Thu.Aug 03, 2023

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‘Ancient DNA’ tools and 23andMe database uncover African American ancestries of thousands

STAT

New research that combines technology to sequence “ancient DNA” with direct-to-consumer genetic testing has identified tens of thousands people alive today who are genetically linked to enslaved and free African Americans who worked at a once-thriving Maryland iron forge in the late 18th and early 19th century. The findings, reported Thursday in Science , are a step toward restoring difficult-to-obtain ancestry knowledge to African Americans who descended from enslaved people, whos

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New Alzheimer’s treatments are the tip of the iceberg in a long-stymied area of medicine

PharmaVoice

A smaller player in the Alzheimer’s space, Prothena is approaching the next phase of treatments, including prevention and clinical trial evolution.

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Trending Sources

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STAT+: Alarmed by popularity of Ozempic and Wegovy, insurers wage multi-front battle

STAT

Patients are bracing for “D-Day,” the date their insurance companies will stop covering the drugs. Doctors are getting letters from insurance investigators discouraging new prescriptions. And pharmacies are being told by insurers to check for a specific diagnosis when filling prescriptions. It’s a charge on all fronts by insurance companies to contain the spiraling costs of a new class of weight loss-inducing drugs, the GLP-1s.

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Is the COVID-19 market crashing?

PharmaVoice

Pfizer’s recent earnings report could foretell major trouble in the market for pandemic products.

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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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‘Shocking’ heat waves persist through August as federal officials warn of far-ranging health risks

STAT

WASHINGTON — An already record-setting summer heat wave will continue through August and will put more than 51 million Americans at risk of health impacts, according to new data from federal health officials. Most of those vulnerable people live in 26 states and are expected to have at least five extreme heat days this month. Among the highest-risk counties, roughly 45% have high levels of uninsured adults and children and 18% have high senior populations, according to a relatively new mo

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New European monograph for Cannabis flower adopted

European Pharmaceutical Review

The Danish Medicines Agency (Lægemiddelstyrelsen) has announced the European Pharmacopoeia Commission has adopted a new European monograph, which describes quality requirements for the raw material Cannabis flower. EPC’s new Cannabis flower monograph The new monograph Cannabis flower (Cannabis flower, monograph 3028) will be available next year in January 2024 with publication of the supplement 11.5.

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Sarepta offers early look at closely watched gene therapy launch

BioPharma Dive

One patient received its Duchenne gene therapy, Elevidys, this week and a handful more could follow shortly, surprising some analysts and raising near-term sales expectations.

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Stress in childhood linked to physical and cognitive problems in older age, according to new study

STAT

Stressful experiences during childhood could have more far-reaching effects than previously thought, contributing to issues with daily tasks like getting dressed or preparing meals in older age, according to a new national analysis. The authors of the study , published Wednesday in the Journal of General Internal Medicine, say it is the first to link adverse childhood experiences (ACEs) with objective measures of functional impairment in older U.S. adults.

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Total community pharmacy workforce drops 6% in a year

The Pharmacist

The total full-time equivalent (FTE) community pharmacy workforce has fallen by 6% in a year period, despite the overall number of pharmacists remaining ‘almost constant’, latest results from NHS England’s Community Workforce Survey 2022 has shown. Vacancy rates among pharmacists are up 16%, with indications that locum pharmacists are being used more and working fewer […] The post Total community pharmacy workforce drops 6% in a year appeared first on The Pharmacist.

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CDC advisers endorse RSV monoclonal antibody for infants, high-risk young children

STAT

A panel of advisers to the Centers for Disease Control and Prevention unanimously voted Thursday to recommend wide use among infants and some high-risk children of an antibody designed to protect against RSV , the country’s leading cause of infant hospitalization. The 10-0 recommendation from the Advisory Committee on Immunization Practices now goes to CDC Director Mandy Cohen, who is expected to accept it.

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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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Community pharmacist vacancies worst in northern England, finds NHSE survey

The Pharmacist

Integrated care boards (ICBs) in northern England had the highest number of full-time-equivalent (FTE) community pharmacist vacancies last autumn, according to the results of a survey released today by NHS England. Greater Manchester ICB had the highest number of FTE community pharmacist vacancies (180), followed by North East and North Cumbria ICB at 154.

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Opinion: Former Sen. Max Baucus: Breakthrough Alzheimer’s drugs are out of reach for many in rural states like Montana

STAT

New treatments are delaying the progression of Alzheimer’s disease , giving people aging with memory decline the potential to live independently longer. But this benefit can only be fully realized if we ensure equitable access to care. Medicare’s policies are creating obstacles that make it more difficult for patients who are highly likely to benefit to obtain access to diagnosis and treatment.

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Granules Pharma completes USFDA PADE Inspection with zero observations

Express Pharma

Granules India announced that Granules Pharmaceuticals located in Chantilly, Virginia, US has successfully completed the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection for all its entities in the US, including Granules India. The inspection was closed with zero observations. The inspection was conducted at Granules Pharmaceuticals from July 31, 2023 to August 03, 2023.

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STAT+: Study proposing microbiome-based cancer diagnostic comes under fire

STAT

Micronoma, a San Diego-based biotech startup, was founded on the idea that signatures from microbes that colonize tumors could lead to a blood test to detect cancer. The hypothesis was based on a high-profile Nature paper , published in 2020, that suggested these microbes are consistently found in tumors, and that they create such specific signatures they could be used to identify cancer types with nearly 100% accuracy.

