Mon.Jul 17, 2023

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Hearing aids may slow mental decline in those at higher risk of dementia, study finds

STAT

Doctors have long suspected that hearing loss in older adults hastens dementia, the cognitive decline associated with aging. A new study published in The Lancet on Tuesday probes the link between the two conditions further in what could be the first randomized controlled trial of its kind.  More than 55 million people have dementia worldwide; a number that continues to grow as more people live longer.

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Mismatch: Why were there so many unfilled emergency medicine residency positions in 2023?

ALiEM - Pharm Pearls

The Study In an Annals of Emergency Medicine paper , Preiksaitis et al. sought to identify program factors associated with unfilled post-graduate year 1 (PGY-1) emergency medicine (EM) positions in the 2023 Match [1]. The authors completed a cross-sectional, observational study using National Residency Matching Program (NRMP) data and examined 9 variables as potential predictors of unfilled PGY1 positions using regression analyses [2].

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Trending Sources

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Opinion: No one — M.D. or otherwise — should use the honorific ‘doctor’ with patients

STAT

Florida legislators recently passed legislation to prevent advanced practice nurses in Florida with doctorates from using the honorific “doctor.” The state House and Senate bills proposed that nurses with doctorates who introduce themselves to patients as “Dr. Smith, nurse practitioner,” could face disciplinary action. Lobbyists who supported this measure referred to it as a “patient empowerment bill that allows them to understand who is treating them.

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DCTs create fresh privacy challenges for review boards. Now there are guidelines.

PharmaVoice

A new toolkit developed by industry stakeholders paves the way for faster reviews.

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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 approves RSV monoclonal antibody for infants, young children at high risk

STAT

The Food and Drug Administration approved a monoclonal antibody to protect infants and young children from severe illness caused by RSV on Monday, a potential game-changer for a disease that is the No. 1 cause of hospitalization of babies in this country. Use of the antibody treatment, the brand name for which is Beyfortus, still needs to be recommended by the Advisory Committee on Immunization Practices, an independent expert panel that advises the Centers for Disease Control and Prevention.

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Novartis buys a preclinical biotech and its RNA drug technology

BioPharma Dive

For $500 million, Novartis will acquire DTx Pharma and its preclinical neurological disease drugs, marking the Swiss company’s latest investment in gene-silencing medicines.

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Amy Turnquist

Pharma Marketing Network

Amy Turnquist has more than 20 years of experience leading teams to create and deliver innovative, client-centric solutions that connect pharmaceutical brands with their HCP and consumer audiences. In her role as a Principal at North Highland, Amy helps healthcare organizations transform their engagement strategy, driving sustainable change and measurable impact by keeping people at the heart of every decision.

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For a 9-year-old patient at a Los Angeles obesity clinic, barriers to health are everywhere

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about  The Obesity Revolution. LOS ANGELES — On this pleasant spring day, patients and uniformed health care workers crisscross the UCLA medical campus like ants on a picnic table.

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Apellis shares sink on reports of rare side effects with new vision loss drug

BioPharma Dive

An organization of retinal specialists flagged six cases of severe eye inflammation from commercial use of Syfovre. Apellis says the drug’s safety profile is consistent with testing.

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Nearly 8,000 blood tests recalled over risk of missed heart attack diagnosis

STAT

QuidelOrtho has recalled nearly 8,000 potentially faulty blood tests meant to help doctors quickly determine whether a patient is having a heart attack. The tests inaccurately showed low levels of troponin, a protein that indicates damage to the heart. A false negative could lead doctors to mistakenly conclude their patient is not having a heart attack, delaying diagnosis or treatment when time is of the essence.

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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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Bridging Care Delivery with Clinical Research

PharmExec

In this Q&A, Craig Serra, head of commercial solutions and partnerships within the clinical research business unit at Flatiron Health (affiliate of the Roche Group), shares his perspective on clinical research, the role of data, and Flatiron Health’s efforts to that end.

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STAT+: Westlake Village, a West Coast VC firm, raises $450 million fund

STAT

Westlake Village BioPartners, a West Coast biotech venture capital firm founded five years ago by two Amgen veterans, has raised a new fund and brought in two veteran investors from another biotech VC as one of its founders takes a back seat. Westlake just raised $450 million for its third fund. It’s the first without the involvement of co-founder Sean Harper, who started the firm in 2018 with his Amgen colleague Beth Seidenberg.

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five patents… The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: As fear rises over AI, Google and Epic fight stronger regulation of the technology in health care

STAT

Big businesses poised to profit from the advance of artificial intelligence in health care are pushing back against newly proposed federal rules meant to increase oversight and fairness of AI tools used to help make decisions about patient care. The opposition, which includes Google and Amazon as well as large health care providers, insurers, and medical software vendors, is focused on an attempt to put tighter guardrails around the use of AI by the Office of the National Coordinator for Health

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Westlake raises $450M in latest biotech venture fund

BioPharma Dive

Leaders from the firm said that, despite a turbulent biotech market, most of their existing limited partners returned to participate in the new fund, which will support approximately a dozen startups.

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How telehealth startups are trying to fill the menopause care vacuum

STAT

At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease.

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Cannabinoid company expands into oncology

Pharma Times

OCTP develops cannabinoid medicines and is looking at potential treatment of cancer malignancies - News - PharmaTimes

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STAT+: Electronic health record maker NextGen Healthcare to pay $31 million to resolve fraud claims

STAT

The health records company NextGen Healthcare will pay $31 million to resolve allegations that it paid kickbacks to win customers and concealed shortcomings of its software to gain government certification. The settlement caps a lengthy investigation that cast a harsh light on NextGen’s efforts to gain market share in the sharp-elbowed business of selling electronic health records software.

