Sat.Sep 24, 2022 - Fri.Sep 30, 2022

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New Report: Nearly 800 medicines in development to treat chronic condition

PhRMA

Chronic conditions impose a substantial health and economic burden that affects millions of patients, families and communities across the United States each day. While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity.

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Supporting the Next Era of Independent Pharmacies in the US & Abroad

Drug Topics

The future of independent pharmacy requires the combination of what makes independent pharmacy special and the digital landscape found elsewhere in retail.

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Genomic Testing Framework for Chronic Kidney Disease Continues to Grow

Pharmacy Times

Investigators combine research discovery with technological development to determine whether the role of genomics in nephrology should remain with subspecialists or be integrated into general nephrology.

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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

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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 drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Improved Glycemic Control, Time in Target Range Found with iLet Bionic Pancreas

Drug Topics

The iLet Bionic Pancreas was associated with improved glycemic control and time in target glucose range compared to standard care in a cohort of people with type 1 diabetes aged 6-79 years of age.

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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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Lecanemab Hopes to Succeed Where Aduhelm Failed

Drug Topics

The announcement of positive phase 3 results for the investigational Alzheimer’s disease drug comes against a backdrop of Aduhelm flaming out. Both drugs are predicated on the theory that Alzheimer’s is caused by beta-amyloid deposits.

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New Bivalent Omicron-Containing Booster Vaccine May Elicit Higher Antibody Response Against COVID-19

Pharmacy Times

Patients could have a better immune response against the omicron variant of COVID-19 with a second booster of the bivalent mRNA-1273.214 vaccine at a 50 ?g dose.

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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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Ebola experimental vaccine trial may begin soon in Uganda

STAT

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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Efficacy and Safety of Ranibizumab and Lucentis for Wet AMD Compared

Drug Topics

The authors noted that the proportion of patients losing fewer than 15 letters from the baseline BCVA score in the study eye was comparable between the two groups.

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FDA Fast Tracks Treatment for for Select Stage IIB to IV Malignant Melanoma

Pharmacy Times

KIN-2787 is a potential treatment for BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.

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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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STAT+: Biotech turns to new and strange viruses to overcome gene therapy’s limitations

STAT

CAMBRIDGE, Mass. — The fluorescent orange sticker atop the white machine reads “BIOHAZARD,” but it’s a bit of a misnomer. Although Earth abounds with pathogens that can maim, kill, paralyze, and poison, the specimens inside this machine — being pipetted left and right behind glass for sequencing — are probably the most innocuous human viruses you will ever encounter.

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Biogen, Eisai say lecanemab has aced phase 3 Alzheimer’s study

pharmaphorum

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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Increased Menstrual Cycle Length Tied to COVID-19 Vaccine

Drug Topics

In a recent study, participants who had received a COVID-19 vaccine saw an average increase in menstrual cycle length of less than 1 day.

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Expert: Alcohol Dependence Is an Epidemic, Yet Treatments Exist

Pharmacy Times

Pharmacists play an important role in the recovery journey for patients who decide medication assisted treatment is right for them.

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‘Disaster to disaster’: Underinvestment in public health systems obstructs response to Covid, monkeypox, Walensky says

STAT

For the record, Rochelle Walensky, director of the Centers for Disease Control and Prevention, would take the job again.   “I’m a clinician, a physician at heart,” she said Friday. “And when somebody calls you for help, you run.

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Influencer Marketing and Social Health: Optimizing Pharma’s Impact

pharmaphorum

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

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The Effects of Psychedelics in Healthy Participants

Drug Topics

In a well-blinded study, researchers investigated and directly compared the acute effects of LSD and psilocybin in healthy participants.

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FDA Approves Omidenepag Isopropyl for Elevated Intraocular Pressure in Primary Open-Angle Glaucoma, Ocular Hypertension

Pharmacy Times

Omidenepag isopropyl ophthalmic solution (Omlonti) eye drops are indicated to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

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Opinion: Maternal-fetal surgery is not an alternative to abortion care

STAT

Every day, pregnant people across the United States get the news that the futures they imagined for their babies are at risk due to a fetal condition. It may be something relatively minor, like a small benign growth on a lung, or something major, like a life-threatening heart or developmental problem. Some of these problems can be mediated by maternal-fetal surgery.

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NICE backs ‘real-world’ wearable devices for Parkinson’s disease

pharmaphorum

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected. The UK health technology assessment (HTA) organisation said the devices may be more accurate at making a clinical assessment of a patient’s symptoms and disease progression compared to intermittent, in-person appointments at the clinic.

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Is TEE the key for novel antibiotics?

European Pharmaceutical Review

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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Challenges with Current Treatments and Emerging Treatments for C. difficile Infection (CDI)

Pharmacy Times

Drs Chopra and Feuerstadt summarize challenges with current treatments and discuss live biotherapeutic products that are being studied for recurrent C difficile infection (rCDI).

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An Alzheimer’s therapy scores winning results, but what could it mean for patients?

STAT

The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded hit like a blast — at last, a rare win in a disease devastating nearly 6 million Americans and countless more caregivers. The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo.

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Walmart opens 1st of 4 next-generation fulfillment centers in Joliet, Ill.

Drug Store News

​​​​​​​The new high-tech facility will begin operations ahead of the holiday season, bringing next-day or two-day shipping to customers across Illinois, Indiana and Wisconsin.

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Pfizer, Sangamo resume haemophilia gene therapy trial

pharmaphorum

Pfizer and Sangamo have restarted recruitment of patients into their registration trial for haemophilia A gene therapy giroctocogene fitelparvovec, after the FDA lifted a clinical hold on the study. The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the clotting factor that giroctocogene fitelparvovec is designed to produce

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FDA Approves Bevacizumab Biosimilar for Six Types of Cancer

Pharmacy Times

Bevacizumab-adcd (Vegzelma) is indicated for the treatment of nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic colorectal cancer; persistent, recurrent, or metastatic cervical cancer; metastatic renal cell carcinoma; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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STAT+: Burning questions left unanswered about the latest Alzheimer’s therapy

STAT

News of the first clearly successful clinical trial for a new Alzheimer’s disease treatment in two decades has brought hope, scrutiny, and skepticism to a field accustomed to disappointment. Whether that treatment is a meaningful advance or another false dawn depends on scientific details yet to be presented and corporate decisions still to be made.

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Walmart, Claire’s broaden fashion accessory, jewelry availability

Drug Store News

Claire’s fashion accessories and jewelry are now available at more than 2,500 Walmart locations nationwide, online, and at more than 36 Claire’s stores-in-stores within Walmart.

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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S.

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Dapagliflozen May Decrease Fatal Risks of Heart Failure Associated With Higher Ejection Fraction

Pharmacy Times

For patients suffering from a higher left ventricular ejection fraction, a sodium-glucose cotransporter 2 inhibitor could decrease risk of hospitalization or death from heart failure.

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