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 21, 2024

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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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.

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Diabetes 363

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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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

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

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 121

EMCrit Project

JUNE 17, 2024

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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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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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

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.

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Community Pharmacies 114

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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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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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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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

BioPharma Dive

JUNE 20, 2024

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

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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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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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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

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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pharmaphorum

JUNE 17, 2024

Discover how leading tech giants such as Amazon, Google, Apple, and Microsoft are shaping the future of public health diagnostics through MedTech innovations. Explore the potential impact on healthcare and stay informed on the latest developments.

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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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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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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.

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Pharmaceutical Companies Pharmaceutical Companies 113

pharmaphorum

JUNE 17, 2024

Explore the impact and influence of trending health information, like Ozempic and the Eddy Effect on platforms like TikTok, through conversation data analysis. Learn more about these trends and their implications.

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STAT

JUNE 21, 2024

WASHINGTON — A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government.

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Outsourcing Pharma

JUNE 18, 2024

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 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

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Community Pharmacies 104

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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STAT

JUNE 20, 2024

The Food and Drug Administration on Thursday approved Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy, for nearly all patients with the fatal muscle-wasting disease, dramatically expanding the initial, narrow authorization handed down last year. The decision will likely be greeted by many families and doctors as a turning point in the fight against the muscle-wasting disease, even if it’s not nearly the seismic shift some had hoped for just a couple of years ago.

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Pharmafile

JUNE 20, 2024

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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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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pharmaphorum

JUNE 18, 2024

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

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Vaccines 111