Fri.Sep 13, 2024

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Lenacapavir for PrEP Demonstrates Strong Efficacy in Second Phase 3 Trial

Drug Topics

Gilead said data from the study will support global regulatory filings that the company plans to begin by the end of the year.

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Navigating Pharmacy School: Tips for Success

Pharmacy Is Right For Me

Written by: Toni Mikhael, PharmD, Touro College of Pharmacy Class of 2024. PGY-1 Pharmacy Resident, WellSpan Ephrata Community Hospital, Ephrata, PA Edited by: Anastasiya Shor, PharmD, BCPS Pharmacy school is a challenging but rewarding journey. As students embark on this demanding path, it becomes crucial to equip themselves with a toolkit for success.

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Inquiry into unexplained bird flu case in Missouri broadens to a close contact

STAT

A close contact of the person in Missouri who had an unexplained H5N1 bird flu infection last month was also sick around the same time, but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.  The CDC revealed the previously undisclosed information in FluView , its weekly report on influenza activity.

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FDA Approves First-Ever OTC Hearing Aid Software

Drug Topics

Over 30 million American adults experience some hearing loss, yet only one-fifth benefit from hearing aids; the FDA’s approval will expand access to the technology for the patient population.

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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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STAT+: A new drug offers a rare option for brain cancer treatment — and inspires hopes for more

STAT

For more cancer coverage, sign up for STAT’s pop-up newsletter focused on this weekend’s European Society for Medical Oncology conference, one of the biggest oncology meetings of the year. Details here. When Rachel Guberman found out she had brain cancer, she did so much reading and Googling about the disease that she joked she had reached the end of the internet.

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HIV Infections Significantly Reduced With Twice-Yearly Lenacapavir in Cisgender Men, Gender-Diverse Participants

Pharmacy Times

These results build off the PURPOSE 1 trial, contributing to the wealth of evidence surrounding lenacapavir’s positive effects in patients with HIV.

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More Trending

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Experts Develop Multimodal Approach for Treating Long COVID, Other Post-Acute Infectious Syndromes

Pharmacy Times

In the absence of a common treatment for long COVID, researchers from around the world documented the best currently available therapies.

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UTHealth Houston collaborates with OpenAI to offer clinicians HIPAA-compliant ChatGPT solutions

Fierce Healthcare

UTHealth Houston unveiled a partnership with OpenAI on Friday to build and deploy algorithms for use in medical training and at the patient’s bedside. | UTHealth Houston, an academic medical center in Texas, is partnering with OpenAI to give clinicians, faculty and students access to ChatGPT tools to build custom, HIPAA-compliant AI solutions.

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FDA Authorizes OTC Hearing Aid Software Compatible With Apple AirPods

Pharmacy Times

The Hearing Aid Feature can be customized to the user’s needs by amplifying sounds for individuals 18 years or older who have perceived mild to moderate hearing impairments.

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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

Fierce Pharma

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

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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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STAT+: Insurers went all-in on Medicare Advantage. Now, some are scaling back 

STAT

For years, health insurers battled to gain market share in the lucrative privatized Medicare program. Now, the opposite is true. Some of the companies say they designed their 2025 plans with an eye toward ditching members.  Health insurance has always been cyclical — companies go all-in on certain business lines when they’re profitable and get out when they’re not — but next year will mark a particularly drastic turning point for Medicare Advantage , the form of

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FDA Approves Ocrevus Zunovo for 2 Forms of Multiple Sclerosis

Pharmacy Times

The approval marks the first and only twice yearly, health care professional-administrated injection for both forms of multiple sclerosis (MS).

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Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

Fierce Pharma

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.

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Remote Interventions From Pharmacists Shown to Improve Blood Glucose Control for Type 2 Diabetes

Pharmacy Times

Data show the value of the pharmacist is clear for patients with type 2 diabetes, as their role can have a significant impact on reductions in hemoglobin A1c.

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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: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases

Fierce Pharma

Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.

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Opinion: Compounded semaglutide is an ill-defined public health crisis

STAT

I first met Jane (not her real name, of course) on a Friday afternoon in our clinic. She was referred for further evaluation of her chest pain, which, in the context of her family history of early-onset heart attacks and her morbid obesity, understandably concerned her primary care doctor. In the exam room, we dissected her symptoms and decided we’d investigate them further with a stress test.

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West Tennessee Healthcare President, CEO James Ross dies

Fierce Healthcare

James Ross, president and CEO of West Tennessee Healthcare, died Thursday morning, according to an announcement from the health system on social media. | The nurse-executive had been with the seven-hospital nonprofit for nearly four decades and was a prominent member of the Jackson, Tennessee, community.

