Sat.Jun 15, 2024 - Fri.Jun 21, 2024

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STAT+: Vertex reports positive results in stem cell trial for type 1 diabetes

STAT

ORLANDO — Twelve people with type 1 diabetes who received a therapy derived from stem cells were able to produce enough of their own insulin to maintain healthy blood glucose levels 90 days later, Vertex Pharmaceuticals said Friday. All but one reduced or eliminated the need to inject insulin over those three months and three people followed for one year no longer needed to inject insulin at all.

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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’

PharmaVoice

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

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Duchenne approval exposes FDA rift over Sarepta gene therapy

BioPharma Dive

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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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+: Gilead’s twice-yearly antiviral protected women from HIV infection in large trial

STAT

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

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NIH-funded trials fall flat on diversity goals

PharmaVoice

Many clinical trials aren’t meeting enrollment inclusion checkpoints — and some aren’t even setting targets, according to a recent OIG report.

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Pharmacists with a disability: Standing Up for Sitting Down campaign

The Pharmacist

When pharmacists with a disability told the Pharmacists’ Defence Association (PDA) they were having problems with suitable adjustments in their workplace, a campaign was launched to raise awareness of what employers need to consider. Liz Larkin reviews the issues. When members of the PDA’s Ability Network named their campaign against disability discrimination, ‘Standing Up for […] The post Pharmacists with a disability: Standing Up for Sitting Down campaign appeared first on The Pharmacist

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Supreme Court outlawed segregation of disabled people 25 years ago. But change has come slowly

STAT

As a toddler, Veronica Ayala loved Fridays. At 5 o’clock sharp, her mom whisked her away from the grim Moody State School for Cerebral Palsied Children for a 48-hour reprieve. Ayala’s house was mere minutes away, but the doctors insisted that she had to live at the Galveston, Texas institution during the week so she could learn how to walk.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

PharmaVoice

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

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PulmCrit: Bilevel Sequence Intubation (BSI) – The new standard

EMCrit Project

introduction Bilevel Sequence Intubation (BSI) refers to initiation of noninvasive bilevel positive pressure ventilation with a backup rate prior to intubation (either using a BiPAP machine or a full-featured mechanical ventilator). BSI is distinct from traditional rapid sequence intubation (RSI), since BSI involves the delivery of machine-initiated, pressure-controlled breaths following administration of sedation and paralytics. […] EMCrit Project by Josh Farkas.

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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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Two-thirds of pharmacies slash opening hours amid funding pressures

The Pharmacist

Almost two-thirds of pharmacies in England have decreased their opening hours since 2015, latest analysis from the National Pharmacy Association (NPA) has suggested. The research, based on a sample of 110 pharmacies, found that on average there has been a 6.1-hour (10%) reduction in opening hours for every pharmacy. The findings come as up to […] The post Two-thirds of pharmacies slash opening hours amid funding pressures appeared first on The Pharmacist.

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Opinion: Long Covid feels like a gun to my head

STAT

I have spent my career studying infectious diseases that fall under the heading of neglected tropical diseases. Now I have a neglected disease — long Covid — an incurable (for now and for me) disease. As a medical anthropologist working in global health, I thought I understood the despair of poor health. I didn’t. I join 7% of the U.S. adult population — or about 18 million Americans — who have experienced long Covid.

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Blood test could spot Parkinson’s years earlier

pharmaphorum

An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments

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First patient dosed in Assembly Biosciences’ phase 1b trial for hepatitis B treatment

Pharmafile

Assembly Biosciences has announced that the first participant has been dosed in its phase 1b trial of ABI-4334, the company’s next-generation capsid assembly modulator (CAM) candidate currently being developed for the treatment of chronic hepatitis B virus (HBV) infection. The post First patient dosed in Assembly Biosciences’ phase 1b trial for hepatitis B treatment appeared first on Pharmafile.

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FDA lifts hold on PTC Huntington’s disease trial

BioPharma Dive

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

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Inside Anthony Fauci’s ‘On Call’: 9 health and science takeaways from the memoir of America’s most famous doctor

STAT

Anthony Fauci spent 40 years in the top echelons of government. It was no accident. To read the forthcoming memoir by the country’s former top infectious disease expert, “On Call: A Doctor’s Journey in Public Service,” a copy of which was obtained by STAT, is to get a sense of his finesse while advising seven presidents. He strove, he writes, to speak with complete candor and stay out of politics, while remaining strategic in pushing for policies he considered vital t

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Paul Rees: 'We need to keep the pressure up'

The Pharmacist

The Pharmacist caught up with National Pharmacy Association (NPA) chief executive Paul Rees during today's ‘day of action’ to save community pharmacies, at a branch of Green Light Pharmacy in central London. Paul, tell us how the Save Our Pharmacies day of action campaign has been going today? For the first time ever, community pharmacies […] The post Paul Rees: 'We need to keep the pressure up' appeared first on The Pharmacist.