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First continuous mRNA manufacturing platform to be developed

European Pharmaceutical Review

A new three-year research programme led by researchers at Massachusetts Institute of Technology ( MIT ) is aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. The resulting pilot-scale system is intended to improve society’s ability to respond to future pandemics as well as accelerate the development and production of mRNA technologies.

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Listen: Wildfire pollution widens asthma inequities on Long Island

STAT

Wyandanch is a proud, resilient community on Long Island. There’s about 13,000 people who live in this predominantly Black and brown hamlet. In early June, it celebrated its 55th annual Wyandanch Family Day. Hundreds of people lined the streets to watch a parade complete with floats, marching bands, and dancers. It was a blue, nearly cloudless day — much different than the hazy orange skies a few days earlier.

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Sanofi expands research deal with gene editing startup Scribe

BioPharma Dive

Scribe will receive $40 million upfront from Sanofi in a collaboration initially focused on developing an in vivo gene editing treatment for sickle cell disease.

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STAT+: Colombian government explores compulsory licensing for an HIV drug

STAT

The latest clash over the cost of a prescription medicine is playing out in Colombia, where the government is exploring the possibility of issuing a compulsory license for a needed HIV treatment — a move that would spark another battle with the pharmaceutical industry. Last month, Colombian Health Minister Guillermo Alfonso Jaramillo issued a resolution to examine whether the government should pursue a license to obtain lower-cost generic versions of an HIV medicine called dolutegravir ma

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New data suggests novel mAb could delay progression of early Alzheimer’s

European Pharmaceutical Review

Eli Lilly and Company’s TRAILBLAZER-ALZ 2 study has shown donanemab enabled nearly half of participants at earlier stage of Alzheimer’s to experience no clinical progression at one year, according to full results from the Phase III trial. The data was shared at the 2023 Alzheimer’s Association International Conference (AAIC) and published in the Journal of the American Medical Association (JAMA).

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STAT+: Detailed data confirm benefits — and risks — of Eli Lilly’s Alzheimer’s drug

STAT

The benefits and risks of Eli Lilly’s treatment for Alzheimer’s disease were confirmed in detailed scientific disclosures Monday, paving the way for its full approval but leaving physicians with lingering questions about the medicine’s impact on patients as a new era in Alzheimer’s therapy unfolds. The drug, called donanemab, showed a 35% slowing of Alzheimer’s disease progression relative to placebo in a clinical trial that enrolled 1,700 patients with early-s

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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds

European Pharmaceutical Review

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending. T he article, written researchers at Bentley University, is the first to broadly assess NIH’s contribution to clinical development of new drugs and compare the scale of NIH spending relative to reported spending by ind

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STAT+: Key House panel plots a new health care package — complicating the chamber’s agenda

STAT

WASHINGTON — It’s two weeks until Congress leaves town in August, and a prominent House panel is throwing a wrench in what seemed like a smooth path forward for legislation to require more transparency in health care prices, and to change Medicare drug payments. The House Energy & Commerce Committee already introduced, held multiple hearings on, and unanimously passed out of committee a package of legislation including transparency requirements for hospitals and pharmacy b

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FDA approves new RSV drug to protect infants, toddlers

BioPharma Dive

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

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STAT+: BridgeBio heart drug succeeds in pivotal study

STAT

A drug developed by the biotech firm BridgeBio to treat an increasingly common heart condition succeeded in its main goal in a clinical trial, the company said Monday, and also pointed to potential reductions in hospitalization and death. The results may give the medicine, acoramidis, a path to the market after a failure that led its maker’s stock to plunge in December 2021.

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Fighting AMR with a value and subscription model 

Pharmaceutical Technology

The recent reintroduction of the Pasteur Act seeks to address the global threat that antimicrobial-resistant (AMR) infections pose, one subscription contract at a time.

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Free Government Help with Market Research

Integra X Files

Creating and executing an effective marketing program for a pharmacy is easier if you’re armed with market research that reduces uncertainties about market characteristics, demographics, and economic opportunities. Fortunately, some (free) help is available from government sources. Maybe not free, exactly, because you’ve already paid for it when you write your regular check to the IRS.

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FDA expands Veklury’s use to Covid-19 patients with severe kidney disease

Pharmaceutical Technology

The move follows a positive decision made by the EMA earlier this year, broadening the use of Veklury to the high-risk patient group.

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AI startup raises funding to speed up number crunching in clinical trials

Outsourcing Pharma

The U.S. startup Readout AI has closed a pre-seed financing round to fuel the development of an artificial intelligence (AI)-based tool to speed up data analysis in clinical trials.

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Sathgen Therapeutics announces completion of first cohort in phase 1 clinical trial with anti-cancer drug

Express Pharma

Sathgen aims to develop MSP008-22 for difficult-to-treat cancers, starting with triple negative breast cancer (TNBC) and prostate cancer as proof-of-principle Sathgen Therapeutics, a division of a leading chemical conglomerate in India – Godavari Biorefineries Limited (GBL), announced the completion of the first cohort in a Phase 1 clinical trial with their first-in-class New Chemical Entity (NCE), MSP008-22.

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Cumulus Neuroscience announces positive results from CNS-102 study for sclerosis and frontotemporal dementia

Outsourcing Pharma

Cumulus Neuroscience, a global digital health company focused on advancing neuroscience clinical trials and patient care, presented interim data from their first-in-class CNS-102 feasibility study at the European Network to Cure ALS Annual Meeting (ENCALS) in Barcelona, Spain.

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SNIPR celebrates US court’s favourable ruling on CRISPR patent

Pharmaceutical Technology

The US Federal Court overturned a previous ruling in the patent infringement case against Rockefeller University.

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