in, taking vitals, offering blankets, pressing buttons to silence alarms. It would stay quiet for a bit, but then the beeping would start again, telling Tammy Clemons over and over that she was back in the emergency room. She wished she were elsewhere. She wished she were with her sister, who’d just had a stillborn baby in a different hospital, three miles away.

Hospitals 139
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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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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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How Pharmacists Can Make an Impact When Treating Dedifferentiated Liposarcoma With Brigimadlin

Pharmacy Times

Brigimadlin is a new oral MDM2-p53 antagonist under investigation as a potential first-line therapy to improve outcomes for patients with advanced or metastatic dedifferentiated liposarcoma.

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The Supreme Court Decisions Impacting Pharmacy Industry, Agency Interactions | ASPL 2024

Drug Topics

Selina Coleman, JD, Partner in Life Sciences Health Industry Group at Reed Smith LLP, discussed recent developments in Supreme Court decisions impacting pharmacy operations.

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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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FDA Approves Obecabtagene Autoleucel for Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Pharmacy Times

The regulatory approval corresponds with positive safety and efficacy data from the FELIX trial.

FDA 141
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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+: Schizophrenia drug AbbVie picked up in $9 billion acquisition fails in key trials

STAT

AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics. In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.

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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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With US launch progressing, ARS inks another licensing deal for epinephrine spray Neffy worth up to $465M

Fierce Pharma

Although ARS Pharmaceuticals’ approval for its epinephrine nasal spray came later than expected, the company ultimately received a thumbs up from the FDA in August and is now moving fast to expand | ARS Pharmaceuticals said that Denmark’s ALK-Abelló is paying $145 million upfront for the rights to market Neffy in Europe, Canada and “other geographies outside of the U.S.

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Staying in the Know: Pharmacists, Drug Shortages, and What Lies Ahead

Pharmacy Times

Pharmacists should be aware of current discussions, attempted fixes, and expected length of drug shortages.

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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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Canadian teen’s bird flu infection is not the version found in cows

STAT

A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday. The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus.

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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 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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Aignostics leads latest crop of digital health financings

pharmaphorum

Recent funding rounds in the digital health arena feature digital pathology startup Aignostics, remote care specialists TCC, Yazen Health, and Nema Health, wearables developer Alimetry, and clinical trial automation startup Research Grid.Digital pathology specialist Aignostics, which develops artificial intelligence algorithms to glean information from medical images and combine it with epidemiological, clinical, and genomic data, has completed a $34 million Series B financing.

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Overweight, Obesity Linked with Increased Long COVID Risk in Pediatric Patients

Drug Topics

Research has found that children and young adults with overweight or obesity may be at a significantly increased risk of developing long COVID.

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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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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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Oracle to collaborate with Meharry Medical College on innovation hub, wellness center in Nashville

Fierce Healthcare

Meharry Medical College in Nashville, Tennessee, is collaborating with Oracle on a new project to advance healthcare access, innovation and education in Middle Tennessee and beyond. | The organizations plan to establish a joint research collaborative focused on precision medicine and health informatics, a health innovation hub and a community care and wellness center in Nashville.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Black, Hispanic Patients Underrepresented in Food Allergy Immunotherapy Trials

Drug Topics

Researchers compared the racial and ethnic representation of participants in food allergen trials with patients who experience food allergies.

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STAT+: Children’s Hospital Los Angeles tests generative AI to translate discharge notes into Spanish

STAT

When patients and their families leave the emergency room, they’re usually clutching a sheaf of papers: Called discharge notes, they contain important instructions about how to care for themselves and when to follow up with a doctor. If patients don’t speak English, though, they may leave with directions they can’t understand.  At most hospitals, it takes between hours and days to translate discharge notes for outpatients who have limited English proficiency.

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Primary care player Forward shutters after raising $400M, rolling out CarePods

Fierce Healthcare

Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday. | Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

FDA 103
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FDA Aligns with Pharmacists in Ensuring Integrity of Drug Supply Chain | ASPL 2024

Drug Topics

An FDA representative gave a presentation on her organization’s recent updates regarding drug supply chain rules and regulations.

FDA 98
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STAT+: The end of 23andMe’s drug discovery dream

STAT

23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research. In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic da

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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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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

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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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BioNTech acquires its Chinese cancer drug partner

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning, lots of news this morning that we’ll get straight into.

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Zongertinib: A Promising New TKI for HER2-Mutated NSCLC

Pharmacy Times

If approved, zongertinib may be a new first-line oral tyrosine kinase inhibitor (TKI) for patients with HER2-mutated non-small cell lung cancer (NSCLC), a transformative step in TKI drug development.

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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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Q&A: Educating Patients on Importance of Flu Vaccination

Drug Topics

Lauren Angelo, PharmD, MBA, discusses effective ways pharmacists can educate and encourage their communities on the importance of flu vaccination.

Vaccines 106