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Pharma Marketing in the Age of AI: A New Era Begins

PharmExec

This podcast companion to our roundtable feature explores the transformative power of AI in pharmaceutical marketing, six months after the arrival of ChatGPT.

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STAT+: Vertex faces renewed calls to widen access to its cystic fibrosis medicines in poor countries

STAT

Several Latino advocacy groups and more than 100 clinicians from dozens of countries are lending their voices to an expanding campaign to pressure Vertex Pharmaceuticals to widen access to its cystic fibrosis medications. In separate letters sent to the company in recent weeks, the health care providers and advocates maintained there is a notable disparity in access to Vertex medicines between mostly wealthy nations and low- and middle-income countries.

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Waters Launches SEC Columns for Gene Therapy Applications

PharmaTech

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

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TytoCare raises $49 million to build out AI-enhanced chronic care

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Amgen says KRAS drug met goal in late-stage colon cancer trial

BioPharma Dive

The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.

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STAT+: White House drug shortage task force held rare in-person meeting with industry

STAT

WASHINGTON — A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.

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Moderna looks to new COVID booster, RSV shot to curb falling sales

BioPharma Dive

Sales of the company’s COVID-19 vaccine plummeted 94% year over year. But executives believe newer products can help revenue rebound.

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STAT+: Pharmalittle: Patients brace for insurance decisions on weight loss drugs; Indian authorities find multiple problems at pharma plants

STAT

Hello, everyone, and how are you today? Cloudy skies are hovering this morning over the Pharmalot campus, where things have settled down now that the short person has left for an institution of higher learning and the official mascots have assumed their formal snoozing positions. As for us, we are dutifully concocting a few needed cups of stimulation as we dig in for another busy day.

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Generative AI has the potential to revolutionise drug discovery

Pharmaceutical Technology

The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.

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STAT+: Alnylam reports growth in sales of rare disease treatments

STAT

Alnylam Pharmaceuticals said Thursday that sales of its treatments for rare diseases grew 43% in the second quarter compared to the year-ago period, as the biotech prepares for a key meeting with the Food and Drug Administration in September. Net product sales in the quarter were $306 million, led by Amvuttra, the company’s RNAi treatment for hereditary ATTR, with sales of $132 million, exceeding Wall Street forecasts.

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Pharma firms with Rs 250 cr plus turnover must adopt GMP within six months: Mandaviya

Express Pharma

Pharma companies with an annual turnover of over Rs 250 crore will have to mandatorily adopt Good Manufacturing Practices (GMP) within six months, said Mansukh Mandaviya, Union Health Minister said on Wednesday. The minister informed that companies with a turnover of less than Rs 250 crore will have to adopt GMP within 12-months. The companies failing to follow the timelines may be penalised, he added.

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Listen: Biotech layoffs, eye drug drama, & gene therapy milestones

STAT

Can biotech startups survive a downturn? Is Covid-19 a good business? And when did ophthalmology get so dramatic? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss how some recent layoffs and a reverse merger mean for biotech in 2023. We’ll also discuss the latest news in the life sciences, including a dramatic saga in ocular medicine, the volatile business of Covid-19, and some major milestones in gene therapy.

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Theriva Biologics reveals positive VCN-01 study results

Pharma Times

The candidate is a stroma-degrading oncolytic adenovirus for the treatment of pancreatic cancer - News - PharmaTimes

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STAT+: Startup Celsius cuts 75% of staff ahead of first trial start for IBD drug

STAT

Launching your first clinical trial is the type of announcement most biotech executives eagerly anticipate, hoping to celebrate with employees. But for Celsius Therapeutics CEO Tariq Kassum, it’s proving to be more difficult than he anticipated. That’s because in recent days, Celsius, based in Cambridge, Mass., has been forced to conduct a round of layoffs, sources told STAT.

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Sano Genetics receives £330k grant for platform to support at-risk patients of neurodegenerative diseases

Outsourcing Pharma

At-risk families of patients diagnosed with motor neurone disease (MND), better known in the US as amyotrophic lateral sclerosis (ALS) will now have access to genetic sequencing thanks to a financial award from Innovate UK.

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Metrion Biosciences boosts hERG screening service 

Pharma Times

MHRA has made the company a member of the UK GLP compliance monitoring programme - News - PharmaTimes

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New research published in Science highlights potential of a naturally occurring bacterium to help eradicate malaria

World Pharma News

Research published in Science today shows that a naturally occurring bacterium discovered by GSK scientists - Delftia tsuruhatensis Tres Cantos 1 (TC1) - could be the basis for new anti-malarial interventions. Studies done in collaboration at the Johns Hopkins Malaria Research Institute at Johns Hopkins Bloomberg School of Public Health show that the bacterium can significantly reduce the malaria parasite load in both the mosquito midgut and salivary glands indicating the potential of TC1 to inh

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Seattle institute lands $18m funding to develop RNA vaccine for chikungunya

Pharmaceutical Technology

AAHI is developing a novel RNA vaccine that overcomes manufacturing and storage limitations to increase accessibility.

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Scripta, Mark Cuban Cost Plus Drug Company Partner Up on Drug Price Transparency

Pharmaceutical Commerce

The agreement provides Scripta patients with another option when purchasing medication.

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ABM Therapeutics receives FDA orphan drug status for GBM therapy

Pharmaceutical Technology

ABM Therapeutics has received ODD from the US FDA for ABM-1310 to treat patients with glioblastoma (GBM) harbouring the BRAF V600 mutation.

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PacBio builds in short-read sequencing with $110m Apton buy

pharmaphorum

PacBio builds in short-read sequencing with $110m Apton buy Phil.

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