STAT

JUNE 20, 2024

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy. On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.

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Documentation 363

PharmaVoice

JUNE 18, 2024

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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BioPharma Dive

JUNE 17, 2024

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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The Pharmacist

JUNE 21, 2024

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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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.

STAT

JUNE 21, 2024

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.

Diabetes 361

Diabetes 361

PharmaVoice

JUNE 20, 2024

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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The Pharmacist

JUNE 20, 2024

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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Community Pharmacies 125

STAT

JUNE 20, 2024

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.

Drug Development 364

Drug Development 364

PharmaVoice

JUNE 20, 2024

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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Pharmaceutical Technology

JUNE 17, 2024

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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Vaccines 145

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EMCrit Project

JUNE 17, 2024

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STAT

JUNE 20, 2024

In a surprise move, Doctors Without Borders is closing down its access-to-medicines campaign, which has been credited with ensuring needed drugs and vaccines have been made available to countless patients in low-income countries around the world. The organization plans to close its campaign by the end of this year and create a new effort devoted to access to products for health care.

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Vaccines 363

pharmaphorum

JUNE 19, 2024

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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The Pharmacist

JUNE 20, 2024

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.

Community Pharmacies 118

Community Pharmacies 118

Pharmafile

JUNE 19, 2024

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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STAT

JUNE 20, 2024

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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pharmaphorum

JUNE 20, 2024

Discover how AI-powered analytics are revolutionising life sciences marketing. Learn how to leverage these cutting-edge technologies to drive insights and success in the industry.

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Express Pharma

JUNE 21, 2024

Headquartered in Kandivali, Mumbai, Adam Fabriwerk inaugurated its new dedicated testing facility at Plot No. D-57, Ambad, MIDC on June 20 2024. The state-of-the-art facility specialises in Factory Acceptance Testing (FAT), capable of integrating and testing vessels up to 250,000 litres. Established in 1982, Adam Fabriwerk specialised in customised process system solutions for Pharmaceutical and Bio-pharmaceutical industries.

Pharmaceutical Companies 113

Pharmaceutical Companies Pharmaceutical Companies 113

The Pharmacist

JUNE 21, 2024

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

Community Pharmacies 108

Community Pharmacies 108

STAT

JUNE 20, 2024

A coalition of researchers, historians, and journalists is urging that major scientific publishers, including Elsevier and Springer, retract the racist articles of an academic known — and sometimes lauded for — a long career espousing ideas of racial superiority and eugenics. The call for retraction, made Thursday in a First Opinion published in STAT, focuses on hundreds of papers published by the late Richard Lynn of the University of Ulster, who has described “the decay of

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pharmaphorum

JUNE 19, 2024

Discover the importance of data in the process of commercialising drugs for rare diseases and how it plays a critical role in advancing treatment options for patients. Learn more about orphan diseases and drug development.

Drug Development 118

Drug Development 118

Express Pharma

JUNE 19, 2024

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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Diabetes 112

Drug Patent Watch

JUNE 19, 2024

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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STAT

JUNE 21, 2024

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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pharmaphorum

JUNE 18, 2024

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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Express Pharma

JUNE 19, 2024

Syngene International, an integrated research, development and manufacturing services company, announced the second cohort of the scholarship, mentoring and industry orientation for women in STEM (science, technology, engineering, and mathematics) in collaboration with the Research and Innovation Circle of Hyderabad (RICH). This program offers scholarships to women studying STEM subjects at tier two and three institutions across various regions of the country to enable them to gain industry exp

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BioPharma Dive

JUNE 20, 2024

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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STAT

JUNE 19, 2024

Priscilla Agnew-Hines will never be able to forget that day in early 2020. On March 26, just weeks after Covid-19 officially became a global pandemic, her son died from an overdose. Larry, 41, was a chef, a drummer for his gospel church and the son who challenged Priscilla’s barbecue skills during summer cookouts. He also struggled with addiction.

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pharmaphorum

JUNE 18, 2024

Learn about the innovative approach of using neuroplastogens, including psychedelics, to treat neurological diseases. Explore the potential benefits and risks of this novel treatment method.

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Express Pharma

JUNE 20, 2024

Three months after getting the coveted Good Manufacturing Practices (GMP) approval from the United Nations International Children’s Emergency Fund (UNICEF), Venus Remedies has been given a tender by UNICEF for supplying ceftriaxone (1gm), a beta-lactam antibiotic, in dry powder form. Ceftriaxone dry powder is an important drug in Venus Remedies’ extensive antibiotic portfolio.

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Drug Patent Watch

JUNE 17, 2024

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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Biosimilars 110

STAT

JUNE 18, 2024

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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pharmaphorum

JUNE 21, 2024

Explore the latest advancements in genomics and sequencing technologies, and learn how next-generation data management tools are transforming genomic research and applications in this new genomic frontier.

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Express Pharma

JUNE 17, 2024

The recent results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab demonstrated an improvement in progression-free survival (PFS) and showed a favourable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

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Pharma Times

JUNE 20, 2024

The progressive neurodegenerative condition affects more than ten million people worldwide

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