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STAT+: FDA approves Roche’s injectable version of blockbuster multiple sclerosis drug

STAT

Swiss pharma giant Roche won approval from the Food and Drug Administration on Friday for an injectable version of its blockbuster multiple sclerosis therapy Ocrevus, cutting down the time needed to treat patients and potentially staving off growing competition. The approval was driven by the results of a late-stage trial , OCARINA II, in which the company showed that delivering Ocrevus as a 10-minute injection beneath the skin worked as well as the current approach, an hours-long intravenous in

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ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as Pharma&'s combo disappoints

Fierce Pharma

In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. | In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that Pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.

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Positive Airway Pressure Therapy May Improve Mortality, CVD Outcomes in Obstructive Sleep Apnea

Drug Topics

Researchers analyzed the outcomes of positive airway pressure therapy for Medicare beneficiaries with obstructive sleep apnea.

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The news from ESMO: The latest on anti-TIGIT data, a PD-(L)1 injection, and more

STAT

This is the online edition of ESMO in 30 Seconds, a pop-up newsletter from the European Society for Medical Oncology’s annual meeting in Barcelona, Spain. Sign up for the remaining editions here. One of the big presentations of this year’s ESMO (at least in our view) comes tomorrow morning bright and early. David Spigel of Sarah Cannon Research Institute in Nashville will unveil results from the GALAXIES Lung-201 study of an anti-TIGIT therapy from iTeos Therapeutics and GSK in non

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Discussing the Current Landscape of PBM Reform Legislation

Drug Topics

During an interview, Joseph Shields of TransparencyRx discusses the PBM legislation that is expected to move forward in Congress in the next few months.

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Apple AirPods get FDA okay for use as OTC hearing aids

pharmaphorum

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.

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Visual Art Therapy Significantly Improved Patients’ Mental Health Outcomes

Drug Topics

Researchers conducted a meta-analysis detailing previous patient outcomes in response to visual art therapy interventions.

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ESMO: Merck unpacks a mixed bag of gynecological cancer results for Keytruda

Fierce Pharma

Even for Merck’s oncology powerhouse Keytruda, the emerging role of immunotherapies in gynecological cancer treatment represents a bit of a mixed bag. | The company unveiled new data from its KEYNOTE-A18 study in late stage cervical cancer and its failed KEYNOTE-B21 trial testing Keytruda as an adjuvant therapy in newly diagnosed endometrial cancer.

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Can GLP-1 drugs help with type 1 diabetes?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, and congratulations on making it through another week. What’s been helping me get through this week is this baby hippo in Thailand called Moo Deng (which apparently translates to Bouncy Pig). She is very likely the cutest and most relatable animal I’ve ever seen.

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Investigators Link Early Cholesterol Exposure With Faster Atherosclerosis Development

Pharmacy Times

Exposure to high cholesterol levels is a significant risk factor for atherosclerosis cardiovascular disease.

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Lilly ramps up Irish manufacturing investment by $1bn

pharmaphorum

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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4 foods to avoid while on Stelara

The Checkup by Singlecare

Stelara (ustekinumab) is an injectable drug approved by the Food and Drug Administration (FDA) for the treatment of autoimmune conditions, such as plaque psoriasis, active psoriatic arthritis, and inflammatory bowel diseases, including Crohn’s disease , and ulcerative colitis. There are no known food-drug interactions with Stelara. Still, it may cause digestive side effects, especially if you have an inflammatory bowel disease (IBD).

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ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop

Fierce Pharma

As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. | AstraZeneca is detailing Truqap's pivotal trial flop in triple-negative breast cancer, a result that could raise additional doubts around the first-in-class AKT inhibitor.

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Payer Roundup—Minnesota providers drops Humana MA plans; New No Surprises Act bill introduced

Fierce Healthcare

Below is a roundup of payer-centric news headlines you may have missed during the month of September 2024. | This month, Humana faces consequences for prior auth delays, Congress members have introduced new No Surprises Act legislation targeting insurers and Aetna has been sued for denying gender-affirming facial reconstruction surgeries.

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STAT+: BMS immunotherapy improves responses in lung cancer, setting up Phase 3 study

STAT

BARCELONA, Spain — Adding a second immunotherapy from Bristol Myers Squibb to an existing checkpoint inhibitor and chemotherapy improved responses for certain patients with a type of lung cancer, steering the approach into a Phase 3 study.  The Phase 2 RELATIVITY-104 trial was another hurdle for BMS’ Opdualag, which is essentially a combination of the company’s powerhouse PD-1 inhibitor Opdivo and relatlimab, which targets another checkpoint called LAG-3.

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ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value added from new cancer approvals

Fierce Pharma

ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value added from new cancer approvals kdunleavy Fri, 09/13/2024 - 07:38

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