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12 Questions with Caroline Phillips

pharmaphorum

Dive into an exclusive Medscape interview with HCP Caroline Phillips as she shares her insights, experiences, and advice. Discover the key takeaways that can benefit your medical practice.

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Twice-yearly shots of Gilead HIV drug effective in large prevention study

BioPharma Dive

Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.

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New Merck pneumococcal vaccine wins FDA approval

STAT

The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18 and older. The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases.

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Life sciences industry forecasts significant revenue from connected health within 5 years

Express Pharma

A substantial 63 per cent of life sciences companies, including those in biopharma, currently have connected health products on the market or in development. Regardless of their product development stage, these organisations predict that connected health will generate over 20 per cent of their revenue within five years. Yet a lack of essential data capabilities could hamper this ambition.

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Uncovering Lucrative Low-Competition Generic Drug Opportunities

Drug Patent Watch

In the ever-evolving pharmaceutical landscape, savvy businesses are constantly on the lookout for untapped markets and lucrative opportunities. One area that has garnered significant attention is the realm of low-competition generic drugs.

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Obesity drug from Zealand shows potential in early trial

BioPharma Dive

Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.

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Change Healthcare to begin notifying patients that cyberattack compromised their private info

STAT

Change Healthcare is beginning the process of notifying a “substantial proportion” of Americans that their private information, such as Social Security numbers and medical diagnoses, was compromised in the cyberattack that brought portions of the U.S. health care system to a halt earlier this year. On Thursday, Change will begin to notify health care providers, insurance companies, and other customers that their patients’ data was stolen in the company’s February cybe

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NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production

Outsourcing Pharma

Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).

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The Intricate Journey of Drug Patents: From Filing to Expiry

Drug Patent Watch

In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry.

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FDA approves AbbVie’s Skyrizi for UC treatment

Pharmafile

AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and moderate to severe Crohn’s disease. The post FDA approves AbbVie’s Skyrizi for UC treatment appeared first on Pharmafile.

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Vaping is just as good as Chantix at helping people quit cigarettes, new study finds

STAT

WASHINGTON — E-cigarettes were about as effective at helping people quit smoking as the gold-standard pharmaceutical drug, varenicline, according to a clinical trial published Monday in JAMA Internal Medicine. The trial randomized 458 people who smoked daily and wanted to quit to receive either a nicotine-containing e-cigarette and placebo tablets, varenicline and an e-cigarette without nicotine, or a placebo tablet and a nicotine-free e-cigarette for 12 weeks.

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AI and real-world data integration: Transforming clinical trials and drug development - panel at DIA Global

Outsourcing Pharma

During a panel discussion held at DIA Global in San Diego this week, which was moderated by Peter Wahl, industry experts delved into the integration of real-world (RW) data and advanced technologies to accelerate drug development.

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Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies

Drug Patent Watch

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

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Bayer receives Breakthrough Therapy designation in China for BAY 2927088

World Pharma News

Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy designation for BAY 2927088, a potential new targeted therapy for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC), whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

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Substance use experts are sounding the alarm on another addiction: gambling

STAT

LAS VEGAS — Downstairs was a sensory overload: Roulette wheels spun, slot-machine chimes rang, and dealers hurried to scoop up stacks of casino chips resting in front of busted blackjack hands. Many gamblers held a drink in one hand and a cigarette in the other.  It was perhaps a strange setting for a conference about substance use treatment.

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Abortion pill ruling offers measure of relief for FDA, biotech

BioPharma Dive

One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

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Maximizing ROI with Branded Generics: A Comprehensive Guide

Drug Patent Watch

Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point. Branded generics can be an attractive option for both consumers and pharmaceutical companies, offering cost savings while leveraging brand recognition.

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Public support 'Save Our Pharmacies' petition with over 100k signatures

The Pharmacist

A cross-sector petition to ‘save’ community pharmacies reached over 100,000 signatures even before yesterday’s ‘day of action’, during which even more members of the public were invited to sign. The National Pharmacy Association (NPA) reported ‘hundreds of signatures being collected at pharmacies across the four nations each day’, which, when combined with signatures collected online, […] The post Public support 'Save Our Pharmacies' petition with over 100k signatures appeared fi