Sat.Jul 13, 2024 - Fri.Jul 19, 2024

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Opinion: Letters from readers on schools and bird flu, opioid ‘overprescribing,’ and more

STAT

“Preparing schools for the H5N1 bird flu they’re likely to face,” by Mario Ramirez Having been a school nurse during the Covid pandemic I can tell you that most superintendents will only require what the education department in their state recommends. The leaders at the table in schools are not clinical people. Rarely is a nurse included in such discussion and most were not during the last pandemic.

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Mining clues from a library of brain tissue samples, Cerevance takes a precision approach to CNS disorders

PharmaVoice

Mid-stage data from the company’s lead candidate in Parkinson’s is expected later this year and could tee up an IPO.

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Topiramate-Induced Cognitive Impairment

Med Ed 101

In this case scenario, I outline a situation of topiramate-induced cognitive impairment. Topiramate is an anticonvulsant medication that may be used for headache prophylaxis and is known to cause cognitive slowing, manifesting as difficulties in concentration, memory, and speech. JD is a 55-year-old male who presents to the clinic for a routine follow-up.

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The pharmaceutical retail industry: A paradigm shift for growth and compliance driven by data visibility

Express Pharma

The pharmaceutical retail industry presents a paradox: it is highly regulated yet fragmented. This dichotomy arises from the diverse range of stakeholders, each with their own interests and priorities. This fragmentation poses challenges for medical and more retailers in complying with regulations, tracking inventory, and preventing counterfeit products from infiltrating the supply chain.

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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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Bird flu snapshot: As the number of infected dairy herds mount, so too does pessimism about driving H5N1 out of cows

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on the H5N1 flu outbreak in dairy cows that STAT is publishing on Monday mornings. To read future updates, you can also subscribe to STAT’s Morning Rounds newsletter. There are more human cases of H5N1 bird flu infection, and another state has joined the list of those with infected dairy cow herds.

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Is a better CAR-T cell therapy option on the horizon?

PharmaVoice

In vivo CAR-T cell technology has the potential to solve some major issues in the field and could enter the clinic this year.

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More Trending

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

Top Most Common Over-the-Counter Pharmacist Resources What are OTC drugs? Over-the-counter (OTC) drugs refer to non-prescription medications that are readily available to consumers without the need for a doctor’s prescription. These drugs are typically used to treat common, self-diagnosable health issues, such as headaches, allergies, cold symptoms, and minor aches and pains.

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STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show

STAT

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT. Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals.

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New patent expiration for United Therap drug ORENITRAM

Drug Patent Watch

Annual Drug Patent Expirations for ORENITRAM Orenitram is a drug marketed by United Therap and is included in one NDA. It is available from one supplier.

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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

BioPharma Dive

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

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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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Unpacking Pharmacy Stress: A Deep Dive Into the 2023 Well-Being Report

The Happy PharmD

Everything is fine. Everything’s not fine. Okay, let’s dig into it — pharmacists are reportedly less stressed now? The Well-Being Index 2023 Report suggests a decrease in overall pharmacist distress since before the pandemic. [link] The report, based on over 2,500 pharmacist assessments, shows a significant drop in average distress levels from 3.25 in 2019 to 2.59 in 2023.

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What are the odds we get an heir to Paxlovid?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we look at some promising, but early, gene therapy data from Lexeo Therapeutics, examine Medicare’s new price negotiation rules and their impact on innovation, and more.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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Lexeo gene therapy shows signs of heart benefit in small study

BioPharma Dive

The company claims the results support exploring the possibility of an accelerated approval, citing flexibility by FDA officials in reviewing rare disease gene therapies.

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Trial finds over-the-counter nasal sprays could reduce RTIs and antibiotic use

Pharma Times

Affecting parts of the body involving breathing, RTIs impact one in five people in England

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STAT+: Early data from Lexeo’s gene therapy for rare heart disease shows promise

STAT

Lexeo Therapeutics said Monday that a gene therapy designed to prevent fatal cardiac complications of a genetic disorder called Friedrich’s ataxia reduced signs of heart disease in a handful of patients. The data are very early and less-than-clear-cut. But given a top Food and Drug Administration official’s recent efforts to advance gene therapies under accelerated approval — most notably, with the decision to expand approval for Sarepta’s Duchenne muscular dystrophy

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Ozempic’s latest health benefit may be cutting dementia risk

pharmaphorum

Observational study finds lower risk of cognitive problems and nicotine dependence in diabetics using Novo Nordisk's Ozempic

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ApoC3 targeted by Sirnaomics through its announced completion of IND-Enabling studies of safety and efficacy for STP125G with NHP Models

Pharmafile

Sirnaomics, a biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, has announced the completion of IND-enabling studies for STP125G, an siRNA therapeutics targeting Apolipoprotein C3 (ApoC3). These studies strongly support the Investigational New Drug (IND) filing with the US Food and Drug Administration (FDA).

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NIHR and Diabetes UK invest nearly £3m to prevent and treat diabetes distress

Pharma Times

Almost 50% of adults living with type 1 diabetes experience high levels of diabetes distress

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Opinion: Medicare drug pricing rules will delay access to promising therapies

STAT

Medicare’s new guidelines cover how it will conduct the drug price negotiations authorized by the Inflation Reduction Act. Unfortunately, the Centers for Medicare and Medicaid Services is interpreting the law in a way that will discourage companies from finding new uses — sometimes lifesaving new uses — for existing drugs. It will also deter companies from doing research on existing medicines to create improved versions that are more effective and have fewer side effects.

