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. .

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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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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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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.

Drugs 354
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How close are we to getting a male contraceptive?

Pharmaceutical Technology

With advances in clinical studies evaluating male contraceptives, and laws restricting abortion access after Roe v. Wade was overturned in the US, male contraception has been getting increased attention from the public. In June, favourable Phase I safety results from a study that evaluated two progestogenic androgen pills were reported at the annual meeting of the Endocrine Society in Atlanta, Georgia.

Hormones 306

More Trending

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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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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 353
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No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.

Drugs 299
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Are online health searches private?

World of DTC Marketing

A Gizmodo investigation into some of the nation’s biggest data brokers found more than two dozen promoting access to datasets containing digital information on millions of pregnant and potentially pregnant people across the country. At least one of those companies also offered an extensive catalog of people using birth control targeted by more restrictive states, But is this true?

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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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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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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 305
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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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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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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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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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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 305
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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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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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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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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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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.

Medicine 313
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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.

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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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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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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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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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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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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.

Drugs 119
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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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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 273
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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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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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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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Lilly takes long view on Alzheimer’s drug hopeful as FDA starts expedited review

Bio Pharma Dive

The pharma disclosed Thursday the FDA had accepted its application for donanemab, starting a six-month assessment for potential accelerated approval.

Drugs 301