STAT

OCTOBER 21, 2024

Confounding data from a Pfizer clinical trial has rattled the field of gene therapy for Duchenne muscular dystrophy, raising more questions about the regulatory standard used to approve a treatment from Sarepta Therapeutics, and complicating plans for other companies hoping to develop next-generation products.  Scientifically, Pfizer’s gene therapy did what it was supposed to do.

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ALiEM - Pharm Pearls

OCTOBER 21, 2024

A 5-year-old generally healthy fully immunized boy presented to the ED with worsening left ear redness, swelling, and tenderness that his family noticed the day before presentation. His family had also recently noticed an abrasion over that ear. The patient was on amoxicillin for strep throat, which was diagnosed a week before the onset of his symptoms and was improving.

Medical Schools 152

Medical Schools Immunization Immunity 152

PharmaVoice

OCTOBER 21, 2024

After initially declaring the shortage of Eli Lilly’s diabetes and weight loss drugs over, the FDA changed its mind and re-opened the door for GLP-1 compounders.

Compounding 147

Compounding Diabetes 147

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

Shifting blame to the victims of economic policy is an old trick by politicians. Now they’re using obesity to tackle joblessness In early 2023, Lars Fruergaard Jørgensen, chief executive of the Danish pharmaceutical company Novo Nordisk, and its UK corporate vice-president Pinder Sahota, met in Whitehall with the then health secretary Steve Barclay, England’s chief medical officer, Prof Chris Whitty, and various health and Treasury officials.

Documentation 110

Documentation Pharmaceutical Companies Pharmaceutical Companies 110

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STAT

OCTOBER 21, 2024

STAT is publishing this investigation in partnership with The Examination. Perham Gorji was a career government lawyer, helping to lead the Food and Drug Administration’s battle against tobacco and e-cigarettes.  He was there as the agency contemplated a ban on menthol cigarettes, and as vapes of all shapes and sizes flooded the market, hooking a new generation on nicotine.

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Express Pharma

OCTOBER 19, 2024

Over the past years, India has re-emerged as a hub for clinical research due to its cost-effective nature and evolving regulatory landscape. Simultaneously, the Indian pharma industry is exploring its options to move beyond manufacturing generics. The pharma industry has the potential for immense growth in India, however, ever-evolving regulations, rapidly transforming technology, and increasing healthcare demands necessitate the pharmaceutical sector to keep up with these emerging trends.

Drug Development 109

Drug Development Documentation 109

The Honest Apothecary

OCTOBER 20, 2024

One challenge that modern students of the Bible will encounter is that it presents a very different perspective on the way we should think about life. For example, the other day while scrolling through some social media accounts, I saw a post that simply said, “Maintain a very high opinion of yourself.” Clearly this insight […] The post The Bible’s Different Perspective appeared first on The Honest Apothecary.

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STAT

OCTOBER 21, 2024

It began with a burning pain in her right eye. At first, Elisabeth Cohen thought she’d gotten something in it. But the next day, as she was pushing her hair back on that side of her head, she noticed a blister near the hairline. She knew immediately what it was: shingles.  At the time, in 2008, Cohen was director of the Cornea Service at Wills Eye Hospital in Philadelphia.

Hospitals 201

Hospitals 201

pharmacy mentor

OCTOBER 20, 2024

As a pharmacy owner, choosing the right Patient Medication Record (PMR) system is one of the most critical decisions you’ll make for your business. A well-selected PMR system not only enhances the efficiency of your daily operations, but also significantly improves the level of care you provide to your patients. With the UK pharmacy landscape rapidly evolving, finding a PMR system that meets your specific needs and supports the growth of your pharmacy is more important than ever.

Medical Records 52

Medical Records Independent Pharmacies Customer Service Prescription Management 52

PharmaVoice

OCTOBER 21, 2024

PMRs are not new but drug developers can use AI to predict risk and manage costs earlier in studies.

Drug Development 130

Drug Development 130

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

PharmaTech

OCTOBER 20, 2024

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed recent advancements and current challenges in the development of large RNA therapeutics.

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STAT

OCTOBER 21, 2024

Does it make sense for a chain of drug stores to own a major health insurance company? That has been the existential question for CVS Health for six years, since its $70 billion acquisition of the massive insurer Aetna. The biggest pharmacy chain in the U.S. had already been moving beyond retail since its 2007 deal for pharmacy benefit manager Caremark.

Health Insurance Companies 192

Health Insurance Companies 192

Med Ed 101

OCTOBER 20, 2024

In this 10-question psychiatric Pharmacotherapy quiz, we cover antipsychotic use and bipolar pharmacotherapy. If you are looking for a practice exam for the BCPP (Board Certified Psychiatric Pharmacist) exam, you can find that here. If you are looking for comprehensive study guides on the BCPS, BCACP, BCGP, BCMTMS, or NAPLEX exams, feel free to check […] The post Free Psychiatric Pharmacotherapy Quiz appeared first on Med Ed 101.

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Pharmafile

OCTOBER 21, 2024

Wainzua (eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the European Union (EU) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). The drug will be used as a treatment for hereditary transthyretin-mediated amyloidosis in adult patients who have stage 1 or 2 polyneuropathy (commonly referred […] The post Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amylo

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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.