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Lupin receives EIR from U.S. FDA for its Dabhasa facility

Express Pharma

Lupin recently announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility located in Dabhasa, Gujarat. The EIR was issued post the last inspection of the facility conducted from April 8 to April 12, 2024. The inspection concluded with no observations and the facility receiving an inspection classification of “No Action Indicated” (NAI).

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AI-powered prognosis test company Spotlight Medical secures €6.2m in seed funding

Pharmafile

Start-up Spotlight Medical has announced it has raised €6.2m in a seed funding round led by Kurma Partners and Heal Capital. The funds will be put towards bringing the first of Spotlight Medical’s prognostic tests to the clinic. The AI-driven prognosis test will be used to help physicians select the most effective treatment for cancer patients, […] The post AI-powered prognosis test company Spotlight Medical secures €6.2m in seed funding appeared first on Pharmafile.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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STAT+: The effort to reform physician pay is set to pit primary care docs against highly paid specialists

STAT

WASHINGTON — There’s been a long lull in fighting between primary care and specialty doctors over how much they get paid by Medicare, but that truce might not last if Congress overhauls the system that determines physician payment. This year, Congress began considering changes to the Medicare physician pay system for the first time since creating the current version in 2015.

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Synergistic safety profile could increase sublingual apomorphine competitiveness: GlobalData

Express Pharma

Sublingual apomorphine (SL-APO) is a dopamine agonist (DA) marketed by Bial under the brand name Kynmobi in several countries for the on-demand treatment of levodopa wear-off (OFF-episodes) that are not sufficiently controlled by levodopa “add-on” (adjunct) therapies. At the tenth Congress of the European Academy of Neurology (EAN) 2024, Dr Diego Santos García presented a post-hoc analysis of the Phase III, open-label study on SL-APO showing that it was better tolerated by patients on regular DA

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Health Care Appropriations FY2025

Putting Patients First Blog

Health Care Appropriations FY2025 July 15, 2024 By: Allen Pinn, Policy Coordinator As we approach the homestretch of the 118 th Congress, the appropriations process for fiscal year 2025 has recently picked up steam. The fiscal year technically begins October 1, 2024, but it is likely that the process of setting funding levels will extend past the election or possibly into the next calendar year.

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Pharma’s attitudes on AI revealed

European Pharmaceutical Review

A survey by Elsevier has shown that researchers in the pharmaceutical and life sciences sectors consider artificial intelligence (AI) to be positive, with respondents stating that the future impact of the technology will be “transformative or significant.” The data showed that over 38 percent of those who engaged in the survey have used it professionally.

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Working to find a global solution to the “antibiotic emergency”

Commonwealth Pharmacists Association

Working to find a global solution to the “antibiotic emergency” Five representatives of CPA recently attended a critical stakeholder meeting in London on May 16th, 2024 to discuss the economic and human consequences of rising antimicrobial resistance (AMR) Convened by the UK Government and The Royal Society, the UK’s national academy of sciences, the meeting […]

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Transforming medical device assembly with Acopos6D

Express Pharma

The medical device assembly sector is poised for significant expansion, extending its reach into new territories alongside its manufacturing and assembly facilities. This dynamic industry is expanding and driving daily growth, thanks to its exceptional adaptability and commitment to innovation. As per estimates by the Government of India, the sector is growing at a rate of 28 per cent to reach a size of USD 50 bn by 2030.

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Newsletter – July 2024

Fuld & Company Blog

This month’s newsletter shines a spotlight on the crucial role of innovation. Join us for our upcoming webinar, “ Driving Market Success with Innovation ,” where innovation leaders at Catapult, Delta Faucet, and Mary Kay will discuss some of their best tips and strategies. Listen to the latest episode of our new podcast, Debating Net Zero, where Fuld’s energy experts debate the potential impact of white hydrogen as a renewable energy source.

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EMA’s PRAC Offers Recommendations for Glucagon-like Peptide-1 Receptor Agonists and Glatiramer Acetate

PharmaTech

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

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New process for contractors looking to provide off-site Covid vaccines

The Pharmacist

Contractors interested in running a Covid-19 vaccination site away from their pharmacy should check NHS England (NHSE) websites ‘regularly’ as more opportunities are commissioned, Community Pharmacy England (CPE) has advised. NHSE has already invited community pharmacy and GP sites to sign up to provide vaccinations at their registered premises. But where commissioners have identified a […] The post New process for contractors looking to provide off-site Covid vaccines appeared first on Th

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Government drafts notification to regulate advertisements of schedule G drugs

Express Pharma

The Government of India has proposed amendments to the Drugs and Cosmetics Rules, 1945, to include regulations on the advertising of medicines containing Schedule G drugs. Schedule G drugs, which require medical supervision but do not fall under prescription-required categories, are the focus of this initiative aimed at preventing misleading advertisements.

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Merck enhances ophthalmology portfolio with EyeBio acquisition

Pharmaceutical Business Review

The deal, which was announced in May 2024, includes an upfront cash payment of $1.3bn and $1.7bn in milestone payments on meeting developmental, regulatory and commercial goals. Under the deal terms, Merck, through a subsidiary, has acquired all the outstanding shares of the UK-based biotech. The acquisition includes EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway.

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Through the Looking Glass? Loper Bright Will Force FDA to Change Its Approach to Litigation and Advocacy

FDA Law Blog: Biosimilars

By John W.M. Claud & JP Ellison — The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions.