Sat.Jul 30, 2022 - Fri.Aug 05, 2022

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Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

Drugs 363
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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Should you take a job with a biotech startup?

World of DTC Marketing

At first, the opportunity to join a small biotech startup sounds excellent. Smaller staff usually means less bureaucracy and being on the ground floor of a potentially financially rewarding career. But there are risks. Leaving the comforts of a big company with a calcified infrastructure, laser-focused job roles, well-established SOPs, deeper pockets, and excellent job security for the scramble and chaos of a younger company isn’t for everyone. .

Trials 242
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STAT+: Hospitals win higher payments from Medicare after lobbying campaign

STAT News

Hospitals secured significantly larger payments from Medicare for 2023, after months of lobbying centered around arguments that inflation and the pandemic have crippled hospitals’ finances. The increase to the hospital “ market basket update ” — a key metric that determines the price growth of hospital goods and services — is the largest from Medicare since 1998, the Centers for Medicare & Medicaid Services said in the final rule that came out Monday evenin

Marketing 145
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives.

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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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Millions of Americans have long COVID. Many of them are no longer working

NPR Health - Shots

An estimated 4 million workers in the U.S. are struggling to work due to debilitating symptoms from long COVID. The government is urging employers to provide accommodations to keep them on the job.

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How a small UK biotech ended up in Gilead’s hands

Bio Pharma Dive

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research.

Research 352
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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year. That was followed by Europe, which saw a 0.6 year-on-year percentage point change in machine learning roles.

Marketing 264
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U.S. declares monkeypox outbreak a public health emergency

STAT News

The Biden administration declared the ongoing monkeypox outbreak a public health emergency on Thursday, a move that comes amid growing case counts and a groundswell of criticism over the way the administration has handled the outbreak. The declaration comes as news stories chronicle a series of missteps in the administration’s response to the outbreak, from its failure to rapidly divert vaccine stockpiled as a hedge against bioterrorism to combat spread of monkeypox to its slow decision-m

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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States look to regulate weed alternatives like delta-8 as sales explode

NPR Health - Shots

Delta-8 is a hemp product designed to get users high, but misleading labels or added chemicals have caused people to get sick. And a lack of federal regulation or guidance has states stepping in.

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AbCellera inks another venture partnership, this time with Atlas

Bio Pharma Dive

One week after striking a deal with Versant, the antibody specialist is teaming up with Atlas to provide drug candidates to an undisclosed startup backed by the biotech investor.

Antibody 299
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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

Engineer 262
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The campaign to rename monkeypox gets complicated

STAT News

Since the earliest days of the current global monkeypox outbreak, scientists and public health authorities have been calling for the disease to be renamed, arguing that it has racist overtones and carries a stigma that will hinder efforts to stop its spread. In mid-June, World Health Organization Director-General Tedros Adhanom Ghebreyesus said his agency agreed, and would be working with partners to rename the virus itself, the disease it causes, and the two clades or strains of the virus, each

Scientist 138
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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How many animal species have caught COVID? First global tracker has (partial) answers

NPR Health - Shots

Just as human counts are incomplete, so are animal counts. But the first worldwide compilation of animal cases is a start at understanding the extent of human-to-animal transmission, scientists say.

Scientist 141
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Concert to seek approval for hair loss drug after second study success

Bio Pharma Dive

The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share.

Drugs 298
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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

Sales 246
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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Voters in Kansas decide to keep abortion legal in the state, rejecting an amendment

NPR Health - Shots

In the first test of its kind since the Dobbs ruling, Kansas voters have decided not to amend the state constitution, keeping abortion legal in the state — for now.

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IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Bio Pharma Dive

Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.

Licensing 306
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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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Medical Imaging in Clinical Trials with Elizabeth Dalton

Clinical Trial Podcast

In this episode, I’m excited to talk about medical imaging in clinical trials. . We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more. The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Opinion: Life hacks from India on how to stay cool (without an air conditioner)

NPR Health - Shots

Heat wave researcher Gulrez Shah Azhar grew up in Uttar Pradesh, India, without an A/C unit. He shares tips on how to deal with the heat — including wearing a wet scarf around your neck.

Research 137
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FDA approves AstraZeneca, Daiichi drug in breast cancer first

Bio Pharma Dive

Enhertu is the first targeted treatment cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.

Marketing 241
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Patients seeking novel weight loss drugs find a ‘wild west’ of online prescribers

STAT News

Briana Lawson was ready to knock her diabetes into remission. For years, the 47-year-old health care consultant had treated her high blood sugar with metformin. But to avoid a lifetime of medication, she knew she’d need to lose weight. She’d tried fad diets, Weight Watchers, Nutrisystem, and had even considered surgery when the results didn’t stick.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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They lost Medicaid when paperwork was sent to a pasture, signaling the mess to come

NPR Health - Shots

Tennessee expects to soon disenroll about 300,000 people from Medicaid. But families like the Lesters have been entangled in bureaucracy and clerical mistakes, causing them to unfairly lose coverage.

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AbbVie, targeting a well-known protein family, expands a partnership into neuroscience

Bio Pharma Dive

It’s the second deal in as many years between AbbVie and Sosei Heptares, which together have been trying to develop drugs that target so-called G protein-coupled receptors.

Protein 268
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Governments and pharma relationships and implications for antimicrobial resistance

Pharmaceutical Technology

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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STAT+: ‘How can you not be excited?’: AI experts share enthusiasm about its future in health care

STAT News

While the adoption of artificial intelligence in health care has been slow and bumpy at times, three academic AI experts, from Emory, Stanford, and the University of Michigan, spoke optimistically about its future applications in medicine, during a virtual panel discussion Wednesday with STAT’s National Technology Correspondent Casey Ross. They discussed how to integrate AI into clinical workflows with shifting patient populations, and strategies to ensure the technology’s performa

Medicine 119
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.