The Pharmacist

OCTOBER 21, 2024

IT suppliers are testing pharmacy access to GP records with some pharmacies using Cegedim Rx live in a pilot stage, it has been revealed. Speaking at the Pharmacy Show earlier this month, Tahmina Rokib, clinical lead at the clinical digital informatics, transformation directorate at NHS England (NHSE) said that Cegedim had been running a pilot […] The post Pharmacies piloting access to GP records appeared first on The Pharmacist.

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STAT

OCTOBER 20, 2024

Seaport Therapeutics, the startup launched earlier this year by the team behind Karuna Therapeutics, has raised another $225 million just six months after its most recent fundraising round. Seaport raised the Series B funds from General Atlantic, Foresite Capital, T. Rowe Price Associates, and other investors. The startup, which is based in Boston, is developing a new cohort of what executives hope will be faster-acting, more effective treatments for depression, anxiety, and other mental health

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The Honest Apothecary

OCTOBER 19, 2024

Can you start running after 50? Yes, you can. I was never much into running. Basketball was my game in high school. I only ran if there was a hoop at the other end of the court, or maybe a taco. Then I moved into a profession that initially had me standing and moving a […] The post Can You Start Running After 50? Yes! appeared first on The Honest Apothecary.

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BioPharma Dive

OCTOBER 21, 2024

Shares in the Boston-based biotech creator, which had a standout success in forming Karuna Therapeutics, trade around cash levels — a "huge value disconnect" its leaders are trying to bridge.

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The Pharmacist

OCTOBER 21, 2024

Almost two-thirds (62%) of pharmacy team members have reported a reduced ability to offer services or advice to patients because of staffing shortages, a survey by Community Pharmacy England (CPE) has revealed. Nearly all (95%) of pharmacy team members surveyed said that staff shortages had led to increased pressure on remaining staff, while 61% said […] The post Community pharmacies sound alarm over staffing shortages appeared first on The Pharmacist.

Community Pharmacies 61

Community Pharmacies 61

STAT

OCTOBER 21, 2024

WASHINGTON — Most executives at pharmaceutical companies haven’t directly donated to political candidates over the final stretch of the 2024 campaign. But those who have largely gave to Democrats.  A STAT review of contributions by CEOs of member companies and board members of the brand drug lobby PhRMA showed most executives just gave to their companies’ political action committees, if they gave at all.

Drug Pricing 171

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 171

pharmaphorum

OCTOBER 21, 2024

A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.

Diabetes 60

Diabetes 60

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

Becky Gittins calls for cosmetic firms to list ingredients in English, saying current labelling is ‘absolutely bonkers’ Cosmetic companies need to stop forcing people with food allergies to learn Latin to safeguard their health and display warnings written in plain English, according to an MP with a history of severe allergic reactions who is demanding a step change in how sufferers are treated.

Labelling 56

Labelling 56

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Pharmacy Management

Express Pharma

OCTOBER 21, 2024

Johnson & Johnson ‘s subcutaneous (SC) Tremfya (guselkumab) demonstrated strong results in the Phase III GRAVITI trial, marking a major breakthrough in the treatment of Crohn’s disease (CD). This patient-friendly regimen could enhance patient autonomy, improve adherence, and lead to better outcomes. The GRAVITI results position guselkumab as a significant new option in CD, says GlobalData.

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STAT

OCTOBER 21, 2024

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine.  Sign up  to get it in your inbox every Monday. The ‘#1 PRIORITY’ The emails from inside a physician practice owned by UnitedHealth Group sounded cheery, but were all business.

Drug Development 165

Drug Development 165

Pharmaceutical Commerce

OCTOBER 21, 2024

In this video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, explains the top mistakes healthcare organizations make when building and maintaining their software.

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FDA Law Blog: Biosimilars

OCTOBER 20, 2024

By Larry K. Houck — Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead! Bring out your dead!” in the 1975 comedy classic, Monty Python and the Holy Grail. The Drug Enforcement Administration (“DEA”) would do well to update that phrase as “Bring out your meds! Bring out your meds!” to call attention to the 26th National Prescription Take Back Day.

Controlled Substances 59

Controlled Substances 59

Express Pharma

OCTOBER 20, 2024

B&R Industrial Automation has introduced the X20 Drives, designed for automating machine components such as conveyors and adjustment axes. These drives provide a wide range of motion options in a compact format, suitable for controlling motors ranging from a few watts up to 1 kW. The drives aim to deliver cost-effective and energy-efficient solutions for various automation needs.

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STAT

OCTOBER 21, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, calls, and deadlines has predictably returned. To cope, we are firing up the coffee kettle in the Pharmalot cafeteria and brewing another cup of stimulation. Our choice today is the seasonal pumpkin spice.

Vaccines 165

Vaccines Communication 165

BioPharma Dive

OCTOBER 21, 2024

The medicine, which Novo sells as Rybelsus, cut the risk of cardiovascular complications by 14% when added to standard therapies in people with diabetes and heart disease.

Diabetes 57

Diabetes 57

pharmaphorum

OCTOBER 20, 2024

At its second attempt, Astellas won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for claudin 18.

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Express Pharma

OCTOBER 20, 2024

Alembic Pharmaceuticals (Alembic) has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP in 120 mg, 180 mg, and 240 mg formulations. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, manufactured by Allergan Sales LLC (Allergan).

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Dosage Labelling 59

STAT

OCTOBER 21, 2024

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.  Morning! Today, we discuss why disappointing data from Pfizer’s Duchenne muscular dystrophy trial might spell trouble for others developing gene therapies for the condition.

Drug Pricing 159

Drug Pricing Drug Development 159